Rift Valley Fever Clinical Trial
— RVFOfficial 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
Verified date | February 2022 |
Source | U.S. Army Medical Research and Development Command |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is designed to determine the safety and immunogenicity of an inactivated Rift Valley Fever (RVF) Vaccine in adults
Status | Completed |
Enrollment | 98 |
Est. completion date | May 2021 |
Est. primary completion date | February 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. At least 18 years old. 2. 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. 3. Females must not be breast-feeding. 4. Subject must be at risk for exposure to RVF virus. 5. 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. 6. Subject must sign and date the approved informed consent document. 7. For initiation of primary series, RVF PRNT80 <1:10. 8. 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: 1. Older than 65 years of age for the primary series vaccination (able to receive booster doses if no other contraindications). 2. Clinically significant abnormal lab results, including evidence of Hepatitis C, Hepatitis B carrier state, or elevated (2 times normal) liver function tests. 3. Personal history of immunodeficiency or current treatment with immunosuppressive medication. 4. Confirmed positive human immunodeficiency virus (HIV) titer. 5. Any medical condition that, at the discretion of the physician, may jeopardize the safety of the subject. 6. 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 7. Administration of any Investigational New Drug (IND) product or any vaccine within the 28 days before RVF vaccination. 8. Any unresolved adverse event resulting from a previous immunization. |
Country | Name | City | State |
---|---|---|---|
United States | U.S. Army Medical Research Institute of Infectious Diseases | Fort Deterick | Maryland |
Lead Sponsor | Collaborator |
---|---|
U.S. Army Medical Research and Development Command |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PRNT80 = 1:40 after primary series | % vaccinated subjects with PRNT80 = 1:40 after primary series (initial responders). | Between Days 28-42 | |
Primary | PRNT80 = 1:40 after 6-month mandatory booster dose | % vaccinated subjects with PRNT80 = 1:40 after 6-month mandatory booster dose (initial responders only). | 7 months | |
Primary | (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. | up to 5 years | |
Primary | 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. | up to 5 years | |
Primary | 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. | up to 5 years | |
Primary | 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. | up to 1 year | |
Secondary | Subjects without symptoms | Number of subjects without symptoms | 5 years | |
Secondary | Subjects with any category of local reaction (grade 1-4). | Number of subjects with any local reaction | 5 years | |
Secondary | Subjects with mild, moderate, severe, and potentially life-threatening systemic reactions (grade 1-4). | Number of subjects with systemic reactions | 5 years | |
Secondary | Subjects with generalized allergic reactions | Number of subjects with generalized allergic reactions | 5 years |
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