Vaccine · 2026
The Platform trial In COVID-19 priming and BOOsting (PICOBOO): The immunogenicity, reactogenicity and safety of seven licensed COVID-19 vaccines delivered as fifth dose or subsequent boosters in immunocompetent adults.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
C McLeod, Dymock M, Flanagan K L, Plebanski M, Marshall H, Estcourt M J, Tjiam M C, Blyth C C, Subbarao K, Mordant F L, Wilson K, Nicholson S, Karapanagiotidis T, Faust S N, Wadia U, Thornton R B, Tansil S, Tedja C, Ellis Z, Williams P C M, McKenzie A, Marsh J A, McCallum C, Snelling T L, Richmond P
Аннотация
BACKGROUND: PICOBOO is a randomised, adaptive trial evaluating the immunogenicity and reactogenicity of licensed COVID-19 booster vaccines in immunocompetent individuals >12 years old. Here, we present data for seven different vaccines among three pre-specified participant strata defined by age and primary vaccine schedule: those primed with AZD1222 and aged 50 - < 70 or 70+ years old and those primed with BNT162b2 aged 50- < 70 years old until day (D) 365.
METHODS: People who had not received a booster vaccine in the three months prior were eligible. Participants were recruited from January to November 2023 (T1) and from January to September 2024 (T2). Participants recruited during T1 were randomised to receive one of five COVID-19 booster vaccines. Participants recruited during T2 were randomised to receive one of two monovalent XBB.1.5 booster vaccines. Anti-spike Immunoglobulin G (IgG) responses were evaluated in all participants. Anti-spike total Ig was evaluated in participants recruited during T1. Neutralisation responses were evaluated in a pre-defined subset.
FINDINGS: There were 276 and 260 participants recruited in T1 and T2, respectively. All vaccines boosted humoral immune responses. Immunological responses measures at D28, 180 and 365 found peak total immunoglobulin (Ig), IgG and virus neutralisation (ND50) responses at D28. Responses returned to near-baseline levels by D365. Participants in the 50- < 70y-BNT162b2 stratum had higher total Ig, IgG and ND50 compared to those in the strata primed with AZD1222. The proportion who reported at least one severe event following Nvx, Pf BA.1, Mod BA.1, Pf BA.4/5, Mod BA.4/5, Pf XBB.1.5 and Mod XBB.1.5 were 1.1%, 2.9%, 6.7%, 0%, 5.9%, 2.9% and 5.4%, respectively.
INTERPRETATION: All vaccines boosted humoral immunity and had acceptable reactogenicity profiles. Higher binding and neutralising antibody responses were observed in people primed with BNT162b2.
METHODS: People who had not received a booster vaccine in the three months prior were eligible. Participants were recruited from January to November 2023 (T1) and from January to September 2024 (T2). Participants recruited during T1 were randomised to receive one of five COVID-19 booster vaccines. Participants recruited during T2 were randomised to receive one of two monovalent XBB.1.5 booster vaccines. Anti-spike Immunoglobulin G (IgG) responses were evaluated in all participants. Anti-spike total Ig was evaluated in participants recruited during T1. Neutralisation responses were evaluated in a pre-defined subset.
FINDINGS: There were 276 and 260 participants recruited in T1 and T2, respectively. All vaccines boosted humoral immune responses. Immunological responses measures at D28, 180 and 365 found peak total immunoglobulin (Ig), IgG and virus neutralisation (ND50) responses at D28. Responses returned to near-baseline levels by D365. Participants in the 50- < 70y-BNT162b2 stratum had higher total Ig, IgG and ND50 compared to those in the strata primed with AZD1222. The proportion who reported at least one severe event following Nvx, Pf BA.1, Mod BA.1, Pf BA.4/5, Mod BA.4/5, Pf XBB.1.5 and Mod XBB.1.5 were 1.1%, 2.9%, 6.7%, 0%, 5.9%, 2.9% and 5.4%, respectively.
INTERPRETATION: All vaccines boosted humoral immunity and had acceptable reactogenicity profiles. Higher binding and neutralising antibody responses were observed in people primed with BNT162b2.