The Journal of infection · 2026
Immunogenicity and safety of co-administration of a recombinant shingles vaccine with an mRNA COVID-19 or adjuvanted influenza vaccine: a randomised controlled trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеКлиническое исследование IV фазыEquivalence TrialНазвание и аннотация: Перевод в очереди
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Harris Rosie, Thirard Russell, McBrien Claire, Middleditch Alexander, Chadwick David, Jackson John, Moran Ed, Perry James, Payne Ruth A, Goodman Anna L, Cosgrove Catherine, Lillie Patrick, Emmett Stevan, Finn Adam, Pike Katie, Culliford Lucy, Lazarus Rajeka, ZosterFluCov Trial team
Аннотация
BACKGROUND: Coverage of the recombinant herpes zoster vaccine (RZV) could be improved by coadministration with seasonal vaccines. We evaluated the immunogenicity and safety of co-administration of the first or second dose of RZV with an adjuvanted quadrivalent influenza vaccine (aQIV), or mRNA COVID-19 vaccine.
METHODS: A multicentre, randomised, controlled, non-inferiority phase 4 trial with masking, across 13 sites. Healthy adults ≥50 years were randomised (1:1:2:2:2) to one of five groups. Co-primary immunogenicity outcomes were evaluated one month after the relevant vaccine: RZV by anti-gE Ig; COVID-19 by anti-S Ig; and aQIV by haemagglutinin antibody inhibition titres. The co-primary safety outcome was grade 3/4 solicited systemic reaction(s) in the seven days after vaccination.
RESULTS: Between 15/10/2023 and 27/02/2025 967 participants were recruited (median age 60.5 years, 55% female). Non-inferiority was indicated for all coprimary immunogenicity outcomes, i.e. the lower limit of 95% confidence intervals exceeded the pre-specified non-inferiority criteria (geometric mean ratio=0.67). Rates of the primary safety outcome were low, albeit slightly increased with co-administration; maximum 3.3% for co-administration of RZV/COVID-19, minimum 1.2% for COVID-19 alone.
CONCLUSIONS: COVID-19 vaccine and aQIV can be safely co-administered with both doses of RZV without impacting the immunogenicity of any of the vaccines.
METHODS: A multicentre, randomised, controlled, non-inferiority phase 4 trial with masking, across 13 sites. Healthy adults ≥50 years were randomised (1:1:2:2:2) to one of five groups. Co-primary immunogenicity outcomes were evaluated one month after the relevant vaccine: RZV by anti-gE Ig; COVID-19 by anti-S Ig; and aQIV by haemagglutinin antibody inhibition titres. The co-primary safety outcome was grade 3/4 solicited systemic reaction(s) in the seven days after vaccination.
RESULTS: Between 15/10/2023 and 27/02/2025 967 participants were recruited (median age 60.5 years, 55% female). Non-inferiority was indicated for all coprimary immunogenicity outcomes, i.e. the lower limit of 95% confidence intervals exceeded the pre-specified non-inferiority criteria (geometric mean ratio=0.67). Rates of the primary safety outcome were low, albeit slightly increased with co-administration; maximum 3.3% for co-administration of RZV/COVID-19, minimum 1.2% for COVID-19 alone.
CONCLUSIONS: COVID-19 vaccine and aQIV can be safely co-administered with both doses of RZV without impacting the immunogenicity of any of the vaccines.