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

United States Army Medical Research and Development Command (USAMRDC)

Status and phase: Completed; Phase 1

Conditions: Meningitis, Meningococcal, Serogroup B

Treatments: Biological: 25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine; Biological: 50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00248833

WRAIR 1178

HSRRB A-13513

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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34 participants in 3 patient groups

1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o adjuvant

Experimental group

Description:

Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.

Treatment:

Biological: 25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine

2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D with adjuvant

Experimental group

Description:

Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D with AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.

Treatment:

Biological: 25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine

3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o adjuvant

Experimental group

Description:

Subjects received 50ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.

Treatment:

Biological: 50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine