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.: PACTR201303000499409 Date of Registration:
Trial Status:
TRIAL DESCRIPTION
Public title Efficacy Study of ChAd63-MVA ME-TRAP prime-boost Vaccination against Plasmodium
Official scientific title Efficacy Study of ChAd63-MVA ME-TRAP prime-boost Vaccination against Plasmodium
Brief summary describing the background and objectives of the trial It has been recently shown higher levels of immunogenicity by using a chimpanzee adenovirus (ChAd63) followed by an attenuated vaccinia virus to deliver the pre-erythrocytic antigen, multiple epitope string with thrombospondin- related adhesion protein (ME-TRAP).The increase in immunogenicity has led to sterile protection in 3 out of 14 volunteers and partial protection in 5 out of 14 volunteers in challenge studies. It is important to determine efficacy before having larger trials in children.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) VAC047
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 01/06/2012
Actual trial start date 25/07/2012
Anticipated date of last follow up 15/12/2012
Actual Last follow-up date 06/02/2013
Anticipated target sample size (number of participants) 160
Actual target sample size (number of participants) 160
Recruitment status Completed
Publication URL http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0167951
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 A statistician independents of the study was responsible for generating and keeping a randomization code list. The list was sent electronically to a responsible person at the study site in Senegal who was independent of the study The independent person (namely MrEl Hadj Ba, IRD Dakar) made sealed sequential numbered opaque envelopes using the list. As per the protocol, the eligible volunteers were randomised 1:1 to receive vacciantion with rabies vaccine or Ad/MVA ME-TRAP Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group ChAD63 ME-TRAP: 5x 10^10vp MVA ME-TRAP: 2x 10^8pfu heterologoous prime-boost immunisation 2 x 2.5IU Verorab 1 dose verab followed 8wks later by a second dose 60 Active-Treatment of Control Group
Experimental Group Biological: ChAd63 ME-TRAP and MVA ME-TRAP ChAD63 ME-TRAP: 5x 10^10vp MVA ME-TRAP: 2x 10^8pfu heterologoous prime-boost immunisation 8 weeks Vaccination with Ch63 ME-TRAP followed 8 weeks later by boost dose with MVA ME-TRAP 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Consenting adult males aged 18-50 yrs in good health. Will remain resident in the study area for the study duration. Able and willing (in the investigators opinion) to comply with all study requirements Informed consent. 1. Any significant medical disease, disorder, finidng which may significantly increase the risk of the volunteer because of participantion in the sutdy, affect the ability of the volunteer to participate in the study or impair tinterpretation of the study data. 2. Hypersensitivity to HDCRV, the tiral vaccine or the antimalarial use. 3. History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, eg egg products, kathon, neomycin 4. Haemoglobin <10 g/dl 5.Clinically significant abnormalities of laboratory screening tests (full blood count, ALT, creatinine levels) 6. Blood transfusion within month of enrollemnt 7.History of vaccination with previous experimental malaria vaccines or other vaccines likely to impact on findins of study(eg. other MVA or adenovirus vectoredvaccines) 8.Administration of any other vaccine or immunoglobulin with 2 wks before vaccination 9. HIV or Hep B surface antigen seropositivity 10. Current participation in another clin trial of recent participatnin within 12 wks of study 11. Any other finding which in opinion of investigators would increase tisk of adverse outcome from participation in trial 12. Likihood of travel away from 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 30/01/2013 London School of Hygiene and Tropical Medicine
Ethics Committee Address
Street address City Postal code Country
Keppel Street London WC1E7HT United Kingdom
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 18/07/2012 Comite Natinal d'Ethique et de Recherche en Sante
Ethics Committee Address
Street address City Postal code Country
Ministere de la Sante et de l'action sociale, Fann Residence Rue Aime Cesaire Dakar BP4024 Senegal
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary endpoint - Vaccine efficacy We will compate active and control vaccination for time to first episode of P.falciparum infection, defined as 2 or more consecutive blood samples confirmed positive by PCR, for P.falciparum
Secondary Outcome Measures of immunogenicity will include; Ex vivo ELISPOT responses to overlapping pools of ME-TRAP peptides. Cultured ELISPOT responses to overlapping pools of ME-TRAP peptides. ICS by flow cytometry for cell mediated immune responses ELISA for antibodies to malaria antigens. All solicited and unsolicited local ans systemic vaccine-linked adverse events(AEs) including clinically significant laboratory abnormalities.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Dakar Avenue Cheikh Anta Diop Dakar BP 5005 Dakar Fann Senegal
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCP Laan Nieuw Oost Indie 334 The Hague Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Oxford Wellington Square Oxford OX1 2JD United Kingdom University
Secondary Sponsor University Cheikh Anta Diop Avenue Cheikh Anta Diop Dakar BP 5005 Dakar fann Senegal University
COLLABORATORS
Name Street address City Postal code Country
Prof Adrian Hill University of Oxford Oxford OX1 2JD United Kingdom
Dr Babatunde Emukhuede European Vaccine Initiative Heidelberg 69120 Germany
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Badare Cisse badara.cisse@lshtm.ac.uk +221 77 529 03 Av Cheikh Anta Diop
City Postal code Country Position/Affiliation
Dakar BP 5005 Dakar fann Senegal lecturer/lshtm
Role Name Email Phone Street address
Public Enquiries Babrunde Imoukhuede babtunde.imoukhuede@euvaccine.eu +44 793 2684018 69120 Heidelberg
City Postal code Country Position/Affiliation
Heidelberg Germany Director Regulatory affairs/EVI
Role Name Email Phone Street address
Scientific Enquiries Adrian Hill adrian.hill@ndm.ox.ac.uk +44 1865 857418 Centre for Clinical Vaccinoloty & Tropical Medicine - The Jenner Institute
City Postal code Country Position/Affiliation
Ocford OX3 7LJ United Kingdom Prof University Oxford
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information