Pub Date : 2024-10-23DOI: 10.1016/s1473-3099(24)00565-6
Yusuke Okada, Yuji Kumagai, Iori Okura, Mako Otsuki, Natsuki Ishida, Yasuhiro Iwama, Takeshi Minamida, Yukihiro Yagi, Toru Kurosawa, Josephine van Boxmeer, Ye Zhang, Igor Smolenov, Judd L Walson
<h3>Background</h3>We previously showed that ARCT-154, a self-amplifying mRNA COVID-19 vaccine, had improved immunogenicity and antibody persistence compared with conventional mRNA or adenovirus vector vaccines. In this study, we compared ARCT-2301, a bivalent self-amplifying mRNA vaccine (Asp614Gly and omicron BA.4/5 variant), with the bivalent Comirnaty omicron BA.4-5 vaccine, to determine whether this improved response persisted in bivalent formulations against different SARS-CoV-2 variants.<h3>Methods</h3>This randomised, multicentre, phase 3, observer-masked, active-controlled comparative study was done at nine hospitals in Japan. Eligible participants were healthy Japanese adults, aged at least 18 years, who had previously received a full immunisation series of three to five doses of mRNA COVID-19 vaccines (Comirnaty or Spikevax [Moderna]), with the last dose received at least 3 months before screening for this trial. Participants were randomly assigned (1:1) to either ARCT-2301 or Comirnaty BA.4-5 mRNA vaccine using interactive computer-generated randomisation with a block size of four. Randomisation was stratified by gender (men <em>vs</em> women), age group (<65 years <em>vs</em> ≥65 years), type of vaccine used for last vaccination (bivalent omicron BA.1 <em>vs</em> bivalent omicron BA.4/5), and time since last COVID-19 vaccination (<5 months <em>vs</em> ≥5 months). ARCT-2301 was supplied in vials containing 100 μg lyophilised mRNA, 50 μg mRNA each coding for the full-length spike proteins of the ancestral Asp614Gly SARS-CoV-2 strain and omicron BA.4/5 variant. Immediately before use, each vial was reconstituted with 10 mL saline. The comparator original omicron BA.4/5 mRNA vaccine (Comirnaty BA.4-5) was supplied in ready-to-use vials containing a single dose of 30 μg mRNA in 0·3 mL volume. Both vaccines were administered by intramuscular injection in the deltoid of the non-dominant arm. The primary outcome of the study was to show non-inferiority of immunogenicity of ARCT-2301 versus Comirnaty BA.4-5 at day 29 as neutralising antibody geometric mean titres (GMT) and seroresponse rates against omicron BA.4/5. Primary analyses were done in a per-protocol manner. The trial is registered with the Japan Registry for Clinical Trials, jRCT2031230340.<h3>Findings</h3>Between Sept 29 and Nov 18, 2023, we enrolled 930 participants (451 men and 479 women) to receive a booster dose of ARCT-2301 (n=465) or Comirnaty BA.4-5 (n=465). The primary immunogenicity outcome to show that the antibody response at day 29 against omicron BA.4/5 elicited by ARCT-2301 was non-inferior to that elicited with Comirnaty BA.4-5 was achieved, both by GMT ratio (1·49, 95% CI 1·26–1·76) and difference in seroresponse rate (7·2%, 95% CI 0·6–13·7). Furthermore, the differences in antibody response between the groups showed superiority for ARCT-2301 against Wuhan-Hu-1 using both criteria, with a GMT ratio of 1·45 (95% CI 1·28–1·63) and a difference in seroresponse ra
{"title":"Immunogenicity of a booster dose of a bivalent (Asp614Gly and omicron BA.4/5 variant) self-amplifying mRNA SARS-CoV-2 booster vaccine versus the BNT162b2 omicron BA.4/5 mRNA vaccine: a randomised phase 3 trial","authors":"Yusuke Okada, Yuji Kumagai, Iori Okura, Mako Otsuki, Natsuki Ishida, Yasuhiro Iwama, Takeshi Minamida, Yukihiro Yagi, Toru Kurosawa, Josephine van Boxmeer, Ye Zhang, Igor Smolenov, Judd L Walson","doi":"10.1016/s1473-3099(24)00565-6","DOIUrl":"https://doi.org/10.1016/s1473-3099(24)00565-6","url":null,"abstract":"<h3>Background</h3>We previously showed that ARCT-154, a self-amplifying mRNA COVID-19 vaccine, had improved immunogenicity and antibody persistence compared with conventional mRNA or adenovirus vector vaccines. In this study, we compared ARCT-2301, a bivalent self-amplifying mRNA vaccine (Asp614Gly and omicron BA.4/5 variant), with the bivalent Comirnaty omicron BA.4-5 vaccine, to determine whether this improved response persisted in bivalent formulations against different SARS-CoV-2 variants.<h3>Methods</h3>This randomised, multicentre, phase 3, observer-masked, active-controlled comparative study was done at nine hospitals in Japan. Eligible participants were healthy Japanese adults, aged at least 18 years, who had previously received a full immunisation series of three to five doses of mRNA COVID-19 vaccines (Comirnaty or Spikevax [Moderna]), with the last dose received at least 3 months before screening for this trial. Participants were randomly assigned (1:1) to either ARCT-2301 or Comirnaty BA.4-5 mRNA vaccine using interactive computer-generated randomisation with a block size of four. Randomisation was stratified by gender (men <em>vs</em> women), age group (<65 years <em>vs</em> ≥65 years), type of vaccine used for last vaccination (bivalent omicron BA.1 <em>vs</em> bivalent omicron BA.4/5), and time since last COVID-19 vaccination (<5 months <em>vs</em> ≥5 months). ARCT-2301 was supplied in vials containing 100 μg lyophilised mRNA, 50 μg mRNA each coding for the full-length spike proteins of the ancestral Asp614Gly SARS-CoV-2 strain and omicron BA.4/5 variant. Immediately before use, each vial was reconstituted with 10 mL saline. The comparator original omicron BA.4/5 mRNA vaccine (Comirnaty BA.4-5) was supplied in ready-to-use vials containing a single dose of 30 μg mRNA in 0·3 mL volume. Both vaccines were administered by intramuscular injection in the deltoid of the non-dominant arm. The primary outcome of the study was to show non-inferiority of immunogenicity of ARCT-2301 versus Comirnaty BA.4-5 at day 29 as neutralising antibody geometric mean titres (GMT) and seroresponse rates against omicron BA.4/5. Primary analyses were done in a per-protocol manner. The trial is registered with the Japan Registry for Clinical Trials, jRCT2031230340.<h3>Findings</h3>Between Sept 29 and Nov 18, 2023, we enrolled 930 participants (451 men and 479 women) to receive a booster dose of ARCT-2301 (n=465) or Comirnaty BA.4-5 (n=465). The primary immunogenicity outcome to show that the antibody response at day 29 against omicron BA.4/5 elicited by ARCT-2301 was non-inferior to that elicited with Comirnaty BA.4-5 was achieved, both by GMT ratio (1·49, 95% CI 1·26–1·76) and difference in seroresponse rate (7·2%, 95% CI 0·6–13·7). Furthermore, the differences in antibody response between the groups showed superiority for ARCT-2301 against Wuhan-Hu-1 using both criteria, with a GMT ratio of 1·45 (95% CI 1·28–1·63) and a difference in seroresponse ra","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"31 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142488056","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-23DOI: 10.1016/s1473-3099(24)00679-0
Cahal McQuillan
Section snippets
Cholera in Bulgaria
In September, 2024, the Sofia Regional Health Inspectorate registered an imported case of cholera in Bulgaria. This is the first confirmed case of cholera in Bulgaria in 103 years. The patient travelled to New Delhi, India, from Aug 13 to Sept 2, and started experiencing symptoms on Sept 3, upon his return to Bulgaria. His cholera diagnosis was later confirmed by the National Center for Infectious and Parasitic Diseases. The patient was isolated in a private hospital room with its own bathroom
Measles in England
As of Sept 16, 2024, the UK Health Security Agency (UKHSA) reported that there had been 59 new cases of measles confirmed in England in the past 4 weeks. This brings the total number of laboratory-confirmed cases in England since Jan 1, 2024, to 2526, with one reported death—making it the country's biggest outbreak in over a decade. In comparison, there were 362 confirmed cases in England in 2023. According to the UKHSA, 48% of cases in 2024 have been in London, 22% in the West Midlands, and 7%
Marburg virus disease in Rwanda
As of Oct 8, 2024, a total of 58 confirmed cases of Marburg virus disease, including 13 deaths and 12 people who had recovered, had been reported by the Rwanda Biomedical Centre of the Ministry of Health (MoH) in Rwanda. The outbreak was first confirmed by the MoH on Sept 27. On Sept 30, WHO reported that 26 confirmed cases were reported from seven of the country's 30 districts. Health-care workers from two health facilities in Kigali accounted for the majority of confirmed cases. The Sabin
{"title":"Infectious disease surveillance update","authors":"Cahal McQuillan","doi":"10.1016/s1473-3099(24)00679-0","DOIUrl":"https://doi.org/10.1016/s1473-3099(24)00679-0","url":null,"abstract":"<h2>Section snippets</h2><section><section><h2>Cholera in Bulgaria</h2>In September, 2024, the Sofia Regional Health Inspectorate registered an imported case of <span><span>cholera in Bulgaria</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>. This is the first confirmed case of cholera in Bulgaria in 103 years. The patient travelled to New Delhi, India, from Aug 13 to Sept 2, and started experiencing symptoms on Sept 3, upon his return to Bulgaria. His cholera diagnosis was later confirmed by the National Center for Infectious and Parasitic Diseases. The patient was isolated in a private hospital room with its own bathroom</section></section><section><section><h2>Measles in England</h2>As of Sept 16, 2024, the UK Health Security Agency (UKHSA) reported that there had been 59 new cases of <span><span>measles confirmed in England</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span> in the past 4 weeks. This brings the total number of laboratory-confirmed cases in England since Jan 1, 2024, to 2526, with one reported death—making it the country's biggest outbreak in over a decade. In comparison, there were 362 confirmed cases in England in 2023. According to the UKHSA, 48% of cases in 2024 have been in London, 22% in the West Midlands, and 7%</section></section><section><section><h2>Marburg virus disease in Rwanda</h2>As of Oct 8, 2024, a total of 58 confirmed cases of <span><span>Marburg virus disease</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>, including 13 deaths and 12 people who had recovered, had been <span><span>reported</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span> by the Rwanda Biomedical Centre of the Ministry of Health (MoH) in Rwanda. The outbreak was first confirmed by the MoH on Sept 27. On Sept 30, WHO reported that 26 confirmed cases were reported from seven of the country's 30 districts. Health-care workers from two health facilities in Kigali accounted for the majority of confirmed cases. The Sabin</section></section>","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"63 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142488060","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-23DOI: 10.1016/s1473-3099(24)00590-5
Nirianne Marie Q Palacpac, Toshihiro Horii
No Abstract
无摘要
{"title":"Understanding the immunogenicity of RTS,S in infants","authors":"Nirianne Marie Q Palacpac, Toshihiro Horii","doi":"10.1016/s1473-3099(24)00590-5","DOIUrl":"https://doi.org/10.1016/s1473-3099(24)00590-5","url":null,"abstract":"No Abstract","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"125 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142488046","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-23DOI: 10.1016/s1473-3099(24)00593-0
Maarten F Wilbrink, Sander Herfst, Rory D de Vries
No Abstract
无摘要
{"title":"Steps towards licensure of self-amplifying RNA vaccines","authors":"Maarten F Wilbrink, Sander Herfst, Rory D de Vries","doi":"10.1016/s1473-3099(24)00593-0","DOIUrl":"https://doi.org/10.1016/s1473-3099(24)00593-0","url":null,"abstract":"No Abstract","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"17 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142488051","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-23DOI: 10.1016/s1473-3099(24)00685-6
Priya Venkatesan
<h2>Section snippets</h2><section><section><h2>Novel antibodies identified against <em>Klebsiella pneumoniae</em></h2><em>Klebsiella pneumoniae</em>, a common cause of hospital-acquired infections, often infects immunocompromised patients whose adaptive immune system is weakened; however, many of these individuals retain a functioning complement system as part of their innate immunity. Development of complement-enhancing antibodies against specific bacteria may therefore boost the immune response. <span><span>Researchers</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span> in Europe used a dual-staining method of human B memory cells to identify 29 new monoclonal antibodies (mAbs)</section></section><section><section><h2>Fractional doses of pneumococcal vaccines</h2>Many countries cannot afford to sustain the WHO-recommended pneumococcal vaccine programme for infants. Fractional dosing regimens may enable such countries to maintain their vaccination programmes. <span><span>Researchers</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span> in Kenya assessed the immunogenicity of fractional doses versus full doses of GlaxoSmithKline's ten-valent (PCV10) and Pfizer's 13-valent (PCV13) pneumococcal conjugate vaccines in 2100 healthy infants. Participants received two primary doses plus one booster dose of PCV13 or PCV10 given</section></section><section><section><h2>Decline of mpox antibody responses after vaccination</h2>Between 2022 and 2023, <span><span>researchers</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span> assessed the durability of immunity derived from mpox vaccination or infection in individuals who were immunised or infected in 2022, examining serum samples from a US repository from 22 adults who received two vaccine doses, 26 who received one dose, and three who had confirmed mpox infection. The investigators found that whether individuals received either one dose or two doses, binding antibody responses to the mpox antigens M1R, B6R, A35R, A29L, and H3L,</section></section><section><section><h2><em>Helicobacter pylori</em> screening and gastric cancer incidence</h2>In a <span><span>randomised trial</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>, investigators in Taiwan assessed whether inviting individuals to undertake <em>Helicobacter pylori</em> stool antigen screening (HPSA) along with their regular
{"title":"Research in brief","authors":"Priya Venkatesan","doi":"10.1016/s1473-3099(24)00685-6","DOIUrl":"https://doi.org/10.1016/s1473-3099(24)00685-6","url":null,"abstract":"<h2>Section snippets</h2><section><section><h2>Novel antibodies identified against <em>Klebsiella pneumoniae</em></h2><em>Klebsiella pneumoniae</em>, a common cause of hospital-acquired infections, often infects immunocompromised patients whose adaptive immune system is weakened; however, many of these individuals retain a functioning complement system as part of their innate immunity. Development of complement-enhancing antibodies against specific bacteria may therefore boost the immune response. <span><span>Researchers</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span> in Europe used a dual-staining method of human B memory cells to identify 29 new monoclonal antibodies (mAbs)</section></section><section><section><h2>Fractional doses of pneumococcal vaccines</h2>Many countries cannot afford to sustain the WHO-recommended pneumococcal vaccine programme for infants. Fractional dosing regimens may enable such countries to maintain their vaccination programmes. <span><span>Researchers</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span> in Kenya assessed the immunogenicity of fractional doses versus full doses of GlaxoSmithKline's ten-valent (PCV10) and Pfizer's 13-valent (PCV13) pneumococcal conjugate vaccines in 2100 healthy infants. Participants received two primary doses plus one booster dose of PCV13 or PCV10 given</section></section><section><section><h2>Decline of mpox antibody responses after vaccination</h2>Between 2022 and 2023, <span><span>researchers</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span> assessed the durability of immunity derived from mpox vaccination or infection in individuals who were immunised or infected in 2022, examining serum samples from a US repository from 22 adults who received two vaccine doses, 26 who received one dose, and three who had confirmed mpox infection. The investigators found that whether individuals received either one dose or two doses, binding antibody responses to the mpox antigens M1R, B6R, A35R, A29L, and H3L,</section></section><section><section><h2><em>Helicobacter pylori</em> screening and gastric cancer incidence</h2>In a <span><span>randomised trial</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>, investigators in Taiwan assessed whether inviting individuals to undertake <em>Helicobacter pylori</em> stool antigen screening (HPSA) along with their regular ","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"125 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142488055","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-23DOI: 10.1016/s1473-3099(24)00683-2
Alix Boisson-Walsh
No Abstract
无摘要
{"title":"Cholera in Sudan amid war and health system collapse","authors":"Alix Boisson-Walsh","doi":"10.1016/s1473-3099(24)00683-2","DOIUrl":"https://doi.org/10.1016/s1473-3099(24)00683-2","url":null,"abstract":"No Abstract","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"4 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142488054","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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