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Completed

NCT Number: NCT01414504

Pneumococcal Conjugate Vaccine Followup

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.

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Key information

Conditions

Immune Tolerance

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

PNG Institute of Medical Research

Goroka, Eastern Highlands Province, 441, Papua New Guinea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prevenar + PPV

Biological

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

Biological

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

No Prevenar + PPV at 9 months

Biological

no Prevenar, 0.5mL Pneumovax at 9 months, 0.1mL Pneumovax at 3-5 yrs

Control

Biological

control, 0.1mL Pneumovax at 3-5yrs

Primary outcomes

  1. 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

    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 outcomes

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

    Time frame: 2yrs

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

    Time frame: 2yrs

Sponsors and collaborators

Lead sponsor

William Pomat

Other Gov

Collaborators

  • The University of Western Australia

Registry information

Official study 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

Acronym: PCVFU

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Aug 11, 2011
Registry last updated
Sep 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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