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Completed

NCT Number: NCT00869713

Safety and Immunogenicity Study of Rift Valley Fever Vaccine, Inactivated

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

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Key information

Conditions

Rift Valley Fever Animal Diseases Arbovirus Infections Bunyaviridae Infections Digestive System Diseases Hemorrhagic Fevers, Viral Hepatitis Hepatitis, Animal Hepatitis, Viral, Animal Infections Liver Diseases Mosquito-Borne Diseases Nervous System Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

U.S. Army Medical Research Institute of Infectious Diseases

Fort Deterick, Maryland, 21702, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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 outcomes

  1. PRNT80 ≥ 1:40 after primary series

    Time frame: Between Days 28-42

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

  2. PRNT80 ≥ 1:40 after 6-month mandatory booster dose

    Time frame: 7 months

    % vaccinated subjects with PRNT80 ≥ 1:40 after 6-month mandatory booster dose (initial responders only).

  3. (PRNT80 < 1:40) who responded with a PRNT80 ≥ 1:40

    Time frame: up to 5 years

    % initial non-responders (PRNT80 < 1:40) who responded with a PRNT80 ≥ 1:40 after 1, 2, 3, or 4 booster doses.

  4. Median duration of PRNT80 ≥ 1:40 in initial responders

    Time frame: up to 5 years

    Median duration of PRNT80 ≥ 1:40 in initial responders after the primary series and 6-month mandatory booster dose.

  5. Median duration of PRNT80 ≥ 1:40 in initial non-responders

    Time frame: up to 5 years

    Median duration of PRNT80 ≥ 1:40 in initial non-responders after the first booster dose that results in PRNT80 ≥ 1:40.

  6. Number of booster doses needed in initial non-responders to achieve PRNT80 ≥ 1:40

    Time frame: up to 1 year

    Number of booster doses needed in initial non-responders to achieve PRNT80 ≥ 1:40.

Secondary outcomes

  1. Subjects without symptoms

    Time frame: 5 years

    Number of subjects without symptoms

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

    Time frame: 5 years

    Number of subjects with any local reaction

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

    Time frame: 5 years

    Number of subjects with systemic reactions

  4. Subjects with generalized allergic reactions

    Time frame: 5 years

    Number of subjects with generalized allergic reactions

Sponsors and collaborators

Lead sponsor

U.S. Army Medical Research and Development Command

Fed

Registry information

Official study 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

Acronym: RVF

Important dates

Study start
2009
Primary completion
2019
Study completion
2021
First posted
Mar 26, 2009
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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