A Safety and Efficacy Study of R21 +/- ChAd63/MVA ME-TRAP

NCT02905019 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2018-06-13

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and efficacy of adjuvanted R21 alone and in combination with a viral-vectored vaccine regimen (constituting adjuvanted R21 + ChAd63 and MVA encoding ME-TRAP) against malaria sporozoite challenge in healthy malaria-naive volunteers.

Healthy adult volunteers will be recruited in London, Oxford and Southampton.

All vaccinations will be administered intramuscularly. The study involves having either two, three or five vaccinations and then undergoing challenge infection with malaria, or receiving no vaccinations then undergoing challenge infection with malaria.

Conditions

Interventions

BIOLOGICAL

R21 with Matrix-M1

Vaccine

BIOLOGICAL

ChAd63 ME-TRAP

Vaccine

BIOLOGICAL

MVA ME-TRAP

Vaccine

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Adrian V Hill, DPhil FRCP · Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hosptal, Oxford, United Kingdom

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-12-21
Completion
2017-12-21

Countries

  • United Kingdom

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 NCT02905019 on ClinicalTrials.gov