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Trial to Evaluate the Safety, Immunogenicity, and Efficacy of Malaria Infection in Malaria Naïve Adults

NCT03341754 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2020-05-06

No results posted yet for this study

Summary

This is a study designed to assess the safety, tolerability, immunogenicity, and protective efficacy of 2 heterologous prime-boost vaccine regimens in healthy, malaria naïve adults. The study will include 2 vaccine groups and an infectivity control (IC) group consisting of non-immunized subjects. Subjects to be immunized will be randomly assigned to one of two vaccine groups.

Conditions

Interventions

BIOLOGICAL

D/ChAd63-CA

Priming Component (DNA) = NMRC-M3V-D-PfCA (D-CA) Vaccine Boosting Component = ChAd63-PfCA

BIOLOGICAL

D/ChAd63-CAT

Priming Component (DNA) = NMRC-M3V-D-PfCAT (D-CAT) Boosting Component = ChAd63-PfCAT

OTHER

Infectivity Control (IC) Group

Subjects will be exposed to bites of 5 Anopheles stephensi mosquitoes carrying infectious Pf sporozoites within a controlled clinical environment.

Sponsors & Collaborators

  • University of Oxford

    collaborator OTHER

  • Walter Reed Army Institute of Research (WRAIR)

    collaborator FED

  • United States Agency for International Development (USAID)

    collaborator FED

  • Naval Medical Research Center

    collaborator FED

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Nimfa Teneza-Mora, MD · United States Military Malaria Vaccine Program, NMRC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-09-15
Primary Completion
2019-10-28
Completion
2020-03-23
FDA Drug
Yes

Countries

  • United States

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 NCT03341754 on ClinicalTrials.gov