Meningitis, Meningococcal, Serogroup B
Conditions
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.
Interventions
BIOLOGICAL25ug 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.
BIOLOGICAL50ug 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.
Sponsors
Walter Reed Army Institute of Research (WRAIR)
U.S. Army Medical Research and Development Command
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, 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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Severity Summary of Solicited and Unsolicited Adverse Events | 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 |
| Safety: Adverse Event Type Summarized by Dose | 7 days after each vaccination | Adverse events summarized by type and dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weeks to Serconversion | 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. |
| Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 26 weeks | Percentage of subjects with ELISA 2-fold and 4-fold increase from baseline IgG antibody Conversion |
Countries
United States
Participant flow
Recruitment details
34 subjects were enrolled to be randomized into 1 of 3 cohorts at the WRAIR CTC.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 12 |
| 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.
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. | 11 |
| 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.
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. | 11 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 | 1 |
| Overall Study | Other | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | 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 | Total |
|---|---|---|---|---|
| Age, Continuous | 31.6 Years STANDARD_DEVIATION 9.3 | 33.4 Years STANDARD_DEVIATION 7.6 | 29.9 Years STANDARD_DEVIATION 8.4 | 31.6 Years STANDARD_DEVIATION 8.4 |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants | 7 Participants | 7 Participants | 19 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 7 Participants | 5 Participants | 4 Participants | 16 Participants |
| Region of Enrollment United States | 12 participants | 11 participants | 11 participants | 34 participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 5 Participants | 17 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 6 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 12 / 12 | 11 / 11 | 11 / 11 |
| serious Total, serious adverse events | 0 / 12 | 0 / 11 | 0 / 11 |
Outcome results
Primary
Safety: Adverse Event Type Summarized by Dose
Adverse events summarized by type and dose
Time frame: 7 days after each vaccination
Population: Both 25ug groups (1 and 2) were grouped for this analysis as both groups received the same dosage
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Adverse Event Type Summarized by Dose | Gastrointestinal disorders | 3 Number of AEs |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Adverse Event Type Summarized by Dose | Injury, poisoning and procedural complications | 4 Number of AEs |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Adverse Event Type Summarized by Dose | Blood and lymphatic system disorders | 2 Number of AEs |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Adverse Event Type Summarized by Dose | General disorders | 65 Number of AEs |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Adverse Event Type Summarized by Dose | Infection and infestations | 5 Number of AEs |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Adverse Event Type Summarized by Dose | Investigations | 8 Number of AEs |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Adverse Event Type Summarized by Dose | Metabolism and nutrition disorders | 2 Number of AEs |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Adverse Event Type Summarized by Dose | Musculoskeletal and connective tissue disorders | 8 Number of AEs |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Adverse Event Type Summarized by Dose | Nervous system disorders | 11 Number of AEs |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Adverse Event Type Summarized by Dose | Renal and urinary disorders | 5 Number of AEs |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Adverse Event Type Summarized by Dose | Respiratory, thoracic and mediastinal disorders | 3 Number of AEs |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Adverse Event Type Summarized by Dose | Skin and subcutaneous tissue disorders | 1 Number of AEs |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Safety: Adverse Event Type Summarized by Dose | Respiratory, thoracic and mediastinal disorders | 0 Number of AEs |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Safety: Adverse Event Type Summarized by Dose | Infection and infestations | 7 Number of AEs |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Safety: Adverse Event Type Summarized by Dose | Metabolism and nutrition disorders | 0 Number of AEs |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Safety: Adverse Event Type Summarized by Dose | Renal and urinary disorders | 0 Number of AEs |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Safety: Adverse Event Type Summarized by Dose | Blood and lymphatic system disorders | 0 Number of AEs |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Safety: Adverse Event Type Summarized by Dose | Gastrointestinal disorders | 0 Number of AEs |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Safety: Adverse Event Type Summarized by Dose | Musculoskeletal and connective tissue disorders | 8 Number of AEs |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Safety: Adverse Event Type Summarized by Dose | General disorders | 75 Number of AEs |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Safety: Adverse Event Type Summarized by Dose | Skin and subcutaneous tissue disorders | 0 Number of AEs |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Safety: Adverse Event Type Summarized by Dose | Injury, poisoning and procedural complications | 0 Number of AEs |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Safety: Adverse Event Type Summarized by Dose | Nervous system disorders | 10 Number of AEs |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Safety: Adverse Event Type Summarized by Dose | Investigations | 1 Number of AEs |
Primary
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
Time frame: 7 day f/u period after each vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Unsolicited: Mild | 36 AEs |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Solicited: Not related to study drug | 8 AEs |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Solicited: Related to study drug | 62 AEs |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Unsolicited: Not related to study drug | 42 AEs |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Unsolicited: Number of subjects with atleast 1 AE | 10 AEs |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Solicited: Mild | 67 AEs |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Unsolicited: Severe | 4 AEs |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Unsolicited: Moderate | 7 AEs |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Solicited: Moderate | 3 AEs |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Unsolicited: Related to study drug | 5 AEs |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Solicited: Not related to study drug | 3 AEs |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Unsolicited: Severe | 2 AEs |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Solicited: Mild | 92 AEs |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Solicited: Moderate | 16 AEs |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Solicited: Related to study drug | 105 AEs |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Unsolicited: Number of subjects with atleast 1 AE | 10 AEs |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Unsolicited: Mild | 19 AEs |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Unsolicited: Moderate | 2 AEs |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Unsolicited: Not related to study drug | 21 AEs |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Unsolicited: Related to study drug | 2 AEs |
| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Unsolicited: Mild | 14 AEs |
| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Solicited: Mild | 70 AEs |
| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Solicited: Not related to study drug | 6 AEs |
| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Unsolicited: Moderate | 5 AEs |
| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Unsolicited: Severe | 2 AEs |
| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Solicited: Related to study drug | 74 AEs |
| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Unsolicited: Related to study drug | 0 AEs |
| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Unsolicited: Number of subjects with atleast 1 AE | 7 AEs |
| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Solicited: Moderate | 10 AEs |
| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Safety: Severity Summary of Solicited and Unsolicited Adverse Events | Unsolicited: Not related to study drug | 21 AEs |
Secondary
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
Time frame: 26 weeks
Population: Number of participants analyzed represents subjects who experienced increases from baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 2-fold increase from BL: 44/76 NOMV IgG | 80.0 % of subjects |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 2-fold increase from BL: L3, 7 LOS | 30.0 % of subjects |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 2-fold increase from BL: GNA1870 | 0.0 % of subjects |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 2-fold increase from BL: Opc | 60.0 % of subjects |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 2-fold increase from BL: 44/76 P | 60.0 % of subjects |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 4-fold increase from BL: L3, 7 LOS | 10.0 % of subjects |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 4-fold increase from BL: 44/76 NOMV IgG | 20.0 % of subjects |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 4-fold increase from BL: GNA1870 | 0.0 % of subjects |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 4-fold increase from BL: Opc | 20.0 % of subjects |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 4-fold increase from BL: 44/76 P | 40.0 % of subjects |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 4-fold increase from BL: Opc | 22.2 % of subjects |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 2-fold increase from BL: 44/76 NOMV IgG | 88.9 % of subjects |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 2-fold increase from BL: 44/76 P | 77.8 % of subjects |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 4-fold increase from BL: 44/76 NOMV IgG | 55.6 % of subjects |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 2-fold increase from BL: L3, 7 LOS | 66.7 % of subjects |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 4-fold increase from BL: 44/76 P | 22.2 % of subjects |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 4-fold increase from BL: GNA1870 | 11.1 % of subjects |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 2-fold increase from BL: GNA1870 | 66.7 % of subjects |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 4-fold increase from BL: L3, 7 LOS | 22.2 % of subjects |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 2-fold increase from BL: Opc | 33.3 % of subjects |
| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 4-fold increase from BL: GNA1870 | 10.0 % of subjects |
| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 2-fold increase from BL: Opc | 80.0 % of subjects |
| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 2-fold increase from BL: 44/76 P | 80.0 % of subjects |
| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 4-fold increase from BL: Opc | 20.0 % of subjects |
| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 4-fold increase from BL: 44/76 NOMV IgG | 70.0 % of subjects |
| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 4-fold increase from BL: L3, 7 LOS | 10.0 % of subjects |
| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 2-fold increase from BL: 44/76 NOMV IgG | 100.0 % of subjects |
| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 4-fold increase from BL: 44/76 P | 50.0 % of subjects |
| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 2-fold increase from BL: L3, 7 LOS | 60.0 % of subjects |
| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion | 2-fold increase from BL: GNA1870 | 50.0 % of subjects |
Secondary
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.
Time frame: 26 weeks
Population: Number analyzed are subjects that seroconverted
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Weeks to Serconversion | Test Antigen: 9162 | 26.0 Weeks | Standard Deviation 0 |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Weeks to Serconversion | Test Antigen: 44/76 P | 8.0 Weeks | Standard Deviation 0 |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Weeks to Serconversion | Test Antigen: 44/76 | 2.0 Weeks | Standard Deviation 0 |
| 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Weeks to Serconversion | Test Antigen: 8570 | 8.0 Weeks | Standard Deviation 0 |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Weeks to Serconversion | Test Antigen: 9162 | 8.0 Weeks | Standard Deviation 0 |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Weeks to Serconversion | Test Antigen: 44/76 P | 12.5 Weeks | Standard Deviation 9 |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Weeks to Serconversion | Test Antigen: 8570 | 8.0 Weeks | Standard Deviation 0 |
| 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant | Weeks to Serconversion | Test Antigen: 44/76 | 4.0 Weeks | Standard Deviation 4.5 |
| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Weeks to Serconversion | Test Antigen: 44/76 P | 8.0 Weeks | Standard Deviation 0 |
| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Weeks to Serconversion | Test Antigen: 44/76 | 3.0 Weeks | Standard Deviation 2.4 |
| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Weeks to Serconversion | Test Antigen: 8570 | 8.0 Weeks | Standard Deviation 0 |
| 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant | Weeks to Serconversion | Test Antigen: 9162 | 8.0 Weeks | Standard Deviation 0 |