Study to Assess the Immunogenicity and Safety of GSK's Investigational Vaccine (GSK3277511A) When Given to Healthy Smokers and Ex-smokers After Administration of Shingrix Vaccine

Summary

This study will provide information regarding the sequential administration of two vaccines adjuvanted with AS01. The aim of this study is to understand immunogenicity and safety of NTHi-Mcat vaccine when administered sequentially after Shingrix vaccine and to compare to the immunogenicity of NTHi-Mcat vaccine administered alone. This study will also provide information regarding whether a specific time period is required between the administration of these two different vaccines containing the same adjuvant- AS01 components. The population of this study will include healthy smokers and ex-smokers of 50 to 80 years of age which will be used as a proxy for the COPD population.

Timeline

Start

2019-04-23

Primary completion

2020-08-31

Completion

2021-08-13

Publications

• Background Galgani I, Poder A, Jogi R, Anttila VJ, Milleri S, Borobia AM, Launay O, Testa M, Casula D, Grassano L, Tasciotti A, Dozot M, Arora AK. Immunogenicity and safety of the non-typable Haemophilus influenzae-Moraxella catarrhalis (NTHi-Mcat) vaccine administered following the recombinant zoster vaccine versus administration alone: Results from a randomized, phase 2a, non-inferiority trial. Hum Vaccin Immunother. 2023 Dec 31;19(1):2187194. doi: 10.1080/21645515.2023.2187194. Epub 2023 Mar 28.
• de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5.

Drugs

Indications