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

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

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

J Infect. 2024 Dec;89(6):106346. doi: 10.1016/j.jinf.2024.106346. Epub 2024 Nov 15.

Authors

C McLeod¹, M Dymock², K L Flanagan³, M Plebanski⁴, H S Marshall⁵, M J Estcourt⁶, U Wadia⁷, M C Tjiam⁸, C C Blyth⁹, K Subbarao¹⁰, F L Mordant¹¹, S Nicholson¹², N Cain¹¹, R Brizuela¹¹, S N Faust¹³, R B Thornton¹⁴, Z Ellis⁸, A Mckenzie¹⁵, J A Marsh¹⁴, T L Snelling⁶, P C Richmond¹⁶

Affiliations

¹ Wesfarmers Centre of Vaccines and Infectious Diseases, The Kids Research Institute of Australia, Nedlands, Australia; Infectious Diseases Department, Perth Children's Hospital, Nedlands, Australia; Centre for Child Health Research, University of Western Australia, Crawley, Australia; Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Australia. Electronic address: charlie.mcleod@health.wa.gov.au.
² Wesfarmers Centre of Vaccines and Infectious Diseases, The Kids Research Institute of Australia, Nedlands, Australia; School of Population and Global Health, University of Western Australia, Nedlands, Australia.
³ Tasmanian Vaccine Trial Centre, Clifford Craig Foundation, Launceston General Hospital, Tasmania, Australia; School of Health Sciences, College of Health and Medicine, University of Tasmania, Launceston, Tasmania, Australia; School of Health and Biomedical Sciences, Royal Melbourne Institute of Technology University (RMIT), Melbourne, Australia.
⁴ School of Health and Biomedical Sciences, Royal Melbourne Institute of Technology University (RMIT), Melbourne, Australia.
⁵ Women's and Children's Health Network, North Adelaide, Australia; Robinson Research Institute and Adelaide Medical School, The University of Adelaide, Australia.
⁶ Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Australia.
⁷ Wesfarmers Centre of Vaccines and Infectious Diseases, The Kids Research Institute of Australia, Nedlands, Australia; Infectious Diseases Department, Perth Children's Hospital, Nedlands, Australia; Centre for Child Health Research, University of Western Australia, Crawley, Australia.
⁸ Wesfarmers Centre of Vaccines and Infectious Diseases, The Kids Research Institute of Australia, Nedlands, Australia.
⁹ Wesfarmers Centre of Vaccines and Infectious Diseases, The Kids Research Institute of Australia, Nedlands, Australia; Infectious Diseases Department, Perth Children's Hospital, Nedlands, Australia; Centre for Child Health Research, University of Western Australia, Crawley, Australia; Department of Microbiology, Pathwest Laboratory Medicine WA, QEII Medical Centre, Nedlands, Australia.
¹⁰ WHO Collaborating Centre for Reference and Research on Influenza, University of Melbourne, Parkville, Victoria, Australia; Department of Microbiology and Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
¹¹ Department of Microbiology and Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
¹² Victorian Infectious Diseases Reference Laboratory, The Royal Melbourne Hospital at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia; Department of Infectious Diseases, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
¹³ National Institute of Health Research Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom; Faculty of Medicine and Institute for Life Sciences, University of Southampton, United Kingdom.
¹⁴ Wesfarmers Centre of Vaccines and Infectious Diseases, The Kids Research Institute of Australia, Nedlands, Australia; Centre for Child Health Research, University of Western Australia, Crawley, Australia.
¹⁵ The Kids Research Institute of Australia, Nedlands, Australia.
¹⁶ Wesfarmers Centre of Vaccines and Infectious Diseases, The Kids Research Institute of Australia, Nedlands, Australia; Centre for Child Health Research, University of Western Australia, Crawley, Australia; Centre for Child Health Research, University of Western Australia, Crawley, Australia; General Paediatrics and Immunology Departments, Perth Children's Hospital, Nedlands, Australia.

PMID: 39550007
DOI: 10.1016/j.jinf.2024.106346

Abstract

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 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 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.

Keywords: Adaptive trial; COVID-19; Immunisation; Policy; Vaccination.

Publication types

Randomized Controlled Trial

MeSH terms

2019-nCoV Vaccine mRNA-1273 / immunology
Adolescent
Adult
Aged
Antibodies, Neutralizing / blood
Antibodies, Viral* / blood
BNT162 Vaccine* / immunology
COVID-19 Vaccines* / administration & dosage
COVID-19 Vaccines* / adverse effects
COVID-19 Vaccines* / immunology
COVID-19* / immunology
COVID-19* / prevention & control
Female
Humans
Immunization, Secondary*
Immunogenicity, Vaccine*
Male
Middle Aged
SARS-CoV-2* / immunology
Vaccination / methods
Young Adult

Substances

BNT162 Vaccine
Antibodies, Viral
COVID-19 Vaccines
Antibodies, Neutralizing
2019-nCoV Vaccine mRNA-1273
NVX-CoV2373 adjuvated lipid nanoparticle