Pneumococcal Conjugate Vaccine Followup (PCVFU)

This study has been completed.
Sponsor:
Collaborator:
The University of Western Australia
Information provided by (Responsible Party):
William Pomat, Papua New Guinea Institute of Medical Research
ClinicalTrials.gov Identifier:
NCT01414504
First received: August 2, 2011
Last updated: September 14, 2012
Last verified: September 2012
  Purpose

Recently, controversy has emerged regarding the role of the 23vPPV in infants due to potential immunological hypo-responsiveness (i.e. a poorer immune response to repeat vaccination). Although previous experience of 23vPPV in children in PNG has demonstrated protective efficacy against acute lower respiratory tract infection, the investigators feel it is a matter of urgency to determine if 23vPPV administration provides elevated antibody concentrations at 3 to 5 years of age, and to ensure the immunological safety of the 23vPPV in infants.

Following consent and eligibility assessment, a baseline blood sample and nose swab will be taken, a 0.1ml dose of 23vPPV will be administered and a follow up blood sample and nose swab will be collected 28 days later. The investigators will also collect data on incidence of ALRI in all study participants by medical record review.


Condition Intervention Phase
Immune Tolerance
Biological: Prevenar + PPV
Biological: Infant PCV (Prevenar) + PPV at 9 months
Biological: No Prevenar + PPV at 9 months
Biological: Control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pneumococcal Conjugate Vaccine Followup: Investigation of Serotype-specific Antibody Persistence and B Cell Memory at Age 3-5 Years Following 23valent Pneumococcal Polysaccharide Vaccine at Age 9 Months in PNG Children Previously Primed With 7valent Pneumococcal Conjugate Vaccine

Resource links provided by NLM:


Further study details as provided by Papua New Guinea Institute of Medical Research:

Primary Outcome Measures:
  • Measure serotype-specific antibody persistence in children aged 3-5 years after vaccination with 23vPPV at 9 months of age and compared to unvaccinated controls. [ Time Frame: 2yrs ] [ Designated as safety issue: Yes ]
    Children who were previously vaccinated with Pneumovax (23vPPV) at 9 months will be followed up at age 3-5 years of age. They will be given a challenge dose of Pneumovax (0.1mL) and followed up 1 months later. Age matched controls identified from each villages will also be recruited and given a challenge dose of Pneumovax. Serotype-specific antibodies will be measure pre- and post-challenge dose to determine anitbody levels.


Secondary Outcome Measures:
  • Measure the number of circulating serotype-specific memory B-cells pre- & post- booster immunisation [ Time Frame: 2yrs ] [ Designated as safety issue: Yes ]
  • Measure nasopharyngeal pneumococcal serotype-specific carriage rates pre- and post- 23vPPV challenge dose [ Time Frame: 2yrs ] [ Designated as safety issue: Yes ]

Enrollment: 280
Study Start Date: December 2009
Study Completion Date: September 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Neonatal PCV + PPV 9 months
Group 1: Children receiving 7VPCV at 0-1-2 months of age and PPV at 9 months of age
Biological: Prevenar + PPV
0.5mL dose of Prevenar at 0-1-2 months, 0.5mL Pneumovax at 9 months and 0.1mL Pneumovax at 3-5 yrs
Active Comparator: Infant PCV + PPV at 9 months
Group 2: Children receiving 7VPCV at 1-2-3 months of age and PPV at 9 months of age
Biological: Infant PCV (Prevenar) + PPV at 9 months
0.5mL Prevenar at 1-2-3 months,0.5mL Pneumovax (PPV) at 9 months, 0.1mL Pneumovax at 3-5 yrs
Other Names:
  • Prevenar
  • Pneumovax23
Active Comparator: No PCV + PPV at 9 months
Group 3: Children who only received PPV at 9 months of age
Biological: No Prevenar + PPV at 9 months
no Prevenar, 0.5mL Pneumovax at 9 months, 0.1mL Pneumovax at 3-5 yrs
Active Comparator: Control
Group 4: Children who have not received any previous pneumococcal vaccine
Biological: Control
control, 0.1mL Pneumovax at 3-5yrs

  Eligibility

Ages Eligible for Study:   3 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • PNG Infants aged 3 to 5 yrs of age who participated in previous PNG Neonatal PCV study and received PPV between 9 and 12 months of age, or age- and sex-matched controls who live in the same villages or urban area
  • Informed parental/guardian consent

Exclusion Criteria:

  • Known HIV infection or other immunosuppressive condition or treatment.
  • Prior receipt of 2 doses of pneumococcal polysaccharide vaccine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01414504

Locations
Papua New Guinea
PNG Institute of Medical Research
Goroka, Eastern Highlands, Papua New Guinea, 441
Sponsors and Collaborators
William Pomat
The University of Western Australia
Investigators
Principal Investigator: Peter C Richmond, MD School of Paediatrics and Child Health, University of Western Australia
Principal Investigator: Deborah Lehmann, MSc Telethon Institute for Child Health Research
Principal Investigator: William S Pomat, PhD Papua New Guinea Institute of Medical Research
  More Information

No publications provided

Responsible Party: William Pomat, Senior Research Fellow, Papua New Guinea Institute of Medical Research
ClinicalTrials.gov Identifier: NCT01414504     History of Changes
Other Study ID Numbers: PCVFU927
Study First Received: August 2, 2011
Last Updated: September 14, 2012
Health Authority: Papua New Guinea: Medical Research Advisory Committee

Keywords provided by Papua New Guinea Institute of Medical Research:
pneumococcal,
pneumococcal polysaccharide vaccine,
challenge dose,
hyporesponsiveness,
Papua New Guinea

ClinicalTrials.gov processed this record on September 22, 2014