Malaria
Conditions
Interventions
Intervention Group
Control Group
Sponsors
Ifakara Health Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy adults aged 18 to 45 years and infants aged 5-17 months 2. Adults and parents able and willing (in the Investigator's opinion) to comply with all study requirements 3. Permanent residence or planned long term stay (at least 15 months) in the study area or surroundings for the period of the trial. 4. Female participants are required to use an effective form of contraception during this study. Acceptable forms of contraception include: a. Established use of oral, injected or implanted hormonal methods of contraception. b. Placement of an intrauterine device or intrauterine system c. Total abdominal hysterectomy 5. For adults: Written informed consent to receive malaria vaccine candidates 6. For infants: written informed consent to receive malaria vaccine candidates will be obtained from the parent/guardian. 7. Reachable (24 hours and 7 days a week) by mobile phone during the entire study period (From screening to last follow up visit) 8. Answer all questions on the informed consent quiz correctly in a maximum of three attempts.
Exclusion criteria
Exclusion criteria: Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions, such as cardiovascular, pulmonary, renal, hepatic, neurological, dermatological, endocrine, malignant, haematological, infectious, immunodeficient, psychiatric and other disorders, which could compromise the health of the participant during the study or interfere with the interpretation of the study results. 2. Use of immunoglobulins or blood products within 3 months prior to enrolment 3. Previous vaccination with a Malaria vaccine. 4. Pregnancy (determined by positive urine pregnancy test), lactation, or intention to become pregnant during the study. 5. Any other serious chronic illness requiring hospital specialist supervision 6. Volunteers unable to be closely followed for social, geographic, or psychological reasons 7. Positive for P. falciparum parasites by Blood smear at screening or previous participation in any malaria vaccine study. 8. Any other condition or situation that would, in the opinion of the investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol. 9. Clinically significant congenital abnormalities as judged by the PI or other delegated individual. 10. History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g., Kathon, neomycin, beta-propiolactone 11. Any history of anaphylaxis in relation to vaccination. 12. Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period. 13. Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine safety and tolerability of RH5.1 and R78C in Matrix-M co-administered intramuscularly in adults (18-45 years), and infants (5-17 months) residing in a malaria endemic country. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the magnitude of humoral immune responses to RH5.1 and R78C co-administered intramuscularly in adults and infants residing in a malaria endemic country. • To evaluate the functional quality of humoral immune responses to RH5.1 and R78C co-administered intramuscularlyaccording to 0,1,6 and 0,1,6,7-month schedule in adults and infants residing in a malaria endemic country. • To evaluate the longevity of humoral immune responses to RH5.1 and R78Cco-administered intramuscularly in adults and infants residing in a malaria endemic country. | — |
Countries
United Republic of Tanzania
Contacts
Public ContactAinaekisha Kahatano
Co Principal Investigator
Outcome results
None listed