Assessment of protection against malaria by sporozoite challenge of healthy adults vaccinated with the virosomal vaccine PEV3A and FP9-MVA ME-TRAP - Efficacy of the malaria vaccines PEV3A and FP9-MVA ME-TRAP
- Conditions
- Plasmodium falciparum malaria
- Registration Number
- EUCTR2005-001041-42-GB
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Not specified
- Target Recruitment
- 48
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To examine the efficacy of PEV3A alone and PEV3A combined with FP9-MVA ME-TRAP in a malaria challenge study;<br> Secondary Objective: To confirm the safety and immunogenicity of administration of PEV3A and FP9-MVA ME-TRAP to healthy volunteers<br><br> 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.<br> ;<br> Primary end point(s): The time in hours between exposure and parasitaemia as detected by thick-film blood smear<br><br> The number of subjects who develop malaria infection (parasitaemia)<br>
- Secondary Outcome Measures
Name Time Method