Status:
COMPLETED
Safety and Immunogenicity Study of the Malaria Vaccines FP9 PP and MVA PP
Lead Sponsor:
European Vaccine Initiative
Collaborating Sponsors:
University of Oxford
Wellcome Trust
Conditions:
Malaria, Falciparum
Malaria
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This study examines two new malaria vaccines (FP9-PP and MVA-PP) in healthy human volunteers to determine their safety and ability to induce a measurable immune response against malaria.
Detailed Description
Malaria infection kills over 2 million people each year. It is a major problem for those who live in endemic areas and for travellers. There is clearly a great need for a safe effective malaria vaccin...
Eligibility Criteria
Inclusion
- Healthy adults aged 18 to 50 years
- Resident in or near Oxford, UK for the duration of the vaccination study
- Willingness to allow the investigators to access hospital and General Practitioner medical notes
- For females only, willingness to practice continuous effective contraception during the study and if participating, during the subsequent challenge study.
- Agreement to refrain from blood donation during the course of the study
- Written informed consent
- Willingness to undergo an HIV test
Exclusion
- Any deviation from the protocol-defined normal range in biochemistry or haematology blood tests or in urine analysis
- Prior receipt of an investigational malaria vaccine
- Use of any investigational or non-registered drug, vaccine or medical device other than the study vaccine within 30 days preceding dosing of study vaccine, or planned use during the study period
- Administration of chronic immunosuppressive drugs or other immune modifying drugs within six months of vaccination
- History of malaria chemoprophylaxis with chloroquine within 5 months prior to the planned challenge, with Lariam within 6 weeks prior to the challenge, and Riamet within 2 weeks prior to the challenge
- Any history of malaria
- Travel to a malaria endemic country within the previous 6 months prior to the planned challenge
- Planned travel to malarious areas during the study period
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection and asplenia
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
- Evidence of cardiovascular disease
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- History of haemoglobinopathies
- History of diabetes mellitus
- Chronic or active neurological disease
- Chronic gastrointestinal disease
- History of more than 2 hospitalisations for invasive bacterial infections
- Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
- Seropositive for hepatitis B surface antigen (HBsAg)
- Seropositive for hepatitis C virus (antibodies to HCV)
- Hepatomegaly, right upper quadrant abdominal pain or tenderness
- Evidence of serious psychiatric condition
- Any other on-going chronic illness requiring hospital specialist supervision
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00374998
Start Date
April 1 2006
End Date
January 1 2007
Last Update
March 1 2007
Active Locations (1)
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1
Centre for Clinical Vaccinology & Tropical Medicine, University of Oxford
Oxford, United Kingdom, OX3 7LJ