GlaxoSmithKline (GSK) announced positive results from the ongoing Phase 3 trial of their shingles vaccine candidate, Shingrix, which contains Agenus’ immune adjuvant, QS-21 Stimulon.
Zoster-048 (n=430) was a group-matched, non-randomized, open-label, multicenter trial intended to evaluate the safety and immunogenicity of Shingrix in adults aged ≥65 years who had previously been vaccinated against shingles ≥5 years prior with the live-attenuated zoster vaccine (ZVL; Merck) as well as in unvaccinated adults.
The trial met its primary endpoint of non-inferiority to ZVL, and individuals who received ZVL vaccination at least 5 years prior to being vaccinated with Shingrix showed a similar immune response to individuals with no previous exposure. Shingrix was also well-tolerated when assessed up to 1 month after the second dose administration.
“[These results] indicate that Shingrix can be an option for adults over 50 years of age, who previously received the currently available vaccine and are seeking to benefit from revaccination with Shingrix, if recommended,” said Dr. Thomas Breuer, SVP and CMO of GSK Vaccines.
The previous Phase 3 studies – ZOE-50 and ZOE-70 – showed sustained efficacy against shingles with Shingrix that was above 90% over the entire 4-year follow-up.
GSK said in a statement that they expect that data from this trial could eventually inform a policy making decision regarding revaccination.
For more information visit GSK.com.