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.: PACTR201202000356208 Date of Approval: 07/02/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A study to find out if a new malaria vaccine regimen can protect against malaria in African adults.
Official scientific title Efficacy Study of ChAd63-MVA ME-TRAP prime-boost Vaccination against Plasmodium falciparum infection
Brief summary describing the background and objectives of the trial Malaria is a leading cause of illness and deaths in Africa. A malaria vaccine is therefore still a high priority for malaria control in Kenya as well as other African countries. Primary objective To assess the efficacy of a heterologous prime -boost vaccine strategy with ChAd63 ME-TRAP and MVA ME- TRAP in healthy adults in Kenya. Secondary objectives To assess the immunogenicity and correlates of efficacy of a heterologous prime -boost vaccine strategy with ChAd63 ME-TRAP and MVA ME-TRAP in healthy adults in Kenya. To assess the safety and reactogenicity of a heterologous prime -boost vaccine strategy with ChAd63 ME-TRAP and MVA ME-TRAP in healthy adults in Kenya. To assess the impact of natural immunity (cellular and humoural) on time to re-infection in healthy adults in Kenya
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TRAP VAC 046
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/02/2012
Actual trial start date 13/02/2012
Anticipated date of last follow up 22/08/2012
Actual Last follow-up date 03/09/2012
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status Closed to recruitment,follow-up continuing
Publication URL http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0167951
Secondary Ids Issuing authority/Trial register
SSC 2116 KEMRI SSC scientific review committee
ECCT/11/12/02 Pharmacy and Poison's Board regulatory authority
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 Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ChAd63 ME-TRAP and MVA ME-TRAP ChAd63 ME-TRAP 5 ×1010 viral particles (vp) at day 0 then MVA ME-TRAP 2 ×108 plaque forming units (pfu) 8 weeks later. Once two months apart Malaria vaccine 60
Control Group Verorab 0.5 ml once two months apart Rabies vaccine 60 Active-Treatment of Control Group
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. Able and willing (in the Investigator¿s opinion) to comply with all study requirements Informed Consent ¿ Any significant medical disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data ¿ Hypersensitivity to HDCRV,the trial vaccines or the antimalarial used. ¿ History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, kathon, neomycin ¿ History of splenectomy. ¿ Haemoglobin less than 10.0 g/dl ¿ Clinically significant abnormalities of laboratory screening tests (full blood count, ALT, creatinine levels). ¿ Blood transfusion within the month preceding enrolment. ¿ History of vaccination with previous experimental malaria vaccines or other vaccines likely to impact on findings of study (e.g. other MVA or adenovirus vectored vaccines) ¿ Administration of any other vaccine or immunoglobulin within 2 weeks before vaccination. ¿ HIV or Hepatitis B surface antigen seropositivity. ¿ Current participation in another clinical trial or recent participation 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 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 11/10/2011 KEMRI ETHICS REVIEW COMMITTEE
Ethics Committee Address
Street address City Postal code Country
P.O. BOX 5480 NAIROBI 00200 Kenya
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 09/12/2011 OXFORD TROPICAL RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
JOINT RESEARCH OFFICE, BLOCK 60 CHURCHILL HOSPITAL, OXFORD 0X3 7LJT United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome We will compare active and control vaccination for time to first episode of P.falciparum infection, defined as any blood sample confirmed positive by PCR Week 11:D70,D72,D74 Week 12:D77,D79,D81 Week 13:D84 ,D86,D88 Week 14:D91, D93,D95 Week 18:D98 Week 19:D105 Week 20:D112 Week 21:D119
Secondary Outcome Vaccine immunogenicity Day 0 Day 14 Day 63 Day 161
Secondary Outcome Vaccine reactogenicity Day 1 Day 57
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KEMRI - WT RESEARCH PROGRAMME P. O. BOX 230 BOFA ROAD 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
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 OX3 7DQ United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
UCAD Université Cheikh Anta Diop Dakar B.P 5005 Senegal
CNRFP National de Recherche et de Formation sur le Paludisme Ouagadougou 01 B.P. 2208 Burkina Faso
MRC Atlantic Road Fajara P. O. Box 273 Banjul Gambia
VSCR Kölblgasse 10 1030 Vienna 01 7134051 Austria
Okairos Okairòs Srl Via dei Castelli Romani 22 00040 Pomezia (Rome) Italy
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator CAROLINE OGWANG COgwang@kilifi.kemri-wellcome.org (+254) 417 522 535 KEMRI- WELLCOME TRUST RESEARCH PROGRAMME, CTF , P.O BOX 230
City Postal code Country Position/Affiliation
KILIFI 80800 Kenya Investigator
Role Name Email Phone Street address
Public Enquiries PATRICIA NJUGUNA PNjuguna@kilifi.kemri-wellcome.org (+254) 417 522 535 KEMRI WT RESEARCH PROGRAMME, P.O. BOX 230
City Postal code Country Position/Affiliation
KILIFI 80108 Kenya Investigator
Role Name Email Phone Street address
Scientific Enquiries PHILIP BEJON PBejon@kilifi.kemri-wellcome.org (+254) 417 522 535 KEMRI WT RESEARCH PROGRAMME, P.O. BOX 230
City Postal code Country Position/Affiliation
KILIFI 80800 Kenya Investigator
REPORTING
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