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The Platform Trial In COVID-19 Priming and BOOsting (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

The Platform Trial In COVID-19 Priming and BOOsting (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
The Platform Trial In COVID-19 Priming and BOOsting (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

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.

Adaptive trial, COVID-19, Immunisation, Policy
0163-4453
McLeod, C.
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Dymock, M.
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Flanagan, K.L.
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Plebanski, M.
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Marshall, H.
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Estcourt, M.J.
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Tjiam, M.C.
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Blyth, C.C.
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Subbarao, K.
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Mordant, F.L.
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Nicholson, S.
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Faust, S.N.
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Wadia, U.
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Thornton, R.B.
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Ellis, Z.
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Mckenzie, A.
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Marsh, J.A.
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Snelling, T.L.
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Richmond, P.
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McLeod, C.
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Dymock, M.
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Flanagan, K.L.
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Plebanski, M.
107e6993-565b-4cf5-becd-62d73e6c7b5a
Marshall, H.
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Estcourt, M.J.
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Tjiam, M.C.
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Blyth, C.C.
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Subbarao, K.
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Mordant, F.L.
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Nicholson, S.
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Faust, S.N.
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Wadia, U.
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Thornton, R.B.
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Ellis, Z.
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Mckenzie, A.
c3c47143-2635-4436-b168-0d911d08825f
Marsh, J.A.
eb7367ec-757a-4e1b-bfbf-7266180e3898
Snelling, T.L.
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Richmond, P.
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McLeod, C., Dymock, M., Flanagan, K.L., Plebanski, M., Marshall, H., Estcourt, M.J., Tjiam, M.C., Blyth, C.C., Subbarao, K., Mordant, F.L., Nicholson, S., Faust, S.N., Wadia, U., Thornton, R.B., Ellis, Z., Mckenzie, A., Marsh, J.A., Snelling, T.L. and Richmond, P. (2024) The Platform Trial In COVID-19 Priming and BOOsting (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. Journal of Infection, 89 (6), [106286]. (doi:10.1016/j.jinf.2024.106286).

Record type: Article

Abstract

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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Accepted/In Press date: 21 September 2024
e-pub ahead of print date: 26 September 2024
Published date: 15 October 2024
Keywords: Adaptive trial, COVID-19, Immunisation, Policy

Identifiers

Local EPrints ID: 495824
URI: http://eprints.soton.ac.uk/id/eprint/495824
ISSN: 0163-4453
PURE UUID: a9cc2ddd-ab29-48ee-8c64-42baf30aae68
ORCID for S.N. Faust: ORCID iD orcid.org/0000-0003-3410-7642

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Date deposited: 25 Nov 2024 17:35
Last modified: 26 Nov 2024 02:41

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Contributors

Author: C. McLeod
Author: M. Dymock
Author: K.L. Flanagan
Author: M. Plebanski
Author: H. Marshall
Author: M.J. Estcourt
Author: M.C. Tjiam
Author: C.C. Blyth
Author: K. Subbarao
Author: F.L. Mordant
Author: S. Nicholson
Author: S.N. Faust ORCID iD
Author: U. Wadia
Author: R.B. Thornton
Author: Z. Ellis
Author: A. Mckenzie
Author: J.A. Marsh
Author: T.L. Snelling
Author: P. Richmond

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