Rift Valley FeverPhase 2RVFNCT03609398
Phase 2 Safety and Immunogenicity Study of Rift Valley Fever Vaccine
A Phase 2 study testing 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 to collect safety and immunogenicity data for an Rift Valley Fever (RVF) vaccine 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?
- RVF Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2018to Dec 2024
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Be 18 to 65 years old at time of consent.
- Have RVF plaque reduction neutralization 80% titers (PRNT80) <1:10 for primary series.
- Have RVF PRNT80 (plaque reduction neutralization 80% titer) <1:40 for booster series.
- If female of childbearing potential, must agree to have a urine pregnancy test on the same day before each vaccine administration. (Exception: documented hysterectomy or ≥3 years of menopause.) The results must be negative. Females must agree not to become pregnant for 3 months after receipt of the last study treatment (vaccination).
- Be considered at risk for exposure to RVF virus and who have submitted a Request for IND Vaccines for the RVF vaccine.
- Sign and date the approved informed consent document and HIPAA Authorization.
Show all 14Show fewer
- Have in their charts:
- medical history (including concomitant medications) within 60 days of planned first administration of vaccine
- physical examination and laboratory tests within 1 year
- previous chest radiograph results and electrocardiogram
- Be medically cleared for participation by an investigator. (Examinations and/or tests may be repeated at the discretion of the PI.)
- Be willing to return for all follow-up visits.
- Agree to report any adverse events (AEs) that may or may not be associated with administration of the vaccine for at least 28 days after administration and agree to report all serious adverse events (for example, resulting in hospitalization) for the duration of the subject's participation in the study.
- Agree to defer blood donation for 1 year after receipt of the vaccine
Who cannot join
- Have completed previous RVF vaccine study as a nonresponder (PRNT80 <1:40).
- Have clinically significant abnormal laboratory results (including evidence of hepatitis C, hepatitis B carrier state) or elevated liver function tests (two times the normal range or at the discretion of the PI).
- Have a personal history of an immunodeficiency or received treatment with an immunosuppressive medication, such as systemically administered glucocorticoids (eg prednisone) within 1 month before planned administration of the vaccine or with other immunosuppressive therapies within 6 months of planned administration of the vaccine. Other immunosuppressive therapies include all cancer chemotherapeutic agents, drugs to prevent transplant rejection, interferons, monoclonal antibodies, protein kinase inhibitors, methotrexate, TNF (tumor necrosis factor) inhibitors, and any other drug determined to be immunosuppressive by the PI. Current administration of topical, inhalational, or intranasal glucocorticoids is not excluded.
- Have confirmed HIV infection.
- Have positive pregnancy test or be breastfeeding female.
- Have any known allergies to components of the vaccine:
Show all 16Show fewer
- Fetal rhesus monkey lung cells
- Formaldehyde
- Neomycin sulfate
- Streptomycin
- Sodium bisulfite
- Human serum albumin (HAS)
- RVF virus (Entebbe strain)
- Have administration of another vaccine or investigational product within 28 days of RVF vaccination.
- Have any unresolved AE resulting from a previous immunization.
- Have a medical condition that, in the judgment of the PI, would impact subject safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Special Immunization Program, Division of Medicine, USAMRIID
Fort Deterick, Maryland, 21702
Anthony P Cardile, DO, MAJ, 301-619-4653, anthony.p.cardile.mil@mail.mil
Jeannine M Haller, RN, CCRP, 301-619-4652, jannine.m.haller.civ@mail.mil
About this study
Official title: A Phase 2 Open Label Safety and Immunogenicity Study of Rift Valley Fever Vaccine, Inactivated, Dried, TSI-GSD 200, Lot 7, Run 2, in Adult Subjects at Risk of Exposure to Rift Valley Fever Virus
This study is to collect safety and immunogenicity data for an Rift Valley Fever (RVF) vaccine
Read the detailed description
This study is being conducted to collect safety and immunogenicity data for the RVF vaccine, TSI-GSD 200, Lot 7, Run 2. Enrollment in this protocol is offered for personnel who enter areas where this virus is used in research or is endemic (an area where this disease process is found to occur frequently). Subjects who respond with a titer of >1:40 may participate for study duration. Rift Valley Fever Vaccine, Inactivated, Dried (TSI GSD 200) will be administered in 1.0-mL doses SQ in the upper outer aspect of the arm.
- Conditions
- Rift Valley Fever
- Being tested
- RVF Vaccine
- Medical subject headings
- Rift Valley Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RVF VaccineBiological
1.0 mL dose given SQ in upper arm
| Study group | Role | What they receive |
|---|---|---|
| RVF Vaccine | Experimental | 1.0 mL dose given SQ in upper arm Receives: Biological: RVF Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects with Local and Systemic Adverse Events and Their Relationship to the Study Vaccine
Safety assess of local and systemic adverse events and their relationship to the study vaccine. AEs will be recorded for 28 days after each dose of the vaccine for the assessment population (all subjects who receive at least one vaccination under this protocol. Subjects will be contacted by study staff via e-mail or telephone the day after vaccination (Day 1) and once per week for 4 weeks after each vaccination to discuss any reactions.
Measured: 0-28 days after each dose
Percentage of Subjects Who Developed Titers of ≥1:40 of Per-protocol Subjects
Percentage of per-protocol subjects (subjects who adhered to the protocol schedule for both vaccination and blood collects) who developed titers ≥1:40 as determined by PRNT80 (plaque reduction neutralization 80% titer) after vaccination at each scheduled time point for which blood samples are drawn and over the entire study period.
Measured: 21-35 days after each vaccination and month 12
Secondary outcomes (2)
Frequency and Severity of Adverse Events
Frequency and severity of adverse events for the assessment population (all subjects who receive at least one vaccination under this protocol). Subjects will be contacted by study staff via e-mail or telephone the day after vaccination (Day 1) and once per week for 4 weeks after each vaccination to discuss any reactions.
Measured: 0-28 days after each dose
Geometric Mean PRNT80 (plaque reduction neutralization 80% titer) of Per-protocol Subjects
Geometric mean PRNT80 (plaque reduction neutralization 80% titer) of per-protocol subjects at each scheduled time point for which blood samples are drawn and over the entire study period to study completion.
Measured: 21-35 days after each vaccination and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start4 Oct 2018
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
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
- vaccine to be administered in 1.0mL doses SQ in the upper outer aspect of the arm
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609398
- Sponsor's protocol ID
- S-16-12
- Acronym
- RVF
- Status last verified
- Feb 2021
- First submitted
- 24 Jul 2018
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open Label Safety and Immunogenicity Study of Rift Valley Fever Vaccine, Inactivated, Dried, TSI-GSD 200, Lot 7, Run 2, in Adult Subjects at Risk of Exposure to Rift Valley Fever Virus
- ClinicalTrials.gov ID
- NCT03609398
- Acronym / sponsor ID
- RVF / S-16-12
- Conditions
- Rift Valley Fever
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Aug 2018 (actual)
- 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 to collect safety and immunogenicity data for an Rift Valley Fever (RVF) vaccine
Detailed description
This study is being conducted to collect safety and immunogenicity data for the RVF vaccine, TSI-GSD 200, Lot 7, Run 2. Enrollment in this protocol is offered for personnel who enter areas where this virus is used in research or is endemic (an area where this disease process is found to occur frequently). Subjects who respond with a titer of >1:40 may participate for study duration. Rift Valley Fever Vaccine, Inactivated, Dried (TSI GSD 200) will be administered in 1.0-mL doses SQ in the upper outer aspect of the arm.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- vaccine to be administered in 1.0mL doses SQ in the upper outer aspect of the arm
| Arm | Type | Receives |
|---|---|---|
| RVF Vaccine | Experimental | Biological: RVF Vaccine1.0 mL dose given SQ in upper arm |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Be 18 to 65 years old at time of consent.
- Have RVF plaque reduction neutralization 80% titers (PRNT80) <1:10 for primary series.
- Have RVF PRNT80 (plaque reduction neutralization 80% titer) <1:40 for booster series.
- If female of childbearing potential, must agree to have a urine pregnancy test on the same day before each vaccine administration. (Exception: documented hysterectomy or ≥3 years of menopause.) The results must be negative. Females must agree not to become pregnant for 3 months after receipt of the last study treatment (vaccination).
- Be considered at risk for exposure to RVF virus and who have submitted a Request for IND Vaccines for the RVF vaccine.
Key exclusion criteria (16 listed)
- Have completed previous RVF vaccine study as a nonresponder (PRNT80 <1:40).
- Have clinically significant abnormal laboratory results (including evidence of hepatitis C, hepatitis B carrier state) or elevated liver function tests (two times the normal range or at the discretion of the PI).
- Have a personal history of an immunodeficiency or received treatment with an immunosuppressive medication, such as systemically administered glucocorticoids (eg prednisone) within 1 month before planned administration of the vaccine or with other immunosuppressive therapies within 6 months of planned administration of the vaccine. Other immunosuppressive therapies include all cancer chemotherapeutic agents, drugs to prevent transplant rejection, interferons, monoclonal antibodies, protein kinase inhibitors, methotrexate, TNF (tumor necrosis factor) inhibitors, and any other drug determined to be immunosuppressive by the PI. Current administration of topical, inhalational, or intranasal glucocorticoids is not excluded.
- Have confirmed HIV infection.
- Have positive pregnancy test or be breastfeeding female.
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 |
|---|---|---|
| RVF Vaccine1.0 mL dose given SQ in upper arm | Biological | RVF Vaccine |
Primary outcome
Number of Subjects with Local and Systemic Adverse Events and Their Relationship to the Study Vaccine
Time frame: 0-28 days after each dose
Safety assess of local and systemic adverse events and their relationship to the study vaccine. AEs will be recorded for 28 days after each dose of the vaccine for the assessment population (all subjects who receive at least one vaccination under this protocol. Subjects will be contacted by study staff via e-mail or telephone the day after vaccination (Day 1) and once per week for 4 weeks after each vaccination to discuss any reactions.
Percentage of Subjects Who Developed Titers of ≥1:40 of Per-protocol Subjects
Time frame: 21-35 days after each vaccination and month 12
Percentage of per-protocol subjects (subjects who adhered to the protocol schedule for both vaccination and blood collects) who developed titers ≥1:40 as determined by PRNT80 (plaque reduction neutralization 80% titer) after vaccination at each scheduled time point for which blood samples are drawn and over the entire study period.
2 secondary outcomes
Frequency and Severity of Adverse Events
Time frame: 0-28 days after each dose
Geometric Mean PRNT80 (plaque reduction neutralization 80% titer) of Per-protocol Subjects
Time frame: 21-35 days after each vaccination and month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Rift Valley Fever
RecruitingObservational study
RVF and Other Emerging Infectious Diseases in East and Central Africa
Rift Valley Fever, Hemorrhagic Fevers, Viral
Active, not recruitingPhase 1
Study to Evaluate Safety, Tolerability and Pharmacokinetics of IDB-011
Rift Valley Fever
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
Active, not recruitingPhase 2
Safety and Immunogenicity of a Candidate Rift Valley Fever Vaccine (RVF003)
Rift Valley Fever
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.
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 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 14 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 11 Feb 2021. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anthony P Cardile, DO, MAJ (301-619-8833, anthony.p.cardile.mil@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects with Local and Systemic Adverse Events and Their Relationship to the Study Vaccine (time frame: 0-28 days after each dose). The study lists 2 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 11 Feb 2021.