A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GlaxoSmithkline (GSK) Biologicals' Investigational Vaccine GSK2838504A When Administered to Chronic Obstructive Pulmonary Disease (COPD) Patients With Persistent Airflow Obstruction.

Summary

The purpose of this Phase II study is to assess the safety, reactogenicity and immunogenicity of the investigational Non-typeable Haemophilus influenzae (NTHi) vaccine in patients with moderate and severe persistent airflow obstruction.

Timeline

Start

2014-07-08

Primary completion

2017-04-19

Completion

2017-04-19

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper Exploratory analysis showed a statistically non-significant lower yearly rate of moderate/severe exacerbations in the NTHi vaccine group than following placebo PMID 31447126 ↗

Publications

• Baffetta F, Buonsanti C, Moraschini L, Aprea S, Cane M, Lombardi S, Contorni M, Rondini S, Arora AK, Bardelli M, Finco O, Serruto D, Paccani SR. Lung mucosal immunity to NTHi vaccine antigens: Antibodies in sputum of chronic obstructive pulmonary disease patients. Hum Vaccin Immunother. 2024 Dec 31;20(1):2343544. doi: 10.1080/21645515.2024.2343544. Epub 2024 Apr 24.
• Wilkinson TMA, Schembri S, Brightling C, Bakerly ND, Lewis K, MacNee W, Rombo L, Hedner J, Allen M, Walker PP, De Ryck I, Tasciotti A, Casula D, Moris P, Testa M, Arora AK. Non-typeable Haemophilus influenzae protein vaccine in adults with COPD: A phase 2 clinical trial. Vaccine. 2019 Sep 24;37(41):6102-6111. doi: 10.1016/j.vaccine.2019.07.100. Epub 2019 Aug 22.

Drugs

Indications