Pneumococcal Conjugate Vaccine Followup

Immune Tolerance Clinical Trial

— PCVFU  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01414504
• Other study ID #: PCVFU927
• Status: Completed
• Phase: Phase 2
• First received: August 2, 2011
• Last updated: September 14, 2012
• Start date: December 2009
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: Papua New Guinea Institute of Medical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: September 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Immune Tolerance

Intervention

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
• 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
• No Prevenar + PPV at 9 months
no Prevenar, 0.5mL Pneumovax at 9 months, 0.1mL Pneumovax at 3-5 yrs
• Control
control, 0.1mL Pneumovax at 3-5yrs

Locations

Country	Name	City	State
Papua New Guinea	PNG Institute of Medical Research	Goroka	Eastern Highlands

Sponsors (2)

Lead Sponsor	Collaborator
William Pomat	The University of Western Australia

Country where clinical trial is conducted

Papua New Guinea, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	2yrs
Secondary	Measure the number of circulating serotype-specific memory B-cells pre- & post- booster immunisation		2yrs
Secondary	Measure nasopharyngeal pneumococcal serotype-specific carriage rates pre- and post- 23vPPV challenge dose		2yrs