Safety and Immunogenicity Study of Venezuelan Equine Encephalomyelitis (VEE) Vaccine as Booster Vaccine in Adults (VEE)

February 10, 2021 updated by: U.S. Army Medical Research and Development Command

Phase 2 Open-Label Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis (VEE) Vaccine, Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1, as Booster Vaccination in Adult Subjects at Risk of Exposure to VEE Virus

The purpose of this study is to evaluate the safety and immunogenicity of VEE vaccine, C-84, TSI-GSD 205, Lot 7, Run 1, and collect data on the incidence of occupational VEE infection in vaccinated personnel.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1, to be administered as dose(s) of 0.5 mL given subcutaneously in the upper outer aspect of the triceps area. Subjects who showed an initial immune response ≥ 1:20 to TC-83 and whose titer decreased over time or who rollover from a previous VEE C-84 protocol will receive a single 0.5 mL booster dose of C-84 vaccine. Subjects who were initial non-responders (< 1:20) to TC-83 will be given subcutaneous 0.5 mL injections on Days 0, 28-35, and 56-63.

Duration of participation is 12-15 months if the subject demonstrates a PRNT80 of ≥1:20 at 1 year; if not, the vaccination procedure with C-84 will be repeated with a minimum of 28 days between doses. A maximum of four booster doses will be given in a year. If the PRNT80 titer is < 1:20 after four booster doses in any 12-month period, the subject's participation in the study will be placed on hold for 12 months; titers will be repeated at 1 year (± 30 days), and, if required, the subject will be given a booster dose of C-84 vaccine.

Safety endpoint measurements will be evaluated for all subjects receiving at least one vaccination under this protocol regardless of compliance with the protocol. Immunogenicity endpoints will be evaluated for subjects who have been vaccinated in compliance with the protocol and who have had blood for titers drawn in compliance with the protocol.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Fort Deterick, Maryland, United States, 21702
        • Special Immunizations Program/USAMRIID

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be 18 to 65 years old at time of consent
  • Have received VEE TC-83 vaccine
  • Have VEE plaque reduction neutralization 80% titers (PRNT80) <1:20
  • If female of childbearing potential, must agree to have a urine pregnancy test on the same day before each vaccination administration. (Exception: documented hysterectomy or >3 years of menopause). The results must be negative. Females just agree not to become pregnant for 3 months after receipt of the last study treatment (vaccination).
  • Be considered at risk for exposure to VEE virus and who have submitted a Request for IND Vaccines for VDD 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.

Exclusion Criteria:

  • Have completed previous VEE C-84 vaccine study as a non-responder.
  • 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 a breastfeeding female.
  • Have any known allergies to components of the vaccine:
  • Neomycin sulfate
  • Streptomycin
  • VEE virus, inactivated
  • Formaldehyde
  • Eggs
  • Human serum albumin
  • Guinea pig heart cells
  • Sodium bisulfite
  • Have had a previous serious allergic reaction to guinea pigs or guinea pig products. (Subjects who have known allergies to guinea pigs but whose allergic reactions were not severe may still participate in the study but should be referred to an allergy specialist for assessment and recommendation prior to vaccination).
  • Have received or plan to receive another vaccine or investigational product within 28 days of VEE vaccination.
  • Have any unresolved AE resulting from a previous immunization.
  • Have a medical condition that, in the judgment of the PI, would impact subject safety.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A: Initial Non-responders to VEE TC-83 vaccinations
Venezuelan Equine Encephalomyelitis (VEE) Vaccine, Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1, to be administered as dose(s) of 0.5 mL given subcutaneously in the upper outer aspect of the triceps area.
Biological: 0.5 mL Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1

administered as dose(s) of 0.5 mL given subcutaneously in the upper outer aspect of the triceps area. Subjects who showed an initial immune response ≥ 1:20 to TC-83 and whose titer decreased over time or who rollover from a previous VEE C-84 protocol will receive a single 0.5 mL booster dose of C-84 vaccine.

Subjects who were initial non-responders (< 1:20) to TC-83 will be given subcutaneous 0.5 mL injections on Days 0, 28-35, and 56-63
Experimental: Cohort B: Responders to TC-83 or previous C-84 vaccinations

Subjects who showed an initial immune response ≥ 1:20 to TC-83 and whose titer decreased over time or who rollover from a previous VEE C-84 protocol will receive a single 0.5 mL booster dose of C-84 vaccine.

Subjects who were initial non-responders (< 1:20) to TC-83 will be given subcutaneous 0.5 mL injections on Days 0, 28-35, and 56-63
Biological: 0.5 mL Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1

administered as dose(s) of 0.5 mL given subcutaneously in the upper outer aspect of the triceps area. Subjects who showed an initial immune response ≥ 1:20 to TC-83 and whose titer decreased over time or who rollover from a previous VEE C-84 protocol will receive a single 0.5 mL booster dose of C-84 vaccine.

Subjects who were initial non-responders (< 1:20) to TC-83 will be given subcutaneous 0.5 mL injections on Days 0, 28-35, and 56-63

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Who Develop titers of >1:20
Time Frame: Month 12-15
The primary immunogenicity endpoint measurements will be the percentage of per-protocol subjects who develop titers of ≥ 1:20 as determined by PRNT80 after VEE vaccination at each scheduled time point for which blood samples are drawn and over the entire study period to study completion.
Month 12-15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GMT for PRNT80 Titers of Subjects at Each Scheduled Time Point
Time Frame: Month 12-15
The geometric mean PRNT80 titers of per-protocol subjects at each scheduled time point for which blood samples are drawn and over the entire study period to study completion.
Month 12-15
Percentage of Subjects with Adverse Events (AEs) Following Vaccination
Time Frame: Month 12-15
Safety will be evaluated by the nature (body system affected), type [local or systemic], severity, relationship to vaccine, treatment or intervention offered if any, and resolution or outcome) and frequency of AEs for the assessment population
Month 12-15
Percentage of Subjects with Each AE Type (local or systemic)
Time Frame: Month 12-15
Safety will be evaluated by the nature (body system affected), type [local or systemic], severity, relationship to vaccine, treatment or intervention offered if any, and resolution or outcome) and frequency of AEs for the assessment population
Month 12-15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

U.S. Army Medical Research and Development Command

Investigators

  • Principal Investigator: Anthony P Cardile, DO, MAJ, USAMRIID

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

May 8, 2018

First Submitted That Met QC Criteria

May 8, 2018

First Posted (Actual)

May 21, 2018

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-13-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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