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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00746798
First received: September 2, 2008
Last updated: September 27, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
West Nile Fever
Biological: ChimeriVax-WN02 vaccine
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Geometric Mean Titers (GMTs) of Antibodies to Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine [ Time Frame: Day 0 and Day 28 post-vaccination ] [ Designated as safety issue: No ]
    Antibodies to the vaccine antigens were measured by the Plaque Reduction Neutralization Test.

  • Number of Participants With Seroconversion Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. [ Time Frame: Day 0 and Day 28 post-vaccination ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine. [ Time Frame: Day 2 up to Day 14 post-vaccination ] [ Designated as safety issue: No ]
    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.


Enrollment: 479
Study Start Date: October 2008
Study Completion Date: December 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: ChimeriVax-WN02 vaccine, medium dose
Participants randomized to receive ChimeriVax-WN02 vaccine, medium dose
Biological: ChimeriVax-WN02 vaccine
medium dose, approximately 4 x 4log10, given one time
Experimental: ChimeriVax-WN02 vaccine, high dose
Participants randomized to receive ChimeriVax-WN02 vaccine, high dose
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

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746798

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

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00746798     History of Changes
Other Study ID Numbers: H-244-004
Study First Received: September 2, 2008
Results First Received: September 27, 2011
Last Updated: September 27, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
West Nile Fever
ChimeriVax
West Nile Virus Vaccine

Additional relevant MeSH terms:
Fever
West Nile Fever
Body Temperature Changes
Signs and Symptoms
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Encephalitis, Viral
Encephalitis
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 20, 2014