Pneumococcal Conjugate Vaccine Followup

Phase 2

Completed

• Conditions: Immune Tolerance
• Interventions: Biological: Prevenar + PPV; Biological: Infant PCV (Prevenar) + PPV at 9 months; Biological: No Prevenar + PPV at 9 months; Biological: Control

• Registration Number: NCT01414504
• Lead Sponsor: William Pomat

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2011-08-02
• Study First Submitted QC: 2011-08-10
• Study First Posted: 2011-08-11
• Primary Completion: 2011-09
• Status Verified: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2012-09-14
• Last Update Posted: 2012-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neonatal PCV + PPV 9 months	Prevenar + PPV	Group 1: Children receiving 7VPCV at 0-1-2 months of age and PPV at 9 months of age
Infant PCV + PPV at 9 months	Infant PCV (Prevenar) + PPV at 9 months	Group 2: Children receiving 7VPCV at 1-2-3 months of age and PPV at 9 months of age
No PCV + PPV at 9 months	No Prevenar + PPV at 9 months	Group 3: Children who only received PPV at 9 months of age
Control	Control	Group 4: Children who have not received any previous pneumococcal vaccine

Primary Outcome Measures

Name	Time	Method
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.	2yrs	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

Name	Time	Method
Measure the number of circulating serotype-specific memory B-cells pre- & post- booster immunisation	2yrs
Measure nasopharyngeal pneumococcal serotype-specific carriage rates pre- and post- 23vPPV challenge dose	2yrs

Trial Locations

Locations (1)

PNG Institute of Medical Research; 🇵🇬 Goroka, Eastern Highlands, Papua New Guinea