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A Study to Assess the Safety and Immunogenicity of the Malaria Vaccine, R21, Administered With and Without Matrix-M1

NCT02572388 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2019-11-12

Study results available
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Summary

This is a clinical trial in which healthy volunteers will be administered one or two experimental malaria vaccines. The vaccine R21 will either be administered alone or in combination with the adjuvant vaccine Matrix-M1.

All vaccinations will be administered intramuscularly. Each volunteer will receive three vaccinations in total.

There are three different vaccine schedules:

Group 1 will receive 10µg of R21 mixed with 50µg of Matrix-M1 on days 0, 28, and 56.

Group 2 will receive 50µg of R21 on days 0, 28, and 56. .

Group 3 will receive 50µg of R21 mixed with 50µg of Matrix-M1 on days 0, 28, and 56.

The study will assess the safety of the vaccines, and the immune responses to the vaccinations. Immune responses are measured by tests on blood samples.

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

Conditions

Interventions

BIOLOGICAL

R21

BIOLOGICAL

Matrix-M1

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-10-15
Primary Completion
2017-08-29
Completion
2017-08-29

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 NCT02572388 on ClinicalTrials.gov