Immunogenicity, reactogenicity, and safety of a second booster with BNT162b2 or full-dose mRNA-1273: A randomized VACCELERATE trial in adults aged ≥75 years (EU-COVAT-1-AGED Part B).
Int J Infect Dis
; 146: 107161, 2024 Sep.
Article
em En
| MEDLINE
| ID: mdl-38992789
ABSTRACT
OBJECTIVES:
To assess the safety and immunogenicity of a fourth vaccination (second booster) in individuals aged ≥75 years.METHODS:
Participants were randomized to BNT162b2 (Comirnaty, 30 µg) or messenger RNA (mRNA)-1273 (Spikevax, 100 µg). The primary end point was the rate of two-fold antibody titer increase 14 days after vaccination, targeting the receptor binding domain (RBD) region of wild-type SARS-CoV-2. The secondary end points included changes in neutralizing activity against wild-type and 25 variants. Safety was assessed by monitoring solicited adverse events (AEs) for 7 days.RESULTS:
A total of 269 participants (mean age 81 years, mRNA-1273 n = 135/BNT162b2 n = 134) were included. Two-fold anti-RBD immunoglobulin (Ig) G titer increase was achieved by 101 of 129 (78%) and 116 of 133 (87%) subjects in the BNT162b2 and the mRNA-1273 group, respectively (P = 0.054). A second booster of mRNA-1273 provided higher anti-RBD IgG geometric mean titer 21.326 IU/mL (95% confidence interval 18.235-24.940) vs BNT162b2 15.181 IU/mL (95% confidence interval 13.172-17.497). A higher neutralizing activity was noted for the mRNA-1273 group. The most frequent AE was pain at the injection site (51% in mRNA-1273 and 48% in BNT162b2). Participants in the mRNA-1273 group had less vaccine-related AEs (30% vs 39%).CONCLUSIONS:
A second booster of either BNT162b2 or mRNA-1273 provided substantial IgG increase. Full-dose mRNA-1273 provided higher IgG levels and neutralizing capacity against SARS-CoV-2, with similar safety profile for subjects of advanced age.Palavras-chave
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Imunização Secundária
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Anticorpos Neutralizantes
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Imunogenicidade da Vacina
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SARS-CoV-2
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COVID-19
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Vacina BNT162
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Vacina de mRNA-1273 contra 2019-nCoV
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Anticorpos Antivirais
Limite:
Aged
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Aged80
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Female
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Humans
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Male
Idioma:
En
Ano de publicação:
2024
Tipo de documento:
Article