Controlled Human Malaria Infection evaluation of Plasmodium falciparum malaria vaccine ProC6C-AlOH/Matrix-Mtm in healthy Malian adults
- Conditions
- Malaria
- Registration Number
- PACTR202404598604620
- Lead Sponsor
- niversity of Sciences Techniques and Technologies of Bamako
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- All
- Target Recruitment
- 34
In order to be eligible to participate in this study, a participant must meet all of the following criteria:
1.Volunteers aged = 18 and = 50 years and in general good health.
2.Known long-term resident (more than 1 year) of Sotuba or surrounding area.
3.Participant has adequate understanding of the procedures of the study and is able and willing (in the investigator’s opinion) to comply with all study requirements, including, but not limited to:
a.remaining in Sotuba during the challenge period, not travelling during the study period, and remaining reachable (24/7) by mobile telephone throughout the entire study period
b.available to attend all study visits, and willing to sleep in appropriate accommodation close to the trial center during part of the study (from day 5 post-infection until either (i) end of study, or (ii) day 28 if parasitemia does not develop before this time
c.refraining from blood donation throughout the study period and for a 6 week period thereafter
4.Females of childbearing potential must be willing to use reliable contraception from day of screening until end of study (EOS). A reliable method of birth control includes one of the following:
•licenced oral contraceptives
•Intrauterine or implantable device
Exceptions to required pregnancy prevention includes the following:
•Postmenopausal state: defined as no menses for 12 months without an alternative medical cause
•Surgical sterilization
•Sexual abstinence
5.Able to provide proof of identity to the satisfaction of the study clinician completing the enrolment process.
6.Willing to have blood samples stored for future research.
7.Participants will be screened for pre-existing antibodies against malaria parasites to assess exposure and immune status (by Luminex or ELISA). Those participants that are at or below the median amongst those screened will proceed to enrollment.
A potential participant who meets any of the following criteria will be excluded from participation in this study:
1.Pregnancy (as determined by a positive urine or serum beta human choriogonadotropin (ß hCG) test), lactation or intention to become pregnant during the study. (if female)
2.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. These include, but are not limited to, any of the following.
2.1.Body weight <50 kg or Body Mass Index (BMI) <18 or >30 kg/m2 at screening.
2.2.History, or evidence at screening, of elevated risk for cardiovascular disease, including arrhythmia or clinically relevant bradycardia, prolonged QT-interval (>450ms) or other relevant ECG abnormalities; a positive family history of cardiac events in 1st or 2nd degree relatives <50 years old, or of sudden (cardiac) death.
2.3.Severe asthma, defined as asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past 2 years, or that has required the use of oral or parenteral corticosteroids at any time during the past 2 years
2.4.History of a severe allergic reaction or anaphylaxis
2.5.Autoimmune or antibody-mediated disease including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren’s syndrome, or autoimmune thrombocytopenia
2.6.A medical history of functional asplenia or splenectomy, sickle cell disease, thalassaemia trait/disease, G6PD-deficiency, or any other hematologic or other disease that would interfere with normal immunity.
2.7.History of epilepsy in the period of fiv
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Time to patent parasitemia amongst participants in each group (as determined by qPCR) following CHMI (up to D28 post challenge). Additional measures of vaccine efficacy may include the proportion of participants in each group developing patent parasitemia (as determined by qPCR) following CHMI<br>2.Number and severity of adverse events in each group from time of first vaccination until 2 weeks after third vaccination <br>
- Secondary Outcome Measures
Name Time Method 1.Anti-ProC6C antibody titers in each group at baseline (pre-vaccination), 2 weeks after each vaccination and immediately prior to CHMI.<br>2.The functional transmission reducing activity (TRA) in the SMFA of participant sera collected two weeks after the third immunizations (d70), compared to baseline, in each of the Groups.<br>