Last Updated: 25/11/2025
Safety, Tolerability and Efficacy of PfSPZ Vaccine Administered by Direct Venous Inoculation (DVI) to Healthy Children and Infants 5 Months through 12 Months Years of Age Living in an Area of High Malaria Transmission in Western Kenya
Objectives
This project aims to determine whether Plasmodium falciparum sporozoite vaccine is safe, well tolerated, immunogenic, and efficacious in reducing Pf malaria incidence in infants in an area of high malaria transmission.
Principal Investigators / Focal Persons
Partner Institutions
Rationale and Abstract
This study will be conducted in Siaya County in Nyanza Province, western Kenya. Healthy children aged 5 months through 9 years of age living within approximately 10 km of the study clinic(s) (Siaya County Referral Hospital, or Wagai dispensary, a government health facility in Wagai division) will be eligible for participation in Part 1; healthy infants aged 5 months – 12 months inclusive will be eligible for Part 2.
Study Design
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple (ParticipantCare ProviderInvestigatorOutcomes Assessor)
- Primary Purpose: Prevention
- Clinical trial registration: NCT02687373
External reference
Themes
Date
Jan 2016 — Dec 2017
Total Project Funding
$3.3M
Funding Details
Country / Project Site(s)
Related Resources
