Randomised controlled trial reveals no benefit to a 3-month delay in COVID-19 mRNA booster vaccine.

Lee, Wen Shi; Audsley, Jennifer; Trieu, Mai-Chi; Reynaldi, Arnold; Aurelia, L Carissa; Mehta, Palak H; Patterson, Joanne; Kent, Helen E; Nguyen, Julie; Amarasena, Thakshila; Esterbauer, Robyn; Haycroft, Ebene R; Ramanathan, Pradhipa; Davenport, Miles P; Schlub, Timothy E; Sasadeusz, Joseph; Wheatley, Adam K; Chung, Amy W; Juno, Jennifer A; Selva, Kevin J; Kent, Stephen J

Lee, Wen Shi; Audsley, Jennifer; Trieu, Mai-Chi; Reynaldi, Arnold; Aurelia, L Carissa; Mehta, Palak H; Patterson, Joanne; Kent, Helen E; Nguyen, Julie; Amarasena, Thakshila; Esterbauer, Robyn; Haycroft, Ebene R; Ramanathan, Pradhipa; Davenport, Miles P; Schlub, Timothy E; Sasadeusz, Joseph; Wheatley, Adam K; Chung, Amy W; Juno, Jennifer A; Selva, Kevin J; Kent, Stephen J.

Afiliação

Lee WS; Microbiology and Immunology, University of Melbourne, Melbourne, Australia.
Audsley J; Peter Doherty Institute for Infection and Immunity, University of Melbourne and Royal Melbourne Hospital, Melbourne, Australia.
Trieu MC; Microbiology and Immunology, University of Melbourne, Melbourne, Australia.
Reynaldi A; Kirby Institute, University of New South Wales, Kensington, Australia.
Aurelia LC; Microbiology and Immunology, University of Melbourne, Melbourne, Australia.
Mehta PH; Microbiology and Immunology, University of Melbourne, Melbourne, Australia.
Patterson J; Victorian Infectious Diseases Service, Royal Melbourne Hospital, Melbourne, Australia.
Kent HE; Microbiology and Immunology, University of Melbourne, Melbourne, Australia.
Nguyen J; Microbiology and Immunology, University of Melbourne, Melbourne, Australia.
Amarasena T; Microbiology and Immunology, University of Melbourne, Melbourne, Australia.
Esterbauer R; Microbiology and Immunology, University of Melbourne, Melbourne, Australia.
Haycroft ER; Microbiology and Immunology, University of Melbourne, Melbourne, Australia.
Ramanathan P; Microbiology and Immunology, University of Melbourne, Melbourne, Australia.
Davenport MP; Kirby Institute, University of New South Wales, Kensington, Australia.
Schlub TE; Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, Australia.
Sasadeusz J; Peter Doherty Institute for Infection and Immunity, University of Melbourne and Royal Melbourne Hospital, Melbourne, Australia.
Wheatley AK; Microbiology and Immunology, University of Melbourne, Melbourne, Australia.
Chung AW; Microbiology and Immunology, University of Melbourne, Melbourne, Australia.
Juno JA; Microbiology and Immunology, University of Melbourne, Melbourne, Australia.
Selva KJ; Microbiology and Immunology, University of Melbourne, Melbourne, Australia.
Kent SJ; Microbiology and Immunology, University of Melbourne, Melbourne, Australia.

J Clin Invest ; 2024 Jul 11.

Article em En | MEDLINE | ID: mdl-38990644

ABSTRACT

ABSTRACT

BACKGROUND:

There is uncertainty around the timing of booster vaccination against COVID-19 in highly vaccinated populations during the present endemic phase of COVID-19. Studies focused on primary vaccination have previously suggested improved immunity after delaying immunisation.

METHODS:

We conducted a randomised controlled trial (Nov 2022 - Aug 2023) and assigned 52 fully vaccinated adults to an immediate or a 3-month delayed bivalent Spikevax mRNA booster vaccine. Follow-up visits were completed for 48 participants (n = 24 per arm), with saliva and plasma samples collected following each visit.

RESULTS:

The rise in neutralising antibody responses to ancestral and Omicron strains were almost identical between the immediate and delayed vaccination arms. Analyses of plasma and salivary antibody responses (IgG, IgA), plasma antibody-dependent phagocytic activity, and the decay kinetics of antibody responses were similar between the 2 arms. Symptomatic and asymptomatic SARS-CoV-2 infection occurred in 49% (21/49) participants over the median 11.5 months of follow up and were also similar between the 2 arms.

CONCLUSIONS:

Our data suggests no benefit from delaying COVID-19 mRNA booster vaccination in pre-immune populations during the present endemic phase of COVID-19TRIAL REGISTRATION. Australian New Zealand Clinical Trials Registry number 12622000411741.