Malaria
Conditions
Interventions
R0.6C and ProC6C transmission blocking vaccines
Hepatitis B vaccine
Sponsors
University of Sciences Techniques and Technologies of Bamako
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Subject must sign/thumbprint written informed consent to participate in the trial. 2. Subject is a male or non-pregnant and non-lactating female age = 20 and = 45 years and in good health. 3. Subject is able to understand planned study procedures and demonstrate comprehension of the protocol procedures 4. In the opinion of the investigator, the subject can and will comply with the requirements of the protocol. 5. Subjects are available to attend all study visits and are reachable by phone throughout the entire study period from day -28 until day 180 (end of study). 6. The subject will remain within reasonable travelling distance from the study site from day 0 until day 7 after each administration. 7. The subject agrees to refrain from blood donation throughout the study period. 8. Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause. All subjects of childbearing potential must agree to use continuous adequate contraception* until 2 months after completion of the study. Female subjects must agree not to breastfeed from 30 days prior to administration until 2 months after completion of the study. Female subject must have a negative pregnancy test at the inclusion visit.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Acute or chronic disease at time of administration, clinically significant pulmonary, cardiovascular, hepatic, renal, neurological or immunological functional abnormality, as determined by medical history, physical examination or laboratory screening tests 2. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years. 3. History of auto immune disease 4. Subjects with splenectomy 5. Chronic use of i) immunosuppressive drugs, ii) or other immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period. 6. History of drug or alcohol abuse interfering with normal social function in the period of one year prior to study onset. 7. Known history of Human Immunodeficiency Virus (HIV) (No test will be done by the study) 8. Screening tests positive for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV). 9. Use of any other investigational or non-registered product (drug or vaccine) during the study period. 10. Participation in any other clinical study involving an investigational product in the 30 days prior to the start of the study or during the study period. 11. Receipt of any other vaccination within 30 days prior to the first vaccination. 12. Any previous participation in any malaria (vaccine) study. 13. History of anaphylaxis or known severe hypersensitivity to any of the vaccine components (adjuvant or antigen or excipient) 14. Any other condition or situation that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse events and solicited grade 3 local and systemic adverse events (AEs) possibly, probably or definitely related to the vaccine in the period from first vaccination up to 1 month after the last immunization | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The TRA at other timepoints (2 weeks after the first, second and second immunizations) and 4 months post third vaccination compared to baseline (D0) in each of the three dose-adjuvant groups. 2) The anti-6C antibody quantity in volunteer sera collected two weeks after each dose and 4 months post dose 3 compared to baseline in each of the three dose-adjuvant combinations, as determined by ELISA | — |
Countries
Burkina Faso
Contacts
Public ContactIssaka Sagara
PfTBV EDCTP Consortium Coordinator and Sponsor representative
Outcome results
None listed