Clinical trial NCT01379430: Safety and Immunogenicity of AdCh63 ME-TRAP and MVA ME-TRAP Vaccines in Malaria Endemic Areas
Official title: Safety and Immunogenicity of Heterologous Prime-boost With the Candidate Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP in Healthy Adults in a Malaria Endemic Area
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malaria
Keywords: Vaccine
Immune response
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
name: European and Developing Countries Clinical Trials Partnership (EDCTP)
First posted: 2011-06-23
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Safety and reactogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya.
timeFrame: Participants will be followed for the duration of the study, an expected average of 12 months
Secondary outcomes:
measure: Immunogenicity of vaccines
timeFrame: Participants will be followed for the duration of the study, an expected average of 12 months
measure: Immunogenicity of Vaccines
timeFrame: Participants will be followed for the duration of the study, an expected average of 12 months
Other outcomes:
Locations:
city: Kilifi
country: Kenya
facility: KEMRI/Wellcome Trust Programme, Centre for Geographic Medicine Research - Coast
Study officials:
References:
citation: Ogwang C, Afolabi M, Kimani D, Jagne YJ, Sheehy SH, Bliss CM, Duncan CJ, Collins KA, Garcia Knight MA, Kimani E, Anagnostou NA, Berrie E, Moyle S, Gilbert SC, Spencer AJ, Soipei P, Mueller J, Okebe J, Colloca S, Cortese R, Viebig NK, Roberts R, Gantlett K, Lawrie AM, Nicosia A, Imoukhuede EB, Bejon P, Urban BC, Flanagan KL, Ewer KJ, Chilengi R, Hill AV, Bojang K. Safety and immunogenicity of heterologous prime-boost immunisation with Plasmodium falciparum malaria candidate vaccines, ChAd63 ME-TRAP and MVA ME-TRAP, in healthy Gambian and Kenyan adults. PLoS One. 2013;8(3):e57726. doi: 10.1371/journal.pone.0057726. Epub 2013 Mar 19.