Rift Valley FeverPhase 2RVFNCT00584194
Safety and Immunogenicity Study of Rift Valley Fever Vaccine
A Phase 2 study testing TSI-GSD 200 RVF Vaccine in people with Rift Valley Fever, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
This study is designed to determine the safety and immunogenicity of a Rift Valley Fever (RVF) Vaccine Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rift Valley Fever
- What is being tested?
- TSI-GSD 200 RVF Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to May 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parts A \& B:
- At least 18 years old, or if active military duty, 17 years old,
- Females of childbearing potential must agree to have a urine pregnancy test within 48 hours before receipt of each dose of vaccine. The test results must be negative. Females will be advised not to become pregnant for 3 months after the primary series and each booster dose, and must not be breast-feeding,
- Subject must be actively enrolled in the SIP to be vaccinated at USAMRIID or be otherwise authorized (with documentation) by the DOD
- Subjects must be at risk for exposure to RVF virus,
- Subjects 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 may be repeated within 1 year at the discretion of the enrolling physician.
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- Volunteer must have signed and dated the approved informed consent (Volunteer Agreement Explanation and Affidavit).
- Additional Inclusion Criteria for Part B:
- Completion of primary series and any follow-up titer (PRNT80) < 1:40 from the current or a previous RVF IND 365 protocol.
Who cannot join
- Parts A \& B:
- Clinically significant abnormal lab results including evidence of Hepatitis C, Hepatitis B or carrier state, or elevated liver function tests.
- Personal history of immunodeficiency or current treatment with immunosuppressive medication, at the discretion of the physician.
- Confirmed HIV infection.
- Any medical condition that, at the discretion of the physician, may jeopardize the safety of the volunteer.
- Any serious or life-threatening allergies to any component of the vaccine: formalin, human serum albumin, neomycin, streptomycin
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- Administration of any other vaccine within 28 days of any dose of RVF vaccine.
- Any unresolved adverse event resulting from a previous immunization.
- Additional Exclusion Criteria for Part B:
- An adequate PRNT80 (≥ 1:40) after completion of primary series.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.S. Army Medical Research Institute of Infectious Diseases
Fort Deterick, Maryland, 21702
About this study
Official title: Parts A&B: Evaluation of the Safety and Immunogenicity of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200), A Phase 2 Study
This study is designed to determine the safety and immunogenicity of a Rift Valley Fever (RVF) Vaccine
Read the detailed description
Study Objectives:
The objectives of this two-part, primary immunization and booster dose, study are to continue to collect safety data on Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200); and, to continue to collect immunogenicity data on Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200) and analyze interim data to determine whether a 6-month dose is indicated; and, to provide potential protection for personnel at risk for occupational exposure to the RVF virus and collect data on incidence of occupational RVF infection (subclinical and clinical) in immunized personnel.
- Conditions
- Rift Valley Fever
- Being tested
- TSI-GSD 200 RVF Vaccine
- Keywords
- Hemorrhagic Fever, Viral Infections, Neurologic diseases, Arbovirus Infections, RVF
- Medical subject headings
- Rift Valley Fever, Hemorrhagic Fevers, Viral, Virus Diseases, Nervous System Diseases, Arbovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSI-GSD 200 RVF VaccineBiological
Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40.
| Study group | Role | What they receive |
|---|---|---|
| TSI-GSD 200 RVF Vaccine | Experimental | Part A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40. Receives: Biological: TSI-GSD 200 RVF Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: All Incidences of Erythema
Collect data on the occurrence of AEs and SAEs in reference to Erythema (most frequently reported AE) in parts A and B of the study
Measured: 12 months
Secondary outcomes (4)
Immunogenicity: Geometric Mean Titers After 3rd Vaccination
Measurement is the 80% plaque-reduction neutralization titer (PRNT80) antibodies to RVF virus following 3rd vaccination (Parts A and B of study)
Measured: 28 days after dose 3
Immunogenicity: Geometric Mean Titers Before 6-month Booster
Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B
Measured: Before 6-month booster
Immunogenicity: Geometric Mean Titers at 12 Months
Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B.
Measured: at 12 months
Immunogenicity: Geometric Mean Titers After 6-month Booster
Measurement is the 80% plaque-reduction neutralization titer (PRNT80) for study Parts A and B.
Measured: month 6 after dose 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startJun 2004
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rift Valley FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Janice Rusnak, MD, Principal investigator, USAMRIID Medical Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584194
- Sponsor's protocol ID
- A-12592
- Other IDs
- FY03-05
- Acronym
- RVF
- Status last verified
- Dec 2019
- First submitted
- 20 Dec 2007
- Last updated
- 3 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parts A&B: Evaluation of the Safety and Immunogenicity of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200), A Phase 2 Study
- ClinicalTrials.gov ID
- NCT00584194
- Acronym / sponsor ID
- RVF / A-12592
- Conditions
- Rift Valley Fever
- Keywords
- Hemorrhagic Fever, Viral Infections, Neurologic diseases, Arbovirus Infections, RVF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Study start
- Jun 2004 (actual)
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 2 Jan 2008 (estimated)
- Results
- Posted 14 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to determine the safety and immunogenicity of a Rift Valley Fever (RVF) Vaccine
Detailed description
Study Objectives:
The objectives of this two-part, primary immunization and booster dose, study are to continue to collect safety data on Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200); and, to continue to collect immunogenicity data on Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200) and analyze interim data to determine whether a 6-month dose is indicated; and, to provide potential protection for personnel at risk for occupational exposure to the RVF virus and collect data on incidence of occupational RVF infection (subclinical and clinical) in immunized personnel.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TSI-GSD 200 RVF Vaccine | Experimental | Biological: TSI-GSD 200 RVF VaccinePart A: Inactivated, Dried (TSI-GSD 200) RVF vaccine, will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- At least 18 years old, or if active military duty, 17 years old,
- Females of childbearing potential must agree to have a urine pregnancy test within 48 hours before receipt of each dose of vaccine. The test results must be negative. Females will be advised not to become pregnant for 3 months after the primary series and each booster dose, and must not be breast-feeding,
- Subject must be actively enrolled in the SIP to be vaccinated at USAMRIID or be otherwise authorized (with documentation) by the DOD
- Subjects must be at risk for exposure to RVF virus,
- Subjects 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 may be repeated within 1 year at the discretion of the enrolling physician.
Key exclusion criteria (10 listed)
- Clinically significant abnormal lab results including evidence of Hepatitis C, Hepatitis B or carrier state, or elevated liver function tests.
- Personal history of immunodeficiency or current treatment with immunosuppressive medication, at the discretion of the physician.
- Confirmed HIV infection.
- Any medical condition that, at the discretion of the physician, may jeopardize the safety of the volunteer.
- Any serious or life-threatening allergies to any component of the vaccine: formalin, human serum albumin, neomycin, streptomycin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TSI-GSD 200 RVF VaccinePart A: Inactivated, Dried (TSI-GSD 200) RVF vaccine will be given as three 1.0-ml subcutaneous primary series injections, with doses on day 0, once on days 7-14, once on days 28-42 (the third dose will be given at least 21 days after the second dose).Part B: Subcutaneous 1.0-ml booster doses (maximum of four boosters over 12 months) will be given if the volunteer fails to respond to the primary series with a PRNT80 ≥ 1:40 or annually if titer wanes to < 1:40. | Biological | TSI-GSD 200 RVF Vaccine |
Primary outcome
Safety: All Incidences of Erythema
Time frame: 12 months
Collect data on the occurrence of AEs and SAEs in reference to Erythema (most frequently reported AE) in parts A and B of the study
4 secondary outcomes
Immunogenicity: Geometric Mean Titers After 3rd Vaccination
Time frame: 28 days after dose 3
Immunogenicity: Geometric Mean Titers Before 6-month Booster
Time frame: Before 6-month booster
Immunogenicity: Geometric Mean Titers at 12 Months
Time frame: at 12 months
Immunogenicity: Geometric Mean Titers After 6-month Booster
Time frame: month 6 after dose 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice Rusnak, MD principal investigator
USAMRIID Medical Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TSI-GSD 200 RVF Vaccine in people with Rift Valley Fever, run by U.S. Army Medical Research and Development Command at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: All Incidences of Erythema (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.