A Phase I/IIa clinical trial to assess the safety, immunogenicity and efficacy of the blood-stage Plasmodium falciparum malaria vaccine candidate RH5.1/AS01 - Safety, immunogenicity and efficacy of RH5.1/AS01 (VAC063)

niversity of Oxford, CTRG0 sites84 target enrollmentJuly 28, 2016

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: niversity of Oxford, CTRG
Enrollment: 84
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 28, 2016

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

niversity of Oxford, CTRG

Eligibility Criteria

Inclusion Criteria

•The volunteer must satisfy all the following criteria to be eligible for the study:
•Healthy adults aged 18 to 45 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 (GP).
•For females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day(s) of screening and vaccination, and on the day prior to blood\-stage CHMI, and prior to the start of antimalarial treatment for Group 5\-9 volunteers.
•Agreement to refrain from blood donation during the course of the study.
•Provide written informed consent.
•Additional Inclusion Criteria for Groups 5 \- 9
•Agreement to permanently refrain from blood donation, as per current UK Blood Transfusion and Tissue Transplantation Services guidelines.
•Reachable (24 hours a day) by mobile phone during the period between CHMI and completion of antimalarial treatment.

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 or any other investigational vaccine likely to impact on interpretation of the trial data. For Group 7 volunteers undergoing re\-challenge, this exclusion criterion does not extend to the RH5\.1/AS01B vaccine previously received.
•Any medical condition that in the judgment of the investigator would make intramuscular (IM) injection unsafe.
•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 during the period starting six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone 20 mg/day (for adult subjects), or equivalent. Inhaled and topical steroids are allowed.
•Administration of long\-acting immune\-modifying drugs at any time during the study period (e.g. infliximab).
•Chronic use of antibiotics with antimalarial effects (e.g. tetracyclines for dermatologic patients, sulfa for recurrent urinary tract infections, etc.).
•History of malaria chemoprophylaxis within 60 days prior to vaccination.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.