Malaria (plasmodium falciparum)
Conditions
Interventions
Product Name: Chimpanzee Adenovirus 63 expressing Merozoite Sporozoite Protein (MSP1)
Product Code: AdCh63 MSP1
Pharmaceutical Form: Solution for injection
Product Name: Modified vaccinia Ankara viru
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The volunteer must satisfy all the following criteria to be eligible for the study: • Healthy adults aged 18 to 50 years • Able and willing (in the Investigator’s opinion) to comply with all study requirements • Willing to allow the investigators to discuss the volunteer’s medical history with their General Practitioner • For female volunteers, willingness to practice continuous effective contraception for the duration of the study. • Agreement to refrain from blood donation during the course of the study • Written informed consent 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: Exclusion Criteria The volunteer may not enter the study if any of the following apply: • History of clinical P. falciparum malaria • Travel to a malaria endemic region during the study period or within the preceding six months with a risk of malaria exposure. • Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period. • Prior receipt of an investigational malaria vaccine or any other investigational vaccine likely to impact on interpretation of the trial data • Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate • Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed) • Pregnancy, lactation or intention to become pregnant during the study • Contraindication to both anti-malarial drugs; Riamet & chloroquine o Concomitant use with other drugs known to cause QT-interval prolongation (e.g. macrolides, quinolones, amiodarone etc) o History of epilepsy • History of arrhythmia or prolonged QT interval. • Family history for sudden cardiac death. • An estimated, ten year risk of fatal cardiovascular disease of =5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine e.g. egg products, Kathon. • History of clinically significant contact dermatitis • Any history of anaphylaxis post vaccination • History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) • History of serious psychiatric condition that may affect participation in the study • Any other serious chronic illness requiring hospital specialist supervision • Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week • Suspected or known injecting drug abuse in the 5 years preceding enrolment • Seropositive for hepatitis B surface antigen (HBsAg) • Seropositive for hepatitis C virus (antibodies to HCV) • Any clinically significant abnormal finding on biochemistry or haematology blood tests or urinalysis • Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main purpose of this study is to assess the protective effectiveness of six new vaccines against malaria in healthy volunteers. The vaccines are derived from two different types of virus which contain genetic information (DNA) from the malaria parasite. This genetic material produces a parasite component named MSP1, AMA1 or ME-TRAP. Both viruses are changed so that they are unable to multiply within the body. The first vaccine virus is a weakened version of a common cold virus which usually infects chimpanzees and is called an adenovirus. The vaccines made from this virus are called AdCh63 MSP1, AdCh63 AMA1 & AdCH63 ME-TRAP. The other virus is Modified Vaccinia Ankara Virus (MVA) which is a safer form of the virus previously widely used for smallpox vaccination. The vaccines made from this virus are called MVA MSP1, MVA AMA1 & MVA ME-TRAP. Volunteers will receive varying vaccine regimens and will then be infected with malaria to see how effective the vaccines are at pre;Secondary Objective: The secondary purpose of this study is to assess the safety and ability to stimulate the immune system of the six new malaria vaccines. We are especially interested in the safety and effect on the immune system of the co-administration of chimpanzee viral vectored vaccines as this will be the first time these vaccines have been administered in the this way to humans. ;Primary end point(s): Protection against malaria infection in the sporozoite challenge model will be assessed by measuring the number of subjects who develop malaria infection and the time (in hours) between exposure and parasitaemia as detected by thick-film blood smear, compared with controls. End-points • One thick smear positive for one or more morphologically-normal parasites during the 21 day observation period in a volunteer with symptoms suggestive of malaria infection OR • One thick smear positive for one or more morphologically-normal parasites during the 21 day observation period | — |
Countries
United Kingdom
Outcome results
None listed