Efficacy Study of ChAd63-MVA ME-TRAP prime-boost Vaccination against Plasmodium

• Register: PACTR
• Last refreshed on: 27 May 2013
• Main ID: PACTR201303000499409
• Date of registration: 08/02/2013
• Primary sponsor: University of Oxford
• Public title: Efficacy Study of ChAd63-MVA ME-TRAP prime-boost Vaccination against Plasmodium
• Scientific title: Efficacy Study of ChAd63-MVA ME-TRAP prime-boost Vaccination against Plasmodium
• Date of first enrolment: 2012-07-25
• Target sample size: 160
• Recruitment status: Terminated
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201303000499409
• Study type: interventional
• Study design: 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,

Countries of recruitment

South Africa

Contacts

• Name: Babrunde Imoukhuede
• Affiliation: Director Regulatory affairs/EVI

• Name: Adrian Hill
• Affiliation: Prof University Oxford

Key inclusion & exclusion criteria

Inclusion criteria: 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.
Exclusion criteria: 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

Age minimum: 18 Year
Age maximum: 50 Year
Gender: Male

Health Condition(s) or Problem(s) studied

null

Primary Outcome(s)

Primary endpoint - Vaccine efficacy

Secondary Outcome(s)

Measures of immunogenicity will include;

Source(s) of Monetary Support

EDCP

Secondary Sponsor(s)

University Cheikh Anta Diop