Phase 2 Safety and Immunogenicity Study of Rift Valley Fever Vaccine

NCT03609398 | Recruiting Phase 2 FDA Drug

• 1 other identifier: S-16-12
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to collect safety and immunogenicity data for an Rift Valley Fever (RVF) vaccine

Conditions

Rift Valley Fever

Outcome Measures

Primary Outcomes (2)

• Number of Subjects with Local and Systemic Adverse Events and Their Relationship to the Study Vaccine

  Safety assess of local and systemic adverse events and their relationship to the study vaccine. AEs will be recorded for 28 days after each dose of the vaccine for the assessment population (all subjects who receive at least one vaccination under this protocol. Subjects will be contacted by study staff via e-mail or telephone the day after vaccination (Day 1) and once per week for 4 weeks after each vaccination to discuss any reactions.

  0-28 days after each dose

• Percentage of Subjects Who Developed Titers of ≥1:40 of Per-protocol Subjects

  Percentage of per-protocol subjects (subjects who adhered to the protocol schedule for both vaccination and blood collects) who developed titers ≥1:40 as determined by PRNT80 (plaque reduction neutralization 80% titer) after vaccination at each scheduled time point for which blood samples are drawn and over the entire study period.

  21-35 days after each vaccination and month 12

Secondary Outcomes (2)

• Frequency and Severity of Adverse Events

  0-28 days after each dose

• Geometric Mean PRNT80 (plaque reduction neutralization 80% titer) of Per-protocol Subjects

  21-35 days after each vaccination and month 12

Other Outcomes (1)

• Geometric Mean PRNT50 (plaque reduction neutralization 50% titer) of Per-protocol Subjects

  21-35 days after each vaccination and month 12

Study Arms (1)

RVF Vaccine

EXPERIMENTAL

1.0 mL dose given SQ in upper arm

Biological: RVF Vaccine

Interventions

RVF Vaccine BIOLOGICAL

1.0 mL dose given SQ in upper arm

RVF Vaccine

Eligibility Criteria

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

You may qualify if:

• Be 18 to 65 years old at time of consent.
• Have RVF plaque reduction neutralization 80% titers (PRNT80) \<1:10 for primary series.
• Have RVF PRNT80 (plaque reduction neutralization 80% titer) \<1:40 for booster series.
• If female of childbearing potential, must agree to have a urine pregnancy test on the same day before each vaccine administration. (Exception: documented hysterectomy or ≥3 years of menopause.) The results must be negative. Females must agree not to become pregnant for 3 months after receipt of the last study treatment (vaccination).
• Be considered at risk for exposure to RVF virus and who have submitted a Request for IND Vaccines for the RVF vaccine.
• Sign and date the approved informed consent document and HIPAA Authorization.
• Have in their charts:
• medical history (including concomitant medications) within 60 days of planned first administration of vaccine
• physical examination and laboratory tests within 1 year
• previous chest radiograph results and electrocardiogram
• Be medically cleared for participation by an investigator. (Examinations and/or tests may be repeated at the discretion of the PI.)
• Be willing to return for all follow-up visits.
• Agree to report any adverse events (AEs) that may or may not be associated with administration of the vaccine for at least 28 days after administration and agree to report all serious adverse events (for example, resulting in hospitalization) for the duration of the subject's participation in the study.
• Agree to defer blood donation for 1 year after receipt of the vaccine

You may not qualify if:

• Have completed previous RVF vaccine study as a nonresponder (PRNT80 \<1:40).
• Have clinically significant abnormal laboratory results (including evidence of hepatitis C, hepatitis B carrier state) or elevated liver function tests (two times the normal range or at the discretion of the PI).
• Have a personal history of an immunodeficiency or received treatment with an immunosuppressive medication, such as systemically administered glucocorticoids (eg prednisone) within 1 month before planned administration of the vaccine or with other immunosuppressive therapies within 6 months of planned administration of the vaccine. Other immunosuppressive therapies include all cancer chemotherapeutic agents, drugs to prevent transplant rejection, interferons, monoclonal antibodies, protein kinase inhibitors, methotrexate, TNF (tumor necrosis factor) inhibitors, and any other drug determined to be immunosuppressive by the PI. Current administration of topical, inhalational, or intranasal glucocorticoids is not excluded.
• Have confirmed HIV infection.
• Have positive pregnancy test or be breastfeeding female.
• Have any known allergies to components of the vaccine:
• Fetal rhesus monkey lung cells
• Formaldehyde
• Neomycin sulfate
• Streptomycin
• Sodium bisulfite
• Human serum albumin (HAS)
• RVF virus (Entebbe strain)
• Have administration of another vaccine or investigational product within 28 days of RVF vaccination.
• Have any unresolved AE resulting from a previous immunization.

Sponsors & Collaborators

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

Study Sites (1)

Special Immunization Program, Division of Medicine, USAMRIID

Fort Deterick, Maryland, 21702, United States

RECRUITING

MeSH Terms

Conditions

Rift Valley Fever

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Anthony P Cardile, DO, MAJ

CONTACT

301-619-8833; anthony.p.cardile.mil@mail.mil

Jeannine M Haller, RN, CCRP

CONTACT

301-619-4652; jeannine.m.haller.civ@mail.mil

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: vaccine to be administered in 1.0mL doses SQ in the upper outer aspect of the arm

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 1, 2018
• Study Start: October 4, 2018
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)