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

被引：0

作者：

Mcleod, C. ^{[1
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Dymock, M. ^{[1
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Flanagan, Kl ^{[6
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,20
,23
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Plebanski, M. ^{[8
]}

Marshall, Hs ^{[9
,10
,11
]}

Estcourt, Mj ^{[4
]}

Wadia, U. ^{[1
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,3
]}

Tjiam, Mc ^{[1
]}

Blyth, Cc ^{[1
,2
,3
,12
]}

Subbarao, K. ^{[13
,14
]}

Mordant, Fl ^{[14
]}

Nicholson, S. ^{[15
,16
]}

Cain, N. ^{[14
]}

Brizuela, R. ^{[14
]}

Faust, Sn ^{[17
,18
,19
]}

Thornton, Rb ^{[1
,3
]}

Ellis, Z. ^{[1
]}

Mckenzie, A. ^{[21
]}

Marsh, Ja ^{[1
,3
]}

Snelling, Tl ^{[4
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Richmond, Pc ^{[1
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]}

机构：

[1] Wesfarmers Ctr Vaccines & Infect Dis, Kids Res Inst Australia, Nedlands, Australia

[2] Perth Childrens Hosp, Dept Infect Dis, Nedlands, WA, Australia

[3] Univ Western Australia, Ctr Child Hlth Res, Crawley, Australia

[4] Univ Sydney, Fac Med & Hlth, Sydney Sch Publ Hlth, Sydney, Australia

[5] Univ Western Australia, Sch Populat & Global Hlth, Nedlands, Australia

[6] Launceston Gen Hosp, Clifford Craig Fdn, Tasmanian Vaccine Trial Ctr, Hobart, Australia

[7] Univ Tasmania, Coll Hlth & Med, Sch Hlth Sci, Launceston, Tas, Australia

[8] Royal Melbourne Inst Technol RMIT Univ, Sch Sci, Melbourne, Vic, Australia

[9] Womens & Childrens Hlth Network, North Adelaide, Australia

[10] Univ Adelaide, Robinson Res Inst, Adelaide, Australia

[11] Univ Adelaide, Adelaide Med Sch, Adelaide, Australia

[12] QEII Med Ctr, PathWest Lab Med WA, Dept Microbiol, Nedlands, Australia

[13] WHO Collaborating Ctr Reference & Res Influenza, Parkville, Vic, Australia

[14] Univ Melbourne, Peter Doherty Inst Infect & Immun, Dept Microbiol & Immunol, Melbourne, Australia

[15] Royal Melbourne Hosp, Peter Doherty Inst Infect & Immun, Victorian Infect Dis Reference Lab, Melbourne, Australia

[16] Univ Melbourne, Peter Doherty Inst Infect & Immun, Dept Infect Dis, Melbourne, Australia

[17] Univ Hosp Southampton NHS Fdn Trust, Southampton Clin Res Facil, Natl Inst Hlth Res, Southampton, England

[18] Univ Hosp Southampton NHS Fdn Trust, Biomed Res Ctr, Southampton, England

[19] Univ Southampton, Fac Med, Southampton, England

[20] Univ Southampton, Inst Life Sci, Southampton, England

[21] Kids Res Inst Australia, Nedlands, Australia

[22] Perth Childrens Hosp, Gen Paediat Dept, Nedlands, WA, Australia

[23] Perth Childrens Hosp, Immunol Dept, Nedlands, Australia

来源：

JOURNAL OF INFECTION | 2024年 / 89卷 / 06期

基金：

澳大利亚国家健康与医学研究理事会;

关键词：

COVID-19; Vaccination; Adaptive trial; Policy; Immunisation; SARS-COV-2; VACCINES;

D O I：

10.1016/j.jinf.2024.106346

中图分类号：

R51 [传染病];

学科分类号：

100401 ;

摘要：

Objectives: PICOBOO is a randomised, adaptive trial evaluating the immunogenicity, reactogenicity, and safety of COVID-19 booster strategies. Here, we present 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 log(10) 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 were recruited to the trial and had D28 samples available. Of these, 120 and 103 belonged to the 18-<50 y and 50-<70 y 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-<50 y 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-<70 y 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-<50 y stratum and 5 events in the 50-<70 y 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. (c) 2024 Published by Elsevier Ltd on behalf of The British Infection Association. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

引用

页数：10

共 47 条

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