Safety and Immunogenicity Study of the Venezuelan Equine... | NCT00582504

Studies
Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis Vaccine

NCT00582504

Sponsor

U.S. Army Medical Research and Development Command

Status

Unknown status

Last Update Posted

Feb 11, 2021Actual

Enrollment

500Estimated

Phase

Phase 2

Conditions

Venezuelan Equine Encephalomyelitis

Interventions

VEE TC-83

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
FY06-26	Other Identifier	IRB

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007Actual

Primary Completion Date

Dec 2021Estimated

Completion Date

Jun 2022Estimated

First Submitted Date

Dec 19, 2007

First Submission Date that Met QC Criteria

Dec 27, 2007

First Posted Date

Dec 28, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2021

Last Update Posted Date

Feb 11, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vaccination	Experimental	VEE TC-83	Biological: VEE TC-83

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VEE TC-83	Biological	Subjects will receive a single 0.5 mL dose by subcutaneous route in the upper outer aspect of arm	Vaccination

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with a 80% plaque-reduction neutralization titer (PRNT80)		21-35 days, 42-56 days, 12-15 months
Number of adverse events.		7 years

Secondary Outcomes

Measure	Description	Time Frame
Number of confirmed cases of VEE disease among vaccinated subjects who achieved a PRNT 80 ≥ 1:20.		7 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At least 18 years old
VEE PRNT80 < 1:10 before immunization.
(females) Negative serum pregnancy test on same day before vaccination. Not planning pregnancy for 3 months.
Actively enrolled in the SIP
At risk for exposure to virulent VEE virus (with up-to-date risk assessment).
Up-to-date (within 1 year) physical examination/tests.
Sign and date the approved informed consent.
Willing to return for all follow-up visits.
Agree to report adverse event (AE) up to 28 days after vaccination.

Exclusion Criteria:

Over age of 65 years.
Clinically significant abnormal lab results including evidence of Hepatitis C, Hepatitis B carrier state, or elevated liver function tests.
History of immunodeficiency or current treatment with immunosuppressive medication.
(females) Currently breastfeeding.
Confirmed human immunodeficiency virus (HIV) titer.
Family history (first degree relative, but not elderly parent with late onset) diabetes, personal history gestational diabetes, or confirmed elevated fasting serum glucose (> 125 mg/dL).
Serious allergic reaction to guinea pigs/guinea pig products.
Any known allergies to components of the vaccine.
A medical condition that in the judgment of the Principal Investigator (PI) would impact subject safety (i.e-vaccination and or exposure to another alphavirus).
Administration of any vaccine within 28 days of TC-83.
Any unresolved AEs resulting from a previous immunization.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Ronald Reisler, MD	USAMRIID Medical Division	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
U.S. Army Medical Research Institute of Infectious Diseases		Fort Deterick	Maryland	21702	United States

Type	Date	Date Unknown
Release	Jun 15, 2023
Reset	Jul 5, 2023

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jun 15, 2023			Jul 5, 2023

Condition Browse Module

MeSH Terms

ID	Term
D004685	Encephalomyelitis, Venezuelan Equine

Ancestor Terms

ID	Term
D004683	Encephalomyelitis, Equine
D018792	Encephalitis, Viral
D020805	Central Nervous System Viral Diseases
D002494	Central Nervous System Infections

Browse Leaves

Not provided

Browse Branches

Not provided