Phase 2 Safety and Immunogenicity Study of Rift Valley Fever Vaccine (RVF)

  • STATUS
    Recruiting
  • End date
    Dec 19, 2024
  • participants needed
    500
  • sponsor
    U.S. Army Medical Research and Development Command
Updated on 15 February 2022
Accepts healthy volunteers

Summary

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

Description

This study is being conducted to collect safety and immunogenicity data for the RVF vaccine, TSI-GSD 200, Lot 7, Run 2. Enrollment in this protocol is offered for personnel who enter areas where this virus is used in research or is endemic (an area where this disease process is found to occur frequently). Subjects who respond with a titer of >1:40 may participate for study duration. Rift Valley Fever Vaccine, Inactivated, Dried (TSI GSD 200) will be administered in 1.0-mL doses SQ in the upper outer aspect of the arm.

Details
Condition Rift Valley Fever
Treatment RVF Vaccine
Clinical Study IdentifierNCT03609398
SponsorU.S. Army Medical Research and Development Command
Last Modified on15 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
physical examination and laboratory tests within 1 year
previous chest radiograph results and electrocardiogram
Be medically cleared for participation by an investigator. (Examinations and/or tests may be repeated at the discretion of the PI.)
Be willing to return for all follow-up visits
Agree to report any adverse events (AEs) that may or may not be associated with administration of the vaccine for at least 28 days after administration and agree to report all serious adverse events (for example, resulting in hospitalization) for the duration of the subject's participation in the study
Agree to defer blood donation for 1 year after receipt of the vaccine

Exclusion Criteria

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
Neomycin sulfate
Streptomycin
Sodium bisulfite
Human serum albumin (HAS)
RVF virus (Entebbe strain)
Have administration of another vaccine or investigational product within 28 days of RVF vaccination
Have any unresolved AE resulting from a previous immunization
Have a medical condition that, in the judgment of the PI, would impact subject safety
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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