No Immunological Interference or Safety Concerns When Adjuvanted Recombinant Zoster Vaccine Is Coadministered With a Coronavirus Disease 2019 mRNA-1273 Booster Vaccine in Adults Aged 50 Years and Older: A Randomized Trial

Abstract

Background There is growing consensus that COVID-19 booster vaccines may be coadministered with other age-appropriate vaccines. Adding to the limited available data supporting coadministration, especially with adjuvanted vaccines, could enhance vaccine coverage in adults. Methods In this phase 3, randomized, open-label study, eligible adults aged ≥50 years were randomly assigned (1:1) to receive mRNA-1273 (50µg) booster vaccination and a first dose of recombinant zoster vaccine (RZV1) 2 weeks apart (Seq group) or concomitantly (Coad group). The second RZV dose (RZV2) was administered 2 months post- RZV1 in both groups. Primary objectives were noninferiority of anti-glycoprotein E and anti-Spike protein antibody responses in the Coad group compared to the Seq group. Safety and further immunogenicity assessments were secondary objectives. Results 273 participants were randomized to the Seq group, 272 to the Coad group. Protocol-specified non-inferiority criteria were met. The adjusted geometric mean concentration ratio (Seq/Coad) was 1.01 (95% confidence interval [CI], 0.89–1.13) for anti-gE antibodies 1-month post-RZV2, and 1.09 (95% CI 0.90–1.32) for anti-Spike antibodies 1-month post-mRNA-1273 booster. No clinically relevant differences were observed in overall frequency, intensity, or duration of adverse events between the 2 study groups. Most solicited adverse events were mild/moderate in intensity, each with median duration ≤2.5 days. Administration site pain and myalgia were the most frequently reported in both groups. Conclusions Coadministration of mRNA-1273 booster vaccine with RZV in adults aged ≥50 years was immunologically noninferior to sequential administration and had a safety and reactogenicity profile consistent with both vaccines administered sequentially (clinicaltrials.gov NCT05047770).

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

“…This study also evaluated co-administration of recombinant zoster vaccine and mRNA-1273 booster and the results pertaining to these groups have been reported previously. 18 The results of co-administration of QIV and mRNA-1273 booster are reported here.…”

“…We conducted a clinical trial to evaluate the safety and immunogenicity of co-administration of a booster dose of an mRNA COVID-19 vaccine with either an egg-based standard dose seasonal quadrivalent influenza vaccine (QIV) in adults aged ≥18 y, or the recombinant zoster vaccine in adults aged ≥50 y. 18 The goal of the study was to assess immunological interference and changes to the reactogenicity and safety profile when mRNA COVID-19 booster vaccination was co-administered with other recommended vaccines compared to their sequential administration.…”

Immunogenicity of Recombinant Zoster Vaccine: A Systematic Review, Meta-Analysis, and Meta-Regression

“…In eight studies with within-study comparisons of GMC, five evaluated co-administration of the first dose of RZV with other routine adult vaccines, such as the COVID-19 mRNA-1273 vaccine, the 13-valent pneumococcal conjugate vaccine (PCV13), the 23-valent pneumococcal polysaccharide vaccine (PPSV23), the tetanus-diphtheria-pertussis vaccine (Tdap), or the quadrivalent seasonal inactivated influenza vaccine (IIV4) [41][42][43][44][45]. The overall pooled GMC ratio for individuals vaccinated with RZV alone compared with vaccine co-administration was 1.05 (95%CI 1.01-1.10), demonstrating noninferiority between groups (Figure 3).…”