A study of three malaria vaccines to prevent the transmission of malaria in adults in Mali: TBVax2
- Conditions
- Prevention of Plasmodium falciparum transmission in humansInfections and Infestations
- Registration Number
- ISRCTN13649456
- Lead Sponsor
- niversité des Sciences, des Techniques et des Technologies de Bamako
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 115
1. Aged between 18 years old and <50 years old
2. Available for the duration of the trial
3. Known resident or long-term resident (more than 1 year) of Doneguebougou or surrounding villages
4. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
5. In good general health and without clinically significant medical history in the opinion of the investigator
6. Females of childbearing potential must be willing to use reliable contraception from 21 days prior to Study Day 0 and until 1 month after the last vaccination
7. Willing to have blood samples stored for future research
1. Pregnant, as determined by a positive urine or serum beta human choriogonadotropin (ß hCG) test (if female). Note: Pregnancy is also a criterion for discontinuation of any further vaccine dosing.
2. Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and comply with the study protocol at a level appropriate for the subject’s age.
3. Hemoglobin, white blood cell (WBC), absolute neutrophil count, or platelet levels outside the local laboratory-defined limits of normal. Subjects may be included at the investigator’s discretion for not clinically significant” values outside of normal range and = Grade 2.
4. Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined upper limit of normal. Subjects may be included at the investigator’s discretion for not clinically significant” values outside of the normal range and = Grade 2.
5. Infected with HIV
6. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies
7. History of receiving any investigational product within the past 30 days
8. Current or planned participation in an investigational vaccine study until the time period of the last required study visit under this protocol
9. Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
10. History of a severe allergic reaction or anaphylaxis
11. Known:
11.1. 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
11.2. Autoimmune or antibody-mediated disease including but not limited to:
11.2.1. Systemic lupus erythematosus
11.2.2. Rheumatoid arthritis
11.2.3. Multiple sclerosis
11.2.4. Sjögren’s syndrome or autoimmune thrombocytopenia
11.3. Immunodeficiency syndrome
11.4. Seizure disorder (exception: history of simple febrile seizures)
11.5. Asplenia or functional asplenia
11.6. Use of chronic (=14 days) oral or intravenous (IV) corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone >10 mg/day) or immunosuppressive drugs within 30 days of Study Day 0
11.7. Allergy to latex or neomycin
12. Receipt of:
12.1. Live vaccine within 4 weeks prior to enrollment or a killed vaccine within 2 weeks prior to enrollment
12.2. Immunoglobulins and/or blood products within the past 6 months
12.3. Investigational malaria vaccine in the last 2 years
13. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial, interfere with the evaluation of the study objectives or would render the subject unable to comply with the protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method