Clinical Trial: Dose-Finding Study of S.Pneumoniae Whole Cell Vaccine Adsorbed to Alum (PATH-wSP) in Healthy Kenyan Adults and Toddlers

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Dose-Finding Study to Assess the Safety, Tolerability, and Immunogenicity of Inactivated Streptococcus Pneumoniae Whole Cell Vaccine Formulated With Alum (PATH-wSP) in Healthy Kenyan Young Adults an

Brief Summary:

The purpose of this study is to assess the safety and tolerability of PATH-wSP, administered intramuscularly to healthy Kenyan adults and toddlers who have been primed with a pneumococcal conjugate vaccine (PCV).

Additionally, the study will explore whether a measurable immune response is elicited when PATH-wSP is administered to healthy Kenyan adults and toddlers who have been primed with PCV.


Detailed Summary:
Sponsor: PATH

Current Primary Outcome: Proportion of subjects with reactogenicity events [ Time Frame: through 1 week post vaccination ]

Immediate reactions occurring within 60 minutes of administration of any dose, measured as observed by study staff or reported by the subject to study staff whether related or not related.Solicited reactions will be assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.


Original Primary Outcome: Same as current

Current Secondary Outcome: To evaluate the distribution of antibody concentrations in pre- and post-vaccination sera following each vaccination for pneumococcal-specific proteins and for neutralizing antibody responses [ Time Frame: Prior to the first vaccination compared to 1 week after each vaccination ]

Proportion of responders and geometric mean concentration (GMC) for enzyme linked immunosorbent assays of pneumococcal specific proteins on serum specimens obtained pre and post vaccination


Original Secondary Outcome: Same as current

Information By: PATH

Dates:
Date Received: March 17, 2014
Date Started: April 2014
Date Completion:
Last Updated: January 7, 2016
Last Verified: April 2015