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

Not Applicable

• Conditions: Malaria

• Registration Number: PACTR201202000356208
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-07
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Other
• Sex: Male
• Target Recruitment: 120

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
We will compare active and control vaccination for time to first episode of P.falciparum infection, defined as any blood sample confirmed positive by PCR

Secondary Outcome Measures

Name	Time	Method
Vaccine immunogenicity ;Vaccine reactogenicity