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

NCT ID: NCT04275284

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-14
• Study Completion Date: 2022-12-01

Brief 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).

Detailed 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.

Conditions

Pneumonia; Meningitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PCV10 1+1, 6 weeks & 9 months

Follow-up of children who were previously randomized to PCV10 (Synflorix 0.5ml injection) administered at 6 weeks and 9 months of age.

PCV10

Intervention Type: BIOLOGICAL

0.5 ml injection

PCV13 1+1, 6 weeks & 9 months

Follow-up of children who were previously randomized to PCV13 (Prevnar 13, 0.5ml injection) administered at 6 weeks and 9 months of age.

PCV13

Intervention Type: BIOLOGICAL

0.5 ml injection

PCV10 1+1, 14 weeks & 9 months

Follow-up of children who were previously randomized to PCV10 (Synflorix 0.5ml injection) administered at 14 weeks and 9 months of age.

PCV10

Intervention Type: BIOLOGICAL

0.5 ml injection

PCV13 1+1, 14 weeks & 9 months

Follow-up of children who were previously randomized to PCV13 (Prevnar 13, 0.5ml injection) administered at 14 weeks and 9 months of age.

PCV13

Intervention Type: BIOLOGICAL

0.5 ml injection

PCV10 2+1, 6&14 weeks & 9 months

Follow-up of children who were previously randomized to PCV10 (Synflorix 0.5ml injection) administered at 6 weeks, 14 weeks and 9 months of age.

PCV10

Intervention Type: BIOLOGICAL

0.5 ml injection

PCV13 2+1, 6&14 weeks & 9 months

Follow-up of children who were previously randomized to PCV13 (Prevnar 13, 0.5ml injection) administered at 6 weeks, 14 weeks and 9 months of age.

PCV13

Intervention Type: BIOLOGICAL

0.5 ml injection

Interventions

PCV10

0.5 ml injection

Intervention Type: BIOLOGICAL

PCV13

0.5 ml injection

Intervention Type: BIOLOGICAL

Other Intervention Names

Synflorix; Prevnar13

Eligibility Criteria

Inclusion Criteria

1. Children between and including the ages of 36 - 38 months of age at the time of first blood sampling;

2. Subjects who previously participated in the PCV1+1 study and received the full study vaccination regime as per protocol;

3. 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;

4. 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

1. Receipt of any additional pneumococcal vaccine since the end of participation in the PCV1+1 study;

2. Any known or suspected immunodeficiency condition which could affect immune response to vaccination, including living with HIV;

3. Receipt of any immunoglobulins and/or blood products less than 6 months prior to blood sampling;

4. Parent/legal guardian unable or unwilling to attend scheduled study visits.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Witwatersrand, South Africa

OTHER

Sponsor Role: lead

Responsible Party

Farzanah Laher

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shabir A Madhi, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of the Witwatersrand, South Africa

Locations

Chris Hani Baragwanath Academic Hospital - DST/NRF VPD RMPRU

Soweto, Gauteng, South Africa

Countries

South Africa

References

Olwagen CP, Izu A, Van der Merwe L, Jose L, Koen A, Madhi SA. Single priming and a booster dose of 10-valent and 13-valent pneumococcal conjugate vaccine (PCV) maintains suppression of vaccine serotype colonization in South African children at 3, 4, and 5 years of age: a single-centre, open-labelled, randomized trial. Expert Rev Vaccines. 2024 Jan-Dec;23(1):1011-1019. doi: 10.1080/14760584.2024.2417856. Epub 2024 Oct 22.

Reference Type: DERIVED

PMID: 39417218 (View on PubMed)

Other Identifiers

PCV1+1 follow-up

Identifier Type: -

Identifier Source: org_study_id