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Immunization Via Mosquito Bite With Radiation-attenuated Sporozoites

NCT01994525 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2019-09-17

No results posted yet for this study

Summary

This study is to assess the safety, tolerability, and biomarkers of protection in healthy malaria-naïve adults, who will receive bites from Anopheles stephensi mosquitoes either infected with Plasmodium falciparum Sporozoites (PfRAS) (true-immunization) or noninfected (mock-immunization).

Conditions

Interventions

BIOLOGICAL

PfRAS

Radiation-attenuated Plasmodium falciparum sporozoites (PfRAS) administered by the bite of infected Anopheles stephensi mosquitoes

BIOLOGICAL

Placebo

Administered by the bite of noninfected Anopheles stephensi mosquitoes

OTHER

Challenge

5 infectious Anopheles stephensi mosquito bites carrying infectious Plasmodium falciparum sporozoites within a controlled clinical environment.

Sponsors & Collaborators

  • Seattle Children's Hospital

    collaborator OTHER

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Nimfa Teneza-Mora, MD · Naval Medical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-01-24
Primary Completion
2016-12-20
Completion
2017-02-28

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT01994525 on ClinicalTrials.gov