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


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Vaccine Safety Research


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

This study is not yet open for patient recruitment.
Verified by Walter Reed Army Institute of Research (WRAIR) November 2005

Sponsored by: U.S. Army Office of the Surgeon General
Information provided by: Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier: NCT00248833

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
 Vaccine: Meningococcal 44/76 MOS NOMV 5D
Phase I

MedlinePlus related topics:  Bacterial Infections;   Meningitis;   Neurologic Diseases

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Dose Comparison, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Walter Reed Army Institute of Research (WRAIR):
Primary Outcomes: Type and frequency of adverse events over a 7 day follow-up period.
Secondary Outcomes: Seroconversion >= 50% after two doses of vaccine would meet minimum criteria for further vaccine development.
Expected Total Enrollment:  30

Study start: November 2005

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   -   45 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • Healthy military or civilian males or non-pregnant, non-lactating females
  • Age 18-45
  • Give informed consent andn 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 abouse/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 pregnance test prior to vaccination

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00248833

Felicia L Breedy      866-856-3259    clinical1@na.amedd.army.mil
Oman Q Salazar      866-856-3259    clinical1@na.amedd.army.mil

Maryland
      Walter Reed Army Institute of Research, Clinical Trials Center, Silver Spring,  Maryland,  20910,  United States
Felicia L Breedy  866-856-3259 
Trinka S Coster, MD,  Principal Investigator

Study chairs or principal investigators

Trinka S Coster, MD,  Principal Investigator,  Walter Reed Army Institute of Research (WRAIR)   

More Information

Study ID Numbers:  A-13513; 1178
Last Updated:  December 8, 2005
Record first received:  November 2, 2005
ClinicalTrials.gov Identifier:  NCT00248833
Health Authority: United States: Federal Government; United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10


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Page Updated: November 22, 2004
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