Clinical impact of a non-typeable Haemophilus influenzae (NTHi) adjuvanted vaccine in adults with chronic obstructive pulmonary disease (COPD)

Background: An investigational adjuvanted NTHi vaccine had an acceptable safety profile and was immunogenic in adults with moderate/severe COPD (NCT02075541 - phase 2 trial). Aims and Objectives: Vaccine efficacy (VE) against acute exacerbation of COPD (AECOPD) at multiple time points, time to first AECOPD and Hi presence in sputum were assessed in the same study (exploratory analyses). Methods: Observer-blind, controlled trial in Sweden and UK: 40–80-years-old COPD patients were randomized 1:1 to receive 2 doses of NTHi vaccine (NTHi group, N=73) or placebo (Control group, N=72), 60 days apart. Results: Estimated VE is shown in Panel A. A suggestion of delayed onset of first AECOPD was observed in the NTHi group vs Control (Panel B). Proportion of Hi-positive sputum was 43% in the NTHi group and 45% in the Control at baseline, and 62% and 38% at 1-month post-dose 2, respectively. Conclusion: We observed an overall trend towards a lower rate of exacerbations in the NTHi group. Point estimates of VE against AECOPD endpoints tended to be higher in the first 6 months post-dose 2. Onset of first AECOPD after NTHi vaccination occurred later than in Control. An increase of Hi-positive sputum was observed in NTHi group 1-month post-dose 2. Results should be interpreted with caution as this study was not powered to assess vaccine impact. Funding: GlaxoSmithKline Biologicals SA