Safety, Tolerability and Immunogenicity of the Venezuelan Equine Encephalitis (VEE) Attenuated Live-Virus Vaccine

NCT00109304 | Withdrawn Phase 1 DMC

• 1 other identifier: VEE-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to determine the safety and tolerability of a new investigational vaccine referred to as VEE IA/B V3526, which may induce production of specific antibodies in vaccinated humans, and may protect them against infection with the Venezuelan Equine Encephalitis (VEE) Virus.

Conditions

Venezuelan Equine Encephalitis

Keywords

Venezuelan Equine Encephalitis; VEE; Vaccine; Provide protective immunity against VEE subtypes IA/B

Outcome Measures

Primary Outcomes (2)

• Incidence and character of adverse events considered related to the VEE IA/B V3526 vaccine

• Level and duration of serum viremia and viral shedding in nose and/or throat

Secondary Outcomes (3)

• Store samples collected for future use in the development of immunogenicity assays against multiple VEE subtypes IA/B, IE, IIIA, and other possible subtypes

• Store samples collected for the future development of the passive transfer challenge model

• Store VEE IA/B V3526 Positive Control Serum to be used in future studies

Interventions

VEE 3526 BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The volunteer is a male or female between 18 and 40 years of age (inclusive).
• The volunteer is able and willing to comply with the protocol procedures: 2-week 15 nights/ (14-day) in-patient stay and availability for follow-up visits for six months post vaccination.
• The volunteer is in good health, as determined by the Investigator following a complete medical history and physical examination, and the volunteer has had no clinically significant illness by medical history or exam (e.g., asthma, hypertension) or requiring hospitalization within the six months before vaccination in this study.
• The volunteer has the following laboratory parameters within normal range: \*total WBC, \*hemoglobin, \*platelets, \*LFT (liver function tests (AST, ALT, ALP, bilirubin) and \*negative for proteinuria. Other laboratory parameters must be within 10% of the upper or lower limits of the normal range of the Northwest Kinetics clinical laboratory and not clinically significant as assessed by the Investigator and/or Sponsor Medical Monitor.
• Female volunteers must not be pregnant or nursing, or must be of non-childbearing potential (e.g., surgically sterilized or postmenopausal). If volunteers are women of childbearing potential (WCBP), they must verbalize use of an acceptable method of contraception (i.e., hormonal contraception (injectable or oral) or intrauterine device) or abstinence for at least 30 days before and through 180 days after vaccination.
• The volunteer agrees not to donate blood for at least six months after vaccination.
• The volunteer has successfully completed the Test of Understanding for the protocol (answered 90% questions correctly), has signed an ICF (inclusive of the HIPAA authorization).
• The volunteer agrees to have his/her blood samples collected and stored for future investigations related to VEE vaccine development (e.g., assay development) and future VEE-related research studies.
• The volunteer has been provided Northwest Kinetics Site Subject Instructions for participation and agrees with the Northwest Kinetics Site Subject Instructions.

You may not qualify if:

• History of exposure to VEE, WEE (Western Equine Encephalitis), EEE (Eastern Equine Encephalitis), and/or CHIK (Chikungunya) with or without serological evidence (PRN).
• History of allergic reaction to human serum albumin (HSA) or other vaccine components (i.e., DMEM), or history of anaphylaxis or serious adverse reactions to other vaccines.
• History of seizure disorder or history of encephalitic process with sequelae.
• Frequent or severe headaches of any etiology.
• Chronic, severe, or recurrent joint pain or arthritis of any etiology.
• History of diabetes in first degree relatives.
• History of gestational diabetes.
• Abnormal fasting blood glucose.
• Current use of antiviral and other systemic immunomodulatory pharmacotherapy. Use of immunosuppressive agents or corticosteroids (i.e., systemic total dose of 20 mg/day or 2 mg/kg or 20 mg/day, "burst" therapy, intra-nasally administered, or inhaled steroids within the 3 months prior to the study).
• Currently enrolled in an investigational protocol or has participated in any clinical trial using an investigational product within the last month.
• Current or planned participation in a blood donation resulting in a blood volume of \> 450 mL per 8 week period.
• Vaccination with any attenuated live-vaccine (e.g., varicella-zoster vaccine) within 60 days prior to test-vaccine administration.
• Vaccination with any inactivated vaccine (e.g., polio or hepatitis A vaccine) within 30 days prior to test-vaccine administration.
• Oral temperature \>100.0°F at the time of scheduled test-vaccine administration.
• The volunteer has a clinically significant abnormality on the ECG.

Sponsors & Collaborators

• DynPort Vaccine Company LLC, A GDIT Company: lead

Study Sites (1)

Northwest Kinetics, Inc.

Tacoma, Washington, 19087, United States

Location

MeSH Terms

Conditions

Encephalomyelitis, Venezuelan Equine

Condition Hierarchy (Ancestors)

Encephalomyelitis, Equine; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Encephalomyelitis; Infectious Encephalitis; Alphavirus Infections; Arbovirus Infections; Vector Borne Diseases; Encephalitis, Arbovirus; Mosquito-Borne Diseases; Virus Diseases; Togaviridae Infections; RNA Virus Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 27, 2005
• First Posted: April 27, 2005
• Study Start: July 1, 2005
• Study Completion: December 1, 2006
• Last Updated: September 18, 2015

Record last verified: 2015-09

Locations

US (1)