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Clinical Trial
. 2023 Nov 11;77(9):1238-1246.
doi: 10.1093/cid/ciad361.

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

Abdi Naficy  1 , Adrienne Kuxhausen  2 , Paola Pirrotta  3 , Brett Leav  4 , Jacqueline Miller  4 , Kate Anteyi  5 , Jasur Danier  1 , Thomas Breuer  6 , Agnes Mwakingwe-Omari  1
Affiliations
Clinical Trial

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

Abdi Naficy et al. Clin Infect Dis. .

Abstract

Background: There is growing consensus that coronavirus disease 2019 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 (50 µg) 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 (gE) and anti-spike protein antibody responses in the Coad group compared to the Seq group. Safety and further immunogenicity assessments were secondary objectives.

Results: In total, 273 participants were randomized to the Seq group and 272 to the Coad group. Protocol-specified noninferiority criteria were met. The adjusted geometric mean concentration ratio (Seq/Coad) was 1.01 (95% confidence interval [CI], .89-1.13) for anti-gE antibodies 1 month post-RZV2, and 1.09 (95% CI, .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. Clinical Trials Registration. NCT05047770.

Keywords: coadministration; immunogenicity; mRNA COVID-19 vaccine; recombinant zoster vaccine; safety.

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Conflict of interest statement

Potential conflicts of interest. A. N. is employed by GSK. A. K. is employed by GSK. P. P. is employed by GSK. J. D. is employed by GSK and holds shares in GSK. T. B. is employed by GSK and holds shares in GSK. A. M.-O. is employed by GSK and holds shares in GSK. B. L. is employed by Moderna and holds shares in Moderna. J. M. was employed by the GSK until May 2020 and is now employed by Moderna. J. M. also reports she holds shares in GSK and Moderna. K. A. is employed by Moderna and holds shares in Moderna. All authors declare no other financial and non-financial relationships and activities. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Figures

Graphical Abstract
Graphical Abstract
Figure 1.
Figure 1.
Participant flow. The Seq group received the mRNA-1273 booster dose followed 2 weeks later by the first dose of RZV. The Coad group received coadministration of the mRNA-1273 booster and the first dose of RZV. Abbreviations: D, study day; LTFU, lost to follow-up; mRNA-1273, Moderna's messenger RNA COVID-19 vaccine; PPS, per-protocol set; RZV, recombinant zoster vaccine.
Figure 2.
Figure 2.
Percentage of solicited local and systemic adverse events reported per participant after the mRNA-1273 and first RZV vaccinations (exposed set). The Seq group received the mRNA-1273 booster dose followed 2 weeks later by the first dose of RZV. The Coad group received coadministration of the mRNA-1273 booster and the first dose of RZV. Definitions of grade 3 intensity are provided in the Supplementary Material. Abbreviations: AE, adverse event; GI, gastrointestinal; mRNA-1273, Moderna's messenger RNA COVID-19 vaccine; RZV, recombinant zoster vaccine.
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