Pneumococcal Protein Vaccine Safety and Immunogenicity Trial (PPR02)

This study is currently recruiting participants.
Verified January 2013 by International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor:
Collaborator:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT01764126
First received: March 16, 2012
Last updated: November 11, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Adverse Effects
Drug: Pneumococcal protein vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Pneumococcal Protein Vaccine (PPrV) in Healthy Adults, Toddlers and Infants in Bangladesh

Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    We will assess the antibody response using standard methods for each of the three proteins in the vaccine against a pre-vaccination baseline. For infants, this will be done with each of the three vaccine doses.


Estimated Enrollment: 280
Study Start Date: September 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pneumococcal protein vaccine
Pneumococcal protein vaccine
Drug: Pneumococcal protein vaccine
One dose of 50 µg of each of three proteins with adjuvant (aluminium hydroxide) IM
Other Name: pneumococcal common protein vaccine
Drug: Pneumococcal protein vaccine
Three doses, 4 weeks apart, of 10 µg of each of three proteins with adjuvant (aluminium hydroxide) IM
Other Name: pneumococcal common protein vaccine
Drug: Pneumococcal protein vaccine
Three doses, 4 weeks apart, of 25 µg of each of three proteins with adjuvant (aluminium hydroxide) IM
Other Name: pneumococcal common protein vaccine
Drug: Pneumococcal protein vaccine
Three doses, 4 weeks apart, of 25 µg of each of three proteins without adjuvant IM
Other Name: pneumococcal common protein vaccine
Drug: Pneumococcal protein vaccine
Three doses, 4 weeks apart, of 50 µg of each of three proteins with adjuvant (aluminium hydroxide) IM
Other Name: pneumococcal common protein vaccine
Placebo Comparator: Placebo
Placebo
Drug: Pneumococcal protein vaccine
One dose of 50 µg of each of three proteins with adjuvant (aluminium hydroxide) IM
Other Name: pneumococcal common protein vaccine
Drug: Pneumococcal protein vaccine
Three doses, 4 weeks apart, of 10 µg of each of three proteins with adjuvant (aluminium hydroxide) IM
Other Name: pneumococcal common protein vaccine
Drug: Pneumococcal protein vaccine
Three doses, 4 weeks apart, of 25 µg of each of three proteins with adjuvant (aluminium hydroxide) IM
Other Name: pneumococcal common protein vaccine
Drug: Pneumococcal protein vaccine
Three doses, 4 weeks apart, of 25 µg of each of three proteins without adjuvant IM
Other Name: pneumococcal common protein vaccine
Drug: Pneumococcal protein vaccine
Three doses, 4 weeks apart, of 50 µg of each of three proteins with adjuvant (aluminium hydroxide) IM
Other Name: pneumococcal common protein vaccine

Detailed Description:

This is a Phase I, single-center, randomized, placebo-controlled, step-down observer-blind study to assess the safety and immunogenicity of a single injection PPrV vaccine containing 50 µg of each protein (PcpA, PhtD and PlyD1) withadjuvant in healthy adults and toddlers, and of 3 injections in healthy infants (following the Expanded Program on Immunization [EPI] schedule) at 3 ascending dose levels (all adjuvanted 10, 25, and 50µg of each protein per dose level; with an additional un-adjuvanted formulation at 25 µg of each protein per dose level).

Overall, there will be 5 Cohorts. In Cohort I, adults will receive 1 injection of adjuvanted 50 µg PcpA, PhtD and PlyD1 PPrV vaccine (high dose) or placebo.

In Cohort II, toddlers will receive 1 injection of adjuvanted 50 µg PcpA, PhtD and PlyD1 PPrV vaccine or placebo.

In Cohorts III, IV and V, infants will receive 3 injections of one of the following PPrV vaccine formulations: adjuvanted 10 µg each PcpA, PhtD and PlyD1 (low dose), adjuvanted 25 µg each PcpA, PhtD and PlyD1 (middle dose), unadjuvanted 25 µg each PcpA, PhtD and PlyD1 (middle dose un-adjuvanted), or adjuvanted 50 µg each PcpA, PhtD and PlyD1 (high dose) or placebo, according to the EPI schedule (at 6 weeks, 10 weeks and 14 weeks), as well as concomitant applicable standard of care childhood vaccines ( Quinvaxem® [DTwP-HepB-Hib] vaccine, Bacillus Calmette-Guérin vaccine (BCG) (if not received at birth), and oral poliomyelitis vaccine [OPV]).

As a safety precaution, this trial will use a step-down approach for enrollment: for adults, 1 vaccination and acceptable review of safety data collected through Day 7 after injection, followed by enrollment of toddlers, 1 vaccination and acceptable review of safety data collected through Day 7 after injection, and then enrollment of infants (3 injections, EPI schedule). For infants, step-wise dose ascension is conditional upon acceptable safety reviews, which will be conducted after completion of the third vaccination of the EPI series at each dose level, using safety data collected through Day 7 after each of the vaccinations.

An Independent Data Monitoring Committee (IDMC) will be established for safety oversight of this study, for which a formal IDMC charter will be developed. For all safety reviews, blinded safety data will be provided to the Sponsor's Safety Management Team (SMT). The review will be performed by the SMT with presentation of findings, as per standard early safety review process, to the Sponsor's Safety Management Oversight Team (SMOT) in order to assess whether proceeding to the next ascending dose level is appropriate. The results will be communicated to the IDMC after each review. A formal IDMC review is proposed following completion of the Cohort II (toddler) safety review, prior to enrollment of Cohorts III, IV, and V (infants).

The study scheme is summarized in Figure 1, and details of safety reviews are described in the periodic safety data review (SDR) section. Electronic data capture (EDC) will be used for the collection of data generated in this study.

  Eligibility

Ages Eligible for Study:   6 Weeks to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764126

Contacts
Contact: W. Abdullah Brooks, MD, MPH 88 02 988 1662 abrooks@icddrb.org
Contact: Salam Khan 88 02 988 6849 salamk@icddrb.org

Locations
Bangladesh
ICDDR,B Recruiting
Dhaka, Bangladesh
Contact: Salam Khan    88 02 988 6498    salamk@icddrb.org   
Principal Investigator: W. Abdullah Brooks, MD, MPH         
Sub-Investigator: Doli Goswami, MBBS, MPH         
ICDDR,B Active, not recruiting
Dhaka, Bangladesh
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Sanofi Pasteur, a Sanofi Company
Investigators
Principal Investigator: W. Abdullah Brooks, MD, MPH International Centre for Diarrhoeal Disease Research, Bangladesh
  More Information

No publications provided

Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT01764126     History of Changes
Other Study ID Numbers: PR-11023, U1111-1117-7316
Study First Received: March 16, 2012
Last Updated: November 11, 2013
Health Authority: United States: Institutional Review Board
Bangladesh: Directorate of Drug Administration

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Safety
immunogenicity
pneumococcal
protein
vaccine

ClinicalTrials.gov processed this record on April 22, 2014