Pneumococcal Protein Vaccine Safety and Immunogenicity Trial

NCT01764126 | Completed Phase 1 DMC

• 2 other identifiers: PR-11023U1111-1117-7316
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adverse Effects

Keywords

Safety; immunogenicity; pneumococcal; protein; vaccine

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  We will measure solicited and unsolicited adverse events for seven days from the day of vaccination, and serious adverse events for 30 days following vaccination.

  30 days

Secondary Outcomes (1)

• Immunogenicity

  30 days

Study Arms (2)

Pneumococcal protein vaccine

ACTIVE COMPARATOR

Pneumococcal protein vaccine

Drug: Pneumococcal protein vaccine

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Pneumococcal protein vaccine

Interventions

Pneumococcal protein vaccine DRUG

One dose of 50 µg of each of three proteins with adjuvant (aluminium hydroxide) IM

Also known as: pneumococcal common protein vaccine

Placebo; Pneumococcal protein vaccine

Eligibility Criteria

• Age: 6 Weeks - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy volunteers

You may not qualify if:

• 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

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Sanofi Pasteur, a Sanofi Company: collaborator

Study Sites (1)

ICDDR,B

Dhaka, Bangladesh

Location

Study Officials

• W. Abdullah Brooks, MD, MPH

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: January 9, 2013
• Study Start: September 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: July 10, 2014

Record last verified: 2013-01

Locations

BA (1)