Safety and Immunogenicity Study of Rift Valley Fever Vaccine, Inactivated

NCT00869713 | Completed Phase 2

• 2 other identifiers: A-15322FY08-07
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to determine the safety and immunogenicity of an inactivated Rift Valley Fever (RVF) Vaccine in adults

Conditions

Rift Valley Fever

Keywords

Hemorrhagic Fever; Viral Infections; Neurologic diseases; Arbovirus Infections; RVF

Outcome Measures

Primary Outcomes (6)

• PRNT80 ≥ 1:40 after primary series

  % vaccinated subjects with PRNT80 ≥ 1:40 after primary series (initial responders).

  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).

  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.

  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.

  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.

  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.

  up to 1 year

Secondary Outcomes (4)

• Subjects without symptoms

  5 years

• Subjects with any category of local reaction (grade 1-4).

  5 years

• Subjects with mild, moderate, severe, and potentially life-threatening systemic reactions (grade 1-4).

  5 years

• Subjects with generalized allergic reactions

  5 years

Study Arms (1)

primary vaccination with boost

OTHER

Inactivated, Dried (TSI-GSD 200), RVF Vaccine

Biological: Inactivated, Dried (TSI-GSD 200), RVF Vaccine

Interventions

Inactivated, Dried (TSI-GSD 200), RVF Vaccine BIOLOGICAL

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.

primary vaccination with boost

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead

Study Sites (1)

U.S. Army Medical Research Institute of Infectious Diseases

Fort Deterick, Maryland, 21702, United States

Location

MeSH Terms

Conditions

Rift Valley Fever; Hemorrhagic Fevers, Viral; Virus Diseases; Nervous System Diseases; Arbovirus Infections

Interventions

Desiccation

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Animal; Hepatitis, Animal; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Bunyaviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Animal Diseases

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques; Chemical Phenomena

Study Officials

• Ronald Reisler, MD

  USAMRIID Medical Division

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 25, 2009
• First Posted: March 26, 2009
• Study Start: September 1, 2009
• Primary Completion: February 1, 2019
• Study Completion: May 1, 2021
• Last Updated: March 4, 2022

Record last verified: 2022-02

Locations

US (1)