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.: PACTR201401000363170 Date of Approval: 26/02/2012
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Safety of Malaria vaccines in Gambian infants
Official scientific title Safety and immunogenicity of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP in infants in a malaria endemic area
Brief summary describing the background and objectives of the trial A phase 1 study to assess the safety and immunogenicity of a heterologous prime-boost vaccine strategy with AdCh63 ME-TRAP and MVA ME-TRAP in 36 healthy infants in a malaria endemic area. Safety was assessed by clinical evaluations post vaccination, and immunogenicity was assessed by ELISPOT assay and intra-cellular cytokine staining by flow cytometry.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 29/09/2011
Actual trial start date 29/09/2011
Anticipated date of last follow up 22/12/2011
Actual Last follow-up date 22/12/2011
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants) 36
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
Randomised Simple randomisation using a radomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group AdCh63 ME-TRAP followed by MVA ME-TRAP 8 weeks later AdCh63 ME-TRAP: 1 x 1010vp IM followed by 5 x 1010vp and MVA ME-TRAP: 1 x 108 pfu 10 months malaria vaccine 12
Experimental Group AdCh63 ME-TRAP followed by MVA ME-TRAP 8 weeks later AdCh63 ME-TRAP 5 x 1010vp followed by MVA ME-TRAP 8 weeks later AdCh63 ME-TRAP 5 x 1010vp followed by MVA ME-TRAP 8 weeks later Malaria vaccine 12
Control Group No vaccination Not applicable Not applicable No vaccination 12 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
For Stage 1: Healthy male and female infants aged 5-12 months at the time of enrolment with consenting parents. For Stage 2: Healthy male and female infants aged 10 weeks at the time of enrolment with consenting parents. Any of the following constitutes 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. ¿Severe malnutrition. ¿History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, betapropiolactone. ¿History of splenectomy ¿Haemoglobin less than 8.0 g/dL, where judged to be clinically significant in the opinion of the investigator ¿Serum Creatinine concentration greater than 70 ¿mol/L, where judged to be clinically significant in the opinion of the investigator ¿Serum ALT concentration greater than 45 U/L, where judged to be clinically significant in the opinion of the investigator ¿Blood transfusion within one month of enrolment. ¿History of vaccination with previous experimental malaria vaccines. ¿Administration of any other vaccine or immunoglobulin less than two weeks before vaccination with the IMPs ¿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 ¿Maternal HIV infection ¿Positive malaria antigen test at screening ¿Failure to have received, prior to enrolment, the routine EPI vaccinations due according to the Gambian EPI schedule. 10 Month(s) 12 Month(s) Both
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 07/07/2011 The Gambia Government /MRC 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 To assess the safety of heterologous prime-boost vaccination of healthy infants in a malaria-endemic area with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP Each subject will be visited at home daily for three days by a field worker for assessment and recording of any solicited and unsolicited AEs.
Secondary Outcome To assess the immunogenicity of heterologous prime-boost vaccination of healthy infants in a malaria-endemic area with AdCh63 ME-TRAP followed eight weeks later by MVA ME-TRAP Screening, Day 21, Day 56, Day 63, Day 105
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MRC Unit Atlantic Boulevard Fajara PO Box 273 Gambia
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP 334 Laan van Nieuw Oost Indië The Hague P.O.Box 93015, 2509 Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Oxford Heather House,Clinical Trials and Research Governance,Manor House , John Radcliffe Hospital Oxford OX3 9DZ United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
European Vaccine Initiative Im Neuenheimer Feld 326 - 3. OG Heidelberg 69120 Germany
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kalifa Bojang kbojang@mrc.gm +220 449442 ext 4004 Atlantic Boulevard
City Postal code Country Position/Affiliation
Fajara PO Box 273 Gambia Senior Clinical Scientist
Role Name Email Phone Street address
Public Enquiries Sanneh Mamkumba msanneh@mrc.gm 2204495442 x2315 Atlantic Boulevard
City Postal code Country Position/Affiliation
Fajara PO BOx273 Gambia Programme Manager
Role Name Email Phone Street address
Scientific Enquiries Muhammed Afolabi mafolabi@mrc.gm 2204495442 x5037 Atlantic Boulevard
City Postal code Country Position/Affiliation
Fajara PO BOx273 Gambia Clinical scientist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information