Prevention of Plasmodium falciparum transmission in humans Infections and Infestations
Conditions
Interventions
This is a study to assess the safety, tolerability, immunogenicity, and transmission-blocking activity (TBA) of a three-dose regimen of Study Agents (four total) versus rabies vaccine in healthy adult
Sponsors
Université des Sciences, des Techniques et des Technologies de Bamako
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of serious adverse events (SAEs) possibly, probably or definitely related to co-administered vaccinations, measured clinically and by laboratory assessments, measured 7 days after each vaccination in the period from first vaccinations up to 1 month after the last immunization: 1.1. That results in death 1.2. That is life-threatening (places the participant at immediate risk of death from the event as it occurred) 1.3. That requires inpatient hospitalization or prolongs an existing hospitalization 2. Incidence of solicited grade 3 local and systemic adverse events (AEs) possibly, probably or definitely related to co-administered vaccinations, measured clinically and by laboratory assessments, measured 7 days after each vaccination in the period from first vaccinations up to 1 month after the last immunization: 2.1. Systemic adverse events: 2.1.1. Fever (temperature = 38.0°c) 2.1.3. Headache 2.1.4. Nausea/vomiting 2.1.5. Diarrhea 2.1.6. Abdominal pain 2.1.7. Fatigue 2.1.8. Malaise 2.1.9. Myalgia 2.1.10. Arthralgia 2.1.11. Urticarial 2.2. Local reactogenicity following the injection: 2.2.1 Pain/tenderness 2.2.2. Erythema/redness 2.2.3. Swelling 2.2.3. Induration 2.2.4. Pruritus 2.2.5. Limitation of arm movement | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The functional transmission reducing activity (TRA) measured using the standard membrane feeding assay of volunteer sera at two weeks after the third immunizations, compared to baseline within each of the Study Agent Groups 2. The TRA measured using the standard membrane feeding assay of volunteer sera at other time points (2 weeks after first and second immunizations and 4 months post third vaccination) compared to baseline (D0) in each of the Study Agent Groups 3. The Study Agent antibody quantity in volunteer sera measured by ELISA two weeks after each dose and at 4 months post dose compared to baseline (D0) in each of the three dose-adjuvant combinations 4. Incidence of adverse events possibly, probably or definitely related to any investigational vaccines measured clinically and by laboratory assessments at study duration period | — |
Countries
Mali
Contacts
Public ContactIssaka Sagara
Outcome results
None listed