Plasmodium Falciparum Malaria
Conditions
Interventions
Product Name: Chimpanzee adenovirus 63 expressing merozoite surface protein 1 (MSP1)
Product Code: AdCh63 MSP1
Pharmaceutical Form: Solution for injection
Concentration type: up to
Product Name: Modi
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day(s) of vaccination and / or challenge • For males only, to use barrier contraception until three months after the last vaccination • 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: • Significant concern raised by GP in relation to participation • 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 a recombinant adenoviral and/or MVA vectored vaccine. • 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) • 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 • Contraindication to both anti-malarial drugs (Riamet® and chloroquine) o concomitant use with other drugs known to cause QT-interval prolongation, (e.g. macrolides, quinolones, amiodarone etc) • A predicted ten year risk of fatal cardiovascular disease of =5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system • History of arrhythmia or congenital QT interval prolongation • Family history of sudden cardiac death • Any history of anaphylaxis in reaction to vaccination • Pregnancy, lactation or willingness/intention to become pregnant during the study • History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) • History of serious psychiatric condition • 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 • Seropositive for hepatitis B surface antigen (HBsAg) • Seropositive for hepatitis C virus (antibodies to HCV) • Any other significant disease, disorder or finding, which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or may influence the result of the study, or the volunteer’s ability to participate in the study. • Any history of malaria or • Travel to a malaria endemic region during the study period or within the previous six months • Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis • Any other finding which in the opinion of the investigators would significantly increase the risk of having an adverse outcome from participating in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main purpose of this study is to assess the safety and effectiveness of two new vaccines against malaria in healthy volunteers. The vaccines are two different types of virus which contain genetic information (DNA) from the malaria parasite. This genetic material produces a parasite component named MSP1. We will be checking the safety of different doses of one of the vaccines. 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 vaccine is called AdCh63 MSP1. The other virus is Modified Vaccinia Ankara Virus, (MVA), which is a safer form of the virus previously widely used for smallpox vaccination. The vaccine is called MVA MSP1. The safety of the vaccines will also be assessed during a malaria challenge. ;Secondary Objective: The secondary objective is to assess markers of the effectiveness of two new vaccines against malaria. We want to test the response of the human immune system to the vaccines. The vaccines help the body make an immune response against the malaria parasite, and so to test the effectiveness of the vaccine we will also expose a small group of volunteers to experimental malaria infection to see if the vaccine combination can prevent or delay malaria developing. We will take regular blood samples to see what effect the vaccines have had on the immune system. ;Primary end point(s): Primary outcome measures: -To assess the safety in healthy volunteers of two new candidate malaria vaccines, AdCh63 MSP1 and MVA MSP1. The safety of AdCh63 MSP1 when administered alone and in combination with MVA MSP1 will be assessed. -To assess the safety of the prime-boost blood stage vaccine strategy following malaria sporozoite challenge. The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events, including laboratory safety | — |
Countries
United Kingdom
Outcome results
None listed