Phase 2 Safety and Immunogenicity Study of Rift Valley Fever Vaccine (RVF)
Primary Purpose
Rift Valley Fever
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RVF Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Rift Valley Fever
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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
Exclusion Criteria:
- 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:
- 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.
Sites / Locations
- Special Immunization Program, Division of Medicine, USAMRIIDRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RVF Vaccine
Arm Description
1.0 mL dose given SQ in upper arm
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03609398
First Posted
July 24, 2018
Last Updated
February 10, 2021
Sponsor
U.S. Army Medical Research and Development Command
1. Study Identification
Unique Protocol Identification Number
NCT03609398
Brief Title
Phase 2 Safety and Immunogenicity Study of Rift Valley Fever Vaccine
Acronym
RVF
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
U.S. Army Medical Research and Development Command
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rift Valley Fever
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
vaccine to be administered in 1.0mL doses SQ in the upper outer aspect of the arm
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RVF Vaccine
Arm Type
Experimental
Arm Description
1.0 mL dose given SQ in upper arm
Intervention Type
Biological
Intervention Name(s)
RVF Vaccine
Intervention Description
1.0 mL dose given SQ in upper arm
Primary Outcome Measure Information:
Title
Number of Subjects with Local and Systemic Adverse Events and Their Relationship to the Study Vaccine
Description
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.
Time Frame
0-28 days after each dose
Title
Percentage of Subjects Who Developed Titers of ≥1:40 of Per-protocol Subjects
Description
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.
Time Frame
21-35 days after each vaccination and month 12
Secondary Outcome Measure Information:
Title
Frequency and Severity of Adverse Events
Description
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.
Time Frame
0-28 days after each dose
Title
Geometric Mean PRNT80 (plaque reduction neutralization 80% titer) of Per-protocol Subjects
Description
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.
Time Frame
21-35 days after each vaccination and month 12
Other Pre-specified Outcome Measures:
Title
Geometric Mean PRNT50 (plaque reduction neutralization 50% titer) of Per-protocol Subjects
Description
Geometric mean PRNT50 (plaque reduction neutralization 50% 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.
Time Frame
21-35 days after each vaccination and month 12
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:
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.
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
Exclusion Criteria:
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:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony P Cardile, DO, MAJ
Phone
301-619-8833
Email
anthony.p.cardile.mil@mail.mil
First Name & Middle Initial & Last Name or Official Title & Degree
Jeannine M Haller, RN, CCRP
Phone
301-619-4652
Email
jeannine.m.haller.civ@mail.mil
Facility Information:
Facility Name
Special Immunization Program, Division of Medicine, USAMRIID
City
Fort Deterick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony P Cardile, DO, MAJ
Phone
301-619-4653
Email
anthony.p.cardile.mil@mail.mil
First Name & Middle Initial & Last Name & Degree
Jeannine M Haller, RN, CCRP
Phone
301-619-4652
Email
jannine.m.haller.civ@mail.mil
First Name & Middle Initial & Last Name & Degree
Anthony P Cardile, DO, MAJ
First Name & Middle Initial & Last Name & Degree
Jason A Regules, MD, FACP, LTC
First Name & Middle Initial & Last Name & Degree
Elena H Kwon, DO, MPH, MAJ
First Name & Middle Initial & Last Name & Degree
Arthur C Okwesili, DO, MPH, MAJ
First Name & Middle Initial & Last Name & Degree
Maryam K Jahromi, MD, MPH
First Name & Middle Initial & Last Name & Degree
Ronald B Reisler, MD, MPH
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phase 2 Safety and Immunogenicity Study of Rift Valley Fever Vaccine
We'll reach out to this number within 24 hrs