GlaxoSmithKline plc (ADR) (NYSE:GSK) has presented results from a clinical study that was conducted on its vaccine candidate, Shingrix (HZ/su), that is used in the prevention of herpes zoster in people 50 years old and above. The study was conducted to show that Shingrix (HZ/su) improves the immune response of adult who were initially vaccinated against zoster. The results were presented at a meeting convened by US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP).
According to the results, the study fulfilled its main objective of showing a non-inferior immune response. People who were administered the ZVL vaccine five years before being vaccinated with Shingrix portrayed the same immune response like those who never received the ZVL vaccine before. Additionally, Shingrix showed a high level of tolerance in the two studies when examined one month after the second Shingrix dose.
GSK has shared the results from the study on safety, systemic reaction and immunogenicity with the Food and Drug Administration (FDA). The company is hoping that the information will form part of the final determination regarding the use of the drug for revaccination for protection from shingles. The study involved 430 adults patients of 65 years and above and was designed as group-matched, prospective, open-label, non-randomised and multicentre trial in people who were initially vaccinated with ZVL five years earlier.
In a statement, GSK Vaccines Senior Vice President and Chief Medical Officer Dr. Thomas Breuer said they are encouraged by the positive results which have proved that Shingrix can be an alternative for people over 50 and who were previously vaccinated with the available options and who are seeking a Shingrix revaccination.
Zoster-048 is mainly focused on the safety and immune response of Shingrix and less the efficacy part of the study. Zoster-048 works to build on previous clinical data where efficacy and immunogenicity were examined simultaneously.
In two distinct phase III trials, ZOE-70 and ZOE-50 Shingrix showed high levels of efficacy against shingles over 90% plus sustained level of efficacy over the whole follow-up period of 4 years.