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Comparison of the Susceptibility of Naive and Pre-immune Volunteers to Infectious Challenge With Viable Plasmodium Vivax Sporozoites. (ChallengeIII)
This study is a randomized clinical trial designed to compare the susceptibility of naive and pre-immune volunteers to infectious challenge with viable Plasmodium vivax sporozoites. The term preimmune hereafter denoted only previous experience with infection by this parasite and not a definite state of immunity to malaria infection. The study hypothesis is that pre-immune volunteers present a delayed onset of malaria clinical and parasitological manifestations when compared to naive individuals. The development of this study will establish a protocol for evaluating the effectiveness of vaccine candidates against P. vivax in subsequent Phases IIa and IIb clinical trials.
Details
| Lead sponsor | Socrates Herrera Valencia |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | COMPLETED |
| Enrolment | 16 |
| Start date | 2012-10 |
| Completion | 2013-11 |
Conditions
- Malaria
Interventions
- P. vivax infected mosquito bites
Primary outcomes
- Pre-patent period onset — Two months after the challenge
begining at day 7 after mosquito bites exposure, both groups of volunteers will be evaluated with dayly Thick blood smear to compare the malaria onset between the pre-immune and naive groups.
Countries
Colombia