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

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ClinicalTrials.gov Identifier: NCT00248833
Recruitment Status : Completed
First Posted : November 4, 2005
Results First Posted : October 29, 2018
Last Update Posted : October 29, 2018
Sponsor:
Collaborator:
Walter Reed Army Institute of Research (WRAIR)
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command

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.


Condition or disease Intervention/treatment Phase
Meningitis, Meningococcal, Serogroup B Biological: 25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine Biological: 50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
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
Actual Study Start Date : December 5, 2005
Actual Primary Completion Date : November 30, 2006
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Meningitis

Arm Intervention/treatment
Experimental: 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o adjuvant
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
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.

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

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




Primary Outcome Measures :
  1. Safety: Severity Summary of Solicited and Unsolicited Adverse Events [ Time Frame: 7 day f/u period after each vaccination ]
    Solicited and unsolicited summary of severity of adverse events (AEs) during the 7 day follow-up period after each vaccination

  2. Safety: Adverse Event Type Summarized by Dose [ Time Frame: 7 days after each vaccination ]
    Adverse events summarized by type and dose


Secondary Outcome Measures :
  1. Weeks to Serconversion [ Time Frame: 26 weeks ]
    Weeks to seroconversion evaluated by serum bactericidal assay. Immunogenicity was determined by assessing the number of subjects, in each cohort, who seroconverted. Seroconversion was defined as a 4-fold or greater increase in serum bactericidal antibodies against the vaccine strain. The geometric mean bactericidal titer (GMT) for each group was determined prior to vaccination and at 2 weeks after each vaccination. For each group, the GMT ratio relative to baseline and after 1, 2, or 3 vaccinations and the 95% 2-sided confidence interval was determined. A seroconversion of ≥50% of the subjects after 2 or more doses would meet the criteria for further vaccine development.

  2. Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion [ Time Frame: 26 weeks ]
    Percentage of subjects with ELISA 2-fold and 4-fold increase from baseline IgG antibody Conversion



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00248833


Locations
United States, Maryland
Walter Reed Army Institute of Research, Clinical Trials Center
Silver Spring, Maryland, United States, 20910
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Walter Reed Army Institute of Research (WRAIR)
Investigators
Principal Investigator: Barnett Gibbs, MD Walter Reed Army Institute of Research (WRAIR)
Principal Investigator: Paul B Keiser Walter Reed Army Institute of Research (WRAIR)

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00248833     History of Changes
Other Study ID Numbers: WRAIR 1178
HSRRB A-13513
First Posted: November 4, 2005    Key Record Dates
Results First Posted: October 29, 2018
Last Update Posted: October 29, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: WRAIR

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs