C McLeod, M Dymock, K L Flanagan, M Plebanski, H S Marshall, M J Estcourt, U Wadia, M C Tjiam, C C Blyth, K Subbarao, F L Mordant, S Nicholson, N Cain, R Brizuela, S N Faust, R B Thornton, Z Ellis, A Mckenzie, J A Marsh, T L Snelling, P C Richmond
{"title":"COVID-19 接种和加强接种平台试验（PICOBOO）：对 18-<50 岁和 50-<70 岁的 BNT162b2 接种者进行 COVID-19 疫苗接种作为第二次加强接种的免疫原性、反应原性和安全性试验。","authors":"C McLeod, M Dymock, K L Flanagan, M Plebanski, H S Marshall, M J Estcourt, U Wadia, M C Tjiam, C C Blyth, K Subbarao, F L Mordant, S Nicholson, N Cain, R Brizuela, S N Faust, R B Thornton, Z Ellis, A Mckenzie, J A Marsh, T L Snelling, P C Richmond","doi":"10.1016/j.jinf.2024.106346","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>PICOBOO is a randomised, adaptive trial evaluating the immunogenicity, reactogenicity, and safety of COVID-19 booster strategies. Here, we data for second boosters among individuals aged 18-<50 and 50-<70 years old primed with BNT162b2 until Day (D) 84.</p><p><strong>Methods: </strong>Immunocompetent adults who had received two doses of BNT162b2 and any licensed COVID-19 booster at least three months prior were eligible. Participants were randomly allocated to BNT162b2, mRNA-1273 or NVX-CoV2373 1:1:1. The log<sub>10</sub> concentration of anti-spike Ig Total was summarised as the geometric mean concentration (GMC). Reactogenicity and safety outcomes were captured.</p><p><strong>Results: </strong>Between Mar 2022 and Aug 2023, 743 participants recruited to the trial had D28 samples available. Of these, 120 and 103 belonged to the 18-<50y and 50-<70y strata, respectively. The mean adjusted GMCs (95% credible intervals) peaked at D28; these were 41 262 (31 611, 51 105), 45 585 (34 194, 57 441) and 25 281 (20 021, 31 234) U/mL in the 18-<50y stratum and 30 753 (25 071, 36 704), 35 132 (27 523, 42 239) and 17 322 (13 983, 20 641) U/mL in the 50-<70y stratum following BNT162b2, mRNA-1273 and NVX-CoV2373, respectively. Limited neutralisation against Omicron subvariants was found following boosting with all vaccines. There were 4 possibly or probably-related adverse events in the 18-<50y stratum and 5 events in the 50-<70y stratum, and severe reactogenicity events were <10% and <11% in these strata, respectively.</p><p><strong>Conclusions: </strong>Vaccines targeting Ancestral virus elicited boosted antibody responses to Ancestral virus but minimal neutralising antibody against Omicron variants.</p>","PeriodicalId":50180,"journal":{"name":"Journal of Infection","volume":" ","pages":"106346"},"PeriodicalIF":14.3000,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The Platform Trial In COVID-19 priming and BOOsting (PICOBOO): the immunogenicity, reactogenicity, and safety of licensed COVID-19 vaccinations administered as a second booster in BNT162b2 primed individuals aged 18-<50 and 50-<70 years old.\",\"authors\":\"C McLeod, M Dymock, K L Flanagan, M Plebanski, H S Marshall, M J Estcourt, U Wadia, M C Tjiam, C C Blyth, K Subbarao, F L Mordant, S Nicholson, N Cain, R Brizuela, S N Faust, R B Thornton, Z Ellis, A Mckenzie, J A Marsh, T L Snelling, P C Richmond\",\"doi\":\"10.1016/j.jinf.2024.106346\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>PICOBOO is a randomised, adaptive trial evaluating the immunogenicity, reactogenicity, and safety of COVID-19 booster strategies. Here, we data for second boosters among individuals aged 18-<50 and 50-<70 years old primed with BNT162b2 until Day (D) 84.</p><p><strong>Methods: </strong>Immunocompetent adults who had received two doses of BNT162b2 and any licensed COVID-19 booster at least three months prior were eligible. Participants were randomly allocated to BNT162b2, mRNA-1273 or NVX-CoV2373 1:1:1. The log<sub>10</sub> concentration of anti-spike Ig Total was summarised as the geometric mean concentration (GMC). Reactogenicity and safety outcomes were captured.</p><p><strong>Results: </strong>Between Mar 2022 and Aug 2023, 743 participants recruited to the trial had D28 samples available. Of these, 120 and 103 belonged to the 18-<50y and 50-<70y strata, respectively. The mean adjusted GMCs (95% credible intervals) peaked at D28; these were 41 262 (31 611, 51 105), 45 585 (34 194, 57 441) and 25 281 (20 021, 31 234) U/mL in the 18-<50y stratum and 30 753 (25 071, 36 704), 35 132 (27 523, 42 239) and 17 322 (13 983, 20 641) U/mL in the 50-<70y stratum following BNT162b2, mRNA-1273 and NVX-CoV2373, respectively. Limited neutralisation against Omicron subvariants was found following boosting with all vaccines. There were 4 possibly or probably-related adverse events in the 18-<50y stratum and 5 events in the 50-<70y stratum, and severe reactogenicity events were <10% and <11% in these strata, respectively.</p><p><strong>Conclusions: </strong>Vaccines targeting Ancestral virus elicited boosted antibody responses to Ancestral virus but minimal neutralising antibody against Omicron variants.</p>\",\"PeriodicalId\":50180,\"journal\":{\"name\":\"Journal of Infection\",\"volume\":\" \",\"pages\":\"106346\"},\"PeriodicalIF\":14.3000,\"publicationDate\":\"2024-11-14\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Infection\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.jinf.2024.106346\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"INFECTIOUS DISEASES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Infection","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.jinf.2024.106346","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
The Platform Trial In COVID-19 priming and BOOsting (PICOBOO): the immunogenicity, reactogenicity, and safety of licensed COVID-19 vaccinations administered as a second booster in BNT162b2 primed individuals aged 18-<50 and 50-<70 years old.
Objectives: PICOBOO is a randomised, adaptive trial evaluating the immunogenicity, reactogenicity, and safety of COVID-19 booster strategies. Here, we data for second boosters among individuals aged 18-<50 and 50-<70 years old primed with BNT162b2 until Day (D) 84.
Methods: Immunocompetent adults who had received two doses of BNT162b2 and any licensed COVID-19 booster at least three months prior were eligible. Participants were randomly allocated to BNT162b2, mRNA-1273 or NVX-CoV2373 1:1:1. The log10 concentration of anti-spike Ig Total was summarised as the geometric mean concentration (GMC). Reactogenicity and safety outcomes were captured.
Results: Between Mar 2022 and Aug 2023, 743 participants recruited to the trial had D28 samples available. Of these, 120 and 103 belonged to the 18-<50y and 50-<70y strata, respectively. The mean adjusted GMCs (95% credible intervals) peaked at D28; these were 41 262 (31 611, 51 105), 45 585 (34 194, 57 441) and 25 281 (20 021, 31 234) U/mL in the 18-<50y stratum and 30 753 (25 071, 36 704), 35 132 (27 523, 42 239) and 17 322 (13 983, 20 641) U/mL in the 50-<70y stratum following BNT162b2, mRNA-1273 and NVX-CoV2373, respectively. Limited neutralisation against Omicron subvariants was found following boosting with all vaccines. There were 4 possibly or probably-related adverse events in the 18-<50y stratum and 5 events in the 50-<70y stratum, and severe reactogenicity events were <10% and <11% in these strata, respectively.
Conclusions: Vaccines targeting Ancestral virus elicited boosted antibody responses to Ancestral virus but minimal neutralising antibody against Omicron variants.
期刊介绍：
The Journal of Infection publishes original papers on all aspects of infection - clinical, microbiological and epidemiological. The Journal seeks to bring together knowledge from all specialties involved in infection research and clinical practice, and present the best work in the ever-changing field of infection.
Each issue brings you Editorials that describe current or controversial topics of interest, high quality Reviews to keep you in touch with the latest developments in specific fields of interest, an Epidemiology section reporting studies in the hospital and the general community, and a lively correspondence section.
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