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

Completed · Phase 1

Conditions studied: Meningitis, Meningococcal, Serogroup B

In brief

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.

Key facts

Study ID

NCT00248833

Run by

U.S. Army Medical Research and Development Command

People needed

34

Starts

2005-12-05

Expected to finish

2007-12-01

Last updated by the study team

2018-10-29

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Walter Reed Army Institute of Research, Clinical Trials Center — Silver Spring, Maryland, United States

Full record on ClinicalTrials.gov

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