The latform Trial n VID-19 Priming and sting (PICOBOO): The immunogenicity, reactogenicity, and safety of different COVID-19 vaccinations administered as a second booster (fourth dose) in AZD1222 primed individuals aged 50-<70 years old - 06/12/24

Doi : 10.1016/j.jinf.2024.106286

C. McLeod ^a,^b,^c,^⁎,^{^{1
Contributed equally as first authors.}} , M. Dymock ^a,^{^{1
Contributed equally as first authors.}}, K.L. Flanagan ^d,^e,^f, M. Plebanski ^f, H. Marshall ^g,^h, M.J. Estcourt ⁱ, M.C. Tjiam ^a, C.C. Blyth ^a,^b,^c,^j, K. Subbarao ^k,^l, F.L. Mordant ^l, S. Nicholson ^m,ⁿ, S.N. Faust ^o,^p, U. Wadia ^a,^b,^q, R.B. Thornton ^a, Z. Ellis ^a, A. Mckenzie ^a, J.A. Marsh ^a,^c, T.L. Snelling ⁱ, P. Richmond ^a,^c,^q,^r
^a Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Nedlands, Australia
^b Infectious Diseases Department, Perth Children’s Hospital, Nedlands, Australia
^c School of Medicine, University of Western Australia, Crawley, Australia
^d Tasmanian Vaccine Trial Centre, Clifford Craig Foundation, Launceston General Hospital, Tasmania, Australia
^e School of Health Sciences, College of Health and Medicine, University of Tasmania, Launceston, Tasmania, Australia
^f School of Health and Biomedical Sciences, Royal Melbourne Institute of Technology University (RMIT), Melbourne, Australia
^g Women’s and Children’s Health Network, North Adelaide, Australia
^h Robinson Research Institute and Adelaide Medical School, The University of Adelaide, Australia
ⁱ Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Australia
^j Department of Microbiology, Pathwest Laboratory Medicine WA, QEII Medical Centre, Nedlands, Australia
^k WHO Collaborating Centre for Reference and Research on Influenza, University of Melbourne, Parkville, Victoria, Australia
^l Department of Microbiology and Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia
^m Victorian Infectious Diseases Reference Laboratory, The Royal Melbourne Hospital at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia
ⁿ Department of Infectious Diseases, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia
^o National Institute of Health Research Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom
^p Faculty of Medicine and Institute for Life Sciences, University of Southampton, United Kingdom
^q Centre for Child Health Research, University of Western Australia, Crawley, Australia
^r General Paediatrics and Immunology Departments, Perth Children’s Hospital, Nedlands, Australia

^⁎Corresponding author at: Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Nedlands, Australia.Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids InstituteNedlandsAustralia

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Summary

Objectives

PICOBOO is a randomised, adaptive trial evaluating the immunogenicity, reactogenicity, and safety of COVID-19 booster strategies. We report data for second boosters among individuals 50-<70 years old primed with AZD1222 (50-<70y-AZD1222) until Day 84.

Methods

Immunocompetent adults who received any first booster ≥three months prior were eligible. Participants were randomly allocated to BNT162b2, mRNA-1273 or NVX-CoV2373 1:1:1. The concentrations of ancestral anti-spike immunoglobulin were summarised as the geometric mean concentrations (GMC). Reactogenicity and safety outcomes were captured. Additional analyses including neutralising antibodies were performed on a subset. ACTRN12622000238774.

Results

Between Mar 2022 and Aug 2023, 743 participants were recruited and had D28 samples; 155 belonged to the 50-<70y-AZD1222 stratum. The mean adjusted GMCs (95% credible intervals) were 20,690 (17 555−23 883), 23,867 (20 144−27 604) and 8654 (7267−9962) U/mL at D28 following boosting with BNT162b2, mRNA-1273 and NVX-CoV2372, respectively, and 10,976 (8826−13 196), 15,779 (12 512−19 070) and 6559 (5220−7937) U/mL by D84. IgG against Omicron BA.5 was 2.7–2.9 times lower than the ancestral strain. Limited neutralisation against Omicron subvariants was found following all vaccines. Severe reactogenicity events were <4%.

Conclusions

All vaccines were immunogenic with more rapid waning after mRNA vaccines. These data support boosting with vaccines with greater specificity for circulating Omicron subvariants.

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Highlights

•	These are the first comparative RCT data evaluating second booster mRNA and protein subunit COVID-19 vaccines.
•	BNT162b2, mRNA-1273 and NVX-CoV2372 were well tolerated and boosted humoral immune responses until Day 84.
•	Higher antibodies against SARS-CoV-2 were found following boosting with mRNA vaccines compared to NVX-CoV2372 until Day 84.
•	Lower neutralisation against Omicron subvariants BA.5 and XBB.1.5 was observed following all vaccines until Day 84.
•	These data highlight the need for boosting with vaccines with greater specificity for Omicron subvariants.

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Keywords : COVID-19, Adaptive trial, Immunisation, Policy

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Vol 89 - N° 6

Article 106286- décembre 2024 Retour au numéro

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The latform Trial n VID-19 Priming and sting (PICOBOO): The immunogenicity, reactogenicity, and safety of different COVID-19 vaccinations administered as a second booster (fourth dose) in AZD1222 primed individuals aged 50-<70 years old - 06/12/24

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