Phase I open-label, age de-escalation trial to assess safety, tolerability, and immunogenicity of the intramuscularly administered combination of RH5.1 and R78C malaria vaccine with Matrix-MTM adjuvant in healthy adults and infants in Tanzania.

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 60

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine safety and tolerability of RH5.1 and R78C in Matrix-M co-administered intramuscularly in adults <br>(18-45 years), and infants (5-17 months) residing in a malaria endemic country.

Secondary Outcome Measures

Name	Time	Method
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. <br>• 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.<br>• 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.