Recombinant Zoster Vaccine Protection Durable at 10 Years, New Study Finds

The adjuvanted recombinant zoster vaccine (RZV; Shingrix, GSK) provides significant protection against herpes zoster infection for at least 10 years in adults aged ≥50 years, according to interim study findings presented at IDWeek 2022, held from October 19 to 23, in Washington, DC.

The results come from an interim analysis of the ZOSTER-049 open-label extension study that spans up to 10 years of follow-up of participants who completed initial RZV vaccination in GSK’s phase 3 clinical trials, ZOE-50 and ZOE-70, according to a GSK statement.

The primary objective of the current interim analysis was to determine RZV efficacy against herpes zoster during the initial 4-year follow-up period in ZOSTER-049, according to GSK, and a secondary objective evaluated vaccine efficacy from 1 month after the second dose—overall and by year post-vaccination. Researchers also assessed vaccine safety and humoral and cellular mediated responses to the vaccine annually.

Efficacy of RZV against herpes zoster infection over the >4 years of long-term follow-up, representing up to 10 years since participant immunization, was 81.6%. Between 1 month post-second dose and year 4, vaccine efficacy in the in the ZOE-50 and ZOE-70 studies was 89%.

Although the 10-year data remain incomplete, the authors report that estimates of annual efficacy also remained high and ranged from 97.7% after the first year to 73.2% following year 10.

The mean concentration of anti-glycoprotein E (gE) antibodies remained more than fivefold higher than prevaccination levels up to year 10. The median frequency of gE-specific CD4 T cells increased and remained more than 6 times higher than prevaccination levels.

Investigators reported no new safety concerns and noted that the incidence of serious adverse events was consistent with the study population’s older age. There were no deaths or safety adverse events considered related to the vaccine.

ZOSTER-049 will continue to follow participants to evaluate RZV safety and immunogenicity for another 6 years, GSK says.

“The findings from ZOE-LTFU demonstrate that it can provide a decade of protection against the pain, debilitating impact, and potentially severe complications that shingles can cause in people aged 50 and over," said Sabine Luik, GSK chief medical officer and SVP global medical regulatory & quality, in the statement.

"These data significantly add to, and complement, the existing body of evidence demonstrating the long-term benefit of the vaccine, and we look forward to seeing additional results from this ongoing study.”

Reference: Strezova A, Diez-Domingo J, Shawafi KA, et al. Long-term protection against herpes zoster (HZ) by the adjuvanted recombinant zoster vaccine (RZV): interim efficacy, immuno and safety results at approximately 10 years after initial vaccination. Poster presented at: IDWeek 2022; October 19-23; Washington, DC.