NCT02543892

A Study of a Vaccine for Pneumonia in Adults and Toddlers in Kenya

Phase 1-2 Safety and Immunogenicity Study of PATH-wSP in Kenyan Adults and Toddlers

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 1 Year – 40 Years
• Healthy volunteers: Accepted

Summary

This study aimed to determine whether PATH-wSP, a vaccine against a germ that causes pneumonia, is safe and induces immune responses in adults and toddlers. The study vaccine was compared to placebo. First adults received 2 injections of a lower dose of the vaccine or placebo, 28 days apart. Since the lower dose was considered safe, a higher dose was tested. Once the safety was established in adults the lower and higher dose was tested in toddlers, starting with the lower dose and then the higher dose.

Detailed description

S. pneumoniae whole cell vaccine (SPWCV) is a vaccine candidate made from whole unencapsulated pneumococcal cells and adsorbed to aluminum hydroxide adjuvant (Alum). After adsorption of the Alum to SPWCV, the vaccine is referred to as PATH-wSP. PATH-wSP has been previously tested in Phase 1/2 studies in healthy US adults (VAC-002), and in healthy Kenyan adults and toddlers (VAC-010) and showed a favorable safety, tolerability, and immunogenicity profile. The SPWCV and Alum used in previous Phase 1/2 trials were supplied separately in a two-vial configuration; the SPWCV was manufactured at Walter Reed Army Institute of Research and the Alum at Instituto Butantan. A single-vial formulation of PATH wSP, an adsorbed suspension of SPWCV and Alum, has now been manufactured by PT Bio Farma, Indonesia. The purpose of this study was to assess the safety and tolerability of this new formulation.

Conditions

• Pneumonia

Interventions

Type	Name	Description
BIOLOGICAL	PATH-wSP	Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide
BIOLOGICAL	Placebo	Normal Saline

Timeline

• Start date: 2016-08-10
• Primary completion: 2018-01-04
• Completion: 2018-01-04
• First posted: 2015-09-07
• Last updated: 2018-11-28
• Results posted: 2018-11-28

Locations

1 site across 1 country: Kenya