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

NCT00248833 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: WRAIR 1178HSRRB A-13513
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Meningitis, Meningococcal, Serogroup B

Outcome Measures

Primary Outcomes (2)

• Safety: Severity Summary of Solicited and Unsolicited Adverse Events

  Solicited and unsolicited summary of severity of adverse events (AEs) during the 7 day follow-up period after each vaccination

  7 day f/u period after each vaccination

• Safety: Adverse Event Type Summarized by Dose

  Adverse events summarized by type and dose

  7 days after each vaccination

Secondary Outcomes (2)

• Weeks to Serconversion

  26 weeks

• Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion

  26 weeks

Study Arms (3)

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

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

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

Interventions

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

The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.

1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o adjuvant; 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D with adjuvant

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

The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 50µg without adjuvant was administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• Walter Reed Army Institute of Research (WRAIR): collaborator

Study Sites (1)

Walter Reed Army Institute of Research, Clinical Trials Center

Silver Spring, Maryland, 20910, United States

Location

MeSH Terms

Conditions

Meningitis, Meningococcal

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Results Point of Contact

• Title: Paul B. Keiser
• Organization: WRAIR

clinical1@na.amedd.army.mil

866-856-3259

Study Officials

• Barnett Gibbs, MD

  Walter Reed Army Institute of Research (WRAIR)

  PRINCIPAL INVESTIGATOR

• Paul B Keiser

  Walter Reed Army Institute of Research (WRAIR)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The first 2 cohorts were double blind, and the third cohort was not blinded. The investigator preparing the vaccine did not participate in making subsequent study assessments or subject evaluability decisions. After the vaccine was prepared, the subject's identification number was placed onto the drawn syringe. All information, vaccine dose, adjuvant dose (if applicable), and subject identification number, was recorded on the Vaccine Administration Code Form. The form was placed in an envelope. The envelope was sealed and placed in a secured location. The medical personnel who vaccinated the subjects witnessed the dilution and placement of the subject identification number on the syringe. This staff member vaccinated the subject but did not participate in subsequent study visits or the evaluation. The blind was broken after verification that all serology testing was completed.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 2, 2005
• First Posted: November 4, 2005
• Study Start: December 5, 2005
• Primary Completion: November 30, 2006
• Study Completion: December 1, 2007
• Last Updated: October 29, 2018
• Results First Posted: October 29, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)