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

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.

Study Overview

• Status: Completed
• Conditions: Meningitis, Meningococcal, Serogroup B
• Intervention / Treatment: Biological: 25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine; Biological: 50ug Group B Meningococcal 44/76 MOS NOMV 5D 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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Silver Spring, Maryland, United States, 20910
      • Walter Reed Army Institute of Research, Clinical Trials Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weeks to Serconversion	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.	26 weeks
Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion	Percentage of subjects with ELISA 2-fold and 4-fold increase from baseline IgG antibody Conversion	26 weeks

Collaborators and Investigators

• Sponsor: U.S. Army Medical Research and Development Command
• Collaborators: 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)

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 5, 2005
• Primary Completion (ACTUAL): November 30, 2006
• Study Completion (ACTUAL): December 1, 2007

Study Registration Dates

• First Submitted: November 2, 2005
• First Submitted That Met QC Criteria: November 2, 2005
• First Posted (ESTIMATE): November 4, 2005

Study Record Updates

• Last Update Posted (ACTUAL): October 29, 2018
• Last Update Submitted That Met QC Criteria: January 29, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Meningococcal Infections; Neisseriaceae Infections; Meningitis, Meningococcal; Meningitis; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: WRAIR 1178; HSRRB A-13513

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: WRAIR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No