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.: PACTR201008000221638 Date of Approval: 15/06/2010
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Safety of Malaria vaccines in Gambian adults , children and infants
Official scientific title Safety and immunogenicity of a heterologous prime-bosst vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP in healthy adults, children and infants in a malaria endemic area
Brief summary describing the background and objectives of the trial To assess safety and immunogenicity of candidate vaccine, AdCh63 ME-TRAP followed by MVA ME-TRAP in healthy adult volunteers in malaria endemic area. MVA ME-TRAP full dose. AdCh63 ME-TRAP one fifth dose before full dose. All vaccines administered intramuscularly. No placebo group will be used as the objective is to describe the safety profile in a small number of individuals, and confidence intervals would be too wide for meaningful comparison with a placebo. Immunogenicity will be compared with baseline.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 15/06/2010
Actual trial start date 15/06/2010
Anticipated date of last follow up 20/03/2011
Actual Last follow-up date 27/10/2011
Anticipated target sample size (number of participants) 52
Actual target sample size (number of participants) 52
Recruitment status Closed to recruitment,follow-up continuing
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
Randomised simple randomisation using a computer sofware programme for the paediatric study Allocation was determined by study statistician who is situated off site Open-label(Masking Not Used)
Randomised simple randomisation using a computer sofware programme for the paediatric study Allocation was determined by study statistician who is situated off site Open-label(Masking Not Used) Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group AdCh63 ME-TRAP and MVA ME-TRAP AdCh63 ME-TRAP 1 x 10(10) vp IM followed by MVA ME-TRAP 2 x 10 (8) pfu IM 8 weeks later 300 days AdCh63 ME-TRAP and MVA ME-TRAP 6
Experimental Group AdCh63 ME-TRAP and MVA ME-TRAP dose escalation to AdCh63 ME-TRAP 5 x10 (10) vp IM followed by MVA ME-TRAP 2 x 10 (8) pfu IM 8 weeks later 300 days AdCh63 ME-TRAP and MVA ME-TRAP 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Consenting adult males and children aged 2-6 years in good health Any of the following constitute an exclusion criterion: ¿Clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness. ¿History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products, Kathon. ¿History of splenectomy. ¿Haemoglobin less than 9.0 g/dL ¿Serum creatinine concentration above >130mmol/L ¿Serum ALT concentration >69 IU/L ¿Blood transfusion within one month ofenrolment. . ¿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. 2 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 10/12/2009 The Gambia Government/MRC Laboratories Joint Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Atlantic Boulevard Fajara PO Box 273 Gambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Local and systemic solicited and unsolicited adverse events Occurence of solicited events after each vaccination over a 3day follow up period. Occurence of unsolicited symptoms after each vaccination over a 30day follow up period (day of vaccination and 29 subsequent days). Occurence of serious adverse events throughout the study period.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sukuta Health Centre, MRC Laboratories PO Box 273 Fajara Gambia
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP Laan van Nieuw Oost Indie 300 The Hague Po Box 93015 Netherlands
EDCTP Laan van Nieuw Oost Indie 300 The Hague Po Box 93015 Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oxford University, Jenner Institute Old Road Campus Research Building Oxford OX3 7DQ United Kingdom University
Primary Sponsor Oxford University, Jenner Institute Old Road Campus Research Building Oxford OX3 7DQ United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Prof. Adrian Hill Jenner Institute, Old Road Campus Research Building Oxford OX3 7DQ United Kingdom
Prof. Adrian Hill Jenner Institute, Old Road Campus Research Building Oxford OX3 7DQ United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kalifa Bojaang kbojang@mrc.gm 220 4494072-9 Atlantic Boulevard, Fajara
City Postal code Country Position/Affiliation
Banjul PO Box 273 Gambia Research Clinician
Role Name Email Phone Street address
Public Enquiries Sanneh Mamkumba msanneh@mrc.gm 220 4494072-9 Atlantic Boulevard, Fajara
City Postal code Country Position/Affiliation
Banjul PO Box 273 Gambia Project Manager
Role Name Email Phone Street address
Scientific Enquiries Muhammed Afolabi mafolabi@mrc.gm 220 4494072-9 Atlantic Boulevard
City Postal code Country Position/Affiliation
Fajara PO Box 273, Banjul Gambia Research clinician
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information