Safety Study of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine for Meningitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JN-International Medical Corporation
ClinicalTrials.gov Identifier:
NCT01482052
First received: November 23, 2011
Last updated: January 11, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to evaluate the safety of a new conjugate vaccine, NmVac4-A/C/Y/W-135-DT, compared to the safety of a similar, licensed meningococcal A/C/Y/W-135-DT conjugate vaccine. The investigators will also evaluate the production of antibodies to of NmVac4-A/C/Y/W-135-DT™ conjugate vaccine compared to the licensed vaccine, as a measure of vaccine effectiveness.


Condition Intervention Phase
Meningococcal Meningitis
Meningococcal Infections
Biological: meningococcal meningitis conjugate vaccine, quadrivalent
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Double-Blind, Randomized, Controlled, Two Arm Phase 1 Clinical Trial of the Safety and Immunogenicity of Group A, C, Y & W-135 Meningococcal Polysaccharide DT Conjugate Vaccine: NmVac4-A/C/Y/W-135-DT™

Resource links provided by NLM:


Further study details as provided by JN-International Medical Corporation:

Primary Outcome Measures:
  • Adverse Reactions [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
    local and systemic rates throughout the course of the study


Secondary Outcome Measures:
  • Immune Response [ Time Frame: 4 and 8 weeks after injection ] [ Designated as safety issue: No ]
    Antibody titers


Enrollment: 60
Study Start Date: November 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test Vaccine
NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
Biological: meningococcal meningitis conjugate vaccine, quadrivalent
NmVac4-A/C/Y/W-135-DT™conjugate is a vaccine in liquid form composed of purified polysaccharides (PS) conjugated to diphtheria toxoid. Single intramuscular 0.5 mL dose contains 4 µg each Serogroup A, C, W-135, Y PS conjugated to approximately 16 µg total diphtheria toxoid.
Other Name: NmVac4-A/C/Y/W-135-DT™
Active Comparator: US Licensed Vaccine
Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Biological: meningococcal meningitis conjugate vaccine, quadrivalent
Meningococcal (Groups A,C,Y and W-135-DT) Polysaccharide Conjugate Vaccine 0.5 mL dose, intramuscular. Single dose contains 4 µg each Serogroup A, C, W-135, Y PS conjugated to approximately 48 µg total diphtheria toxoid.

Detailed Description:

Meningococcal disease is a potentially life-threatening bacterial infection. The disease most commonly is expressed as either meningococcal meningitis, an inflammation of the membranes surrounding the brain and spinal cord, or meningococcemia, the presence of bacteria in the blood. The most common symptoms include high fever, headache, neck stiffness, confusion, nausea, vomiting, lethargy, and rash. If not treated the disease can progress rapidly and can lead to shock and death, often within hours of the onset of symptoms. Neisseria meningitidis capsular polysaccharides are poor immunogens. However, conjugation of bacterial polysaccharides to immunogenic carrier proteins generally results in conjugates that induce strong anti-polysaccharide T-helper cell dependent immune responses, creating a longer-lasting immune response and thus protection against meningococcal infection. This study compares safety and antibody production induced by one intramuscular injection of either NmVac4-A/C/Y/W-135-DT or a licensed meningococcal A/C/Y/W-135-DT conjugate vaccine. Participants will attend a screening visit up to 4 weeks prior to Day 0, then will attend study visits for 8 weeks. There will be a study phone call at Days 2-3, then a post-study telephone call to subjects to assess safety at 26 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Willing and able to give informed consent and comply with all aspects of the evaluation after the nature of the study is explain
  • For the purpose of this study, a healthy volunteer is defined as healthy male or female, with no significant chronic conditions
  • Age 18 to 50 years old
  • Either gender. Abstinence or use of contraception during the eight weeks after vaccination will be required for non menopausal (< two years post-menopause) or non surgically sterile women
  • Persons with antibody titer(s) of <2 µg/mL to serogroup(s) A, C, Y, or W-135 polysaccharides as measured by ELISA

Exclusion Criteria:

  • Age less than 18 years or over 50 years.
  • History of Guillain-Barré syndrome (GBS).
  • Pregnancy or lactation.
  • History of meningococcal meningitis.
  • History of invasive (clinical or laboratory diagnosis) meningococcal disease.
  • History of meningococcal meningitis vaccination.
  • Screening laboratory abnormalities (in the opinion of the Investigator) that would raise safety concerns for participation in the study.
  • Use of immunosuppressive drugs within 30 days prior to study enrollment, not including topical or inhaled steroids/cytotoxic agents.
  • History of anaphylactic shock, asthma, urticaria, or other allergic or hypersensitivity reactions following vaccination.
  • History of severe allergic disorders or autoimmune connective tissue disorders, including rheumatoid arthritis. A high sensitivity C-Reactive Protein (CRP) test at screening will be used as part of the assessment of autoimmune disorders by the Principal Investigator.
  • Use of systemic antibiotics within 72 hours prior to study enrollment.
  • History of cirrhosis.
  • Positive results of testing for HepBsAg, Hepatitis C or HIV-1 or HIV-2 antibodies.
  • Positive results of drug screen (amphetamine, THC, cocaine).
  • Persons with antibody titer(s) of >2 µg/mL to serogroup (s) A, C, Y, or W 135 as measured by ELISA.
  • Unable to understand all of the study requirements.
  • Prisoners.
  • Participation in a clinical trial in the last three months.
  • History of any serious chronic medical or psychiatric illnesses.
  • History of significant head trauma, alcohol or substance abuse or other medical illnesses that could cause a neurological deficit (e.g., cerebro-vascular disease) .
  • Chronic medication use that, in the opinion of the Investigator, may influence or bias the clinical outcome of the trial.
  • Individuals will be excluded from participation in this trial if they are judged by the Principal Investigator as having a significant impairment in their capacity for judgment or reasoning that compromise their ability to make decisions in their best interest.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482052

Locations
United States, California
Kings Cardiology Group
Hanford, California, United States, 93230
Sponsors and Collaborators
JN-International Medical Corporation
Investigators
Principal Investigator: Sudesh Nagavalli, MD
  More Information

No publications provided

Responsible Party: JN-International Medical Corporation
ClinicalTrials.gov Identifier: NCT01482052     History of Changes
Other Study ID Numbers: JN-NM-001
Study First Received: November 23, 2011
Last Updated: January 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by JN-International Medical Corporation:
Central Nervous System Infections
Meningitis
toxoid
Meningococcal vaccine
conjugate vaccines

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Meningococcal Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on April 17, 2014