tetano
Editor, Senior Moderator
Hum Vaccin Immunother
. 2024 Dec 31;20(1):2327736.
doi: 10.1080/21645515.2024.2327736. Epub 2024 Mar 21. No immunological interference or concerns about safety when seasonal quadrivalent influenza vaccine is co-administered with a COVID-19 mRNA-1273 booster vaccine in adults: A randomized trial
Abdi Naficy[SUP] 1 [/SUP], Adrienne Kuxhausen[SUP] 1 [/SUP], Harry Seifert[SUP] 1 [/SUP], Andrew Hastie[SUP] 1 [/SUP], Brett Leav[SUP] 2 [/SUP], Jacqueline Miller[SUP] 2 [/SUP], Kate Anteyi[SUP] 2 [/SUP], Agnes Mwakingwe-Omari[SUP] 1 [/SUP]
Affiliations
The objective of the study was to assess the safety and immunogenicity of mRNA-1273 COVID-19 booster vaccination when co-administered with an egg-based standard dose seasonal quadrivalent influenza vaccine (QIV). This was a phase 3, randomized, open-label study. Eligible adults aged ≥ 18 years were randomly assigned (1:1) to receive mRNA-1273 (50 µg) booster vaccination and QIV 2 weeks apart (Seq group) or concomitantly (Coad group). Primary objectives were non-inferiority of haemagglutinin inhibition (HI) and anti-Spike protein antibody responses in the Coad compared to Seq group. 497/498 participants were randomized and vaccinated in the Seq/Coad groups, respectively. The adjusted geometric mean titer/concentration ratios (95% confidence intervals) (Seq/Coad) for HI antibodies were 1.02 (0.89-1.18) for A/H1N1, 0.93 (0.82-1.05) for A/H3N2, 1.00 (0.89-1.14] for B/Victoria, and 1.04 (0.93-1.17) for B/Yamagata; and 0.98 (0.84-1.13) for anti-Spike antibodies, thus meeting the protocol-specified non-inferiority criteria. The most frequently reported adverse events in both groups were pain at the injection site and myalgia. The 2 groups were similar in terms of the overall frequency, intensity, and duration of adverse events. In conclusion, co-administration of mRNA-1273 booster vaccine with QIV in adults was immunologically non-inferior to sequential administration. Safety and reactogenicity profiles were similar in both groups (clinicaltrials.gov NCT05047770).
Keywords: COVID-19 vaccine; Co-administration; immunogenicity; influenza vaccine; mRNA-1273.
. 2024 Dec 31;20(1):2327736.
doi: 10.1080/21645515.2024.2327736. Epub 2024 Mar 21. No immunological interference or concerns about safety when seasonal quadrivalent influenza vaccine is co-administered with a COVID-19 mRNA-1273 booster vaccine in adults: A randomized trial
Abdi Naficy[SUP] 1 [/SUP], Adrienne Kuxhausen[SUP] 1 [/SUP], Harry Seifert[SUP] 1 [/SUP], Andrew Hastie[SUP] 1 [/SUP], Brett Leav[SUP] 2 [/SUP], Jacqueline Miller[SUP] 2 [/SUP], Kate Anteyi[SUP] 2 [/SUP], Agnes Mwakingwe-Omari[SUP] 1 [/SUP]
Affiliations
- PMID: 38513689
- DOI: 10.1080/21645515.2024.2327736
The objective of the study was to assess the safety and immunogenicity of mRNA-1273 COVID-19 booster vaccination when co-administered with an egg-based standard dose seasonal quadrivalent influenza vaccine (QIV). This was a phase 3, randomized, open-label study. Eligible adults aged ≥ 18 years were randomly assigned (1:1) to receive mRNA-1273 (50 µg) booster vaccination and QIV 2 weeks apart (Seq group) or concomitantly (Coad group). Primary objectives were non-inferiority of haemagglutinin inhibition (HI) and anti-Spike protein antibody responses in the Coad compared to Seq group. 497/498 participants were randomized and vaccinated in the Seq/Coad groups, respectively. The adjusted geometric mean titer/concentration ratios (95% confidence intervals) (Seq/Coad) for HI antibodies were 1.02 (0.89-1.18) for A/H1N1, 0.93 (0.82-1.05) for A/H3N2, 1.00 (0.89-1.14] for B/Victoria, and 1.04 (0.93-1.17) for B/Yamagata; and 0.98 (0.84-1.13) for anti-Spike antibodies, thus meeting the protocol-specified non-inferiority criteria. The most frequently reported adverse events in both groups were pain at the injection site and myalgia. The 2 groups were similar in terms of the overall frequency, intensity, and duration of adverse events. In conclusion, co-administration of mRNA-1273 booster vaccine with QIV in adults was immunologically non-inferior to sequential administration. Safety and reactogenicity profiles were similar in both groups (clinicaltrials.gov NCT05047770).
Keywords: COVID-19 vaccine; Co-administration; immunogenicity; influenza vaccine; mRNA-1273.