Malaria, Malaria, Falciparum
Conditions
Keywords
Malaria, Vaccine, Prime-boost
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 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)
Interventions
BIOLOGICALFP9-PP (FP9 polyprotein)
Sponsors
University of Oxford
Wellcome Trust
European Vaccine Initiative
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immediate reactogenicity | — |
| Adverse events occurring before the end of the trial | — |
| Biological safety (haematological and biochemical indices) | — |
Secondary
| Measure | Time frame |
|---|---|
| T-cell immunogenicity (prime-boost groups) | — |
| Humoral immunogenicity (prime-boost groups) | — |
| Gene expression (prime-boost groups) | — |
Countries
United Kingdom
Outcome results
None listed