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Venezuelan Equine EncephalitisPhase 1NCT00109304

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

A Phase 1 study testing VEE 3526 in people with Venezuelan Equine Encephalitis, run by DynPort Vaccine Company LLC, A GDIT Company at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Venezuelan Equine Encephalitis
What is being tested?
VEE 3526
How many people
0 participants
Where
1 siteUnited States
Study dates
Jul 2005to Dec 2006
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • The volunteer has a body mass index >= 40 kg/m2 or is greater than or equal to 100 lbs over the ideal body weight.
  • Personal or family history of multiple sclerosis, as immune system stimulation may exacerbate this disorder.
  • Signs or symptoms of illness at the time of scheduled test-vaccine administration, which are considered clinically relevant by the Principal Investigator (PI, Study Doctor).
  • WCBP with current or planned pregnancy within 30 days before scheduled test-vaccine administration and/or during the study (i.e., Day 0 through Day 180). Female volunteer (WCBP) is pregnant, breastfeeding, tests positive on a pregnancy test any time before vaccination, or is unwilling to use an acceptable method of contraception (i.e., hormonal contraception (injectable or oral) or intrauterine device) or abstinence within 30 days before and during the 180 days of the study.
  • Positive HIV, HBsAg or HCV serology.
  • The volunteer has a positive result on a urine drug screen that tests for common substances of abuse such as amphetamines, barbiturates, benzodiazepines, cocaine, opiates, and cannabinoids. (If positive on screen, confirmatory testing shall be performed where applicable).
  • The volunteer has a previous diagnosis of any serious psychiatric disorder. For this purpose, serious psychiatric disorder is defined as illness requiring hospitalization within previous 12 months and/or routine administration of more than one medication to control anxiety, mood, or sleep disorder; or history of suicide attempt.
  • The volunteer is considered, for any reason, by the Investigator to be an unsuitable candidate for receipt of an investigational treatment. The specific reason for exclusion under this element must be completely documented in the screening case report form.
  • The volunteer is unwilling to comply with all aspects of the protocol through the post vaccination Day 180 (±7 days) assessment, or the volunteer's medical or psychiatric condition or occupational responsibilities preclude compliance with the protocol-specified procedures.
  • The volunteer has screening laboratory values for total WBC, Hemoglobin, platelets, LFT (AST, ALT, ALP, Bilirubin) that are not within normal range and/or a positive urine test for proteinuria.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Northwest Kinetics, Inc.

    Tacoma, Washington, 19087

Other trials in United States

About this study

Official title: Safety, Tolerability and Immunogenicity of the Venezuelan Equine Encephalitis (VEE) Attenuated Live-Virus Vaccine VEE IA/B V3526 in VEE-Naive Healthy Volunteers After Single Dose Subcutaneous Administration

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.

Read the detailed description

Safety Objectives: 1) To determine preliminary safety, reactogenicity, and tolerability of VEE IA/B V3526 in VEE-naïve healthy volunteers after single dose subcutaneous (SC) administration; 2) To evaluate virological safety by assessing serum viremia and viral shedding in nose and throat.

Immunogenicity Objectives: 1) To assess the humoral immune response (plaque reduction neutralizing antibody titer (PRNT)) against VEE subtype IA/B after SC administration of different dose-levels of the VEE IA/B V3526 vaccine candidate; 2) To assess duration of immune response over six months after the VEE IA/B V3526 vaccination based on PRNT; and 3) To identify two suitable VEE IA/B V3526 vaccine dose-levels for future administration in dose optimization and expanded safety studies.

Exploratory Objectives: 1) To collect and store serum for future development of immunogenicity assays (e.g., ELISA) against multiple VEE subtypes IA/B, IE, IIIA, and other possible subtypes; 2) To collect and store serum for future use in the development of a passive transfer challenge model; 3) Collect VEE IA/B V3526 positive serum (Positive Control Serum) at the Day 21 visit.

Being tested
VEE 3526
Keywords
Venezuelan Equine Encephalitis, VEE, Vaccine, Provide protective immunity against VEE subtypes IA/B
Medical subject headings
Encephalomyelitis, Venezuelan Equine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VEE 3526Biological

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (3)

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2005 (estimated)
  2. Study startJul 2005
  3. Study completionDec 2006

Why it stopped: Funding withdrawn

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00109304
Sponsor's protocol ID
VEE-01
Status last verified
Sep 2015
First submitted
27 Apr 2005
Last updated
18 Sep 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VEE 3526 in people with Venezuelan Equine Encephalitis, run by DynPort Vaccine Company LLC, A GDIT Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and character of adverse events considered related to the VEE IA/B V3526 vaccine. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00109304.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2015.

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