Last Updated: 02/12/2024
PfSPZ Vaccine by direct venous inoculation to healthy children and infants 5 months through 9 years of age in western Kenya: age de-escalation and dose escalation
Objectives
The objective of this study is to evaluate the safety and tolerability of PfSPZ vaccine administered in healthy children and infants living in an area of high malaria transmission.
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 type: Interventional
Enrollment: 337 participant
Primary purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel assignment
Masking : Quadruple (Participant, Investigator, Care provider, Outcome assessor)
NCT number: NCT02687373
Phase: Phase I/II
- Article: Feasibility of direct venous inoculation of the radiation-attenuated Plasmodium falciparum whole sporozoite vaccine in children and infants in Siaya, western Kenya
- Article: Safety, immunogenicity and efficacy of PfSPZ Vaccine against malaria in infants in western Kenya: a double-blind, randomized, placebo-controlled phase 2 trial
- Article: Safety, Tolerability, and Immunogenicity of Plasmodium falciparum Sporozoite Vaccine Administered by Direct Venous Inoculation to Infants and Young Children: Findings From an Age De-escalation, Dose-Escalation, Double-blind, Randomized Controlled Study in Western Kenya
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