Trial Outcomes & Findings for Safety and Immunogenicity Study of Group B Meningococcal Vaccine to Prevent Meningitis. (NCT NCT00248833)
NCT ID: NCT00248833
Last Updated: 2018-10-29
Results Overview
Solicited and unsolicited summary of severity of adverse events (AEs) during the 7 day follow-up period after each vaccination
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
7 day f/u period after each vaccination
Results posted on
2018-10-29
Participant Flow
34 subjects were enrolled to be randomized into 1 of 3 cohorts at the WRAIR CTC.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
11
|
|
Overall Study
COMPLETED
|
9
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
|
Overall Study
Other
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Immunogenicity Study of Group B Meningococcal Vaccine to Prevent Meningitis.
Baseline characteristics by cohort
| Measure |
1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant
n=12 Participants
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.
|
2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant
n=11 Participants
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.
|
3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant
n=11 Participants
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.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31.6 Years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
33.4 Years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
29.9 Years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
31.6 Years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
11 participants
n=5 Participants
|
34 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 7 day f/u period after each vaccinationSolicited and unsolicited summary of severity of adverse events (AEs) during the 7 day follow-up period after each vaccination
Outcome measures
| Measure |
1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant
n=12 Participants
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.
|
2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant
n=11 Participants
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.
|
3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant
n=11 Participants
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.
|
|---|---|---|---|
|
Safety: Severity Summary of Solicited and Unsolicited Adverse Events
Solicited: Not related to study drug
|
8 AEs
|
3 AEs
|
6 AEs
|
|
Safety: Severity Summary of Solicited and Unsolicited Adverse Events
Solicited: Related to study drug
|
62 AEs
|
105 AEs
|
74 AEs
|
|
Safety: Severity Summary of Solicited and Unsolicited Adverse Events
Unsolicited: Mild
|
36 AEs
|
19 AEs
|
14 AEs
|
|
Safety: Severity Summary of Solicited and Unsolicited Adverse Events
Solicited: Mild
|
67 AEs
|
92 AEs
|
70 AEs
|
|
Safety: Severity Summary of Solicited and Unsolicited Adverse Events
Solicited: Moderate
|
3 AEs
|
16 AEs
|
10 AEs
|
|
Safety: Severity Summary of Solicited and Unsolicited Adverse Events
Unsolicited: Number of subjects with atleast 1 AE
|
10 AEs
|
10 AEs
|
7 AEs
|
|
Safety: Severity Summary of Solicited and Unsolicited Adverse Events
Unsolicited: Moderate
|
7 AEs
|
2 AEs
|
5 AEs
|
|
Safety: Severity Summary of Solicited and Unsolicited Adverse Events
Unsolicited: Severe
|
4 AEs
|
2 AEs
|
2 AEs
|
|
Safety: Severity Summary of Solicited and Unsolicited Adverse Events
Unsolicited: Not related to study drug
|
42 AEs
|
21 AEs
|
21 AEs
|
|
Safety: Severity Summary of Solicited and Unsolicited Adverse Events
Unsolicited: Related to study drug
|
5 AEs
|
2 AEs
|
0 AEs
|
PRIMARY outcome
Timeframe: 7 days after each vaccinationPopulation: Both 25ug groups (1 and 2) were grouped for this analysis as both groups received the same dosage
Adverse events summarized by type and dose
Outcome measures
| Measure |
1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant
n=23 Participants
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.
|
2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant
n=11 Participants
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.
|
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.
|
|---|---|---|---|
|
Safety: Adverse Event Type Summarized by Dose
Blood and lymphatic system disorders
|
2 Number of AEs
|
0 Number of AEs
|
—
|
|
Safety: Adverse Event Type Summarized by Dose
Gastrointestinal disorders
|
3 Number of AEs
|
0 Number of AEs
|
—
|
|
Safety: Adverse Event Type Summarized by Dose
General disorders
|
65 Number of AEs
|
75 Number of AEs
|
—
|
|
Safety: Adverse Event Type Summarized by Dose
Infection and infestations
|
5 Number of AEs
|
7 Number of AEs
|
—
|
|
Safety: Adverse Event Type Summarized by Dose
Injury, poisoning and procedural complications
|
4 Number of AEs
|
0 Number of AEs
|
—
|
|
Safety: Adverse Event Type Summarized by Dose
Investigations
|
8 Number of AEs
|
1 Number of AEs
|
—
|
|
Safety: Adverse Event Type Summarized by Dose
Metabolism and nutrition disorders
|
2 Number of AEs
|
0 Number of AEs
|
—
|
|
Safety: Adverse Event Type Summarized by Dose
Musculoskeletal and connective tissue disorders
|
8 Number of AEs
|
8 Number of AEs
|
—
|
|
Safety: Adverse Event Type Summarized by Dose
Nervous system disorders
|
11 Number of AEs
|
10 Number of AEs
|
—
|
|
Safety: Adverse Event Type Summarized by Dose
Renal and urinary disorders
|
5 Number of AEs
|
0 Number of AEs
|
—
|
|
Safety: Adverse Event Type Summarized by Dose
Respiratory, thoracic and mediastinal disorders
|
3 Number of AEs
|
0 Number of AEs
|
—
|
|
Safety: Adverse Event Type Summarized by Dose
Skin and subcutaneous tissue disorders
|
1 Number of AEs
|
0 Number of AEs
|
—
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Number analyzed are subjects that seroconverted
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.
Outcome measures
| Measure |
1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant
n=9 Participants
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.
|
2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant
n=12 Participants
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.
|
3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant
n=13 Participants
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.
|
|---|---|---|---|
|
Weeks to Serconversion
Test Antigen: 44/76
|
2.0 Weeks
Standard Deviation 0.0
|
4.0 Weeks
Standard Deviation 4.5
|
3.0 Weeks
Standard Deviation 2.4
|
|
Weeks to Serconversion
Test Antigen: 8570
|
8.0 Weeks
Standard Deviation 0.0
|
8.0 Weeks
Standard Deviation 0.0
|
8.0 Weeks
Standard Deviation 0.0
|
|
Weeks to Serconversion
Test Antigen: 9162
|
26.0 Weeks
Standard Deviation 0.0
|
8.0 Weeks
Standard Deviation 0.0
|
8.0 Weeks
Standard Deviation 0.0
|
|
Weeks to Serconversion
Test Antigen: 44/76 P
|
8.0 Weeks
Standard Deviation 0.0
|
12.5 Weeks
Standard Deviation 9.0
|
8.0 Weeks
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Number of participants analyzed represents subjects who experienced increases from baseline
Percentage of subjects with ELISA 2-fold and 4-fold increase from baseline IgG antibody Conversion
Outcome measures
| Measure |
1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant
n=10 Participants
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.
|
2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant
n=9 Participants
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.
|
3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant
n=10 Participants
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.
|
|---|---|---|---|
|
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
|
88.9 % of subjects
|
100.0 % of subjects
|
|
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
|
66.7 % of subjects
|
60.0 % of subjects
|
|
Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion
2-fold increase from BL: GNA1870
|
0.0 % of subjects
|
66.7 % of subjects
|
50.0 % of subjects
|
|
Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion
2-fold increase from BL: Opc
|
60.0 % of subjects
|
33.3 % of subjects
|
80.0 % of subjects
|
|
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
|
77.8 % of subjects
|
80.0 % of subjects
|
|
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
|
55.6 % of subjects
|
70.0 % of subjects
|
|
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
|
22.2 % of subjects
|
10.0 % of subjects
|
|
Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion
4-fold increase from BL: GNA1870
|
0.0 % of subjects
|
11.1 % of subjects
|
10.0 % of subjects
|
|
Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion
4-fold increase from BL: Opc
|
20.0 % of subjects
|
22.2 % of subjects
|
20.0 % of subjects
|
|
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
|
22.2 % of subjects
|
50.0 % of subjects
|
Adverse Events
1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant
n=12 participants at risk
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.
|
2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant
n=11 participants at risk
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.
|
3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant
n=11 participants at risk
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.
|
|---|---|---|---|
|
General disorders
Pain
|
100.0%
12/12 • Number of events 22 • 7 days after each vaccination
|
100.0%
11/11 • Number of events 52 • 7 days after each vaccination
|
100.0%
11/11 • Number of events 31 • 7 days after each vaccination
|
|
General disorders
Swelling
|
41.7%
5/12 • Number of events 5 • 7 days after each vaccination
|
72.7%
8/11 • Number of events 8 • 7 days after each vaccination
|
63.6%
7/11 • Number of events 7 • 7 days after each vaccination
|
|
Injury, poisoning and procedural complications
Tenderness
|
100.0%
12/12 • Number of events 17 • 7 days after each vaccination
|
100.0%
11/11 • Number of events 28 • 7 days after each vaccination
|
100.0%
11/11 • Number of events 21 • 7 days after each vaccination
|
|
General disorders
Pain lifting arm
|
66.7%
8/12 • Number of events 8 • 7 days after each vaccination
|
100.0%
11/11 • Number of events 17 • 7 days after each vaccination
|
100.0%
11/11 • Number of events 13 • 7 days after each vaccination
|
|
General disorders
Warmth
|
0.00%
0/12 • 7 days after each vaccination
|
27.3%
3/11 • Number of events 3 • 7 days after each vaccination
|
9.1%
1/11 • Number of events 1 • 7 days after each vaccination
|
|
Skin and subcutaneous tissue disorders
Erythema
|
58.3%
7/12 • Number of events 7 • 7 days after each vaccination
|
81.8%
9/11 • Number of events 9 • 7 days after each vaccination
|
45.5%
5/11 • Number of events 5 • 7 days after each vaccination
|
|
General disorders
Induration
|
16.7%
2/12 • Number of events 2 • 7 days after each vaccination
|
9.1%
1/11 • Number of events 1 • 7 days after each vaccination
|
9.1%
1/11 • Number of events 1 • 7 days after each vaccination
|
|
Injury, poisoning and procedural complications
Bruise
|
16.7%
2/12 • Number of events 2 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
9.1%
1/11 • Number of events 1 • 7 days after each vaccination
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/12 • 7 days after each vaccination
|
9.1%
1/11 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Blood and lymphatic system disorders
Hypochromasia
|
16.7%
2/12 • Number of events 2 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/12 • 7 days after each vaccination
|
9.1%
1/11 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/12 • 7 days after each vaccination
|
9.1%
1/11 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
16.7%
2/12 • Number of events 2 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
General disorders
Fatigue
|
25.0%
3/12 • Number of events 3 • 7 days after each vaccination
|
9.1%
1/11 • Number of events 1 • 7 days after each vaccination
|
18.2%
2/11 • Number of events 2 • 7 days after each vaccination
|
|
General disorders
Malaise
|
8.3%
1/12 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
9.1%
1/11 • Number of events 1 • 7 days after each vaccination
|
|
General disorders
Pyrexia
|
8.3%
1/12 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/12 • 7 days after each vaccination
|
9.1%
1/11 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Infections and infestations
Lyme disease
|
8.3%
1/12 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
9.1%
1/11 • Number of events 1 • 7 days after each vaccination
|
|
Infections and infestations
Rhinitis
|
0.00%
0/12 • 7 days after each vaccination
|
9.1%
1/11 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Infections and infestations
Sinusitis
|
8.3%
1/12 • Number of events 1 • 7 days after each vaccination
|
9.1%
1/11 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
3/12 • Number of events 3 • 7 days after each vaccination
|
27.3%
3/11 • Number of events 3 • 7 days after each vaccination
|
45.5%
5/11 • Number of events 5 • 7 days after each vaccination
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
9.1%
1/11 • Number of events 1 • 7 days after each vaccination
|
|
Infections and infestations
Viral infection
|
0.00%
0/12 • 7 days after each vaccination
|
9.1%
1/11 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Injury, poisoning and procedural complications
Chest injury
|
8.3%
1/12 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/12 • 7 days after each vaccination
|
9.1%
1/11 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Injury, poisoning and procedural complications
Thermal burn
|
8.3%
1/12 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
8.3%
1/12 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Injury, poisoning and procedural complications
Wound
|
8.3%
1/12 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
1/12 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Investigations
Blood bilirubin inconjugated increated
|
8.3%
1/12 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Investigations
Blood pressure increased
|
16.7%
2/12 • Number of events 2 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Investigations
Haemoglobin decreased
|
16.7%
2/12 • Number of events 2 • 7 days after each vaccination
|
18.2%
2/11 • Number of events 2 • 7 days after each vaccination
|
9.1%
1/11 • Number of events 1 • 7 days after each vaccination
|
|
Investigations
Haptoglobin increased
|
8.3%
1/12 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Investigations
Liver function test abnormal
|
8.3%
1/12 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.3%
1/12 • Number of events 1 • 7 days after each vaccination
|
9.1%
1/11 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
2/12 • Number of events 2 • 7 days after each vaccination
|
9.1%
1/11 • Number of events 1 • 7 days after each vaccination
|
9.1%
1/11 • Number of events 1 • 7 days after each vaccination
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/12 • 7 days after each vaccination
|
9.1%
1/11 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
9.1%
1/11 • Number of events 1 • 7 days after each vaccination
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
2/12 • Number of events 2 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
9.1%
1/11 • Number of events 1 • 7 days after each vaccination
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
9.1%
1/11 • Number of events 1 • 7 days after each vaccination
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
8.3%
1/12 • Number of events 1 • 7 days after each vaccination
|
9.1%
1/11 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Nervous system disorders
Disturbance in attention
|
8.3%
1/12 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • Number of events 2 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/12 • 7 days after each vaccination
|
9.1%
1/11 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • Number of events 2 • 7 days after each vaccination
|
27.3%
3/11 • Number of events 3 • 7 days after each vaccination
|
54.5%
6/11 • Number of events 6 • 7 days after each vaccination
|
|
Renal and urinary disorders
Glycosuria
|
8.3%
1/12 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Renal and urinary disorders
Proteinuria
|
33.3%
4/12 • Number of events 4 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
1/12 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.3%
1/12 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
8.3%
1/12 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
8.3%
1/12 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
|
Vascular disorders
Hypertension
|
0.00%
0/12 • 7 days after each vaccination
|
9.1%
1/11 • Number of events 1 • 7 days after each vaccination
|
0.00%
0/11 • 7 days after each vaccination
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place