Phase 1 of direct venous inoculation of PfSPZ Vaccine in Equatoguinean adults

The study to be conducted in Baney District, Bioko Island, Equatorial Guinea (EG), will be to establish whether three doses of the higher regimen – three doses of 2.7×10^5 PfSPZ of the PfSPZ vaccine administered at 8 week intervals – is as well-tolerated and efficacious in malaria exposed African adults as the five dose regimens. Specifically, the trial will address the following objectives: is the three-dose regimen:
1. Safe and well tolerated in Equatoguinean (EG) adults.
2. As immunogenic in EG adults as is the five-dose regimen of 1.35×10^5 PfSPZ in Tanzanian and U.S. adults or as three-, four- and five-dose regimens of 2.7×10^5 PfSPZ being tested in Tanzanian, Malian and U.S. adults.
In addition, as an exploratory objective, the volunteers in the EG trial will be followed longitudinally to measure the incidence of malaria during the initial six months following immunization, providing a preliminary assessment of efficacy.

Study type: Interventional
Enrollment: 33 participant
Primary purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel assignment
Masking :Quadruple (Participant, Investigator, Care provider, Outcome assessor)
NCT number: NCT02418962
Phase: Phase I

Clinical trial registration

Vaccines

Apr 2015 — Feb 2016

Equatorial Guinea

Genome-wide sieve analysis and immunological validation to identify targets of protective efficacy in field trials of a whole-organism malaria vaccine