Safety and Immunogenicity Study of Rift Valley Fever Vaccine, Inactivated (RVF)
Primary Purpose
Rift Valley Fever
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Inactivated, Dried (TSI-GSD 200), RVF Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Rift Valley Fever focused on measuring Hemorrhagic Fever, Viral Infections, Neurologic diseases, Arbovirus Infections, RVF
Eligibility Criteria
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.
Sites / Locations
- U.S. Army Medical Research Institute of Infectious Diseases
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
primary vaccination with boost
Arm Description
Inactivated, Dried (TSI-GSD 200), RVF Vaccine
Outcomes
Primary Outcome Measures
PRNT80 ≥ 1:40 after primary series
% vaccinated subjects with PRNT80 ≥ 1:40 after primary series (initial responders).
PRNT80 ≥ 1:40 after 6-month mandatory booster dose
% vaccinated subjects with PRNT80 ≥ 1:40 after 6-month mandatory booster dose (initial responders only).
(PRNT80 < 1:40) who responded with a PRNT80 ≥ 1:40
% initial non-responders (PRNT80 < 1:40) who responded with a PRNT80 ≥ 1:40 after 1, 2, 3, or 4 booster doses.
Median duration of PRNT80 ≥ 1:40 in initial responders
Median duration of PRNT80 ≥ 1:40 in initial responders after the primary series and 6-month mandatory booster dose.
Median duration of PRNT80 ≥ 1:40 in initial non-responders
Median duration of PRNT80 ≥ 1:40 in initial non-responders after the first booster dose that results in PRNT80 ≥ 1:40.
Number of booster doses needed in initial non-responders to achieve PRNT80 ≥ 1:40
Number of booster doses needed in initial non-responders to achieve PRNT80 ≥ 1:40.
Secondary Outcome Measures
Subjects without symptoms
Number of subjects without symptoms
Subjects with any category of local reaction (grade 1-4).
Number of subjects with any local reaction
Subjects with mild, moderate, severe, and potentially life-threatening systemic reactions (grade 1-4).
Number of subjects with systemic reactions
Subjects with generalized allergic reactions
Number of subjects with generalized allergic reactions
Full Information
NCT ID
NCT00869713
First Posted
March 25, 2009
Last Updated
February 16, 2022
Sponsor
U.S. Army Medical Research and Development Command
1. Study Identification
Unique Protocol Identification Number
NCT00869713
Brief Title
Safety and Immunogenicity Study of Rift Valley Fever Vaccine, Inactivated
Acronym
RVF
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 2009 (Actual)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
May 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
U.S. Army Medical Research and Development Command
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to determine the safety and immunogenicity of an inactivated Rift Valley Fever (RVF) Vaccine in adults
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rift Valley Fever
Keywords
Hemorrhagic Fever, Viral Infections, Neurologic diseases, Arbovirus Infections, RVF
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
primary vaccination with boost
Arm Type
Other
Arm Description
Inactivated, Dried (TSI-GSD 200), RVF Vaccine
Intervention Type
Biological
Intervention Name(s)
Inactivated, Dried (TSI-GSD 200), RVF Vaccine
Intervention Description
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.
Primary Outcome Measure Information:
Title
PRNT80 ≥ 1:40 after primary series
Description
% vaccinated subjects with PRNT80 ≥ 1:40 after primary series (initial responders).
Time Frame
Between Days 28-42
Title
PRNT80 ≥ 1:40 after 6-month mandatory booster dose
Description
% vaccinated subjects with PRNT80 ≥ 1:40 after 6-month mandatory booster dose (initial responders only).
Time Frame
7 months
Title
(PRNT80 < 1:40) who responded with a PRNT80 ≥ 1:40
Description
% initial non-responders (PRNT80 < 1:40) who responded with a PRNT80 ≥ 1:40 after 1, 2, 3, or 4 booster doses.
Time Frame
up to 5 years
Title
Median duration of PRNT80 ≥ 1:40 in initial responders
Description
Median duration of PRNT80 ≥ 1:40 in initial responders after the primary series and 6-month mandatory booster dose.
Time Frame
up to 5 years
Title
Median duration of PRNT80 ≥ 1:40 in initial non-responders
Description
Median duration of PRNT80 ≥ 1:40 in initial non-responders after the first booster dose that results in PRNT80 ≥ 1:40.
Time Frame
up to 5 years
Title
Number of booster doses needed in initial non-responders to achieve PRNT80 ≥ 1:40
Description
Number of booster doses needed in initial non-responders to achieve PRNT80 ≥ 1:40.
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
Subjects without symptoms
Description
Number of subjects without symptoms
Time Frame
5 years
Title
Subjects with any category of local reaction (grade 1-4).
Description
Number of subjects with any local reaction
Time Frame
5 years
Title
Subjects with mild, moderate, severe, and potentially life-threatening systemic reactions (grade 1-4).
Description
Number of subjects with systemic reactions
Time Frame
5 years
Title
Subjects with generalized allergic reactions
Description
Number of subjects with generalized allergic reactions
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Reisler, MD
Organizational Affiliation
USAMRIID Medical Division
Official's Role
Principal Investigator
Facility Information:
Facility Name
U.S. Army Medical Research Institute of Infectious Diseases
City
Fort Deterick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Immunogenicity Study of Rift Valley Fever Vaccine, Inactivated
We'll reach out to this number within 24 hrs