Persistence of Immunogenicity Following Reduced PCV Dosing Schedules in South African Children

  • STATUS
    Recruiting
  • participants needed
    600
  • sponsor
    University of Witwatersrand, South Africa
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Updated on 16 February 2024
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vaccination
pneumococcal
conjugate vaccine
booster
pneumococcal conjugate

Summary

This study will evaluate the persistence of immunogenicity following a reduced dosing schedule of 10- or 13-valent Pneumococcal Conjugate Vaccine (PCV10, PCV13). This is the follow-up of a randomized controlled trial in which children received a single priming dose of PCV10 or PCV13 (at 6 or 14 weeks of age) followed by booster dose at 9 months of age (1+1 schedule), compared to a 2+1 PCV schedule (6, 14 weeks of age and 9 months of age).

Description

Between 2017 and 2019, we conducted an open-labelled, randomized controlled trial to evaluate for non-inferiority in the post-booster serotype-specific geometric mean concentrations (GMC's) in children randomized to receive either PCV10 or PCV13 as a 1+1 schedule (with the first dose occurring either at 6 or 14 weeks of age) compared to infants who received a two dose primary series (6 and 14 weeks of age). All six study groups received a booster dose at 40 weeks of age, and serotype-specific IgG and opsonophagocytic activity was measured one-month post booster. Subjects were planned to be followed-up until 18 months of age as part of the initial study. In the present study, we propose to extent the follow-up of the cohort to include annual visit at 3, 4 and 5 years of age, to evaluate the sustainability of the humoral immune response of the different PCV dosing schedules.

Details
Condition Pulmonary Disease, Meningitis, Meningitis, Upper respiratory infection, Pneumonia, Pneumonia
Age 3years - 5years
Treatment PCV10, PCV13
Clinical Study IdentifierNCT04275284
SponsorUniversity of Witwatersrand, South Africa
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Children between and including the ages of 36 - 38 months of age at the time of first blood sampling
Subjects who previously participated in the PCV1+1 study and received the full study vaccination regime as per protocol
The parent or legal guardian of the child must be able and willing to provide written informed consent for all 3 visits and comply with all study requirements
The parent or legal guardian of the child must indicate the intention to remain in the study area for the duration of the trial - or be willing to bring the child for all visits

Exclusion Criteria

Receipt of any additional pneumococcal vaccine since the end of participation in the PCV1+1 study
Any known or suspected immunodeficiency condition which could affect immune response to vaccination, including living with HIV
Receipt of any immunoglobulins and/or blood products less than 6 months prior to blood sampling
Parent/legal guardian unable or unwilling to attend scheduled study visits
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