Coadministration of RSV and Shingles Vaccines Found Safe and Effective in Older Adults: Study
Administering RSV and shingles vaccines simultaneously in older adults appears to be safe and does not compromise immune response. Studies show that individuals receiving both vaccines together developed similar immunity compared to those vaccinated separately, with minimal serious adverse effects, supporting the convenience and practicality of coadministration. The study was published in the journal Clinical Infectious Diseases by Jean-F. and colleagues.
In order to assess the clinical safety, reactogenicity, and immune response of the aforementioned dual vaccine approach, a phase III randomized clinical study was conducted on 530 adult subjects ≥50 years of age. Subjects were equally randomized in a 1:1 ratio to two parallel arms, which included Co-Administration arm (Co-Ad, n=265) and Sequential control arm (Control, n=265). Patients in the Co-Ad arm received first dose of the Shingles vaccine (RZV) and RSV vaccine (adjuvanted RSVPreF3) together at Visit 1 (Day 1) and RZV dose 2 after 61 days (Day 61).
Subjects in the control arm got first dose of the Shingles vaccine (RZV) at Day 1, followed by a dose of RSVPreF3 after one month (Day 31) and RZV dose 2 after 61 days (Day 61). Non-inferiority of the co-administration schedule was mathematically determined; upper limits of 95% CI for geometric mean ratio (Control/Co-Ad) of RSV neutralizing antibody titer and VZV anti-gE antibody concentration needed to be ≤1.5.
Key findings:
- GMT ratio (Control/Co-Ad) for RSV-A was 1.1 (95% CI = 1.0-1.4) and 1.0 (95% CI = 0.8-1.2) for RSV-B, clearly exceeding the stringent non-inferiority margin.
- GMC ratio of antibodies against gE protein was 1.2 (95% CI = 1.1-1.4), which confirmed that shingles immunogenicity remained unaffected by concomitant RSV vaccination.
- Within 7 days from the administration, local reactions at the injection site affected 71.7% of the Co-Ad subjects (Grade 3 = 3.9%), while they were recorded in 58.5% of the sequential control group after the first RZV dose (Grade 3 = 1.9%) and 47.8% of the control group after the RSVPreF3 dose only (Grade 3 = 1.2%).
- Systemic reactions such as fatigue and headache happened in 73.6% of Co-Ad patients (Grade 3 = 9.3%) and 60.4% of control subjects (Grade 3 = 6.2%) within one week from Visit 1.
- Unsolicited adverse events during the 30-day period following any dose were observed in 23.4% of the Co-Ad cohort (Grade 3 = 0.8%) and 30.2% of the control group (Grade 3 = 1.1%), with no fatal or serious adverse events related to the vaccine reported in both arms.
This Phase III clinical study presents convincing evidence to demonstrate the feasibility of the co-administration of the adjuvanted RSVPreF3 vaccine and the recombinant herpes zoster vaccine. The observation that combined administration is non-inferior to the sequential administration method, in terms of immunogenicity, without compromising on the safety and reactogenicity aspects makes this a big win for preventive medicine.
Reference:
Jean-François Roussy, Patrick Dennis, Anil K Gupta, Garry Wallace, Alexander Abitbol, Naresh Aggarwal, Joseph G Surber, Theodore Lee, Brian A Smith, Catherine Gérard, Hiwot Amare Hailemariam, Marie-Pierre David, Archana M Jastorff, Marie Van der Wielen, on behalf of RSV-020 Study Group, Immunogenicity and Safety of the Adjuvanted Respiratory Syncytial Virus Prefusion F Protein-Based Vaccine When Co-administered With the Adjuvanted Recombinant Herpes Zoster Subunit Vaccine in Adults ≥ 50 Years of Age, Clinical Infectious Diseases, 2026;, ciag208, https://doi.org/10.1093/cid/ciag208
