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

NCT01482052 | Completed Phase 1 DMC

• 1 other identifier: JN-NM-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Meningococcal Meningitis; Meningococcal Infections

Keywords

Central Nervous System Infections; Meningitis; toxoid; Meningococcal vaccine; conjugate vaccines

Outcome Measures

Primary Outcomes (1)

• Adverse Reactions

  local and systemic rates throughout the course of the study

  up to 6 months

Secondary Outcomes (1)

• Immune Response

  4 and 8 weeks after injection

Study Arms (2)

Test Vaccine

EXPERIMENTAL

NmVac4-A/C/Y/W-135-DT™ conjugate vaccine

Biological: meningococcal meningitis conjugate vaccine, quadrivalent

US Licensed Vaccine

ACTIVE COMPARATOR

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Biological: meningococcal meningitis conjugate vaccine, quadrivalent

Interventions

meningococcal meningitis conjugate vaccine, quadrivalent BIOLOGICAL

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.

Also known as: NmVac4-A/C/Y/W-135-DT™

Test Vaccine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• JN-International Medical Corporation: lead

Study Sites (1)

Kings Cardiology Group

Hanford, California, 93230, United States

Location

MeSH Terms

Conditions

Meningitis, Meningococcal; Meningococcal Infections; Central Nervous System Infections; Meningitis

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Study Officials

• Sudesh Nagavalli, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2011
• First Posted: November 30, 2011
• Study Start: November 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 14, 2013

Record last verified: 2013-01

Locations

US (1)