Status:
COMPLETED
Sporozoite Challenge of Polyprotein Vaccinees
Lead Sponsor:
European Vaccine Initiative
Collaborating Sponsors:
University of Oxford
Wellcome Trust
Conditions:
Malaria, Falciparum
Malaria
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
Brief Summary
This study examines the ability of two new malaria vaccines (FP9-PP and MVA-PP) to prevent the development of malaria infection after controlled exposure to the parasite. Volunteers for this trial wil...
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 non-pregnant adults aged 18 to 50 years
- The vaccinated group will be subjects who have received the vaccine regime described for group 6 or 7 in VAC027.1
- Resident in or near Oxford, UK for the duration of the challenge study
- For females only, willingness to practice effective contraception during the challenge study.
- Agreement to refrain from blood donation during the course of the study
- Written informed consent
- Willingness to allow the investigators to access hospital and General Practitioner medical notes
- 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 (unless administered in VAC027.1)
- Use of any investigational or non-registered drug, live 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 3 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
- 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 requiring ongoing specialist supervision
- Chronic gastrointestinal disease requiring ongoing specialist supervision
- History of \> 2 hospitalisations for invasive bacterial infections (pneumonia, meningitis)
- 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
- Acute disease at the time of enrolment
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- Pregnant or lactating female
- Female who is willing or intends to become pregnant during the study
- History of severe reactions or allergy to mosquito bites
- PI assessment of lack of willingness to participate and comply with all requirements of the protocol
- History or clinical evidence of intravenous drug abuse
- Any other finding which in the opinion of the investigator would significantly increase the risk of having an adverse outcome from participating in this protocol
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00375128
Start Date
September 1 2006
End Date
April 1 2007
Last Update
October 19 2007
Active Locations (2)
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1
Imperial College, University of London
London, United Kingdom, SW7 2AZ
2
Centre for Clinical Vaccinology & Tropical Medicine, University of Oxford
Oxford, United Kingdom, OX3 7LJ