Trial Outcomes & Findings for Mucosal Immunity Against Neisseria Gonorrhoeae After 4CMenB Vaccination (NCT NCT04722003)
NCT ID: NCT04722003
Last Updated: 2024-11-05
Results Overview
Rectal mucosal IgG concentrations (geometric mean titers, GMT) against GC OMV antigen Ng1291 by ELISA at Day 1, 29, 43, 57, and 181 in each treatment group
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Day 1 through Day 181
Results posted on
2024-11-05
Participant Flow
Participants were males and non-pregnant females, 18 to 49 years of age, inclusive, who were in good health and meet all eligibility criteria.
Participant milestones
| Measure |
4CMenB
Participants will receive two doses (0.5 mL each) of 4CMenB vaccine on Day 1 and Day 29. Each single dose of vaccine will be administered via intramuscular (IM) injection into the deltoid muscle of the preferred arm.
Meningococcal Group B Vaccine: A combination vaccine consisting of recombinant proteins Neisserial adhesin A (NadA), Neisserial Heparin Binding Antigen (NHBA), and factor H binding protein (fHbp), Outer Membrane Vesicles (OMV), aluminum hydroxide, sodium chloride, histidine, and sucrose.
|
Placebo
Participants will receive two doses (0.5 mL each) of placebo injections (saline) on Day 1 and Day 29. Each single dose of placebo will be administered via intramuscular (IM) injection into the deltoid muscle of the preferred arm.
Placebo: 0.9% Sodium Chloride, USP injection.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
11
|
|
Overall Study
COMPLETED
|
38
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
4CMenB
Participants will receive two doses (0.5 mL each) of 4CMenB vaccine on Day 1 and Day 29. Each single dose of vaccine will be administered via intramuscular (IM) injection into the deltoid muscle of the preferred arm.
Meningococcal Group B Vaccine: A combination vaccine consisting of recombinant proteins Neisserial adhesin A (NadA), Neisserial Heparin Binding Antigen (NHBA), and factor H binding protein (fHbp), Outer Membrane Vesicles (OMV), aluminum hydroxide, sodium chloride, histidine, and sucrose.
|
Placebo
Participants will receive two doses (0.5 mL each) of placebo injections (saline) on Day 1 and Day 29. Each single dose of placebo will be administered via intramuscular (IM) injection into the deltoid muscle of the preferred arm.
Placebo: 0.9% Sodium Chloride, USP injection.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Mucosal Immunity Against Neisseria Gonorrhoeae After 4CMenB Vaccination
Baseline characteristics by cohort
| Measure |
4CMenB
n=41 Participants
Participants will receive two doses (0.5 mL each) of 4CMenB vaccine on Day 1 and Day 29. Each single dose of vaccine will be administered via intramuscular (IM) injection into the deltoid muscle of the preferred arm.
Meningococcal Group B Vaccine: A combination vaccine consisting of recombinant proteins Neisserial adhesin A (NadA), Neisserial Heparin Binding Antigen (NHBA), and factor H binding protein (fHbp), Outer Membrane Vesicles (OMV), aluminum hydroxide, sodium chloride, histidine, and sucrose.
|
Placebo
n=11 Participants
Participants will receive two doses (0.5 mL each) of placebo injections (saline) on Day 1 and Day 29. Each single dose of placebo will be administered via intramuscular (IM) injection into the deltoid muscle of the preferred arm.
Placebo: 0.9% Sodium Chloride, USP injection.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.5 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
29.8 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
31.1 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 181Population: Immunogenicity Population: For the primary outcome analysis, the immunogenicity population at a specified follow-up visit will include all eligible participants who have received all doses of study product prior to that visit and have immunogenicity data available for that visit. Which includes all participants who received at least one dose of study vaccine and contributed at least one sample for immunogenicity testing for which valid results were reported.
Rectal mucosal IgG concentrations (geometric mean titers, GMT) against GC OMV antigen Ng1291 by ELISA at Day 1, 29, 43, 57, and 181 in each treatment group
Outcome measures
| Measure |
4CMenB
n=40 Participants
Participants will receive two doses (0.5 mL each) of 4CMenB vaccine on Day 1 and Day 29. Each single dose of vaccine will be administered via intramuscular (IM) injection into the deltoid muscle of the preferred arm.
Meningococcal Group B Vaccine: A combination vaccine consisting of recombinant proteins Neisserial adhesin A (NadA), Neisserial Heparin Binding Antigen (NHBA), and factor H binding protein (fHbp), Outer Membrane Vesicles (OMV), aluminum hydroxide, sodium chloride, histidine, and sucrose.
|
Placebo
n=11 Participants
Participants will receive two doses (0.5 mL each) of placebo injections (saline) on Day 1 and Day 29. Each single dose of placebo will be administered via intramuscular (IM) injection into the deltoid muscle of the preferred arm.
Placebo: 0.9% Sodium Chloride, USP injection.
|
|---|---|---|
|
Rectal Mucosal IgG Concentrations (Geometric Mean Titers [GMT]) Against N. Gonorrhoeae Outer Membrane Vesicle (OMV) Antigen Ng1291
Day 1
|
0.07 titer
Interval 0.027 to 0.182
|
0.072 titer
Interval 0.025 to 0.213
|
|
Rectal Mucosal IgG Concentrations (Geometric Mean Titers [GMT]) Against N. Gonorrhoeae Outer Membrane Vesicle (OMV) Antigen Ng1291
Day 29
|
0.089 titer
Interval 0.041 to 0.192
|
0.097 titer
Interval 0.056 to 0.167
|
|
Rectal Mucosal IgG Concentrations (Geometric Mean Titers [GMT]) Against N. Gonorrhoeae Outer Membrane Vesicle (OMV) Antigen Ng1291
Day 43
|
0.078 titer
Interval 0.046 to 0.133
|
0.047 titer
Interval 0.024 to 0.09
|
|
Rectal Mucosal IgG Concentrations (Geometric Mean Titers [GMT]) Against N. Gonorrhoeae Outer Membrane Vesicle (OMV) Antigen Ng1291
Day 57
|
0.135 titer
Interval 0.095 to 0.192
|
0.062 titer
Interval 0.028 to 0.137
|
|
Rectal Mucosal IgG Concentrations (Geometric Mean Titers [GMT]) Against N. Gonorrhoeae Outer Membrane Vesicle (OMV) Antigen Ng1291
Day 181
|
0.182 titer
Interval 0.123 to 0.268
|
0.055 titer
Interval 0.03 to 0.1
|
PRIMARY outcome
Timeframe: Day 1 through day 181Population: Immunogenicity Population: For the primary outcome analysis, the immunogenicity population at a specified follow-up visit will include all eligible participants who have received all doses of study product prior to that visit and have immunogenicity data available for that visit. Which includes all participants who received at least one dose of study vaccine and contributed at least one sample for immunogenicity testing for which valid results were reported.
Rectal mucosal IgG concentrations (geometric mean titers, GMT) against GC OMV antigen CNG20 by ELISA at Day 1, 29, 43, 57, and 181 in each treatment group
Outcome measures
| Measure |
4CMenB
n=40 Participants
Participants will receive two doses (0.5 mL each) of 4CMenB vaccine on Day 1 and Day 29. Each single dose of vaccine will be administered via intramuscular (IM) injection into the deltoid muscle of the preferred arm.
Meningococcal Group B Vaccine: A combination vaccine consisting of recombinant proteins Neisserial adhesin A (NadA), Neisserial Heparin Binding Antigen (NHBA), and factor H binding protein (fHbp), Outer Membrane Vesicles (OMV), aluminum hydroxide, sodium chloride, histidine, and sucrose.
|
Placebo
n=11 Participants
Participants will receive two doses (0.5 mL each) of placebo injections (saline) on Day 1 and Day 29. Each single dose of placebo will be administered via intramuscular (IM) injection into the deltoid muscle of the preferred arm.
Placebo: 0.9% Sodium Chloride, USP injection.
|
|---|---|---|
|
Rectal Mucosal IgG Concentrations (Geometric Mean Titers [GMT]) Against N. Gonorrhoeae Outer Membrane Vesicle (OMV) Antigen CNG20
Day 1
|
0.125 titer
Interval 0.063 to 0.25
|
0.156 titer
Interval 0.07 to 0.345
|
|
Rectal Mucosal IgG Concentrations (Geometric Mean Titers [GMT]) Against N. Gonorrhoeae Outer Membrane Vesicle (OMV) Antigen CNG20
Day 29
|
0.165 titer
Interval 0.086 to 0.318
|
0.104 titer
Interval 0.042 to 0.255
|
|
Rectal Mucosal IgG Concentrations (Geometric Mean Titers [GMT]) Against N. Gonorrhoeae Outer Membrane Vesicle (OMV) Antigen CNG20
Day 43
|
0.136 titer
Interval 0.084 to 0.221
|
0.087 titer
Interval 0.039 to 0.195
|
|
Rectal Mucosal IgG Concentrations (Geometric Mean Titers [GMT]) Against N. Gonorrhoeae Outer Membrane Vesicle (OMV) Antigen CNG20
Day 57
|
0.181 titer
Interval 0.113 to 0.29
|
0.048 titer
Interval 0.025 to 0.093
|
|
Rectal Mucosal IgG Concentrations (Geometric Mean Titers [GMT]) Against N. Gonorrhoeae Outer Membrane Vesicle (OMV) Antigen CNG20
Day 181
|
0.207 titer
Interval 0.128 to 0.333
|
0.066 titer
Interval 0.037 to 0.119
|
SECONDARY outcome
Timeframe: Day 1 through Day 181Population: Immunogenicity Population: The immunogenicity population at a specified follow-up visit will include all eligible participants who have received all doses of study product prior to that visit and have immunogenicity data available for that visit. Which includes all participants who received at least one dose of study vaccine and contributed at least one sample for immunogenicity testing for which valid results were reported.
Serum IgG concentrations (geometric mean titers, GMT) against GC OMV antigen Ng1291 at Day 1, 29, 43, 57, and 181 in each treatment group
Outcome measures
| Measure |
4CMenB
n=40 Participants
Participants will receive two doses (0.5 mL each) of 4CMenB vaccine on Day 1 and Day 29. Each single dose of vaccine will be administered via intramuscular (IM) injection into the deltoid muscle of the preferred arm.
Meningococcal Group B Vaccine: A combination vaccine consisting of recombinant proteins Neisserial adhesin A (NadA), Neisserial Heparin Binding Antigen (NHBA), and factor H binding protein (fHbp), Outer Membrane Vesicles (OMV), aluminum hydroxide, sodium chloride, histidine, and sucrose.
|
Placebo
n=11 Participants
Participants will receive two doses (0.5 mL each) of placebo injections (saline) on Day 1 and Day 29. Each single dose of placebo will be administered via intramuscular (IM) injection into the deltoid muscle of the preferred arm.
Placebo: 0.9% Sodium Chloride, USP injection.
|
|---|---|---|
|
Serum IgG Concentrations (Geometric Mean Titers [GMT]) Against N. Gonorrhoeae Outer Membrane Vesicle (OMV) Antigen Ng1291
Day 1
|
75.233 titer
Interval 54.898 to 103.101
|
144.85 titer
Interval 99.992 to 209.832
|
|
Serum IgG Concentrations (Geometric Mean Titers [GMT]) Against N. Gonorrhoeae Outer Membrane Vesicle (OMV) Antigen Ng1291
Day 29
|
227.844 titer
Interval 176.002 to 294.956
|
154.356 titer
Interval 96.714 to 246.352
|
|
Serum IgG Concentrations (Geometric Mean Titers [GMT]) Against N. Gonorrhoeae Outer Membrane Vesicle (OMV) Antigen Ng1291
Day 43
|
324.931 titer
Interval 267.057 to 395.347
|
143.878 titer
Interval 94.851 to 218.245
|
|
Serum IgG Concentrations (Geometric Mean Titers [GMT]) Against N. Gonorrhoeae Outer Membrane Vesicle (OMV) Antigen Ng1291
Day 57
|
301.169 titer
Interval 246.083 to 368.585
|
156.602 titer
Interval 108.694 to 225.626
|
|
Serum IgG Concentrations (Geometric Mean Titers [GMT]) Against N. Gonorrhoeae Outer Membrane Vesicle (OMV) Antigen Ng1291
Day 181
|
163.493 titer
Interval 131.056 to 203.958
|
143 titer
Interval 92.976 to 219.938
|
SECONDARY outcome
Timeframe: Day 1 through day 181Population: Immunogenicity Population: The immunogenicity population at a specified follow-up visit will include all eligible participants who have received all doses of study product prior to that visit and have immunogenicity data available for that visit. Which includes all participants who received at least one dose of study vaccine and contributed at least one sample for immunogenicity testing for which valid results were reported.
Serum IgG concentrations (geometric mean titers, GMT) against GC OMV antigen CNG20 at Day 1, 29, 43, 57, and 181 in each treatment group
Outcome measures
| Measure |
4CMenB
n=40 Participants
Participants will receive two doses (0.5 mL each) of 4CMenB vaccine on Day 1 and Day 29. Each single dose of vaccine will be administered via intramuscular (IM) injection into the deltoid muscle of the preferred arm.
Meningococcal Group B Vaccine: A combination vaccine consisting of recombinant proteins Neisserial adhesin A (NadA), Neisserial Heparin Binding Antigen (NHBA), and factor H binding protein (fHbp), Outer Membrane Vesicles (OMV), aluminum hydroxide, sodium chloride, histidine, and sucrose.
|
Placebo
n=11 Participants
Participants will receive two doses (0.5 mL each) of placebo injections (saline) on Day 1 and Day 29. Each single dose of placebo will be administered via intramuscular (IM) injection into the deltoid muscle of the preferred arm.
Placebo: 0.9% Sodium Chloride, USP injection.
|
|---|---|---|
|
Serum IgG Concentrations (Geometric Mean Titers [GMT]) Against N. Gonorrhoeae Outer Membrane Vesicle (OMV) Antigen CNG20
Day 1
|
50.09 titer
Interval 34.906 to 71.877
|
90.931 titer
Interval 58.09 to 142.338
|
|
Serum IgG Concentrations (Geometric Mean Titers [GMT]) Against N. Gonorrhoeae Outer Membrane Vesicle (OMV) Antigen CNG20
Day 29
|
181.509 titer
Interval 136.805 to 240.82
|
89.334 titer
Interval 56.738 to 140.658
|
|
Serum IgG Concentrations (Geometric Mean Titers [GMT]) Against N. Gonorrhoeae Outer Membrane Vesicle (OMV) Antigen CNG20
Day 43
|
292.209 titer
Interval 238.827 to 357.524
|
86.342 titer
Interval 53.586 to 139.122
|
|
Serum IgG Concentrations (Geometric Mean Titers [GMT]) Against N. Gonorrhoeae Outer Membrane Vesicle (OMV) Antigen CNG20
Day 57
|
262.937 titer
Interval 215.848 to 320.298
|
90.205 titer
Interval 55.521 to 146.556
|
|
Serum IgG Concentrations (Geometric Mean Titers [GMT]) Against N. Gonorrhoeae Outer Membrane Vesicle (OMV) Antigen CNG20
Day 181
|
136.722 titer
Interval 108.9 to 171.653
|
100.148 titer
Interval 61.631 to 162.735
|
SECONDARY outcome
Timeframe: Day 1 through Day 181Population: The safety analysis population includes all participants who received at least one dose of study treatment. For analyses using the safety population, participants will be grouped by study treatment received
Frequency and severity of any adverse events (AE) related to 4CMenB immunization
Outcome measures
| Measure |
4CMenB
n=41 Participants
Participants will receive two doses (0.5 mL each) of 4CMenB vaccine on Day 1 and Day 29. Each single dose of vaccine will be administered via intramuscular (IM) injection into the deltoid muscle of the preferred arm.
Meningococcal Group B Vaccine: A combination vaccine consisting of recombinant proteins Neisserial adhesin A (NadA), Neisserial Heparin Binding Antigen (NHBA), and factor H binding protein (fHbp), Outer Membrane Vesicles (OMV), aluminum hydroxide, sodium chloride, histidine, and sucrose.
|
Placebo
n=11 Participants
Participants will receive two doses (0.5 mL each) of placebo injections (saline) on Day 1 and Day 29. Each single dose of placebo will be administered via intramuscular (IM) injection into the deltoid muscle of the preferred arm.
Placebo: 0.9% Sodium Chloride, USP injection.
|
|---|---|---|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Malaise · Severe
|
2 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Myalgia · Mild
|
21 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Myalgia · Moderate
|
4 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Myalgia · Severe
|
1 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Any Symptom · Mild
|
12 Participants
|
5 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Any Symptom · Moderate
|
24 Participants
|
1 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Any Symptom · Severe
|
5 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Any Systemic Symptom · Mild
|
24 Participants
|
4 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Any Systemic Symptom · Moderate
|
12 Participants
|
1 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Any Systemic Symptom · Severe
|
3 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Arthralgia · Mild
|
5 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Arthralgia · Moderate
|
3 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Arthralgia · Severe
|
0 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Fatigue · Mild
|
17 Participants
|
1 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Fatigue · Moderate
|
6 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Fatigue · Severe
|
2 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Headache · Mild
|
16 Participants
|
4 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Headache · Moderate
|
3 Participants
|
1 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Headache · Severe
|
0 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Malaise · Mild
|
15 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Malaise · Moderate
|
3 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Nausea · Mild
|
4 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Nausea · Moderate
|
1 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Nausea · Severe
|
1 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Pyrexia · Mild
|
7 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Pyrexia · Moderate
|
4 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Pyrexia · Severe
|
2 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Any Local Symptom · Mild
|
12 Participants
|
2 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Any Local Symptom · Moderate
|
24 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Any Local Symptom · Severe
|
4 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Administration Site Bruise · Mild
|
3 Participants
|
1 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Administration Site Bruise · Moderate
|
0 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Administration Site Bruise · Severe
|
0 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Administration Site Erythema · Mild
|
6 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Administration Site Erythema · Moderate
|
2 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Administration Site Erythema · Severe
|
0 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Administration Site Induration · Mild
|
8 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Administration Site Induration · Moderate
|
1 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Administration Site Induration · Severe
|
1 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Administration Site Pain · Mild
|
22 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Administration Site Pain · Moderate
|
15 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Administration Site Pain · Severe
|
1 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Administration Site Pruritus · Mild
|
3 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Administration Site Pruritus · Moderate
|
0 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Administration Site Pruritus · Severe
|
0 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Administration Site Tenderness · Mild
|
16 Participants
|
1 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Administration Site Tenderness · Moderate
|
21 Participants
|
0 Participants
|
|
The Reactogenicity of 4CMenB in Healthy Adult Participants
Administration Site Tenderness · Severe
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 181Population: The safety analysis population includes all participants who received at least one dose of study treatment. For analyses using the safety population, participants will be grouped by study treatment received
Frequency of SAEs through the end of the study.
Outcome measures
| Measure |
4CMenB
n=41 Participants
Participants will receive two doses (0.5 mL each) of 4CMenB vaccine on Day 1 and Day 29. Each single dose of vaccine will be administered via intramuscular (IM) injection into the deltoid muscle of the preferred arm.
Meningococcal Group B Vaccine: A combination vaccine consisting of recombinant proteins Neisserial adhesin A (NadA), Neisserial Heparin Binding Antigen (NHBA), and factor H binding protein (fHbp), Outer Membrane Vesicles (OMV), aluminum hydroxide, sodium chloride, histidine, and sucrose.
|
Placebo
n=11 Participants
Participants will receive two doses (0.5 mL each) of placebo injections (saline) on Day 1 and Day 29. Each single dose of placebo will be administered via intramuscular (IM) injection into the deltoid muscle of the preferred arm.
Placebo: 0.9% Sodium Chloride, USP injection.
|
|---|---|---|
|
Frequency of Serious Adverse Events (SAE)
|
0 Participants
|
0 Participants
|
Adverse Events
4CMenB
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
4CMenB
n=41 participants at risk
Participants will receive two doses (0.5 mL each) of 4CMenB vaccine on Day 1 and Day 29. Each single dose of vaccine will be administered via intramuscular (IM) injection into the deltoid muscle of the preferred arm.
Meningococcal Group B Vaccine: A combination vaccine consisting of recombinant proteins Neisserial adhesin A (NadA), Neisserial Heparin Binding Antigen (NHBA), and factor H binding protein (fHbp), Outer Membrane Vesicles (OMV), aluminum hydroxide, sodium chloride, histidine, and sucrose.
|
Placebo
n=11 participants at risk
Participants will receive two doses (0.5 mL each) of placebo injections (saline) on Day 1 and Day 29. Each single dose of placebo will be administered via intramuscular (IM) injection into the deltoid muscle of the preferred arm.
Placebo: 0.9% Sodium Chloride, USP injection.
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General disorders
Administration site bruise
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7.3%
3/41 • Number of events 3 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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9.1%
1/11 • Number of events 1 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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General disorders
Administration site erythema
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19.5%
8/41 • Number of events 9 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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0.00%
0/11 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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General disorders
Administration site induration
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24.4%
10/41 • Number of events 14 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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0.00%
0/11 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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General disorders
Administration site pain
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92.7%
38/41 • Number of events 68 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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0.00%
0/11 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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General disorders
Administration site pruritus
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7.3%
3/41 • Number of events 4 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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0.00%
0/11 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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General disorders
Administration site tenderness
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97.6%
40/41 • Number of events 77 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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9.1%
1/11 • Number of events 2 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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General disorders
Fatigue
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61.0%
25/41 • Number of events 38 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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9.1%
1/11 • Number of events 2 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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General disorders
Malaise
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48.8%
20/41 • Number of events 24 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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0.00%
0/11 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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General disorders
Pyrexia
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31.7%
13/41 • Number of events 16 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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0.00%
0/11 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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Musculoskeletal and connective tissue disorders
Arthraliga
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19.5%
8/41 • Number of events 12 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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0.00%
0/11 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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Musculoskeletal and connective tissue disorders
Myalgia
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63.4%
26/41 • Number of events 36 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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0.00%
0/11 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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Nervous system disorders
Headache
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46.3%
19/41 • Number of events 25 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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45.5%
5/11 • Number of events 6 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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Gastrointestinal disorders
Nausea
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14.6%
6/41 • Number of events 7 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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0.00%
0/11 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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Gastrointestinal disorders
Haemorrhoids
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0.00%
0/41 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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9.1%
1/11 • Number of events 1 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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Reproductive system and breast disorders
Abnormal uterine bleeding
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0.00%
0/41 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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9.1%
1/11 • Number of events 1 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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Infections and infestations
COVID-19
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7.3%
3/41 • Number of events 3 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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0.00%
0/11 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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Infections and infestations
Fungal infection
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0.00%
0/41 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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9.1%
1/11 • Number of events 1 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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Injury, poisoning and procedural complications
Meniscus injury
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0.00%
0/41 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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9.1%
1/11 • Number of events 1 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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Surgical and medical procedures
Meniscus operation
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0.00%
0/41 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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9.1%
1/11 • Number of events 1 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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Respiratory, thoracic and mediastinal disorders
Nasal congestion
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4.9%
2/41 • Number of events 2 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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9.1%
1/11 • Number of events 1 • Solicited injection site and systemic reactogenicity events were documented and reported from Day 1 through Day 8 and Day 29 through Day 36. Unsolicited AEs were collected and assessed through the end of the protocol-defined follow up period (181 days post first vaccination)
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Additional Information
Varun K. Phadke, MD
Emory University Vaccine and Treatment Evaluation Unit (VTEU)
Phone: 404-712-9046
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60