RECRUITING

Phase 2 Safety and Immunogenicity Study of Rift Valley Fever Vaccine

Talk to us

Conditions

Rift Valley Fever

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase 2 Open Label Safety and Immunogenicity Study of Rift Valley Fever Vaccine, Inactivated, Dried, TSI-GSD 200, Lot 7, Run 2, in Adult Subjects at Risk of Exposure to Rift Valley Fever Virus

Quick Facts

Study Start:2018-10-04
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03609398

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Be 18 to 65 years old at time of consent.
  2. * Have RVF plaque reduction neutralization 80% titers (PRNT80) \<1:10 for primary series.
  3. * Have RVF PRNT80 (plaque reduction neutralization 80% titer) \<1:40 for booster series.
  4. * 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).
  5. * Be considered at risk for exposure to RVF virus and who have submitted a Request for IND Vaccines for the RVF vaccine.
  6. * Sign and date the approved informed consent document and HIPAA Authorization.
  7. * Have in their charts:
  8. * medical history (including concomitant medications) within 60 days of planned first administration of vaccine
  9. * physical examination and laboratory tests within 1 year
  10. * previous chest radiograph results and electrocardiogram
  11. * Be medically cleared for participation by an investigator. (Examinations and/or tests may be repeated at the discretion of the PI.)
  12. * Be willing to return for all follow-up visits.
  13. * 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.
  14. * Agree to defer blood donation for 1 year after receipt of the vaccine
  1. * Have completed previous RVF vaccine study as a nonresponder (PRNT80 \<1:40).
  2. * 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).
  3. * 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.
  4. * Have confirmed HIV infection.
  5. * Have positive pregnancy test or be breastfeeding female.
  6. * Have any known allergies to components of the vaccine:
  7. * Fetal rhesus monkey lung cells
  8. * Formaldehyde
  9. * Neomycin sulfate
  10. * Streptomycin
  11. * Sodium bisulfite
  12. * Human serum albumin (HAS)
  13. * RVF virus (Entebbe strain)
  14. * Have administration of another vaccine or investigational product within 28 days of RVF vaccination.
  15. * Have any unresolved AE resulting from a previous immunization.
  16. * Have a medical condition that, in the judgment of the PI, would impact subject safety.

Contacts and Locations

Study Contact

Anthony P Cardile, DO, MAJ
CONTACT
301-619-8833
anthony.p.cardile.mil@mail.mil
Jeannine M Haller, RN, CCRP
CONTACT
301-619-4652
jeannine.m.haller.civ@mail.mil

Study Locations (Sites)

Special Immunization Program, Division of Medicine, USAMRIID
Fort Deterick, Maryland, 21702
United States

Collaborators and Investigators

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-10-04
Study Completion Date2024-12

Study Record Updates

Study Start Date2018-10-04
Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

  • Rift Valley Fever