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Exposure of Naive and Pre-immune Subjects to P. Vivax Challenge

NCT01585077 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2014-01-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

P. vivax infected mosquito bites

All volunteers will receive one dose of 2-4 P. vivax infected mosquito bites. All the mosquitoes will correspond to the same mosquito batch to make sure that all volunteers receive the same P. vivax strain.

Sponsors & Collaborators

  • Socrates Herrera Valencia

    lead OTHER

Principal Investigators

  • Sócrates Herrera, MD · Malaria Vaccine and Drug Development Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-06-30
Completion
2013-11-30

Countries

  • Colombia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01585077 on ClinicalTrials.gov