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A Safety and Efficacy Study of Concomitant Administration of ChAd63/MVA ME-TRAP + RTS,S

NCT02252640 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2015-12-03

No results posted yet for this study

Summary

The purpose of this study is to assess two types of new malaria vaccines in different combinations. The study will enable us to assess:

1. The ability of the vaccines to prevent malaria infection.
2. The safety of the vaccines in healthy participants.
3. The response of the human immune system to the vaccines.

We will do this by giving 48 participants three sets of vaccinations over 8 weeks, then exposing them to malaria infection by allowing mosquitoes infected with malaria to bite under carefully regulated conditions. We will follow participants closely to observe if and when they develop malaria. If the vaccine combination provides some protection against malaria, participants will take longer to develop malaria than usual or will not develop malaria at all. We will also recruit 4 individuals to be control subjects - these participants won't receive any vaccinations but will be challenged with malaria.

Vaccinated volunteers who do not develop malaria infection in the blood after being infected with malaria by mosquito bite the first time may be invited back to be again infected with malaria in a repeat challenge experiment. This would happen approximately 5-7 months after the first challenge. The purpose of this second challenge will be to see how long the protection of the investigational vaccine against malaria lasts.

Conditions

  • Plasmodium Falciparum Malaria

Interventions

BIOLOGICAL

RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01)

BIOLOGICAL

RTS,S/AS01B (10mcg of RTS,S and one fifth of the standard dose of AS01)

BIOLOGICAL

ChAd63 ME-TRAP (5 x 10^10 vp)

BIOLOGICAL

MVA ME-TRAP (2 x 10^8 pfu)

Sponsors & Collaborators

  • The PATH Malaria Vaccine Initiative (MVI)

    collaborator OTHER

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • University of Oxford

    lead OTHER

Principal Investigators

  • Adrian VS Hill · University of Oxford

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
2015-01-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United Kingdom

Study Locations

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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 NCT02252640 on ClinicalTrials.gov