Pub Date : 2025-01-12Epub Date: 2024-11-29DOI: 10.1016/j.vaccine.2024.126562
Paul D Kasaija, Fredrick Kabi, Jimmy Semakula, Ivan Kyakuwa, Marinela Contreras, Gabriela de la Fuente, Justus Rutaisire, Swidiq Mugerwa, Christian Gortázar, José de la Fuente
After approval of the Subolesin-based anti-tick vaccine in Uganda, we completed a one-year follow-up evaluation study. The results showed significantly 2.1-5.0-fold higher anti-SUB IgG antibody titers in vaccinated cattle in Mbarara and Maruzi with vaccine effectiveness higher than 95 %. In Mbarara, total number of ticks were 0.8-fold lower in vaccinated cattle with a negative correlation tendency between anti-SUB antibody titers and tick counts. The CCHFV-seropositive cattle significantly decreased in 40 % in SUB-vaccinated animals with a significant positive correlation between CCHFV-seropositive cattle and the total number of ticks per animal and a negative correlation tendency between anti-SUB antibody titers and CCHFV-seropositive cattle. A boosting vaccine dose yearly after primary vaccination with three doses is sufficient to maintain protective antibody titers against ticks and tick-borne diseases affecting human and animal health. These results are relevant for implementation of anti-tick Subolesin-based vaccines in Uganda and other countries in Sub-Saharan Africa.
{"title":"One-year follow-up evaluation of approved Subolesin anti-tick vaccine in Uganda.","authors":"Paul D Kasaija, Fredrick Kabi, Jimmy Semakula, Ivan Kyakuwa, Marinela Contreras, Gabriela de la Fuente, Justus Rutaisire, Swidiq Mugerwa, Christian Gortázar, José de la Fuente","doi":"10.1016/j.vaccine.2024.126562","DOIUrl":"10.1016/j.vaccine.2024.126562","url":null,"abstract":"<p><p>After approval of the Subolesin-based anti-tick vaccine in Uganda, we completed a one-year follow-up evaluation study. The results showed significantly 2.1-5.0-fold higher anti-SUB IgG antibody titers in vaccinated cattle in Mbarara and Maruzi with vaccine effectiveness higher than 95 %. In Mbarara, total number of ticks were 0.8-fold lower in vaccinated cattle with a negative correlation tendency between anti-SUB antibody titers and tick counts. The CCHFV-seropositive cattle significantly decreased in 40 % in SUB-vaccinated animals with a significant positive correlation between CCHFV-seropositive cattle and the total number of ticks per animal and a negative correlation tendency between anti-SUB antibody titers and CCHFV-seropositive cattle. A boosting vaccine dose yearly after primary vaccination with three doses is sufficient to maintain protective antibody titers against ticks and tick-borne diseases affecting human and animal health. These results are relevant for implementation of anti-tick Subolesin-based vaccines in Uganda and other countries in Sub-Saharan Africa.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"44 ","pages":"126562"},"PeriodicalIF":3.5,"publicationDate":"2025-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142755946","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-12Epub Date: 2024-11-29DOI: 10.1016/j.vaccine.2024.126544
Nicolas Gemander, Delphine Kemlin, Stéphanie Depickère, Natasha S Kelkar, Shilpee Sharma, Pieter Pannus, Alexandra Waegemans, Véronique Olislagers, Daphnée Georges, Emilie Dhondt, Margarida Braga, Leo Heyndrickx, Johan Michiels, Anaïs Thiriard, Anne Lemy, Thomas Baudoux, Marylène Vandevenne, Maria E Goossens, André Matagne, Isabelle Desombere, Kevin K Ariën, Margaret E Ackerman, Alain Le Moine, Arnaud Marchant
Background: Clinical risk factors of deficient immune responses to COVID-19 mRNA vaccination in SARS-CoV-2 naive hemodialysis recipients (HDR) have already been identified. Clinical factors influencing hybrid immunity induced by SARS-CoV-2 infection and vaccination in HDR have not been reported.
Methods: A comprehensive analysis of antibody (Ab) and T cell responses to two doses of BNT162b2 mRNA vaccination was performed in 103 HDR, including 75 SARS-CoV-2 naive and 28 experienced patients, and in 106 healthy controls (HC) not undergoing HD, including 40 SARS-CoV-2 naive and 66 experienced subjects. Clinical risk factors associated with lower humoral and cellular immunity were analyzed in SARS-CoV-2 naive and experienced HDR by univariate and multivariate analyses.
Results: Naive HDR had lower neutralizing and non-neutralizing antibody responses to vaccination than naive HC; lower vaccine responses were correlated with previous transplantation, immunosuppressive treatment, corticosteroid treatment, hypoalbuminemia, older age, hypertension, and negative response to hepatitis B vaccination. In contrast, vaccine responses of SARS-CoV-2 experienced HDR were similar to those of HC and were correlated with time between infection and vaccination and with previous transplantation, but not with the other risk factors associated with lower vaccine responses in naive HDR.
Conclusion: COVID-19 vaccine responses are influenced by distinct risk factors in SARS-CoV-2 naive and experienced HDR. These observations have important implications for the understanding of vaccine-induced immunity and for the management of this vulnerable patient population.
{"title":"COVID-19 vaccine responses are influenced by distinct risk factors in naive and SARS-CoV-2 experienced hemodialysis recipients.","authors":"Nicolas Gemander, Delphine Kemlin, Stéphanie Depickère, Natasha S Kelkar, Shilpee Sharma, Pieter Pannus, Alexandra Waegemans, Véronique Olislagers, Daphnée Georges, Emilie Dhondt, Margarida Braga, Leo Heyndrickx, Johan Michiels, Anaïs Thiriard, Anne Lemy, Thomas Baudoux, Marylène Vandevenne, Maria E Goossens, André Matagne, Isabelle Desombere, Kevin K Ariën, Margaret E Ackerman, Alain Le Moine, Arnaud Marchant","doi":"10.1016/j.vaccine.2024.126544","DOIUrl":"10.1016/j.vaccine.2024.126544","url":null,"abstract":"<p><strong>Background: </strong>Clinical risk factors of deficient immune responses to COVID-19 mRNA vaccination in SARS-CoV-2 naive hemodialysis recipients (HDR) have already been identified. Clinical factors influencing hybrid immunity induced by SARS-CoV-2 infection and vaccination in HDR have not been reported.</p><p><strong>Methods: </strong>A comprehensive analysis of antibody (Ab) and T cell responses to two doses of BNT162b2 mRNA vaccination was performed in 103 HDR, including 75 SARS-CoV-2 naive and 28 experienced patients, and in 106 healthy controls (HC) not undergoing HD, including 40 SARS-CoV-2 naive and 66 experienced subjects. Clinical risk factors associated with lower humoral and cellular immunity were analyzed in SARS-CoV-2 naive and experienced HDR by univariate and multivariate analyses.</p><p><strong>Results: </strong>Naive HDR had lower neutralizing and non-neutralizing antibody responses to vaccination than naive HC; lower vaccine responses were correlated with previous transplantation, immunosuppressive treatment, corticosteroid treatment, hypoalbuminemia, older age, hypertension, and negative response to hepatitis B vaccination. In contrast, vaccine responses of SARS-CoV-2 experienced HDR were similar to those of HC and were correlated with time between infection and vaccination and with previous transplantation, but not with the other risk factors associated with lower vaccine responses in naive HDR.</p><p><strong>Conclusion: </strong>COVID-19 vaccine responses are influenced by distinct risk factors in SARS-CoV-2 naive and experienced HDR. These observations have important implications for the understanding of vaccine-induced immunity and for the management of this vulnerable patient population.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"44 ","pages":"126544"},"PeriodicalIF":3.5,"publicationDate":"2025-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11655250/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142752391","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-12Epub Date: 2024-11-29DOI: 10.1016/j.vaccine.2024.126570
Qiang Wang, Liuqing Yang, Lan Li, Shixin Xiu, Min Yang, Xuwen Wang, Yuan Shen, Weibing Wang, Leesa Lin
Introduction: Our study aimed to assess parents' perceptions of respiratory syncytial virus (RSV) and their attitudes towards the RSV vaccine in China.
Method: The cross-section study was performed between August 21 and November 15, 2023, in Jiangsu province, eastern China. We collected socio-demographics, awareness, knowledge, perceptions of susceptibility and severity of RSV, and attitudes towards RSV vaccine using online survey questionnaire from parents of child aged ≤14 years old. The chi-square test and logistic regression model to explore the associated factors.
Results: A total of 2135 participants were included. About 26.0 % indicated that they had never heard of RSV (556/2135) and were unaware that infants and young children are at a high risk of contracting RSV (557/2135). The proportion of parents with a child under 1 year of age who were unaware of RSV was notably higher than that of parents with children in other age groups. 42.9 % of parents (916/2135) showed low level of perceived susceptibility of contacting RSV infection for their child. 70.6 % of parents (1508/2135) expressed their willingness to vaccinate their child against RSV. The most common reason for refusing the RSV vaccine was "Concern about vaccine's safety or side effects." 60.8 % of participants (1299/2135) considered a price of the RSV vaccine below 200 CNY (28 USD) as acceptable.
Conclusion: The parents, particularly those with younger children, exhibited limited awareness and knowledge regarding RSV infection. Our study also showed the potential role of vaccine price as a barrier to the future use of RSV vaccine in China.
{"title":"Investigating parental perceptions of respiratory syncytial virus (RSV) and attitudes to RSV vaccine in Jiangsu, China: Insights from a cross-section study.","authors":"Qiang Wang, Liuqing Yang, Lan Li, Shixin Xiu, Min Yang, Xuwen Wang, Yuan Shen, Weibing Wang, Leesa Lin","doi":"10.1016/j.vaccine.2024.126570","DOIUrl":"10.1016/j.vaccine.2024.126570","url":null,"abstract":"<p><strong>Introduction: </strong>Our study aimed to assess parents' perceptions of respiratory syncytial virus (RSV) and their attitudes towards the RSV vaccine in China.</p><p><strong>Method: </strong>The cross-section study was performed between August 21 and November 15, 2023, in Jiangsu province, eastern China. We collected socio-demographics, awareness, knowledge, perceptions of susceptibility and severity of RSV, and attitudes towards RSV vaccine using online survey questionnaire from parents of child aged ≤14 years old. The chi-square test and logistic regression model to explore the associated factors.</p><p><strong>Results: </strong>A total of 2135 participants were included. About 26.0 % indicated that they had never heard of RSV (556/2135) and were unaware that infants and young children are at a high risk of contracting RSV (557/2135). The proportion of parents with a child under 1 year of age who were unaware of RSV was notably higher than that of parents with children in other age groups. 42.9 % of parents (916/2135) showed low level of perceived susceptibility of contacting RSV infection for their child. 70.6 % of parents (1508/2135) expressed their willingness to vaccinate their child against RSV. The most common reason for refusing the RSV vaccine was \"Concern about vaccine's safety or side effects.\" 60.8 % of participants (1299/2135) considered a price of the RSV vaccine below 200 CNY (28 USD) as acceptable.</p><p><strong>Conclusion: </strong>The parents, particularly those with younger children, exhibited limited awareness and knowledge regarding RSV infection. Our study also showed the potential role of vaccine price as a barrier to the future use of RSV vaccine in China.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"44 ","pages":"126570"},"PeriodicalIF":3.5,"publicationDate":"2025-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142756009","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-31DOI: 10.1016/j.vaccine.2024.126616
C E Gurry, J M Mwenda, A Nardone, S Cohuet, A Worwui, M Valenciano, H C Lewis, C S Wiysonge, R Katsande, R Mukaro, F Braka, A S Gueye, T Balde, I Bergeri, B Impouma
Population-level vaccination with newly developed vaccines to respond to the COVID-19 pandemic created a need to monitor vaccine effectiveness (VE) in the context of emerging SARS-CoV-2 variants and changing epidemiology. WHO and partners launched the African Region Monitoring Vaccine Effectiveness (AFRO-MoVE) Network in March 2021 to assess the performance of COVID-19 vaccines in real-world conditions in Africa. The Network aimed to facilitate and support comparable COVID-19 vaccine effectiveness studies in the African region, to provide a platform of scientific expertise and infrastructure, encourage the use of robust similar study designs to enable pooling to produce regional VE estimates and to build a sustainable network of hospitals, institutions, and experts to evaluate vaccines against pandemic and endemic respiratory pathogens. In the two years since its inception, the network has coordinated VE studies in the region and provided technical guidance and generic protocols employing robust methodologies. It brought together over 200 experts, representing 22 African countries and 55 organisations, and strengthened capacities by hosting ten webinars and six technical workshops. Of the 55 partners organisations, 25 based in 13 countries collaborated on implementing VE studies in the region. AFRO-MoVE supported study implementation in two phases, first targeting COVID-19 vaccination priority groups, then the general population. The network provides technical and financial support to nine studies, including three cohort studies in health workers and adults with comorbidities, and six test-negative design studies evaluating VE against symptomatic and severe disease. A data platform was established for pooled regional estimates. The AFRO-MoVE Network can form a sustainable platform to provide data for evidence informed decisions and timely VE monitoring for existing and new vaccines against respiratory pathogens and other diseases in the African region. Further development and consolidation of the network's activities can enable rapid response to future epidemics and pandemics.
{"title":"Establishing the African region monitoring vaccine effectiveness (AFRO-MoVE) network for respiratory pathogens.","authors":"C E Gurry, J M Mwenda, A Nardone, S Cohuet, A Worwui, M Valenciano, H C Lewis, C S Wiysonge, R Katsande, R Mukaro, F Braka, A S Gueye, T Balde, I Bergeri, B Impouma","doi":"10.1016/j.vaccine.2024.126616","DOIUrl":"10.1016/j.vaccine.2024.126616","url":null,"abstract":"<p><p>Population-level vaccination with newly developed vaccines to respond to the COVID-19 pandemic created a need to monitor vaccine effectiveness (VE) in the context of emerging SARS-CoV-2 variants and changing epidemiology. WHO and partners launched the African Region Monitoring Vaccine Effectiveness (AFRO-MoVE) Network in March 2021 to assess the performance of COVID-19 vaccines in real-world conditions in Africa. The Network aimed to facilitate and support comparable COVID-19 vaccine effectiveness studies in the African region, to provide a platform of scientific expertise and infrastructure, encourage the use of robust similar study designs to enable pooling to produce regional VE estimates and to build a sustainable network of hospitals, institutions, and experts to evaluate vaccines against pandemic and endemic respiratory pathogens. In the two years since its inception, the network has coordinated VE studies in the region and provided technical guidance and generic protocols employing robust methodologies. It brought together over 200 experts, representing 22 African countries and 55 organisations, and strengthened capacities by hosting ten webinars and six technical workshops. Of the 55 partners organisations, 25 based in 13 countries collaborated on implementing VE studies in the region. AFRO-MoVE supported study implementation in two phases, first targeting COVID-19 vaccination priority groups, then the general population. The network provides technical and financial support to nine studies, including three cohort studies in health workers and adults with comorbidities, and six test-negative design studies evaluating VE against symptomatic and severe disease. A data platform was established for pooled regional estimates. The AFRO-MoVE Network can form a sustainable platform to provide data for evidence informed decisions and timely VE monitoring for existing and new vaccines against respiratory pathogens and other diseases in the African region. Further development and consolidation of the network's activities can enable rapid response to future epidemics and pandemics.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":" ","pages":"126616"},"PeriodicalIF":0.0,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142916757","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-02Epub Date: 2024-10-19DOI: 10.1016/j.vaccine.2024.126459
Jolanta Smok-Kalwat, Stanisław Góźdź, Paweł Macek, Piotr Wasiński, Maryna Khalavka, Przemyslaw Raczkiewicz, Andrzej Stepulak, Joanna Depciuch
Lung cancer is one of the most lethal cancers. Unfortunately, respiratory tract infections are very common in lung cancer patients, delaying appropriate anticancer therapy. To increase therapy efficiency, in this study we examined the effect of 13-Valent Pneumococcal Conjugate Vaccine on the immune response in lung cancer patients, which indirectly affects the success of anticancer therapy. The study was done using biochemical tests and Fourier Transform InfraRed (FTIR) spectroscopy. For this purpose, serum from lung cancer patients aged 52 ± 9 years (III and IV clinical stage; 79 %; n = 103) before and seven as well as 30 days after vaccination was collected. Obtained results showed increasing concentrations of immunoglobulin IgG and IgG2 groups in patients after vaccination in comparison with group before vaccination. This result was confirmed by FTIR spectroscopy, where higher absorbances of amides vibrations were observed after vaccination. Interestingly, lack of differences in the amides absorbances between patients 7 and 30 days after vaccination were noticed. FTIR spectra also showed changes in the ratio between amide I and amide III as well as between amide II and amide III in the groups of patients after vaccination. From deconvolution of made I range (1600 cm-1-1700 cm-1) decrease of the ratio between α-helix and β-sheet around 0.05 was noticed in serum collected from patients after vaccination in comparison with patients before vaccination. Using Principal Component Analysis (PCA) analysis of FTIR data it was observed that serum collected from all three analyzed groups of samples was possible to differentiate. The highest accuracy in differentiation group of samples before and 7 days after vaccination was visible in amide I, while before and 30 days after vaccination using amide II. Correlation between immunoglobulin IgG and IgG2 concentrations obtained by biochemical assays and FTIR were noticed only in the group of serum collected 30 days after vaccination, which suggested that FTIR spectroscopy reflects biochemical data.
肺癌是最致命的癌症之一。不幸的是,呼吸道感染在肺癌患者中非常常见,从而延误了适当的抗癌治疗。为了提高治疗效率,我们在本研究中探讨了 13 价肺炎球菌结合疫苗对肺癌患者免疫反应的影响,因为免疫反应会间接影响抗癌治疗的成功与否。研究采用了生化测试和傅立叶变换红外光谱(FTIR)技术。为此,研究人员收集了 52 ± 9 岁肺癌患者(临床分期为 III 和 IV 期;79%;n = 103)在接种疫苗前、接种疫苗后 7 天和 30 天的血清。结果显示,与接种疫苗前相比,接种疫苗后患者体内免疫球蛋白 IgG 和 IgG2 组的浓度有所增加。傅立叶变换红外光谱证实了这一结果,接种疫苗后酰胺振动的吸光度更高。有趣的是,接种疫苗 7 天和 30 天后,患者的酰胺吸光度没有差异。傅立叶变换红外光谱还显示,接种疫苗后各组患者的酰胺 I 和酰胺 III 之间以及酰胺 II 和酰胺 III 之间的比例发生了变化。与接种疫苗前相比,接种疫苗后患者的血清中α-螺旋体和β-片状体之间的比例下降了约0.05。通过对傅立叶变换红外光谱数据进行主成分分析 (PCA) 发现,从所有三组分析样本中采集的血清都可以进行区分。在接种疫苗前和接种疫苗后 7 天的样本组中,酰胺 I 的分辨准确率最高,而在接种疫苗前和接种疫苗后 30 天的样本组中,酰胺 II 的分辨准确率最高。只有在接种疫苗 30 天后采集的血清组中,生化测定和傅立叶变换红外光谱法获得的免疫球蛋白 IgG 和 IgG2 浓度之间才存在相关性,这表明傅立叶变换红外光谱法反映了生化数据。
{"title":"FTIR monitoring of the 13-valent pneumococcal conjugate vaccine for lung cancer patients: Changes in amides vibrations correlated with biochemical assays.","authors":"Jolanta Smok-Kalwat, Stanisław Góźdź, Paweł Macek, Piotr Wasiński, Maryna Khalavka, Przemyslaw Raczkiewicz, Andrzej Stepulak, Joanna Depciuch","doi":"10.1016/j.vaccine.2024.126459","DOIUrl":"10.1016/j.vaccine.2024.126459","url":null,"abstract":"<p><p>Lung cancer is one of the most lethal cancers. Unfortunately, respiratory tract infections are very common in lung cancer patients, delaying appropriate anticancer therapy. To increase therapy efficiency, in this study we examined the effect of 13-Valent Pneumococcal Conjugate Vaccine on the immune response in lung cancer patients, which indirectly affects the success of anticancer therapy. The study was done using biochemical tests and Fourier Transform InfraRed (FTIR) spectroscopy. For this purpose, serum from lung cancer patients aged 52 ± 9 years (III and IV clinical stage; 79 %; n = 103) before and seven as well as 30 days after vaccination was collected. Obtained results showed increasing concentrations of immunoglobulin IgG and IgG2 groups in patients after vaccination in comparison with group before vaccination. This result was confirmed by FTIR spectroscopy, where higher absorbances of amides vibrations were observed after vaccination. Interestingly, lack of differences in the amides absorbances between patients 7 and 30 days after vaccination were noticed. FTIR spectra also showed changes in the ratio between amide I and amide III as well as between amide II and amide III in the groups of patients after vaccination. From deconvolution of made I range (1600 cm<sup>-1</sup>-1700 cm<sup>-1</sup>) decrease of the ratio between α-helix and β-sheet around 0.05 was noticed in serum collected from patients after vaccination in comparison with patients before vaccination. Using Principal Component Analysis (PCA) analysis of FTIR data it was observed that serum collected from all three analyzed groups of samples was possible to differentiate. The highest accuracy in differentiation group of samples before and 7 days after vaccination was visible in amide I, while before and 30 days after vaccination using amide II. Correlation between immunoglobulin IgG and IgG2 concentrations obtained by biochemical assays and FTIR were noticed only in the group of serum collected 30 days after vaccination, which suggested that FTIR spectroscopy reflects biochemical data.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"42 26","pages":"126459"},"PeriodicalIF":3.5,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142484738","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-02Epub Date: 2024-10-30DOI: 10.1016/j.vaccine.2024.126476
Dina A Moustafa, Emma Lou, Morgan E Schafer-Kestenman, Margalida Mateu-Borrás, Antonio Doménech-Sanchez, Sebastián Albertí, Joanna B Goldberg
Pseudomonas aeruginosa is a Gram-negative, opportunistic pathogen that infects immunocompromised individuals, especially in the hospital setting. This bacterium is an important pathogen in people with weakened immune systems, injuries, and other underlying physiologic dysfunctions. P. aeruginosa is responsible for up to 20 % of all hospital-acquired pneumonias. It is one of the major causes of nosocomial infections and has been noted to be one of the most common bacteria co-infecting patients with COVID-19 or causing super-infections following COVID-19 infections. Despite improvements in antimicrobial therapy and hospital care, P. aeruginosa bacteremia and pneumonia remain fatal in about 30 % of cases. P. aeruginosa is also the leading cause of chronic life-threatening lung infections in cystic fibrosis patients. This bacterium is naturally antibiotic resistant, and infections are notoriously difficult to treat once established, with no vaccine available. We have previously shown that elongation factor-Tu (EF-Tu), a protein best known for its role in protein synthesis, is surface exposed on P. aeruginosa. As this protein is highly expressed, evolutionally conserved, and essential, we hypothesized it would make a good vaccine target. In this study, we found that P. aeruginosa EF-Tu is immunogenic in people, and that mice can develop an immune response following immunization with recombinant P. aeruginosa EF-Tu. Furthermore, immunized mice were protected from subsequent P. aeruginosa pneumonia and transfer of this vaccine antisera to naïve mice resulted in decreased colonization. Altogether these findings support the consideration of EF-Tu as a new vaccine candidate against P. aeruginosa.
{"title":"Pseudomonas aeruginosa elongation factor-Tu (EF-Tu) is an immunogenic protective protein antigen.","authors":"Dina A Moustafa, Emma Lou, Morgan E Schafer-Kestenman, Margalida Mateu-Borrás, Antonio Doménech-Sanchez, Sebastián Albertí, Joanna B Goldberg","doi":"10.1016/j.vaccine.2024.126476","DOIUrl":"10.1016/j.vaccine.2024.126476","url":null,"abstract":"<p><p>Pseudomonas aeruginosa is a Gram-negative, opportunistic pathogen that infects immunocompromised individuals, especially in the hospital setting. This bacterium is an important pathogen in people with weakened immune systems, injuries, and other underlying physiologic dysfunctions. P. aeruginosa is responsible for up to 20 % of all hospital-acquired pneumonias. It is one of the major causes of nosocomial infections and has been noted to be one of the most common bacteria co-infecting patients with COVID-19 or causing super-infections following COVID-19 infections. Despite improvements in antimicrobial therapy and hospital care, P. aeruginosa bacteremia and pneumonia remain fatal in about 30 % of cases. P. aeruginosa is also the leading cause of chronic life-threatening lung infections in cystic fibrosis patients. This bacterium is naturally antibiotic resistant, and infections are notoriously difficult to treat once established, with no vaccine available. We have previously shown that elongation factor-Tu (EF-Tu), a protein best known for its role in protein synthesis, is surface exposed on P. aeruginosa. As this protein is highly expressed, evolutionally conserved, and essential, we hypothesized it would make a good vaccine target. In this study, we found that P. aeruginosa EF-Tu is immunogenic in people, and that mice can develop an immune response following immunization with recombinant P. aeruginosa EF-Tu. Furthermore, immunized mice were protected from subsequent P. aeruginosa pneumonia and transfer of this vaccine antisera to naïve mice resulted in decreased colonization. Altogether these findings support the consideration of EF-Tu as a new vaccine candidate against P. aeruginosa.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"42 26","pages":"126476"},"PeriodicalIF":3.5,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11645190/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142549928","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-02Epub Date: 2024-10-21DOI: 10.1016/j.vaccine.2024.126456
Sarah E Brewer, Jessica R Cataldi, Cathryn Perreira, Andrea Nederveld, Michael P Fisher, Anna Furniss, Charnetta Williams, Sean T O'Leary, Amanda F Dempsey
Purpose: Vaccination rates are significantly lower among adolescents living in rural areas compared to those living in urban areas. The objective of this study was to understand the factors contributing to disparities in vaccination between adolescents in rural compared to urban areas.
Methods: Semi-structured qualitative interviews were conducted with parents and providers in 16 rural and 4 urban counties of Colorado. Interview questions followed the socioecological model of health and addressed personal, interpersonal, community, and environment/structural barriers and facilitators that impact adolescent vaccination rates. Qualitative content analysis with a directed content analysis approach was used. Urban and rural interviews were compared to identify barriers unique to rural communities.
Findings: Reported barriers included lack of vaccine access at primary care, lack of routine preventive care utilization, the need to take off time from work and school, and misinformation about vaccines. Barriers that were unique to rural communities included structural barriers such as lack of evening and weekend appointments, providers not stocking vaccines, short provider tenures, and costs; logistical barriers such as the need for multiple visits to multiple locations and distance and travel time; and beliefs and behaviors such as an overreliance on sports physicals (in lieu of preventive visits) and natural lifestyle cultures.
Conclusions: There are unique challenges to adolescent vaccination in rural areas that contribute to fewer adolescents receiving their recommended vaccines. Addressing structural barriers may address this disparity.
{"title":"\"But then that's another barrier\": A qualitative study of parent and provider perspectives on rural versus urban disparities in adolescent vaccination.","authors":"Sarah E Brewer, Jessica R Cataldi, Cathryn Perreira, Andrea Nederveld, Michael P Fisher, Anna Furniss, Charnetta Williams, Sean T O'Leary, Amanda F Dempsey","doi":"10.1016/j.vaccine.2024.126456","DOIUrl":"10.1016/j.vaccine.2024.126456","url":null,"abstract":"<p><strong>Purpose: </strong>Vaccination rates are significantly lower among adolescents living in rural areas compared to those living in urban areas. The objective of this study was to understand the factors contributing to disparities in vaccination between adolescents in rural compared to urban areas.</p><p><strong>Methods: </strong>Semi-structured qualitative interviews were conducted with parents and providers in 16 rural and 4 urban counties of Colorado. Interview questions followed the socioecological model of health and addressed personal, interpersonal, community, and environment/structural barriers and facilitators that impact adolescent vaccination rates. Qualitative content analysis with a directed content analysis approach was used. Urban and rural interviews were compared to identify barriers unique to rural communities.</p><p><strong>Findings: </strong>Reported barriers included lack of vaccine access at primary care, lack of routine preventive care utilization, the need to take off time from work and school, and misinformation about vaccines. Barriers that were unique to rural communities included structural barriers such as lack of evening and weekend appointments, providers not stocking vaccines, short provider tenures, and costs; logistical barriers such as the need for multiple visits to multiple locations and distance and travel time; and beliefs and behaviors such as an overreliance on sports physicals (in lieu of preventive visits) and natural lifestyle cultures.</p><p><strong>Conclusions: </strong>There are unique challenges to adolescent vaccination in rural areas that contribute to fewer adolescents receiving their recommended vaccines. Addressing structural barriers may address this disparity.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"42 26","pages":"126456"},"PeriodicalIF":3.5,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142515708","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-02Epub Date: 2024-11-01DOI: 10.1016/j.vaccine.2024.126481
Allya Makhijani, Narelle Jenkins, Jessica Kaufman, Monsurul Hoq, Sabine Priestley, Sonja Elia, Ian McKenzie, Andrew Davidson, Paul Leong, Teresa Lazzaro, Sarah McNab, Margie Danchin
Virtual reality for routine immunisations in needle phobic children with and without developmental disabilities: a pilot study.
Background: Virtual Reality (VR) headsets can improve needle procedure success and experiences for children, but they have not been evaluated to support immunisation in children with anxiety and behavioural challenges. This study assessed the feasibility and acceptability of VR for immunisation in children with needle phobia, including children with and without developmental disabilities.
Methods: A mixed method pilot study was conducted at the Royal Children's Hospital, Melbourne. Children with needle phobia aged 4-14 years scheduled for immunisation with distraction and conscious sedation were eligible. VR was offered to children with needle anxiety and/or developmental disabilities before and during immunisation in addition to standard care. Children and caregivers completed electronic surveys pre- and post-immunisation, followed by qualitative interviews post-immunisation. Clinicians completed post-immunisation surveys. Primary outcomes were feasibility and acceptability of VR according to children, caregivers and clinicians.
Results: Between May and December 2022, we screened 54 children and included 30; 15 with and 15 without developmental disability. Preparation to use VR took less than five minutes for most children (24/30; 80 %). Twenty nine (96 %) used VR immediately before immunisation, and 17 (57 %) continued using it during immunisation (7 with developmental disability, 10 without). Twenty seven (90 %) children were immunised successfully, with a small reduction in required sedation. Of those who used VR during immunisation, 16/17 (94 %) reported a more positive overall experience. Of those who only used VR before immunisation, 3/13 (23 %) still reported benefit. VR was therefore described as beneficial for 19/30 (63 %) participants (9 with developmental disability, 10 without). Caregivers reported willingness to use VR in future immunisation encounters for 23/30 (77 %) children (11 with developmental disability, 12 without).
Discussion: This pilot study suggests VR was feasible and acceptable for many children with needle phobia, both with and without developmental disability. These findings will inform a randomised controlled trial to assess effectiveness.
{"title":"Virtual reality for routine immunisations in needle phobic children with and without developmental disabilities: A pilot study.","authors":"Allya Makhijani, Narelle Jenkins, Jessica Kaufman, Monsurul Hoq, Sabine Priestley, Sonja Elia, Ian McKenzie, Andrew Davidson, Paul Leong, Teresa Lazzaro, Sarah McNab, Margie Danchin","doi":"10.1016/j.vaccine.2024.126481","DOIUrl":"10.1016/j.vaccine.2024.126481","url":null,"abstract":"<p><p>Virtual reality for routine immunisations in needle phobic children with and without developmental disabilities: a pilot study.</p><p><strong>Background: </strong>Virtual Reality (VR) headsets can improve needle procedure success and experiences for children, but they have not been evaluated to support immunisation in children with anxiety and behavioural challenges. This study assessed the feasibility and acceptability of VR for immunisation in children with needle phobia, including children with and without developmental disabilities.</p><p><strong>Methods: </strong>A mixed method pilot study was conducted at the Royal Children's Hospital, Melbourne. Children with needle phobia aged 4-14 years scheduled for immunisation with distraction and conscious sedation were eligible. VR was offered to children with needle anxiety and/or developmental disabilities before and during immunisation in addition to standard care. Children and caregivers completed electronic surveys pre- and post-immunisation, followed by qualitative interviews post-immunisation. Clinicians completed post-immunisation surveys. Primary outcomes were feasibility and acceptability of VR according to children, caregivers and clinicians.</p><p><strong>Results: </strong>Between May and December 2022, we screened 54 children and included 30; 15 with and 15 without developmental disability. Preparation to use VR took less than five minutes for most children (24/30; 80 %). Twenty nine (96 %) used VR immediately before immunisation, and 17 (57 %) continued using it during immunisation (7 with developmental disability, 10 without). Twenty seven (90 %) children were immunised successfully, with a small reduction in required sedation. Of those who used VR during immunisation, 16/17 (94 %) reported a more positive overall experience. Of those who only used VR before immunisation, 3/13 (23 %) still reported benefit. VR was therefore described as beneficial for 19/30 (63 %) participants (9 with developmental disability, 10 without). Caregivers reported willingness to use VR in future immunisation encounters for 23/30 (77 %) children (11 with developmental disability, 12 without).</p><p><strong>Discussion: </strong>This pilot study suggests VR was feasible and acceptable for many children with needle phobia, both with and without developmental disability. These findings will inform a randomised controlled trial to assess effectiveness.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"42 26","pages":"126481"},"PeriodicalIF":3.5,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142565369","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-02Epub Date: 2024-10-25DOI: 10.1016/j.vaccine.2024.126427
Elke Jordan, Victoria Jenkins, Günter Silbernagl, Maria Paulina Velasco Chávez, Darja Schmidt, Frauke Schnorfeil, Stephanie Schultz, Liddy Chen, Fernanda Salgado, Jeanne-Marie Jacquet, Tobias Welte, Laurence De Moerlooze
Respiratory syncytial virus (RSV) causes a significant disease burden in older adults. The live recombinant vaccine based on a nonreplicating modified vaccinia Ankara (MVA-BN) poxvirus, MVA-BN-RSV, encoding for multiple proteins of RSV subtypes A and B, was assessed for efficacy against respiratory disease caused by RSV. Adults aged ≥60 years, with or without underlying chronic conditions, were enrolled and randomized in a 1:1 ratio to receive a single dose of vaccine or placebo and were followed for disease caused by RSV infection during the 2022-2023 season. The 2 primary endpoints were RSV-associated lower respiratory tract disease (LRTD) with ≥3 and ≥ 2 symptoms; acute respiratory disease (ARD) was a key secondary endpoint. The humoral RSV-specific immune response was assessed at baseline and 14 days post-vaccination. Safety was evaluated by collection of solicited adverse events (AEs) and unsolicited AEs for 7 and 28 days post-vaccination respectively, and SAEs for the entire study period. In total, 18,348 participants were included in the final efficacy and safety analyses. Vaccine efficacy was 42.9 % (95 % CI: -16.1; 71.9) against RSV-associated LRTD with ≥3 symptoms, 59.0 % (95 % CI: 34.7; 74.3) against LRTD with ≥2 symptoms, and 48.8 % (95 % CI: 25.8; 64.7) against ARD. The primary objective was not met for LRTD with ≥3 symptoms since the lower bound of the 95 % CI was below 20 %, the prespecified success criterion. The vaccine-elicited immune response showed mean fold-increases of 1.7 for RSV A and B neutralizing antibodies and 2.9 and 4.3 for RSV-specific IgG and IgA, respectively. The vaccine displayed mild to moderate reactogenicity, and no safety concerns were identified. MVA-BN-RSV induced suboptimal protection against RSV-associated LRTD, likely due to suboptimal neutralizing antibody response. The vaccine had an acceptable safety profile and confirmed immunogenicity, overall showing promise for MVA-BN-vectored constructs targeting other diseases. Trial Registration:Clinicaltrials.gov Identifier NCT05238025 (Registered February 14, 2022).
{"title":"A multivalent RSV vaccine based on the modified vaccinia Ankara vector shows moderate protection against disease caused by RSV in older adults in a phase 3 clinical study.","authors":"Elke Jordan, Victoria Jenkins, Günter Silbernagl, Maria Paulina Velasco Chávez, Darja Schmidt, Frauke Schnorfeil, Stephanie Schultz, Liddy Chen, Fernanda Salgado, Jeanne-Marie Jacquet, Tobias Welte, Laurence De Moerlooze","doi":"10.1016/j.vaccine.2024.126427","DOIUrl":"10.1016/j.vaccine.2024.126427","url":null,"abstract":"<p><p>Respiratory syncytial virus (RSV) causes a significant disease burden in older adults. The live recombinant vaccine based on a nonreplicating modified vaccinia Ankara (MVA-BN) poxvirus, MVA-BN-RSV, encoding for multiple proteins of RSV subtypes A and B, was assessed for efficacy against respiratory disease caused by RSV. Adults aged ≥60 years, with or without underlying chronic conditions, were enrolled and randomized in a 1:1 ratio to receive a single dose of vaccine or placebo and were followed for disease caused by RSV infection during the 2022-2023 season. The 2 primary endpoints were RSV-associated lower respiratory tract disease (LRTD) with ≥3 and ≥ 2 symptoms; acute respiratory disease (ARD) was a key secondary endpoint. The humoral RSV-specific immune response was assessed at baseline and 14 days post-vaccination. Safety was evaluated by collection of solicited adverse events (AEs) and unsolicited AEs for 7 and 28 days post-vaccination respectively, and SAEs for the entire study period. In total, 18,348 participants were included in the final efficacy and safety analyses. Vaccine efficacy was 42.9 % (95 % CI: -16.1; 71.9) against RSV-associated LRTD with ≥3 symptoms, 59.0 % (95 % CI: 34.7; 74.3) against LRTD with ≥2 symptoms, and 48.8 % (95 % CI: 25.8; 64.7) against ARD. The primary objective was not met for LRTD with ≥3 symptoms since the lower bound of the 95 % CI was below 20 %, the prespecified success criterion. The vaccine-elicited immune response showed mean fold-increases of 1.7 for RSV A and B neutralizing antibodies and 2.9 and 4.3 for RSV-specific IgG and IgA, respectively. The vaccine displayed mild to moderate reactogenicity, and no safety concerns were identified. MVA-BN-RSV induced suboptimal protection against RSV-associated LRTD, likely due to suboptimal neutralizing antibody response. The vaccine had an acceptable safety profile and confirmed immunogenicity, overall showing promise for MVA-BN-vectored constructs targeting other diseases. Trial Registration:Clinicaltrials.gov Identifier NCT05238025 (Registered February 14, 2022).</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"42 26","pages":"126427"},"PeriodicalIF":3.5,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142515709","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-02Epub Date: 2024-10-23DOI: 10.1016/j.vaccine.2024.126460
Delese Mimi Darko, Seth Kwaku Seaneke, Eric Karikari-Boateng, Edwin Nkansah, Kwame Amponsa-Achiano, Naziru Tanko Mohamed, Harriet Affran Bonful, Richard Osei Buabeng, Adela Ashie, Abena Asamoa-Amoakohene, Jeremiah Ewudzie-Sampson, Alexander Mwinteru Derizie, Adjabui D Neimatu, Agongo A Wilfred, Comfort Ogar, Aida Hagos, George Tsey Sabblah
Introduction: The development of COVID-19 vaccines during the pandemic occurred with an unprecedented speed, requiring extraordinary post-approval safety monitoring to facilitate ongoing evaluation of their benefit-risk profile. In Ghana, the Food and Drugs Authority granted emergency use authorization to six of these vaccines including the two mRNA COVID-19 vaccines, namely, Pfizer-BioNTech and Moderna COVID-19 vaccines. The objective of the study was to estimate the incidence of adverse events following immunization (AEFIs) and adverse events of special interest (AESIs) in persons vaccinated with mRNA COVID-19 vaccines, and to identify factors associated with the development of AEFIs.
Methods: We conducted a prospective cohort event monitoring study in seven selected static vaccination center in six of Ghana's 16 regions. The choice of regions was based on their geographical locations and the incidence rate of COVID-19 at the time of the study. The study was conducted with people aged 15 years and older who were vaccinated with mRNA COVID-19 vaccines, including pregnant women. Study participants were recruited starting in November 2021, with the last participant followed up in August 2022. Persons vaccinated were followed up on days 1, 7, and 28 post-dose 1 and up to 91 days after dose 2. AEFIs were described with the most specific, or lowest-level, term using the Medical Dictionary for Regulatory Activities (MedDRA) version 26.1. Frequencies of AEFIs after each vaccine dose and vaccination center were determined. Cox-proportional hazard regression was used to assess the independent risk factors associated with the incidence of AEFI among the participants.
Results: Overall, 4678 persons who received Pfizer-BioNTech or Moderna COVID-19 vaccines from the seven vaccination centers were enrolled in the study. The mean age of participants was 32.9 years (SD ± 14.4). A total of 17.4 % (95 % CI: 16.3 % to 18.5 %) of participants experienced AEFI, with a higher incidence among Moderna COVID-19 vaccine recipients (20.4 %) compared to Pfizer-BioNTech COVID-19 vaccine recipients (14.0 %). The top five common AEFIs included injection site pain, headache, dizziness, fatigue, and fever. No serious AEFIs were reported during the study. Factors such as vaccination center and history of chronic medical conditions influenced the risk of experiencing an AEFI. Cox-proportional hazard regression revealed a 37 % lower risk of AEFI with the Pfizer-BioNTech COVID-19 vaccine compared to the Moderna COVID-19 vaccine.
Conclusion: The study on mRNA COVID-19 vaccines in Ghana showed that the vaccines are tolerated well with no significant safety concerns. Reports of systemic and local events were consistent with those reported in the summary of product characteristics of the two vaccines. The study's outcome showed that there were no safety issues with mRNA COVID-19 vaccines in Ghana.
{"title":"Safety of mRNA COVID-19 vaccines among persons 15- years and above in Ghana: A cohort event monitoring study.","authors":"Delese Mimi Darko, Seth Kwaku Seaneke, Eric Karikari-Boateng, Edwin Nkansah, Kwame Amponsa-Achiano, Naziru Tanko Mohamed, Harriet Affran Bonful, Richard Osei Buabeng, Adela Ashie, Abena Asamoa-Amoakohene, Jeremiah Ewudzie-Sampson, Alexander Mwinteru Derizie, Adjabui D Neimatu, Agongo A Wilfred, Comfort Ogar, Aida Hagos, George Tsey Sabblah","doi":"10.1016/j.vaccine.2024.126460","DOIUrl":"10.1016/j.vaccine.2024.126460","url":null,"abstract":"<p><strong>Introduction: </strong>The development of COVID-19 vaccines during the pandemic occurred with an unprecedented speed, requiring extraordinary post-approval safety monitoring to facilitate ongoing evaluation of their benefit-risk profile. In Ghana, the Food and Drugs Authority granted emergency use authorization to six of these vaccines including the two mRNA COVID-19 vaccines, namely, Pfizer-BioNTech and Moderna COVID-19 vaccines. The objective of the study was to estimate the incidence of adverse events following immunization (AEFIs) and adverse events of special interest (AESIs) in persons vaccinated with mRNA COVID-19 vaccines, and to identify factors associated with the development of AEFIs.</p><p><strong>Methods: </strong>We conducted a prospective cohort event monitoring study in seven selected static vaccination center in six of Ghana's 16 regions. The choice of regions was based on their geographical locations and the incidence rate of COVID-19 at the time of the study. The study was conducted with people aged 15 years and older who were vaccinated with mRNA COVID-19 vaccines, including pregnant women. Study participants were recruited starting in November 2021, with the last participant followed up in August 2022. Persons vaccinated were followed up on days 1, 7, and 28 post-dose 1 and up to 91 days after dose 2. AEFIs were described with the most specific, or lowest-level, term using the Medical Dictionary for Regulatory Activities (MedDRA) version 26.1. Frequencies of AEFIs after each vaccine dose and vaccination center were determined. Cox-proportional hazard regression was used to assess the independent risk factors associated with the incidence of AEFI among the participants.</p><p><strong>Results: </strong>Overall, 4678 persons who received Pfizer-BioNTech or Moderna COVID-19 vaccines from the seven vaccination centers were enrolled in the study. The mean age of participants was 32.9 years (SD ± 14.4). A total of 17.4 % (95 % CI: 16.3 % to 18.5 %) of participants experienced AEFI, with a higher incidence among Moderna COVID-19 vaccine recipients (20.4 %) compared to Pfizer-BioNTech COVID-19 vaccine recipients (14.0 %). The top five common AEFIs included injection site pain, headache, dizziness, fatigue, and fever. No serious AEFIs were reported during the study. Factors such as vaccination center and history of chronic medical conditions influenced the risk of experiencing an AEFI. Cox-proportional hazard regression revealed a 37 % lower risk of AEFI with the Pfizer-BioNTech COVID-19 vaccine compared to the Moderna COVID-19 vaccine.</p><p><strong>Conclusion: </strong>The study on mRNA COVID-19 vaccines in Ghana showed that the vaccines are tolerated well with no significant safety concerns. Reports of systemic and local events were consistent with those reported in the summary of product characteristics of the two vaccines. The study's outcome showed that there were no safety issues with mRNA COVID-19 vaccines in Ghana. ","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":"42 26","pages":"126460"},"PeriodicalIF":3.5,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142515713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}