A Phase I/II Study to assess the safety, immunogenicity and protective efficacy of novel malaria vaccine candidates ChAdOx1 LS2 and MVA LS2 in healthy UK adults - A Safety and Efficacy Study of ChAdOx1 LS2 and MVA LS2 (VAC067)

niversity of Oxford, CTRG0 sites18 target enrollmentMay 2, 2017

Overview

No summary available.

Registry

who.int

Start Date

May 2, 2017

End Date

December 20, 2017

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

niversity of Oxford, CTRG

•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
•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 to participate in the trial.
•Additional inclusion criteria for group 2 and control groups A\&B
•Agreement to refrain from blood donation during the course of the study and for at least 3 years after the end of their involvement in the study.
•Reachable (24/7\) by mobile phone during the period between CHMI and completion of antimalarial treatment.

•The volunteer may not enter the study if any of the following apply:
•History of clinical malaria (any species).
•Travel to a clearly malaria endemic locality during the study period or within the preceding six months
•Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period.
•Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data as assessed by the investigator. This may include non\-malaria adenovirus vectored experimental vaccine. If any volunteers in Group 2 undergo rechallenge, this exclusion criterion does not extend to the vaccines previously received in the VAC067 trial.
•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).
•Use of immunoglobulins or blood products within 3 months prior to enrolment.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (e.g. egg products, Kathon) or malaria infection.
•Any history of anaphylaxis post vaccination.
•History of clinically significant contact dermatitis.