Rift Valley FeverPhase 2RVFNCT00869713
Safety and Immunogenicity Study of Rift Valley Fever Vaccine, Inactivated
A Phase 2 study testing Inactivated, Dried (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 an inactivated Rift Valley Fever (RVF) Vaccine in adults Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rift Valley Fever
- What is being tested?
- Inactivated, Dried (TSI-GSD 200), RVF Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to May 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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: 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
Read the 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
- Conditions
- Rift Valley Fever
- Being tested
- Inactivated, Dried (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.
Inactivated, Dried (TSI-GSD 200), RVF VaccineBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| primary vaccination with boost | Other | Inactivated, Dried (TSI-GSD 200), RVF Vaccine Receives: Biological: Inactivated, Dried (TSI-GSD 200), RVF Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRNT80 ≥ 1:40 after primary series
% vaccinated subjects with PRNT80 ≥ 1:40 after primary series (initial responders).
Measured: Between Days 28-42
PRNT80 ≥ 1:40 after 6-month mandatory booster dose
% vaccinated subjects with PRNT80 ≥ 1:40 after 6-month mandatory booster dose (initial responders only).
Measured: 7 months
(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.
Measured: up to 5 years
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.
Measured: up to 5 years
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.
Measured: up to 5 years
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.
Measured: up to 1 year
Secondary outcomes (4)
Subjects without symptoms
Number of subjects without symptoms
Measured: 5 years
Subjects with any category of local reaction (grade 1-4).
Number of subjects with any local reaction
Measured: 5 years
Subjects with mild, moderate, severe, and potentially life-threatening systemic reactions (grade 1-4).
Number of subjects with systemic reactions
Measured: 5 years
Subjects with generalized allergic reactions
Number of subjects with generalized allergic reactions
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startSep 2009
- Primary completionFeb 2019
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 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)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ronald Reisler, MD, Principal investigator, USAMRIID Medical Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869713
- Sponsor's protocol ID
- A-15322
- Other IDs
- FY08-07
- Acronym
- RVF
- Status last verified
- Feb 2022
- First submitted
- 25 Mar 2009
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00869713
- Acronym / sponsor ID
- RVF / A-15322
- Conditions
- Rift Valley Fever
- Keywords
- Hemorrhagic Fever, Viral Infections, Neurologic diseases, Arbovirus Infections, RVF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Study start
- Sep 2009 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 26 Mar 2009 (estimated)
- Results
- Not posted in the source record
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 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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| primary vaccination with boost | Other | Biological: Inactivated, Dried (TSI-GSD 200), RVF VaccineInactivated, Dried (TSI-GSD 200), RVF Vaccine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Inactivated, Dried (TSI-GSD 200), RVF VaccineAll 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. | Biological | primary vaccination with boost |
Primary outcome
PRNT80 ≥ 1:40 after primary series
Time frame: Between Days 28-42
% vaccinated subjects with PRNT80 ≥ 1:40 after primary series (initial responders).
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).
(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.
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.
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.
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.
4 secondary outcomes
Subjects without symptoms
Time frame: 5 years
Subjects with any category of local reaction (grade 1-4).
Time frame: 5 years
Subjects with mild, moderate, severe, and potentially life-threatening systemic reactions (grade 1-4).
Time frame: 5 years
Subjects with generalized allergic reactions
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
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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.
Ronald Reisler, 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 Inactivated, Dried (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 8 inclusion and 8 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 4 Mar 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PRNT80 ≥ 1:40 after primary series (time frame: Between Days 28-42). The study lists 6 primary outcomes in all. 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 4 Mar 2022.