Pneumococcal Protein Vaccine Safety and Immunogenicity Trial
Status:
Completed
Trial end date:
2014-02-01
Target enrollment:
Participant gender:
Summary
This is an observer-blind, randomised, vaccine-controlled, vaccine trial to determine the
safety and immunogenicity of a pneumococcal protein vaccine. It will use an age step-down
approach beginning with adults, then toddlers then infants, with data safety review at each
stage before stepping down to the next age group. Adults and toddlers will receive the same
dose of this three-protein (trivalent) vaccine (PcpA, PhtD, and PlyD1 proteins) at 50µg each.
Infants will then be started at a low dose (10 µg), then medium dose (25µg) then high dose
(50µg), with safety reviews at each stage before ascending to the next highest dose. Infants
will also receive concomitant standard EPI childhood vaccines. Safety will be assessed by
close monitoring beginning on the day of vaccination (day 0) and for the subsequent seven
days, with recording of solicited and non-solicited adverse events. Immunogenicity will be
assessed by specific antibody response to the three proteins. The study aims to recruit 280
study subjects across all age groups.
Phase:
Phase 1
Details
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh