Safety and Immunogenicity Study of Group B Meningococcal Vaccine to Prevent Meningitis. - Full Text View

Sponsor:	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	Biological: Meningococcal 44/76 MOS NOMV 5D	Phase I

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

Resource links provided by NLM:

MedlinePlus related topics: Meningitis

U.S. FDA Resources

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
Estimated Study Completion Date:	November 2006

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

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

Study ID Numbers:	WRAIR 1178, HSRRB A-13513
Study First Received:	November 2, 2005
Last Updated:	October 27, 2006
ClinicalTrials.gov Identifier:	NCT00248833 History of Changes
Health Authority:	United States: Federal Government; United States: Food and Drug Administration

Additional relevant MeSH terms:

Bacterial Infections
Central Nervous System Infections
Meningococcal Infections
Meningitis, Bacterial
Nervous System Diseases
Central Nervous System Bacterial Infections

Meningitis, Meningococcal
Central Nervous System Diseases
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Meningitis

ClinicalTrials.gov processed this record on February 08, 2010