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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
RVF Vaccine
Biological/Vaccine1.0 mL dose given SQ in upper arm
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: RVF VaccineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Subjects with Local and Systemic Adverse Events and Their Relationship to the Study Vaccine
Safety assess of local and systemic adverse events and their relationship to the study vaccine. AEs will be recorded for 28 days after each dose of the vaccine for the assessment population (all subjects who receive at least one vaccination under this protocol. Subjects will be contacted by study staff via e-mail or telephone the day after vaccination (Day 1) and once per week for 4 weeks after each vaccination to discuss any reactions.
Time frame
0-28 days after each dose2
Percentage of Subjects Who Developed Titers of ≥1:40 of Per-protocol Subjects
Percentage of per-protocol subjects (subjects who adhered to the protocol schedule for both vaccination and blood collects) who developed titers ≥1:40 as determined by PRNT80 (plaque reduction neutralization 80% titer) after vaccination at each scheduled time point for which blood samples are drawn and over the entire study period.
Time frame
21-35 days after each vaccination and month 12Secondary outcomes
1
Frequency and Severity of Adverse Events
Frequency and severity of adverse events for the assessment population (all subjects who receive at least one vaccination under this protocol). Subjects will be contacted by study staff via e-mail or telephone the day after vaccination (Day 1) and once per week for 4 weeks after each vaccination to discuss any reactions.
Time frame
0-28 days after each dose2
Geometric Mean PRNT80 (plaque reduction neutralization 80% titer) of Per-protocol Subjects
Geometric mean PRNT80 (plaque reduction neutralization 80% titer) of per-protocol subjects at each scheduled time point for which blood samples are drawn and over the entire study period to study completion.
Time frame
21-35 days after each vaccination and month 12Other outcomes
1
Geometric Mean PRNT50 (plaque reduction neutralization 50% titer) of Per-protocol Subjects
Geometric mean PRNT50 (plaque reduction neutralization 50% titer) of per-protocol subjects at each scheduled time point for which blood samples are drawn and over the entire study period to study completion.
Time frame
21-35 days after each vaccination and month 12Sponsors and contacts
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Source ClinicalTrials.gov