A study to find out if a new malaria vaccine regimen can protect against malaria in African adults.

• Register: PACTR
• Last refreshed on: 27 May 2013
• Main ID: PACTR201202000356208
• Date of registration: 07/02/2012
• Primary sponsor: University of Oxford
• Public title: A study to find out if a new malaria vaccine regimen can protect against malaria in African adults.
• Scientific title: Efficacy Study of ChAd63-MVA ME-TRAP prime-boost Vaccination against Plasmodium falciparum infection
• Date of first enrolment: 2012-02-13
• Target sample size: 120
• Recruitment status: Closed to recruitment: follow up complete
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201202000356208
• Study type: interventional
• Study design: 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,

Countries of recruitment

South Africa

Contacts

• Name: PATRICIA NJUGUNA
• Affiliation: Investigator

• Name: PHILIP BEJON
• Affiliation: Investigator

Key inclusion & exclusion criteria

Inclusion criteria: 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

Exclusion criteria: ? 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


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

Health Condition(s) or Problem(s) studied

Malaria
null

Primary Outcome(s)

First episode of P.falciparum infection, defined as 2 or more consecutive blood samples confirmed positive by PCR, for P.falciparum.

Secondary Outcome(s)

Vaccine immunogenicity

Vaccine reactogenicity

Secondary ID(s)

ECCT/11/12/02

SSC 2116

Source(s) of Monetary Support

EDCTP