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VAC 072-An Efficacy Study of R21/MM in Different Dose Schedules

NCT03970993 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2021-10-13

No results posted yet for this study

Summary

An open label, partially blinded clinical trial in which healthy volunteers will be administered experimental malaria vaccines. There will be seven experimental groups of volunteers, of which five receive vaccination with the novel malaria vaccine candidate, R21, in combination with the vaccine adjuvant, Matrix M.

The study will assess the safety \& immune responses to vaccination, and the efficacy of the vaccine.

Conditions

Interventions

BIOLOGICAL

R21 Matrix-M vaccination

Three dose vaccination of 2μg, 10μg or 50μg of R21 and 50ug Matrix-M delivered intramuscularly

BIOLOGICAL

R21 Matrix-M vaccination and CHMI

Three dose vaccination of 2μg, 10μg or 50μg of R21 and 50ug Matrix-M delivered intramuscularly. Volunteers then have the option to be challenged with malaria by mosquito bite

BIOLOGICAL

R21 Matrix-M vaccination booster

Optional R21 Matrix-M vaccination booster following a three dose vaccination schedule

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-06-17
Primary Completion
2021-08-24
Completion
2021-08-24

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 NCT03970993 on ClinicalTrials.gov