Leishmania
Conditions
Interventions
Normal Saline
live attenuated leishmania vaccine
Sponsors
Gennova Biopharmaceuticals Ltd GBL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult males and non-pregnant females between 18 years and 50 years of age, inclusive and in sufficiently good health to be safely enrolled in this study as determined by medical history, medication use, and abbreviated physical exam. 2. Understanding and willingness to follow all study procedures 3. Available for the duration of the trial. 4. Willingness to participate in the study, including allowing skin biopsies 5. Female participants of childbearing potential must agree to use effective birth control methods 6. Males of childbearing potential who agree to use condoms or other methods to ensure effective contraception with partner during study participation or at a minimum 12 weeks postvaccination. 7. Willing to refrain from blood donation during their participation in the study.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating OR planning to become pregnant at any time from 30 days prior to vaccination and continuing through at the study follow-up period. 2. Evidence of clinically significant and uncontrolled, neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, endocrinologic, oncologic, hematologic or renal disease by medical history, physical examination and/or laboratory studies. 3. Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol. 4. Use of systemic steroid preparations or immunosuppressive drugs within 14 days prior to vaccination or who anticipate use of systemic steroids or immunosuppressive drugs during the study period a. Limited use of topical steroid preparations is permitted except at the site of vaccination. 5. Evidence of alcohol or drug dependence within the 12 months before enrollment. 6. Other conditions that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial or would render the subject unable to comply with the protocol. 7. Positive serology results for HIV, HBsAg, Leishmania or HCV antibodies. 8. Screening labs (CBC, ALT, total bilirubin, creatinine) that are greater than Grade 1 severity a. An exception is the neutrophil count where a value of >1000 cells/mm3 will be acceptable for enrollment and vaccination if the value is deemed by the investigator to be due to “benign ethnic neutropenia”. 9. Known immunodeficiency or autoimmune syndrome. 10. Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to vaccination or planned receipt within 3 months of vaccination. 11. Receipt of blood or blood-derived products (including immunoglobulin [Ig]) within 6 months prior to vaccination. 12. Receipt of any investigational vaccine or drug within 30 days of vaccination or plan to receive during the time of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Determine and assess the frequency and severity of vaccine related events, in LmCen -/- vaccine vs. placebo recipients. •Determine and assess the frequency of Serious Adverse Events (SAEs) in LmCen -/- vaccine vs. placebo recipients. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Determine frequency of LmCen-/- (live parasite) cultured from skin biopsies of vaccine vs placebo recipients. • Assess length of time after vaccination that LmCen-/- (live parasite) is able to be cultured from skin biopsies. • Evaluate frequency of LmCen-/- genome detectable in blood of vaccine vs. placebo recipients by PCR • Determine interferon-gamma (IFN-?) levels in stimulated PBMCs of participants at various timepoints after vaccination. • Assess the local and systemic cellular immune response of vaccine vs. placebo recipients at various timepoints after vaccination. | — |
Countries
Kenya
Contacts
Public ContactMary Leelgo
KEMRI Walter Reed Project
Outcome results
None listed