Safety and Immunogenicity of Dry Powder Measles Vaccine Administered by Inhalation: A Randomized Controlled Phase I Clinical Trial Public Deposited
  • Background: Measles is a highly infectious respiratory disease which causes 122,000 deaths annually.Although measles vaccine is extremely safe and effective, vaccine coverage could be improved by a vaccinethat is more easily administered and transported. We developed an inhalable dry powder measles vaccine(MVDP) and two delivery devices, and demonstrated safety, immunogenicity, and efficacy of the vaccinein preclinical studies. Here we report the first clinical trial of MVDP delivered by inhalation.Methodology: Sixty adult males aged 18 to 45 years, seropositive for measles antibody, were enrolled inthis controlled Phase I clinical study. Subjects were randomly assigned in 1:1:1 ratio to receive eitherMVDP by Puffhaler®or by SoloventTMdevices or the licensed subcutaneous measles vaccine. Adverseevents (AEs) were recorded with diary cards until day 28 post-vaccination and subjects were followedfor 180 days post-vaccination to assess potential serious long term adverse events. Measles antibodywas measured 7 days before vaccination and at days 21 and 77 after vaccination by ELISA and a plaquereduction neutralization test.Results: All subjects completed the study according to protocol. Most subjects had high levels of base-line measles antibody. No adverse events were reported. MVDP produced serologic responses similar tosubcutaneous vaccination.Conclusions: MVDP was well tolerated in all subjects. Most subjects had high baseline measles antibodytiter which limited ability to measure the serologic responses, and may have limited the adverse eventsfollowing vaccination. Additional studies in subjects without pre-existing measles antibody are neededto further elucidate the safety and immunogenicity of MVDP.
Date Issued
  • 2014-10-22
Academic Affiliation
Journal Title
Journal Issue/Number
  • 49.0
Journal Volume
  • 32.0
Last Modified
  • 2019-12-06
Resource Type
Rights Statement
  • 10.1016/j.vaccine.2014.09.071
  • 0264-410X