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Safety and Immunogenicity Study of Group B Meningococcal Vaccine to Prevent Meningitis.

This study has been completed.
Sponsor:
Information provided by:
Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier:
NCT00248833
First received: November 2, 2005
Last updated: April 27, 2010
Last verified: April 2010
  Purpose

The purpose of this study is to determine if the vaccine called Group B Meningococcal 44/76 MOS NOMV 5D Vaccine is safe and free from side effects and if it will protect people from meningitis.

This study will vaccinate three groups of people. In the first 2 groups, the study will be double-blinded. This means that neither the volunteer or the medical team will know which formulation of the vaccine was administered. The third group of volunteers and the medical team will know that they are receiving the higher dose of the vaccine.


Condition Intervention Phase
Meningitis, Meningococcal, Serogroup B
Biological: Meningococcal 44/76 MOS NOMV 5D
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Phase 1 Dose Esc Study of Safety and Immun of 3 Injections, Given at 0, 6 and 24 Wks, of Grp B Meningococcal 44/76 MOS NOMV 5D Vaccine Admin to Healthy Subjs IM With and Without Adjuvant

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Institute of Research (WRAIR):

Primary Outcome Measures:
  • Type and frequency of adverse events over a 7 day follow-up period.

Secondary Outcome Measures:
  • Seroconversion >= 50% after two doses of vaccine would meet minimum criteria for further vaccine development.

Estimated Enrollment: 30
Study Start Date: December 2005
Study Completion Date: December 2007
Detailed Description:

Meningococcal disease is a contagious bacterial disease caused by Neisseria meningitidis that can kill children and young adults very quickly. Meningococci are divided into distinct sergroups based on their polysaccharide outer capsule, which is the usual target antigen for vaccines. Serogroup A is the main cause of epidemics in Africa and in the United States, sergroups B, C and Y predominate. In the United States, no vaccine is yet available to offer protection against serogroup B which currently accounts for 32% of all meningococcal disease in the United States.

This study serves as a proof of concept for our new NOMV Group B single strain monovalent vaccine model which is obtained from a genetically modified parent. If successful we plan to develop a multivalent Group B vaccine for routine use for military recruits at the beginning of basic training, for college students, particularly those who live in dormitories, and for use by travelers to countries recognized as having hyperendemic disease.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy military or civilian males or non-pregnant, non-lactating females
  • Age 18-45
  • Give informed consent and understand risk and benefit of study
  • Understands and willing to comply with all protocol procedures and time commitment
  • FEMALES only: surgically sterilized or received a negative pregnancy test on day of first injection AND agrees to practice adequate birth control, if necessary, for the next 7 months after first vaccination.

Exclusion Criteria:

  • Currently has or has had a history of significant organ/system disease
  • History of allergy to any vaccine
  • Allergy to component of vaccine such as aluminum hydroxide
  • Presence of significant unexplained laboratory abnormality
  • HIV sero-positive or any other immunosuppressive state
  • Positive test for HBsAg, or hepatitis C
  • Ongoing drug abuse/dependence
  • Received any live vaccine, experimental products or immunosuppressive therapy in the last 28 days or inactivated vaccine in the past 14 days, or received parenteral immunoglobulin or blood products within the past 3 months
  • Intention to leave study area for an extended period of time during the study
  • Females: positive urine pregnancy test prior to vaccination
  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: NCT00248833

Locations
United States, Maryland
Walter Reed Army Institute of Research, Clinical Trials Center
Silver Spring, Maryland, United States, 20910
Sponsors and Collaborators
U.S. Army Office of the Surgeon General
Investigators
Principal Investigator: Barnett Gibbs, MD Walter Reed Army Institute of Research (WRAIR)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00248833     History of Changes
Other Study ID Numbers: WRAIR 1178, HSRRB A-13513
Study First Received: November 2, 2005
Last Updated: April 27, 2010
Health Authority: United States: Federal Government
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014