Malaria Clinical Trial
Official title:
Phase 1, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety and Immunogenicity of Direct Venous Inoculation of a Radiation-attenuated Plasmodium Falciparum Sporozoite Vaccine (PfSPZ Vaccine) in Equatoguinean Adults
This is a single center, randomized, placebo-controlled, double-blind trial to assess the
safety and immunogenicity of PfSPZ Vaccine administered by direct venous inoculation (DVI).
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 2.7x10^5 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 1.35x10^5 PfSPZ in Tanzanian
and U.S. adults or as three-, four- and five-dose regimens of 2.7x10^5 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.
This is a single center, Phase 1, randomized, double-blind, placebo-controlled trial.
Thirty-three healthy male volunteers, aged 18 to 35 years will be recruited into three
groups. The first group will be comprised of 3 volunteers who will be vaccinated first
before the rest for demonstration of safety. The safety volunteers will receive 2 escalating
doses of PfSPZ vaccine at a two week interval, 1.35x10^5 and 2.7x10^5 PfSPZ. The second
group of 14 - 20 volunteers will receive three vaccinations of 2.7x10^5 PfSPZ that will be
given at 0, 8 and 16 weeks (in the Tanzania trial, volunteers will receive a five dose
regimen at 0, 4, 8, 12 and 18 weeks). The third group of 7 - 10 volunteers will act as
control group for group 2 and will receive three injections of normal saline at 0, 8 and 16
weeks respectively.
Volunteers in groups 2 and 3 will only be injected when the Safety Monitoring Committee
(SMC) provides clearance based on the results from the sentinel 3 volunteers (group 1). For
groups 2 and 3, five volunteers will be vaccinated with the first dose before the remaining
volunteers are vaccinated on a subsequent day.
The control volunteers will help better assess the occurrence of adverse events compared to
background disease patterns that occur in this tropical area. The decision to dose escalate
in group 1 and to immunize a larger number of volunteers in group 2 in Bioko will be made
with full knowledge of all safety data generated in other ongoing trials where the PfSPZ
Vaccine is being tested.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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