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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

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

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

About this trial

This is an interventional prevention trial for Meningitis, Meningococcal, Serogroup B

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Walter Reed Army Institute of Research, Clinical Trials Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

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

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

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Safety: Adverse Event Type Summarized by Dose

Adverse events summarized by type and dose

Secondary Outcome Measures

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.

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

Full Information

NCT ID

NCT00248833

First Posted

November 2, 2005

Last Updated

January 29, 2018

Sponsor

U.S. Army Medical Research and Development Command

Collaborators

Walter Reed Army Institute of Research (WRAIR)

1. Study Identification

Unique Protocol Identification Number

NCT00248833

Brief Title

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

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

December 5, 2005 (Actual)

Primary Completion Date

November 30, 2006 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

U.S. Army Medical Research and Development Command

Collaborators

Walter Reed Army Institute of Research (WRAIR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meningitis, Meningococcal, Serogroup B

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

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

ParticipantCare ProviderInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

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

Arm Title

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

Arm Type

Experimental

Arm Description

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

Arm Title

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

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

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

Intervention 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). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.

Intervention Type

Biological

Intervention Name(s)

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

Intervention 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). 50µg without adjuvant was administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.

Primary Outcome Measure Information:

Title

Safety: Severity Summary of Solicited and Unsolicited Adverse Events

Description

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

Time Frame

7 day f/u period after each vaccination

Title

Safety: Adverse Event Type Summarized by Dose

Description

Adverse events summarized by type and dose

Time Frame

7 days after each vaccination

Secondary Outcome Measure Information:

Title

Weeks to Serconversion

Description

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.

Time Frame

26 weeks

Title

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

Description

Percentage of subjects with ELISA 2-fold and 4-fold increase from baseline IgG antibody Conversion

Time Frame

26 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barnett Gibbs, MD

Organizational Affiliation

Walter Reed Army Institute of Research (WRAIR)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Paul B Keiser

Organizational Affiliation

Walter Reed Army Institute of Research (WRAIR)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Walter Reed Army Institute of Research, Clinical Trials Center

City

Silver Spring

State/Province

Maryland

ZIP/Postal Code

20910

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

WRAIR

Meningitis, Meningococcal, Serogroup B

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial