Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR2010020001771828 Date of Approval: 29/01/2010
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title TRAP VAC TRIAL
Official scientific 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
Brief summary describing the background and objectives of the trial This is a phase Ib study to assess safety & reactogenicity and evaluate the immunogenicty of Heterologous Prime-Boost Candidate Malaria Vaccines AdCh63 ME-TRAP and MVA ME- TRAP in Healthy adults in Kilifi - Kenya. The primary objective is to obtain preliminary data of AdCh63 ME-TRAP followed by MVA ME-TRAP in males in Kenya. The secondary objective is to compare intra-muscular and intra-dermal MVA ME-TRAP routes.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) TRAP VAC
Disease(s) or condition(s) being studied Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 10/06/2010
Actual trial start date 10/06/2010
Anticipated date of last follow up 18/05/2011
Actual Last follow-up date 18/05/2011
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Screened participants will be allocated a sequential study ID number. That study ID number will correspond to the specific treatment allocation which will be randomly allocated to either group 1 as A1 or B1 or group 2 as A2 or B2. Block randomisation, computed in five blocks of six distributing subject into two groups at 1:2 ration (group 1 = 10 subject, group2 = 20 subject) Sealed envelopes. Independent statistician will generate randomisation list and print onto allocation cards and sealed. Sealed envelopes labeled wtih sequential study ID will be opened by subjects when eligible Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Screened participants will be allocated a sequential study ID number. That study ID number will correspond to the specific treatment allocation which will be randomly allocated to either group 1 as A1 or B1 or group 2 as A2 or B2. Block randomisation, computed in five blocks of six distributing subject into two groups at 1:2 ration (group 1 = 10 subject, group2 = 20 subject) Sealed envelopes. Independent statistician will generate randomisation list and print onto allocation cards and sealed. Sealed envelopes labeled wtih sequential study ID will be opened by subjects when eligible Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group2 Day 0 High dose AdCh63 ME-TRAP followed by day 63 MVA ME-TRAP AdCh63 ME-TRAP at 5x10 power 10 vp then Single intramuscular dose for ADCh63 ME-TRAP. High dose AdCh63 ME-TRAP intramuscularly followed by MVA ME-TRAP given either IM (10) or ID (10) 20
Experimental Group Group1 Day 0 low dose AdCh63 ME-TRAP followed by day 63 MVA ME-TRAP AdCh63 ME-TRAP at x10 power 10 vp then Single intramuscular dose for ADCh63 ME-TRAP. Low dose AdCh63 ME-TRAP intramuscularly followed by MVA ME-TRAP given either IM (5) or ID (5) 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
·Consenting adult males aged 18-50 years in good health. ·Will remain resident in the study area for the study duration ·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) 18 Year(s) 50 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/04/2010 National Ethics Review Commitee (ERC), Kenya
Ethics Committee Address
Street address City Postal code Country
KEMRI Headquaters, Mbagathi Road, P.o Box 54840-00200, NAIROBI, Kenya Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Reactogenicity of the vaccines Immediate reactogenicity actively solicited at days 0-3 Any time adverse event occurs
Primary Outcome Clinical and biological safety At day 0 Daily within 3 days Week 3 Week 10 Week 14 Week 45
Secondary Outcome Immunogenicity Day 0 Day 7 Week 3 week 9 Week 10 week 14 Week 14 Week 45
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Rea Vipingo Sisal Plantations, C/o KEMRI/WTRP, Hospital grounds, Po Box 230 Kilifi 80108 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP Francie van Zijl Drive, Parowvallei Cape town Tygerberg 7505 South Africa
EDCTP Francie van Zijl Drive, Parowvallei Cape town Tygerberg 7505 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Oxford Old Road Campus Research Building, Oxford University Oxford Oxford OX3 7DQ United Kingdom University
Primary Sponsor University of Oxford Old Road Campus Research Building, Oxford University Oxford Oxford OX3 7DQ United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
UCAD Université Cheikh Anta Diop B.P 5005 - Dakar-Fann - Sénégal - Dakar -------- Senegal
UCAD Université Cheikh Anta Diop B.P 5005 - Dakar-Fann - Sénégal - Dakar -------- Senegal
CNRFP National de Recherche et de Formation sur le Paludisme, Ouagadougou (CNRFP), 01 B.P. 2208, Ouagadougou 01, Burkina Faso ... Ouagadougou ------------- Burkina Faso
CNRFP National de Recherche et de Formation sur le Paludisme, Ouagadougou (CNRFP), 01 B.P. 2208, Ouagadougou 01, Burkina Faso ... Ouagadougou ------------- Burkina Faso
MRC-The Gambia Atlantic Road Fajara P. O. Box 273. Banjul The Gambia Fajara-Banjui ---- Gambia
MRC-The Gambia Atlantic Road Fajara P. O. Box 273. Banjul The Gambia Fajara-Banjui ---- Gambia
VSCR Kölblgasse 10 1030 Vienna, Austria 01 7134051 Veinna 1030 Austria
VSCR Kölblgasse 10 1030 Vienna, Austria 01 7134051 Veinna 1030 Austria
KEMRI/WTRP Hospital grounds-off bofa road, Po Box 230 Kilifi 80108 Kenya
KEMRI/WTRP Hospital grounds-off bofa road, Po Box 230 Kilifi 80108 Kenya
Okairos Okairòs Srl Via dei Castelli Romani 22 00040 Pomezia (Rome) Rome ---------- Italy
Okairos Okairòs Srl Via dei Castelli Romani 22 00040 Pomezia (Rome) Rome ---------- Italy
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Caroline Ogwang cogwang@kilifi.kemri-wellcome.org (+254)417 522063 KEMRI/WTRP, Hospital grounds, Po box 230
City Postal code Country Position/Affiliation
KILIFI 80108 Kenya Principal Investigator
Role Name Email Phone Street address
Public Enquiries Peninah Menza psoipei@kilifi.kemri-wellcome.org (+254)417 522063 KEMRI/WTRP, Hospital grounds, Po box 230
City Postal code Country Position/Affiliation
KILIFI 80108 Kenya Study Coordinator
Role Name Email Phone Street address
Scientific Enquiries Philip Bejon PBejon@kilifi.kemri-wellcome.org (+254)417 522063 KEMRI/WTRP, Hospital grounds, Po box 230
City Postal code Country Position/Affiliation
KILIFI 80108 Kenya Core- PI
REPORTING
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