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

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

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

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Fort Deterick, Maryland, United States, 21702
        • U.S. Army Medical Research Institute of Infectious Diseases

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: primary vaccination with boost
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PRNT80 ≥ 1:40 after primary series
Time Frame: Between Days 28-42
% vaccinated subjects with PRNT80 ≥ 1:40 after primary series (initial responders).
Between Days 28-42
PRNT80 ≥ 1:40 after 6-month mandatory booster dose
Time Frame: 7 months
% vaccinated subjects with PRNT80 ≥ 1:40 after 6-month mandatory booster dose (initial responders only).
7 months
(PRNT80 < 1:40) who responded with a PRNT80 ≥ 1:40
Time Frame: 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.
up to 5 years
Median duration of PRNT80 ≥ 1:40 in initial responders
Time Frame: up to 5 years
Median duration of PRNT80 ≥ 1:40 in initial responders after the primary series and 6-month mandatory booster dose.
up to 5 years
Median duration of PRNT80 ≥ 1:40 in initial non-responders
Time Frame: 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.
up to 5 years
Number of booster doses needed in initial non-responders to achieve PRNT80 ≥ 1:40
Time Frame: up to 1 year
Number of booster doses needed in initial non-responders to achieve PRNT80 ≥ 1:40.
up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjects without symptoms
Time Frame: 5 years
Number of subjects without symptoms
5 years
Subjects with any category of local reaction (grade 1-4).
Time Frame: 5 years
Number of subjects with any local reaction
5 years
Subjects with mild, moderate, severe, and potentially life-threatening systemic reactions (grade 1-4).
Time Frame: 5 years
Number of subjects with systemic reactions
5 years
Subjects with generalized allergic reactions
Time Frame: 5 years
Number of subjects with generalized allergic reactions
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (ACTUAL)

September 1, 2009

Primary Completion (ACTUAL)

February 1, 2019

Study Completion (ACTUAL)

May 1, 2021

Study Registration Dates

First Submitted

March 25, 2009

First Submitted That Met QC Criteria

March 25, 2009

First Posted (ESTIMATE)

March 26, 2009

Study Record Updates

Last Update Posted (ACTUAL)

March 4, 2022

Last Update Submitted That Met QC Criteria

February 16, 2022

Last Verified

February 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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