RVF: Safety and Immunogenicity Study of Rift Valley Fever Vaccine, Inactivated

Sponsor
U.S. Army Medical Research and Development Command (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00869713
Collaborator
(none)
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Study Details

Study Description

Brief Summary

This study is designed to determine the safety and immunogenicity of an inactivated Rift Valley Fever (RVF) Vaccine in adults

Condition or Disease Intervention/Treatment Phase
  • Biological: Inactivated, Dried (TSI-GSD 200), RVF Vaccine
Phase 2

Detailed Description

The primary objectives are to assess safety of Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200) and to assess immunogenicity of Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200). The secondary objective is to assess incidence of RVF infection in vaccinated personnel

Study Design

Study Type:
Interventional
Actual Enrollment :
98 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Open-label, Phase 2, uncontrolled, vaccine study to assess the safety, immunogenicity of RVF (inactivated) vaccine (1.0 mL subcutaneous, SQ). Three primary series doses; for responders to the vaccine (PRNT80 ≥ 1:40), 6 month mandatory vaccine booster dose; Three primary series doses; for non-responders to the vaccine (PRNT80 < 1:40) may be boosted before 6 months.Open-label, Phase 2, uncontrolled, vaccine study to assess the safety, immunogenicity of RVF (inactivated) vaccine (1.0 mL subcutaneous, SQ). Three primary series doses; for responders to the vaccine (PRNT80 ≥ 1:40), 6 month mandatory vaccine booster dose; Three primary series doses; for non-responders to the vaccine (PRNT80 < 1:40) may be boosted before 6 months.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Long-Term Open-Label Primary Vaccination and Booster Dose Study of the Safety and Immunogenicity of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) in At-Risk Adults
Actual Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Feb 1, 2019
Actual Study Completion Date :
May 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: primary vaccination with boost

Inactivated, Dried (TSI-GSD 200), RVF Vaccine

Biological: Inactivated, Dried (TSI-GSD 200), RVF Vaccine
All subjects: 1.0-mL (SQ)doses on day 0, once between days 7 & 14, & once between days 28-42. Initial responders: A 6-month mandatory vaccine booster dose (1.0 mL, SQ) will be given if the PRNT80 is ≥1:40 after the primary series. Subsequent booster doses will be given for PRNT80 titer <1:40. Initial non-responders: Individual who has a PRNT80 titer <1:40 following the primary series may be administered a booster dose before 6 months. The individual will not receive the mandatory 6-month booster dose. Once an initial non-responder achieves PRNT80 ≥1:40, additional booster doses will be given for subsequent PRNT80 <1:40). All subjects: RVF booster dose will be administered within 90 days after a PRNT80 result of <1:40.

Outcome Measures

Primary Outcome Measures

  1. PRNT80 ≥ 1:40 after primary series [Between Days 28-42]

    % vaccinated subjects with PRNT80 ≥ 1:40 after primary series (initial responders).

  2. PRNT80 ≥ 1:40 after 6-month mandatory booster dose [7 months]

    % vaccinated subjects with PRNT80 ≥ 1:40 after 6-month mandatory booster dose (initial responders only).

  3. (PRNT80 < 1:40) who responded with a PRNT80 ≥ 1:40 [up to 5 years]

    % initial non-responders (PRNT80 < 1:40) who responded with a PRNT80 ≥ 1:40 after 1, 2, 3, or 4 booster doses.

  4. Median duration of PRNT80 ≥ 1:40 in initial responders [up to 5 years]

    Median duration of PRNT80 ≥ 1:40 in initial responders after the primary series and 6-month mandatory booster dose.

  5. Median duration of PRNT80 ≥ 1:40 in initial non-responders [up to 5 years]

    Median duration of PRNT80 ≥ 1:40 in initial non-responders after the first booster dose that results in PRNT80 ≥ 1:40.

  6. Number of booster doses needed in initial non-responders to achieve PRNT80 ≥ 1:40 [up to 1 year]

    Number of booster doses needed in initial non-responders to achieve PRNT80 ≥ 1:40.

Secondary Outcome Measures

  1. Subjects without symptoms [5 years]

    Number of subjects without symptoms

  2. Subjects with any category of local reaction (grade 1-4). [5 years]

    Number of subjects with any local reaction

  3. Subjects with mild, moderate, severe, and potentially life-threatening systemic reactions (grade 1-4). [5 years]

    Number of subjects with systemic reactions

  4. Subjects with generalized allergic reactions [5 years]

    Number of subjects with generalized allergic reactions

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. At least 18 years old.

  2. Females of childbearing potential must have a negative serum or urine pregnancy test within 48 hours before each vaccination. Females will be advised not to become pregnant for 3 months after the primary series and each booster dose.

  3. Females must not be breast-feeding.

  4. Subject must be at risk for exposure to RVF virus.

  5. Subject must have an up-to-date (within 1 year) medical history, physical examination, and laboratory tests in their charts and be medically cleared for participation by an investigator. Examinations or tests to qualify for enrollment may be repeated at the discretion of the investigators.

  6. Subject must sign and date the approved informed consent document.

  7. For initiation of primary series, RVF PRNT80 <1:10.

  8. For RE-ENTRY into this protocol or ROLLOVER from an earlier RVF protocol to receive a booster, RVF PRNT80 <1:40 within past 1 year

Exclusion Criteria:
  1. Older than 65 years of age for the primary series vaccination (able to receive booster doses if no other contraindications).

  2. Clinically significant abnormal lab results, including evidence of Hepatitis C, Hepatitis B carrier state, or elevated (2 times normal) liver function tests.

  3. Personal history of immunodeficiency or current treatment with immunosuppressive medication.

  4. Confirmed positive human immunodeficiency virus (HIV) titer.

  5. Any medical condition that, at the discretion of the physician, may jeopardize the safety of the subject.

  6. Any serious or life-threatening allergies to any component of the vaccine: formalin human serum albumin neomycin streptomycin fetal rhesus lung cells RVF virus inactivated

  7. Administration of any Investigational New Drug (IND) product or any vaccine within the 28 days before RVF vaccination.

  8. Any unresolved adverse event resulting from a previous immunization.

Contacts and Locations

Locations

Site City State Country Postal Code
1 U.S. Army Medical Research Institute of Infectious Diseases Fort Deterick Maryland United States 21702

Sponsors and Collaborators

  • U.S. Army Medical Research and Development Command

Investigators

  • Principal Investigator: Ronald Reisler, MD, USAMRIID Medical Division

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier:
NCT00869713
Other Study ID Numbers:
  • A-15322
  • FY08-07
First Posted:
Mar 26, 2009
Last Update Posted:
Mar 4, 2022
Last Verified:
Feb 1, 2022
Keywords provided by U.S. Army Medical Research and Development Command
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 4, 2022