A Phase I Study to Assess the Safety and Immunogenicity of a Protein Particle Malaria Vaccine Candidate, R21, Administered With AS01B in Healthy UK Volunteers

University of Oxford2 sites in 1 country20 target enrollmentDecember 8, 2015

ConditionsMalaria

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Malaria
Sponsor: University of Oxford
Enrollment: 20
Locations: 2
Primary Endpoint: Safety and tolerability of administration of R21 with adjuvant AS01B. This will be done by recording the number of participants who experience adverse events, and the severity of any adverse events.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a clinical trial in which healthy volunteers will be administered an experimental malaria vaccine, R21. The R21 vaccine will be administered with the adjuvant AS01B.

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

There are two different vaccine schedules:

Group 1 will receive R21 10µg with AS01B on days 0, 28, and 56. Group 2 will receive R21 50µg with AS01B on days 0, 28, and 56.

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

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

Registry

clinicaltrials.gov

Start Date

December 8, 2015

End Date

January 19, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Oxford

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The volunteer must satisfy all the following criteria to be eligible for the study:
•Healthy adults aged 18 to 50 years
•Able and willing (in the Investigator's opinion) to comply with all study requirements
•Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
•For females only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination
•Agreement to refrain from blood donation during the course of the study
•Provide written informed consent

Exclusion Criteria

•The volunteer may not enter the study if any of the following apply:
•Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
•Prior receipt of an investigational malaria vaccine likely to impact on interpretation of the trial data.
•Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
•Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
•Any history of anaphylaxis in relation to vaccination
•Pregnancy, lactation or willingness/intention to become pregnant during the study
•History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
•History of serious psychiatric condition likely to affect participation in the study

Outcomes

Primary Outcomes

Safety and tolerability of administration of R21 with adjuvant AS01B. This will be done by recording the number of participants who experience adverse events, and the severity of any adverse events.

Time Frame: 34 weeks