Malaria Clinical Trial
Official title:
Assessment of Protection Against Malaria by Sporozoite Challenge of Healthy Adults Vaccinated With the Polyprotein Malaria Vaccines 'FP9−PP, MVA−PP' and Control Non−Vaccinated Volunteers
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 will have received these vaccines in the preceding trial VAC027.1.
Status | Completed |
Enrollment | 26 |
Est. completion date | April 2007 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United Kingdom | Imperial College, University of London | London | |
United Kingdom | Centre for Clinical Vaccinology & Tropical Medicine, University of Oxford | Oxford |
Lead Sponsor | Collaborator |
---|---|
European Malaria Vaccine Initiative | University of Oxford, Walter Reed Army Institute of Research (WRAIR), Wellcome Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy (time in hours to parasitaemia) | |||
Secondary | Immunogenicity |
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