safety and immunogenicity study of the malaria vaccines fp9 pp and mva pp

Conditions: Malaria, Falciparum; Malaria

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.

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 vaccine. the purpose of this study is to test two candidate malaria vaccines (fp9-pp and mva-pp) in different concentrations and combinations. these live viral vectors encode a 'polyprotein' of six fused malaria antigens expressed at liver and blood stages of the malaria parasite lifecycle. mva-pp uses the modified virus ankara vector, a weakened form of the smallpox vaccine, vaccinia. fp9-pp uses a highly attenuated avian pox virus (fp9) as the vector instead. the two vaccines will be used in combination in a 'prime boost' strategy to enhance the response of the cellular immune system. this study will: 1. examine safety 2. examine immunogenicity 3. provide a subgroup of vaccinated volunteers to test clinical efficacy in the following malaria challenge study (vac027.2)

Eligibility criteria:
inclusion criteria: * 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 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 * 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

Keywords: malaria vaccine prime-boost