NCT02146365

Nasopharyngeal Carriage Study in Healthy Kenyan Toddlers

A Prospective Study to Assess the Nasopharyngeal Carriage of Streptococcus Pneumoniae (SPn), Long Term Safety and Immune Persistence in Healthy Kenyan PCV-Primed Toddlers (12-15 Months of Age) Who Received a Whole Cell Pneumococcal Vaccine (PATH-wSP) Compared to Controls

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 297 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 12 Months – 15 Months
• Healthy volunteers: Accepted

Summary

This study evaluated the change in nasopharyngeal carriage (NPC) of Streptococcus pneumoniae (SPn), hypothesizing that it would be reduced post-vaccination with Streptococcus pneumoniae whole cell vaccine with aluminum hydroxide adjuvant (PATH-wSP) and that PATH-wSP would remain safe and well-tolerated over the course of the study.

Detailed description

This study enrolled healthy Kenyan toddlers (12-15 months of age) who participated in the randomized control trial of VAC-010 (NCT02097472), as well as healthy toddlers aged 12 to 15 months who had not participated in the VAC-010 Study. All participants must have received a primary dose of pneumococcal conjugate vaccine (PCV) per local practice prior to enrollment in either VAC-010 or VAC-011. No treatments were administered during this study. The study consisted of the following four groups: Participants who were randomized in study VAC-010 (2:2:1 ratio), defined according to the treatment received in VAC-010: * 1\. PATH-wSP + Booster * 2\. PATH-wSP Only * 3\. Booster Only Participants who did not participate in VAC-010: * 4\. No Intervention Each group consisted of 2 cohorts of participants, Cohort 1 (300 µg PATH-wSP) and Cohort 2 (600 µg PATH-wSP). Enrollment into Cohorts 1 and 2 occurred sequentially; participants in groups 3 and 4 who did not receive PATH-wSP were also enrolled over time and allocated into one of the two cohorts (300 and 600 µg) in order to control for potential seasonal variation in the NPC of S. pneumoniae. Each participant completed a total of 5 scheduled visits. For toddlers enrolled simultaneously in VAC-010, visits corresponded to enrollment (Baseline) and 4, 8, 12, and 24 weeks post final vaccination in VAC-010. For toddlers in the No Intervention group, the first visit corresponded to Baseline and the second to fifth visits corresponded to 12, 16, 20, and 32 weeks later. Nasopharyngeal swabs were taken at each visit following World Health Organization (WHO) guidelines for analysis of nasopharyngeal burden. Treatments received during VAC-010 included: * PATH-wSP: Streptococcus pneumoniae whole cell vaccine with aluminum hydroxide adjuvant * Synflorix™ booster vaccine: pneumococcal polysaccharide conjugate vaccine (adsorbed) * Pentavac booster vaccine: diphtheria, tetanus, pertussis (Whole Cell), hepatitis B (recombinant deoxyribonucleic acid \[rDNA\]) and Haemophilus influenzae type b conjugate vaccine (adsorbed). * Saline control

Conditions

• Pneumococcal Disease

Timeline

• Start date: 2014-09-25
• Primary completion: 2016-02-18
• Completion: 2016-02-18
• First posted: 2014-05-23
• Last updated: 2020-02-17
• Results posted: 2020-02-17

Locations

1 site across 1 country: Kenya