Pneumococcal Protein Vaccine Safety and Immunogenicity Trial

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
• Collaborator: Sanofi Pasteur, a Sanofi Company
• Treatments: Aluminum Hydroxide; Vaccines

Criteria

Inclusion Criteria:

• Healthy volunteers

Exclusion Criteria:

• Acute or chronic condition that would interfere with the ability to complete the observation period

• Allergy to egg or other vaccine components

• Receipt of antibiotics

• Receipt of immune modulating or blood products

• Receipt of pneumococcal vaccine or concomitant participation in other vaccine or drug trials