Pneumococcal Conjugate Vaccine Followup

Condition(s) targeted: Vaccination,; Serotype-specific Antibody,; Immune Tolerance

Intervention: Prevenar + PPV (Biological); Infant PCV (Prevenar) + PPV at 9 months (Biological); No Prevenar + PPV at 9 months (Biological); Control (Biological)

Phase: Phase 2

Status: Recruiting

Sponsored by: Papua New Guinea Institute of Medical Research

Official(s) and/or principal investigator(s):
Peter C Richmond, MD, Principal Investigator, Affiliation: School of Paediatrics and Child Health, University of Western Australia
Deborah Lehmann, MSc, Principal Investigator, Affiliation: Telethon Institute for Child Health

Overall contact:
William S Pomat, PhD, Phone: +675 5322800, Ext: 206, Email: william.pomat@pngimr.org.pg

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: 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.

Secondary outcome:

Measure the number of circulating serotype-specific memory B-cells pre- & post- booster immunisation

Measure nasopharyngeal pneumococcal serotype-specific carriage rates pre- and post- 23vPPV challenge dose

Minimum age: 3 Years. Maximum age: 5 Years. Gender(s): Both.

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

William S Pomat, PhD, Phone: +675 5322800, Ext: 206, Email: william.pomat@pngimr.org.pg

PNG Institute of Medical Research, Goroka, Eastern Highlands 441, Papua New Guinea; Recruiting
William S Pomat, PhD, Phone: +675 5322800, Ext: 206, Email: william.pomat@pngimr.org.pg
William S Pomat, PhD, Principal Investigator
Peter M Siba, PhD, Sub-Investigator

Starting date: December 2009
Last updated: August 10, 2011