Safety and Immunogenicity Study of Rift Valley Fever Vaccine, Inactivated

NCT ID: NCT00869713

Last Updated: 2022-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2021-05-31

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

Conditions

Rift Valley Fever

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

primary vaccination with boost

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

Group Type: OTHER

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald Reisler, MD

Role: PRINCIPAL_INVESTIGATOR

USAMRIID Medical Division

Locations

U.S. Army Medical Research Institute of Infectious Diseases

Fort Deterick, Maryland, United States

Countries

United States

Other Identifiers

FY08-07

Identifier Type: OTHER

Identifier Source: secondary_id

A-15322

Identifier Type: -

Identifier Source: org_study_id