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Immunization of Human Volunteers With P. Vivax Irradiated Sporozoites

NCT01082341 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2018-03-23

No results posted yet for this study

Summary

It is possible to safely protect human volunteers immunized with P. vivax irradiated sporozoites from P. vivax challenge with live sporozoites.

Conditions

Interventions

BIOLOGICAL

Immunization with P. vivax irradiated sporozoites

Anopheles albimanus mosquitoes will be infected by artificial membrane feeding using blood from P. vivax infected donors. Once mosquitoes are positive will be irradiated at 15000 cGy and kept in boxes until use. 14 Fy(+) human volunteers in the experimental group will be immunized with 1,000-2,000 P. vivax irrad-spz bites. Seven Fy(+) volunteers in the control group will be exposed to non-infected mosquito bites. Six Fy(-) volunteers will be exposed to infective mosquito bites. For the challenge both the immunized and control groups will be exposed to 3 ± 1 infective mosquito bites. Volunteers will be closely monitored post infection and will be treated with antimalarials.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Asoclinic Inmunología Ltda.

    collaborator INDUSTRY

  • Malaria Vaccine and Drug Development Center

    lead OTHER

Principal Investigators

  • Socrates Herrera, MD · Malaria Vaccine Develepment Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-05-31
Completion
2017-09-30

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 NCT01082341 on ClinicalTrials.gov