Safety and Immunogenicity of AdCh63 ME-TRAP and MVA ME-TRAP Vaccines in Malaria Endemic Areas
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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 10, 2011
CompletedFirst Posted
Study publicly available on registry
June 23, 2011
CompletedOctober 3, 2012
October 1, 2012
11 months
June 10, 2011
October 2, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and reactogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya.
To assess safety and reactogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya by recording local and systemic solicited and unsolicited adverse events
Participants will be followed for the duration of the study, an expected average of 12 months
Secondary Outcomes (2)
Immunogenicity of vaccines
Participants will be followed for the duration of the study, an expected average of 12 months
Immunogenicity of Vaccines
Participants will be followed for the duration of the study, an expected average of 12 months
Study Arms (2)
Group 1
EXPERIMENTALIntramuscular arm
Group 2
EXPERIMENTALIntradermal arm
Interventions
AdCh63 ME-TRAP 1x10\^10 vp intramuscularly, MVA ME-TRAP 2x10\^8 pfu intramuscularly
Eligibility Criteria
You may qualify if:
- Consenting adult males aged 18-50 years in good health.
- Will remain resident in the study area for the study duration
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
KEMRI/Wellcome Trust Programme, Centre for Geographic Medicine Research - Coast
Kilifi, PO Box 43640, 00100, Kenya
Related Publications (1)
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.
PMID: 23526949DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2011
First Posted
June 23, 2011
Study Start
June 1, 2010
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
October 3, 2012
Record last verified: 2012-10