RecruitingRift Valley Fever

Phase 2 Safety and Immunogenicity Study of Rift Valley Fever Vaccine

Eligible age

18–65 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

Yes

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

This study is to collect safety and immunogenicity data for an Rift Valley Fever (RVF) vaccine

Sponsor: U.S. Army Medical Research and Development Command

✓ Be 18 to 65 years old at time of consent.
✓ Have RVF plaque reduction neutralization 80% titers (PRNT80) \<1:10 for primary series.
✓ Have RVF PRNT80 (plaque reduction neutralization 80% titer) \<1:40 for booster series.
✓ If female of childbearing potential, must agree to have a urine pregnancy test on the same day before each vaccine administration. (Exception: documented hysterectomy or ≥3 years of menopause.) The results must be negative. Females must agree not to become pregnant for 3 months after receipt of the last study treatment (vaccination).
✓ Be considered at risk for exposure to RVF virus and who have submitted a Request for IND Vaccines for the RVF vaccine.
✓ Sign and date the approved informed consent document and HIPAA Authorization.
✓ Have in their charts:
✓ medical history (including concomitant medications) within 60 days of planned first administration of vaccine

✕ Have completed previous RVF vaccine study as a nonresponder (PRNT80 \<1:40).
✕ Have clinically significant abnormal laboratory results (including evidence of hepatitis C, hepatitis B carrier state) or elevated liver function tests (two times the normal range or at the discretion of the PI).
✕ Have a personal history of an immunodeficiency or received treatment with an immunosuppressive medication, such as systemically administered glucocorticoids (eg prednisone) within 1 month before planned administration of the vaccine or with other immunosuppressive therapies within 6 months of planned administration of the vaccine. Other immunosuppressive therapies include all cancer chemotherapeutic agents, drugs to prevent transplant rejection, interferons, monoclonal antibodies, protein kinase inhibitors, methotrexate, TNF (tumor necrosis factor) inhibitors, and any other drug determined to be immunosuppressive by the PI. Current administration of topical, inhalational, or intranasal glucocorticoids is not excluded.
✕ Have confirmed HIV infection.
✕ Have positive pregnancy test or be breastfeeding female.
✕ Have any known allergies to components of the vaccine:
✕ Fetal rhesus monkey lung cells
✕ Formaldehyde

Fort Deterick

Source: ClinicalTrials.gov · NCT03609398 · last updated 2021-02-11