Back to resultsSafety and Immunogenicity of AdCh63 ME-TRAP and MVA ME-TRAP Vaccines in Malaria Endemic Areas
Primary Purpose
Malaria
Status
Completed
Phase
Phase 1
Locations
Kenya
Study Type
Interventional
Intervention
AdCh63 ME-TRAP followed by MVA ME-TRAP
AdCh63 ME-TRAP followed by MVA ME-TRAP
Sponsored by
About this trial
This is an interventional prevention trial for Malaria focused on measuring Vaccine, Immune response
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)
Sites / Locations
- KEMRI/Wellcome Trust Programme, Centre for Geographic Medicine Research - Coast
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group 2
Arm Description
Intramuscular arm
Intradermal arm
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Immunogenicity of vaccines
To evaluate the immunogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya by assessing induced antibody and T cell response to the vaccine insert.
Immunogenicity of Vaccines
To compare the use of intra-muscular and intra-dermal MVA ME-TRAP
Full Information
NCT ID
NCT01379430
First Posted
June 10, 2011
Last Updated
October 2, 2012
Sponsor
University of Oxford
Collaborators
Kenya Medical Research Institute, European and Developing Countries Clinical Trials Partnership (EDCTP)
1. Study Identification
Unique Protocol Identification Number
NCT01379430
Brief Title
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
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
Kenya Medical Research Institute, European and Developing Countries Clinical Trials Partnership (EDCTP)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Vaccine, Immune response
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Intramuscular arm
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Intradermal arm
Intervention Type
Biological
Intervention Name(s)
AdCh63 ME-TRAP followed by MVA ME-TRAP
Intervention Description
AdCh63 ME-TRAP 1x10^10 vp intramuscularly, MVA ME-TRAP 2x10^8 pfu intramuscularly
Intervention Type
Biological
Intervention Name(s)
AdCh63 ME-TRAP followed by MVA ME-TRAP
Intervention Description
AdCh63 ME-TRAP 5x10^10 vp intramuscularly, MVA ME-TRAP 2x10^8 pfu intradermal
Primary Outcome Measure Information:
Title
Safety and reactogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya.
Description
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
Time Frame
Participants will be followed for the duration of the study, an expected average of 12 months
Secondary Outcome Measure Information:
Title
Immunogenicity of vaccines
Description
To evaluate the immunogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya by assessing induced antibody and T cell response to the vaccine insert.
Time Frame
Participants will be followed for the duration of the study, an expected average of 12 months
Title
Immunogenicity of Vaccines
Description
To compare the use of intra-muscular and intra-dermal MVA ME-TRAP
Time Frame
Participants will be followed for the duration of the study, an expected average of 12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Facility Information:
Facility Name
KEMRI/Wellcome Trust Programme, Centre for Geographic Medicine Research - Coast
City
Kilifi
ZIP/Postal Code
PO Box 43640, 00100
Country
Kenya
12. IPD Sharing Statement
Citations:
PubMed Identifier
23526949
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.
Results Reference
derived
Learn more about this trial
Safety and Immunogenicity of AdCh63 ME-TRAP and MVA ME-TRAP Vaccines in Malaria Endemic Areas
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