Clinical trial NCT00248833: Safety and Immunogenicity Study of Group B Meningococcal Vaccine to Prevent Meningitis.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Meningitis, Meningococcal, Serogroup B
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
Collaborators: name: Walter Reed Army Institute of Research (WRAIR)
First posted: 2005-11-04
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). Two dosage levels were investigated: 25 µg with and without adjuvant and 50 µg of protein without adjuvant. Each dose was given intramuscularly at 0, 6, and 24 weeks.
Primary purpose: PREVENTION

Brief summary: 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.

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 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

Primary outcomes:
measure: Safety: Severity Summary of Solicited and Unsolicited Adverse Events
timeFrame: 7 day f/u period after each vaccination
measure: Safety: Adverse Event Type Summarized by Dose
timeFrame: 7 days after each vaccination
Secondary outcomes:
measure: Weeks to Serconversion
timeFrame: 26 weeks
measure: Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Silver Spring
country: United States
facility: Walter Reed Army Institute of Research, Clinical Trials Center
state: Maryland
Study officials:
affiliation: Walter Reed Army Institute of Research (WRAIR)
name: Barnett Gibbs, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Walter Reed Army Institute of Research (WRAIR)
name: Paul B Keiser
role: PRINCIPAL_INVESTIGATOR
References: