- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00869713
Safety and Immunogenicity Study of Rift Valley Fever Vaccine, Inactivated (RVF)
February 16, 2022 updated by: U.S. Army Medical Research and Development Command
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
Intervention / Treatment
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
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Fort Deterick, Maryland, United States, 21702
- U.S. Army Medical Research Institute of Infectious Diseases
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-
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:
- At least 18 years old.
- 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.
- Females must not be breast-feeding.
- Subject must be at risk for exposure to RVF virus.
- 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.
- Subject must sign and date the approved informed consent document.
- For initiation of primary series, RVF PRNT80 <1:10.
- 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:
- Older than 65 years of age for the primary series vaccination (able to receive booster doses if no other contraindications).
- Clinically significant abnormal lab results, including evidence of Hepatitis C, Hepatitis B carrier state, or elevated (2 times normal) liver function tests.
- Personal history of immunodeficiency or current treatment with immunosuppressive medication.
- Confirmed positive human immunodeficiency virus (HIV) titer.
- Any medical condition that, at the discretion of the physician, may jeopardize the safety of the subject.
- 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
- Administration of any Investigational New Drug (IND) product or any vaccine within the 28 days before RVF vaccination.
- 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).
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Between Days 28-42
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PRNT80 ≥ 1:40 after 6-month mandatory booster dose
Time Frame: 7 months
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% vaccinated subjects with PRNT80 ≥ 1:40 after 6-month mandatory booster dose (initial responders only).
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7 months
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(PRNT80 < 1:40) who responded with a PRNT80 ≥ 1:40
Time Frame: up to 5 years
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% initial non-responders (PRNT80 < 1:40) who responded with a PRNT80 ≥ 1:40 after 1, 2, 3, or 4 booster doses.
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up to 5 years
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Median duration of PRNT80 ≥ 1:40 in initial responders
Time Frame: up to 5 years
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Median duration of PRNT80 ≥ 1:40 in initial responders after the primary series and 6-month mandatory booster dose.
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up to 5 years
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Median duration of PRNT80 ≥ 1:40 in initial non-responders
Time Frame: up to 5 years
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Median duration of PRNT80 ≥ 1:40 in initial non-responders after the first booster dose that results in PRNT80 ≥ 1:40.
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up to 5 years
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Number of booster doses needed in initial non-responders to achieve PRNT80 ≥ 1:40
Time Frame: up to 1 year
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Number of booster doses needed in initial non-responders to achieve PRNT80 ≥ 1:40.
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up to 1 year
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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
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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
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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
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Liver Diseases
- Arbovirus Infections
- Vector Borne Diseases
- Bacterial Infections and Mycoses
- Parasitic Diseases
- Protozoan Infections
- Mycoses
- Body Temperature Changes
- Hemorrhagic Fevers, Viral
- Hepatitis
- Bunyaviridae Infections
- Hepatitis, Viral, Animal
- Hepatitis, Animal
- Fever
- Coccidioidomycosis
- Coccidiosis
- Rift Valley Fever
Other Study ID Numbers
- A-15322
- FY08-07 (OTHER: IRB)
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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