Clinical trial NCT00869713: Safety and Immunogenicity Study of Rift Valley Fever Vaccine, Inactivated
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rift Valley Fever
Keywords: Hemorrhagic Fever
Viral Infections
Neurologic diseases
Arbovirus Infections
RVF
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
First posted: 2009-03-26
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

Brief summary: 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

Eligibility criteria: 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.

Primary outcomes:
measure: PRNT80 ≥ 1:40 after primary series
timeFrame: Between Days 28-42
measure: PRNT80 ≥ 1:40 after 6-month mandatory booster dose
timeFrame: 7 months
measure: (PRNT80 < 1:40) who responded with a PRNT80 ≥ 1:40
timeFrame: up to 5 years
measure: Median duration of PRNT80 ≥ 1:40 in initial responders
timeFrame: up to 5 years
measure: Median duration of PRNT80 ≥ 1:40 in initial non-responders
timeFrame: up to 5 years
measure: Number of booster doses needed in initial non-responders to achieve PRNT80 ≥ 1:40
timeFrame: up to 1 year
Secondary outcomes:
measure: Subjects without symptoms
timeFrame: 5 years
measure: Subjects with any category of local reaction (grade 1-4).
timeFrame: 5 years
measure: Subjects with mild, moderate, severe, and potentially life-threatening systemic reactions (grade 1-4).
timeFrame: 5 years
measure: Subjects with generalized allergic reactions
timeFrame: 5 years
Other outcomes:
Locations:
city: Fort Deterick
country: United States
facility: U.S. Army Medical Research Institute of Infectious Diseases
state: Maryland
Study officials:
affiliation: USAMRIID Medical Division
name: Ronald Reisler, MD
role: PRINCIPAL_INVESTIGATOR
References: