Safety and Immunogenicity of Novel Vaccination Schedules With Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP

This is an open label phase I study, to assess the safety and immunogenicity of novel schedules for vaccination with the candidate malaria vaccines AdCh63 ME-TRAP and MVA ME-TRAP. These vaccines have been evaluated previously in a number of clinical trials proved to be safe and capable of inducing protective cellular immune response following challenge with the parasite. All volunteers recruited will be healthy adults. They will be primed with AdCh63 ME-TRAP administered intramuscularly and boosted several times with AdCh63 ME-TRAP and MVA ME-TRAP according to various schedules.. Safety data will be collected for each of the seven regimens. Secondary aims of this study will be to assess the immune responses generated by each of these regimes.

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford

Oxford, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 their medical history with their General Practitioner
For female volunteers, willingness to practice continuous effective contraception during the study
Agreement to refrain from blood donation during the course of the study
Written informed consent

Exclusion criteria

Participation in another research study involving 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
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)
Pregnancy, lactation, or intention to become pregnant during the study
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products, Kathon History of clinically significant contact dermatitis
Any history of anaphylaxis in relation to vaccination
Any history of malaria Travel to a malaria endemic region during the study period or within the six months preceding enrolment in the study
History of serious psychiatric condition that may affect participation in the study
Any other serious chronic illness requiring hospital specialist supervision -Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
Suspected or known injecting drug abuse in the five years preceding enrolment -Seropositive for hepatitis B surface antigen (HBsAg)
Seropositive for hepatitis C virus (antibodies to HCV)
Any relevant history of cancer (excludes basal cell carcinoma of the skin and cervical carcinoma in situ)
Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of study data