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Non-typeable Haemophilus influenzae protein vaccine in adults with COPD: A phase 2 clinical trial
Univ Southampton, Southampton Gen Hosp, Clin & Expt Sci, Fac Med, Southampton, Hants, England;Southampton Gen Hosp, Southampton NIHR Resp Biomed Res Unit, Southampton, Hants, England;Univ Southampton, Southampton Gen Hosp, Wessex Invest Sci Hub, Fac Med, Southampton, Hants, England.
Univ Dundee, Scottish Ctr Resp Res, Dundee, Scotland.
Univ Leicester, Inst Lung Hlth, Dept Infect Immun & Inflammat, Leicester, Leics, England.
Salford Royal NHS Fdn Trust, Salford, Lancs, England.
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2019 (English)In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 37, no 41, p. 6102-6111Article in journal (Refereed) Published
Abstract [en]

Loss of airway microbial diversity is associated with non-typeable Haemophilus influenzae (NTHi) infection and increased risk of exacerbation in chronic obstructive pulmonary disease (COPD). We assessed the safety and immunogenicity of an investigational vaccine containing NTHi antigens, recombinant protein D (PD) and combined protein E and Pilin A (PE-PilA), and AS01 adjuvant in adults with moderate/-severe COPD and prior exacerbations. In this phase 2, observer-blind, controlled trial (NCT02075541), 145 COPD patients aged 40-80 years randomly (1:1) received two doses of NTHi vaccine or placebo 60 days apart, on top of standard care. Reactogenicity in the 7-day post-vaccination period was higher following NTHi vaccine than placebo. Most solicited adverse events (AEs) were mild/moderate. At least one unsolicited AE was reported during the 30-day post-vaccination period by 54.8% of NTHi vaccine and 51.4% of placebo recipients. One serious AE (placebo group) was assessed by the investigator as vaccine-related. Anti-PD, anti-PE and anti-PiIA geometric mean antibody concentrations increased up to 30 days after each NTHi vaccine dose, waned thereafter, but remained higher than baseline (non-overlapping confidence intervals) up to 13 months post-dose 2. The frequency of specific CD4(+) T cells increased following two doses of NTHi vaccine and remained higher than baseline. Exploratory analysis showed a statistically non-significant lower yearly rate of moderate/severe exacerbations in the NTHi vaccine group than following placebo (1.49 versus 1.73) in the one-year period post-dose 2, with estimated vaccine efficacy of 13.3% (95% confidence interval -24.2 to 39.5; p = 0.44). The NTHi vaccine had an acceptable safety and reactogenicity profile and good immunogenicity in adults with COPD.

Place, publisher, year, edition, pages
2019. Vol. 37, no 41, p. 6102-6111
Keywords [en]
Non-typeable Haemophilus influenzae, COPD, Exacerbation, Vaccine, Safety, Immunogenicity
National Category
Respiratory Medicine and Allergy
Identifiers
URN: urn:nbn:se:uu:diva-395796DOI: 10.1016/j.vaccine.2019.07.100ISI: 000487568800012PubMedID: 31447126OAI: oai:DiVA.org:uu-395796DiVA, id: diva2:1365714
Available from: 2019-10-25 Created: 2019-10-25 Last updated: 2019-10-25Bibliographically approved

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