A Study to Test if a Third Dose of the Vaccine is Safe in Current and Former Smokers Aged 40 to 80 Years Old and to Gather Information on the Immune Response Following the Third Dose of the Vaccine

Summary

The purpose of this study is to test two different vaccine schedules to be used for administering the investigational NTHi Mcat vaccine that will be targeting patients with chronic obstructive pulmonary disease (COPD) to prevent acute exacerbations. An acute exacerbation is when the breathlessness in COPD patients will get even worse than it normally already is, sometimes to the point where oxygen therapy is required. In previous studies, study participants have received two doses of the vaccine according to a 0, 2 month vaccination schedule, in addition to standard care. The current study will find out if a third dose of the study vaccine against NTHi/Mcat is safe and working well. The study will also investigate if the third dose of vaccine works best when given after 6 months or after 12 months.

Timeline

Start

2018-03-20

Primary completion

2019-12-31

Completion

2020-09-23

Publications

• Galgani I, Annaratone M, Casula D, Di Maro G, Janssens M, Tasciotti A, Schwarz T, Ferguson M, Arora AK. Safety and immunogenicity of three doses of non-typeable Haemophilus influenzae-Moraxella catarrhalis (NTHi-Mcat) vaccine when administered according to two different schedules: a phase 2, randomised, observer-blind study. Respir Res. 2022 May 4;23(1):114. doi: 10.1186/s12931-022-02019-4.

Drugs

Indications