Safety and Immunogenicity Study of ChimeriVax West Nile Vaccine in Healthy Adults (WinVax004)

March 17, 2015 updated by: Sanofi Pasteur, a Sanofi Company

Randomized, Modified, Double-blind, Placebo-controlled, Phase II, Dose-ranging Study of the Safety and Immunogenicity of Single Dose ChimeriVax-WN02 Vaccine in Healthy Adults.

The purpose of this study is to determine if ChimeriVax West Nile vaccine is safe and effective in preventing West Nile disease in adults over 50 years of age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Currently, the only method of prevention of West Nile infection is control of the mosquito vectors associated or avoidance of mosquito bites, which has proven largely ineffective. Developing a safe, effective vaccine and making it widely available will enhance the prospects of prevention and control of this disease. In addition, natural infections with the YF virus and WN virus are more severe in the elderly. Therefore, a study among healthy older subjects or those with well controlled chronic diseases will provide data to determine a ChimeriVax-WN02 vaccine dose that is immunogenic and well tolerated.

Study Type

Interventional

Enrollment (Actual)

479

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 Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Advanced Clinical Research Inst.
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Lynn Health Science Institute
    • Florida
      • South Miami, Florida, United States, 33143
        • Miami Research
    • Idaho
      • Boise, Idaho, United States, 83642
        • Advanced Clinical Research- Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Idaho Falls Infectious diseases
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Johnson County Clinical Trials
      • Overland Park, Kansas, United States, 66211
        • Vince & Associates
    • Missouri
      • Springfield, Missouri, United States, 65802
        • Bio-Kinetic
    • Montana
      • Butte, Montana, United States, 59701
        • Big Sky Clinical Research
      • Missoula, Montana, United States, 59802
        • Infectious Disease Specialists, PC
    • North Dakota
      • Fargo, North Dakota, United States, 88104
        • Odyssey Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
    • Texas
      • Dallas, Texas, United States, 75234
        • Research Across America
      • Fort Worth, Texas, United States, 76135
        • BenchMark
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Radiant Research

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent
  • Medically stable, ambulatory male or female ≥ 50 years of age.
  • Attend all scheduled visits and to comply with all study procedures.
  • Negative serum pregnancy test at Screening, and a negative urine pregnancy test on Day 0.

Exclusion Criteria:

  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term (at least 2 weeks within the previous 3 months) systemic corticosteroids therapy (at a dose of at least 10 mg of prednisone or equivalent), or depot preparation within the previous 3 months. Topical steroids are allowed.
  • Administration of immunoglobulins and/or any blood products within 3 months before enrollment or planned administration during treatment period of study.
  • Presence of acute or chronic illness associated with an oral temperature of >38.0 °C or requiring hospitalization at time of enrollment.
  • Any of the following serological findings at Screening:

positive Hepatitis B surface antigen (HBsAg), positive Hepatitis C (anti-HCV), or positive human immunodeficiency virus (HIV).

  • Personal or family history of thymic pathology (e.g., thymoma), thymectomy, or myasthenia.
  • History of significant allergic reaction to the vaccine components
  • Asplenia, functional asplenia, or any condition resulting in the absence or removal of the spleen.
  • Active or potentially progressive neurologic disease or injury including but not limited to: Parkinson's, Guillain Barré, epilepsy, seizures (except febrile seizures under the age of 2), cerebrovascular accident, head trauma requiring hospitalization within the preceding 3 years, or any other neurologic condition thought to impact the integrity of the blood brain barrier.
  • Clinically significant abnormal ECG findings at Screening
  • Impaired hepatic function, and/or clinically significant or unexplained elevations of alanine aminotransferase (ALT, SGPT), or aspartate aminotransferase (AST, SGOT) > 3X the upper limit of normal.
  • Impaired renal function, as shown by but not limited to, serum creatinine >2.0 mg/dL.
  • Impaired hematopoietic function and/or clinically significant hematological laboratory abnormalities.
  • A history of alcohol or drug abuse within 12 months prior to study entry.
  • Pregnant or lactating women and women of childbearing potential who are not using an acceptable method of contraception at least 28 days prior to enrollment. Post menopausal women will be considered not of childbearing potential 1 year after last menstrual period.
  • Behavioral, cognitive, or psychiatric disease that, in the opinion of the Investigator affects the ability of the subject to understand the scope of the study and/or unlikely to be able to be compliant with the study procedures and visits.
  • Any other condition, which in the Investigator's judgment, might result in an increased risk to the subject, or would affect the subject's participation in the study.
  • Participation in another clinical trial investigating a vaccine, drug or medical procedure in the 30 days preceding informed consent.
  • Any vaccine administered within 30 days prior to study vaccination. Note: Influenza vaccine can be administered 1 week preceding study vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • Planned receipt of any vaccine in the 4 weeks following the trial vaccination.
  • Research site personnel or their family members cannot be enrolled as subjects in this trial.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ChimeriVax WN02 vaccine, low dose
Participants randomized to receive ChimeriVax WN02 vaccine, low dose
Biological: ChimeriVax-WN02 vaccine
low dose, approximately 4 x 3log10, given one time subcutaneously
Biological: ChimeriVax-WN02 vaccine
medium dose, approximately 4 x 4log10, given one time
Biological: ChimeriVax-WN02 vaccine
high dose, approximately 4 x 5log10, given one time subcutaneously
Experimental: ChimeriVax-WN02 vaccine, medium dose
Participants randomized to receive ChimeriVax-WN02 vaccine, medium dose
Biological: ChimeriVax-WN02 vaccine
low dose, approximately 4 x 3log10, given one time subcutaneously
Biological: ChimeriVax-WN02 vaccine
medium dose, approximately 4 x 4log10, given one time
Biological: ChimeriVax-WN02 vaccine
high dose, approximately 4 x 5log10, given one time subcutaneously
Experimental: ChimeriVax-WN02 vaccine, high dose
Participants randomized to receive ChimeriVax-WN02 vaccine, high dose
Biological: ChimeriVax-WN02 vaccine
low dose, approximately 4 x 3log10, given one time subcutaneously
Biological: ChimeriVax-WN02 vaccine
medium dose, approximately 4 x 4log10, given one time
Biological: ChimeriVax-WN02 vaccine
high dose, approximately 4 x 5log10, given one time subcutaneously
Placebo Comparator: Placebo
Participants randomized to receive Placebo (Saline)
Biological: Placebo
0.9%Normal Saline for Injection, given one time subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geometric Mean Titers (GMTs) of Antibodies to Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine
Time Frame: Day 0 and Day 28 post-vaccination
Antibodies to the vaccine antigens were measured by the Plaque Reduction Neutralization Test.
Day 0 and Day 28 post-vaccination
Number of Participants With Seroconversion Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Time Frame: Day 0 and Day 28 post-vaccination

Antibodies to vaccine were measured by the Plaque Reduction Neutralization Test.

Seroconversion was defined as a four-fold or greater rise in titer between pre- and post-injection samples; or a post-vaccination (Day 28) titers of ≥ 1:20 in participants with baseline titer ≤ 1:10.
Day 0 and Day 28 post-vaccination
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Time Frame: Day 0 up to Day 14 post-vaccination
Day 0 up to Day 14 post-vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.
Time Frame: Day 2 up to Day 14 post-vaccination
Viremia is defined as number of subjects in the analysis population dose group with detected (≥ 20 Plaque forming units [pfu]/mL) viremia at the reported visit.
Day 2 up to Day 14 post-vaccination

Collaborators and Investigators

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

Sponsor

Sanofi Pasteur, a Sanofi Company

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.

Helpful Links

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

October 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

September 2, 2008

First Submitted That Met QC Criteria

September 3, 2008

First Posted (Estimate)

September 4, 2008

Study Record Updates

Last Update Posted (Estimate)

April 3, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-244-004

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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