Safety and Immunogenicity of AdCh63 ME-TRAP and MVA ME-TRAP Vaccines in Malaria Endemic Areas

University of Oxford

Status and phase

Completed

Phase 1

Conditions

Malaria

Treatments

Biological: AdCh63 ME-TRAP followed by MVA ME-TRAP

Study type

Interventional

Funder types

Other

Identifiers

NCT01379430

VAC040

Details and patient eligibility

About

The purpose of this trial is to assess the safety and immunogenicity of AdCh63 ME-TRAP and MVA ME-TRAP candidate vaccines in healthy adult volunteers in a malaria endemic region. The regime proposed in this trial has protected non-immune volunteers against sporozoite challenge in clinical trials performed by Oxford, and so may be protective against naturally acquired infection in Kenya.The study population will comprise 30 healthy adult males aged 18-50.

The investigators do not propose to include a placebo group. At this stage the investigators objective is to describe the safety profile in a small number of individuals, and the confidence intervals for the proportion of individuals with a particular event would be too wide for meaningful comparison with a placebo group. Immunogenicity will be judged by comparison with baseline.

Enrollment

30 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Consenting adult males aged 18-50 years in good health.
Will remain resident in the study area for the study duration

Exclusion criteria

Clinically significant history of the following conditions; skin disorder (eczema, etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness.
History of splenectomy
Haemoglobin less than 9.0 g/dl
Clinically significant abnormalities of laboratory screening tests (full blood count, ALT, creatinine levels, urine dipstick examination for blood and protein).
Blood transfusion within one month of the beginning of the study
History of vaccination with previous experimental malaria vaccines
Administration of any other vaccine or immunoglobulin within two weeks before vaccination.
Current participation in another clinical trial, or within 12 weeks of this study
Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial.
Likelihood of travel away from the study area
HIV positive.
History of contact dermatitis (due to the use of a potentially irritant disinfectant that may be present in trace amounts in the AdCh63 ME-TRAP vaccine, see the investigators brochure for details, attached)