CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 31 enrolled
Drug / intervention
R21 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02572388
NCT02572388Phase 1Completed

Safety and Immunogenicity of a Protein Particle Malaria Vaccine Candidate, R21, Administered With and Without Matrix-M1 in Healthy UK Volunteers

University of Oxford·interventional·Posted Oct 8, 2015·Updated Nov 12, 2019

In Brief

A Phase 1 clinical trial evaluating R21 and Matrix-M1 for Malaria. Completed, enrolled 31 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 8, 2015
Enrollment StartOct 15, 2015
Primary CompletionAug 29, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 10.7 years ago

Interventions

R21biological

Matrix-M1biological