Safety and Immunogenicity Study of Group B Meningococcal Vaccine to Prevent Meningitis.
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 10/31/2018 |
| Start Date: | December 5, 2005 |
| End Date: | December 2007 |
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
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.
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.
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.
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.
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
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