Plasmodium falciparum malaria
Conditions
Interventions
Product Name: PEV3A
Product Code: PEV3A
Pharmaceutical Form: Injection*
Current Sponsor code: PEV301
Other descriptive name: Virosomal A
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy adults aged 18 to 50 years Written informed consent Resident in or near Oxford for the duration of the vaccination study For females only, willingness to practice continuous effective contraception during the study and during the subsequent challenge study Agreement to refrain from blood donation during the course of the study Willingness to undergo an HIV test Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Abnormal biochemistry or haematology blood tests or urine analysis (see Appendix A of trial protocol) 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 immunosuppressants or other immune modifying drugs within 6 months of vaccination Any history of malaria, travel to a malaria endemic country within the previous 3 months prior to the study Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV and asplenia Seropositive for hepatitis B or C History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) Any on-going chronic illness requiring hospital specialist supervision Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine the efficacy of PEV3A alone and PEV3A combined with FP9-MVA ME-TRAP in a malaria challenge study; Secondary Objective: To confirm the safety and immunogenicity of administration of PEV3A and FP9-MVA ME-TRAP to healthy volunteers To assess long term efficacy of PEV3A alone and PEV3A with FP9-MVA ME-TRAP in a late malaria challenge of volunteers protected at initial challenge. ; Primary end point(s): The time in hours between exposure and parasitaemia as detected by thick-film blood smear The number of subjects who develop malaria infection (parasitaemia) | — |
Countries
United Kingdom
Outcome results
None listed