Phase 2 Safety and Immunogenicity Study of Rift Valley Fever Vaccine
ConditionRift Valley Fever
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorU.S. Army Medical Research and Development Command
About this trial
This study is to collect safety and immunogenicity data for an Rift Valley Fever (RVF) vaccine
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- RVF Vaccine
Treatment groups
500 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov