Pneumococcal vaccine schedules acquisition, immunogenicity, and pneumococcal conjugate and yellow fever vaccine co-administration study

Phase 4

• Conditions: Pneumococcal acquisition and vaccine immunogenicity; Infections and Infestations

• Registration Number: ISRCTN72821613
• Lead Sponsor: ondon School of Hygiene & Tropical Medicine

Brief Summary

2022 Protocol article in https://doi.org/10.1186/s13063-021-05949-4 (added 24/05/2022)

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-28
• Last Update Posted: 26 August 2024
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 827

Inclusion Criteria

1. Resident in the study area (PVS-AcqImm trial)
2. Age 0-6 weeks
3. Intention to reside in cluster until 18 months of age

Exclusion Criteria

1. Intent to move out of the study area before 18 months of age
2. Age greater than 6 weeks
3. Prematurity <34 weeks gestation
4. Birth weight <2.0kg or weight <2.5 kg
5. History of invasive bacterial infection or measles
6. Receiving long-term antibiotic therapy, defined as greater than 4 weeks
7. HIV infection in the infant or mother
8. Chronic debilitating illness
9. Immunosuppressive therapy or immunodeficiency disorder
10. Contraindication to PCV13 – severe hypersensitivity to a previous dose of PCV13
11. Contraindication to YF vaccine

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Nasopharyngeal acquisition of vaccine-type pneumococci measured using latex sweep serotyping at five timepoints between 9 and 14 months of age<br>2. Concentration of pneumococcal vaccine-type serotype-specific IgG measured by enzyme-linked immunosorbent assay at 18 months of age<br>3. Yellow fever neutralizing antibody titre expressed as the serum dilution that yields neutralisation of greater than or equal to 50% of virus infections of a standard cell line, measured 1 month after administration of yellow fever vaccine

Secondary Outcome Measures

Name	Time	Method
1. Rate of non-vaccine type pneumococcal nasopharyngeal acquisition between 9 and 14 months of age<br>2. Proportion with vaccine-type pneumococcal colonisation at 6, 9 and 18 months of age<br>3. Proportion with geometric mean concentration of pneumococcal vaccine-type serotype-specific IgG =0.35 µg/ml, 4 weeks after the primary series and 4 weeks after the booster dose at age 9 months, and at 18 months of age<br>4. Pneumococcal vaccine-type opsonophagocytic antibody titres following a single dose of PCV13 at age 6 weeks, following three primary doses, following the booster dose at age 9 months, and at 18 months of age<br>5. Geometric mean concentrations of pneumococcal vaccine-type serotype-specific IgG 4 weeks after administration of PCV13 at 9 months of age with and without co-administration with yellow fever vaccine