Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Views
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

GSK Presents Positive Results from Phase 3 Shingrix Study

By GSK | June 27, 2017

GSK will be presenting new results from a clinical study showing that its candidate vaccine for the prevention of herpes zoster (shingles) in people aged 50 years or older, Shingrix (HZ/su), induces a strong immune response in older adults who have previously been vaccinated against shingles with the currently available live-attenuated zoster vaccine (ZVL). The results of the Zoster-048 study will be presented today at the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) meeting.

The study met its primary objective of demonstrating non-inferior immune response (i.e. antibody concentrations). People who received the ZVL vaccine at least 5 years prior to being vaccinated with Shingrix showed a similar immune response to people without previous exposure to the ZVL vaccine. In addition, Shingrix was well-tolerated in both study groups when assessed up to one month after the second dose of Shingrix.

GSK is sharing these data on safety, local and systemic reactions, and immunogenicity with the US Food and Drug Administration (FDA) and expects that the data could eventually inform a policymaking decision regarding revaccination for protection against shingles with Shingrix. The ongoing study of 430 adults aged 65 years and older was designed as a prospective, group-matched, non-randomised, open-label, multicentre trial in those previously vaccinated with ZVL at least 5 years earlier and in previously unvaccinated subjects.

The current standard of care ZVL provides protection against shingles, but studies suggest that this protection wanes over time.

Dr. Thomas Breuer, Senior Vice President and Chief Medical Officer of GSK Vaccines said: “We are encouraged by these results, which 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.”

Zoster-048 is focused on the immune response and safety of Shingrix, rather than efficacy, and builds on previously released clinical trial data where the immunogenicity and efficacy were tested simultaneously. The most common local and systemic reactions were in line with previous observations and no clinically significant safety signs were observed.

In two separate phase III studies, ZOE-50 and ZOE-70, Shingrix demonstrated efficacy against shingles above 90%, independent of age (>50, >70, >80 years of age), as well as sustained efficacy over the entire follow-up period of 4 years.

The study presented today has been submitted for publication in a peer-reviewed scientific journal. 

The candidate shingles vaccine, Shingrix, was submitted for regulatory approval to the FDA in October 2016, to Canadian regulatory authorities and the European Medicines Agency in November 2016, and to Japanese regulatory authorities in April 2017. Shingrix is not currently approved for use anywhere in the world.


Filed Under: Drug Discovery

 

Related Articles Read More >

Korean team reports all-in-one cancer nanomedicine in pre-clinical studies
Nektar’s Phase 2b atopic dermatitis win triggers 1,746% analyst target surge, but legal tussle with ex-partner Lilly could complicate path forward
Dupixent approved to treat bullous pemphigoid
EVEREST lead investigator on why Dupixent sets a new bar for treating coexisting CRSwNP and asthma
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Views
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE