Trial Outcomes & Findings for Study to Assess Gonorrhoeae Immune Responses Induced by a N. Meningitidis Vaccine (NCT NCT04094883)
NCT ID: NCT04094883
Last Updated: 2021-07-15
Results Overview
The change in concentrations presented as the difference in geometric mean concentration in human serum of IgG binding to N. gonorrhoeae strain FA1090 surface antigens Outer-membrane vesicles (OMV) determined by ELISA in serum from entry visit and week 7 visit
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
11 participants
Primary outcome timeframe
pre-vaccination at entry visit (prior to first vaccination, Day 0) and week 7 visit (2 weeks after second vaccination)
Results posted on
2021-07-15
Participant Flow
Participant milestones
| Measure |
4CMenB Vaccine
Participants will receive the 4CMenB (Bexsero) vaccine by an injection in the deltoid region of the upper arm or the higher front area on one side of the thigh at the enrollment visit (Day 0) and at week 5.
Meningococcal Group B Vaccine: All participants will receive the 4CMenB vaccine, 0.5 mL, at entry (Day 0) and at week 5.
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|---|---|
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Overall Study
STARTED
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11
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
4CMenB Vaccine
Participants will receive the 4CMenB (Bexsero) vaccine by an injection in the deltoid region of the upper arm or the higher front area on one side of the thigh at the enrollment visit (Day 0) and at week 5.
Meningococcal Group B Vaccine: All participants will receive the 4CMenB vaccine, 0.5 mL, at entry (Day 0) and at week 5.
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|---|---|
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
Study to Assess Gonorrhoeae Immune Responses Induced by a N. Meningitidis Vaccine
Baseline characteristics by cohort
| Measure |
4CMenB Vaccine
n=11 Participants
Participants will receive the 4CMenB (Bexsero) vaccine by an injection in the deltoid region of the upper arm or the higher front area on one side of the thigh at the enrollment visit (Day 0) and at week 5.
Meningococcal Group B Vaccine: All participants will receive the 4CMenB vaccine, 0.5 mL, at entry (Day 0) and at week 5.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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11 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Sex: Female, Male
Female
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4 Participants
n=5 Participants
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Sex: Female, Male
Male
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7 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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3 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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8 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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4 Participants
n=5 Participants
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|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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7 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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11 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: pre-vaccination at entry visit (prior to first vaccination, Day 0) and week 7 visit (2 weeks after second vaccination)The change in concentrations presented as the difference in geometric mean concentration in human serum of IgG binding to N. gonorrhoeae strain FA1090 surface antigens Outer-membrane vesicles (OMV) determined by ELISA in serum from entry visit and week 7 visit
Outcome measures
| Measure |
4CMenB Vaccine
n=10 Participants
Participants will receive the 4CMenB (Bexsero) vaccine by an injection in the deltoid region of the upper arm or the higher front area on one side of the thigh at the enrollment visit (Day 0) and at week 5.
Meningococcal Group B Vaccine: All participants will receive the 4CMenB vaccine, 0.5 mL, at entry (Day 0) and at week 5.
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Change in Anti-N. Gonorrhoeae Outer-membrane Vesicle Specific Immunoglobulin G (IgG) Concentrations After Immunization
Anti-N. gonorrhoeae OMV titer (dilution giving half maximal response) - Entry Visit
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61.57 titers
Interval 38.7 to 97.97
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Change in Anti-N. Gonorrhoeae Outer-membrane Vesicle Specific Immunoglobulin G (IgG) Concentrations After Immunization
Anti-N. gonorrhoeae OMV titer (dilution giving half maximal response) - Week 7 Visit
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206.2 titers
Interval 141.9 to 299.5
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PRIMARY outcome
Timeframe: pre-vaccination at entry visit (prior to first vaccination, Day 0) and week 7 visit (2 weeks after second vaccination)The change in concentrations presented as the difference in geometric mean concentration in human serum of IgM binding to N. gonorrhoeae strain FA1090 surface antigens (Outer-membrane vesicles) determined by ELISA in serum from entry visit and week 7 visit
Outcome measures
| Measure |
4CMenB Vaccine
n=10 Participants
Participants will receive the 4CMenB (Bexsero) vaccine by an injection in the deltoid region of the upper arm or the higher front area on one side of the thigh at the enrollment visit (Day 0) and at week 5.
Meningococcal Group B Vaccine: All participants will receive the 4CMenB vaccine, 0.5 mL, at entry (Day 0) and at week 5.
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Change in Anti-N. Gonorrhoeae Outer-membrane Vesicle Specific Immunoglobulin M (IgM) Concentrations After Immunization
Anti-N. gonorrhoeae OMV titer (dilution giving half maximal response) - Entry Visit
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86.89 titer
Interval 58.96 to 128.1
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Change in Anti-N. Gonorrhoeae Outer-membrane Vesicle Specific Immunoglobulin M (IgM) Concentrations After Immunization
Anti-N. gonorrhoeae OMV titer (dilution giving half maximal response) - Week 7 Visit
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83.84 titer
Interval 57.34 to 122.6
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PRIMARY outcome
Timeframe: pre-vaccination at entry visit (prior to first vaccination, Day 0) and week 7 visit (2 weeks after second vaccination)The change in concentrations presented as the difference in geometric mean concentration in human serum of IgA binding to N. gonorrhoeae strain FA1090 surface antigens (Outer-membrane vesicles) determined by ELISA in serum from entry visit and week 7 visit
Outcome measures
| Measure |
4CMenB Vaccine
n=10 Participants
Participants will receive the 4CMenB (Bexsero) vaccine by an injection in the deltoid region of the upper arm or the higher front area on one side of the thigh at the enrollment visit (Day 0) and at week 5.
Meningococcal Group B Vaccine: All participants will receive the 4CMenB vaccine, 0.5 mL, at entry (Day 0) and at week 5.
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Change in Anti-N. Gonorrhoeae Outer-membrane Vesicle Specific Immunoglobulin A (IgA ) Concentrations After Immunization
Anti-N. gonorrhoeae OMV titer (dilution giving half maximal response) - Entry Visit
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3.689 titer
Interval 2.155 to 6.315
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Change in Anti-N. Gonorrhoeae Outer-membrane Vesicle Specific Immunoglobulin A (IgA ) Concentrations After Immunization
Anti-N. gonorrhoeae OMV titer (dilution giving half maximal response) - Week 7 Visit
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4.725 titer
Interval 3.044 to 7.335
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PRIMARY outcome
Timeframe: pre-vaccination at entry visit (prior to first vaccination, Day 0) and week 7 visit (2 weeks after second vaccination)Flow cytometry used to measure the number of CD4+ lymphocytes expressing Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), Interleukin-2 (IL-2), and Cluster of Differentiation 107a (CD107a) after in vitro stimulation with N. gonorrhoeae strain FA1090 Outer-membrane vesicles in circulating peripheral blood mononuclear cells (PBMC). The frequency of CD4+ T cells expressing at least two activation markers will be expressed as a proportion of total CD4+ lymphocytes. The change in frequency will be presented as the difference between frequency of cells measured at entry visit and at week 7 visit.
Outcome measures
| Measure |
4CMenB Vaccine
n=10 Participants
Participants will receive the 4CMenB (Bexsero) vaccine by an injection in the deltoid region of the upper arm or the higher front area on one side of the thigh at the enrollment visit (Day 0) and at week 5.
Meningococcal Group B Vaccine: All participants will receive the 4CMenB vaccine, 0.5 mL, at entry (Day 0) and at week 5.
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Mean Change in Proportion of Cluster of Differentiation 4 Positive (CD4+) T Cells Expressing at Least Two Different Activation Markers After Immunization
proportion of CD4+ positive lymphocytes expressing least two activation markers -Entry Visit
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0.002750 proportion CD4 cells
Interval 0.001222 to 0.004279
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Mean Change in Proportion of Cluster of Differentiation 4 Positive (CD4+) T Cells Expressing at Least Two Different Activation Markers After Immunization
proportion of CD4+ positive lymphocytes expressing least two activation markers - week 7 Visit
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0.003058 proportion CD4 cells
Interval 0.002552 to 0.003564
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Adverse Events
4CMenB Vaccine
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 |
4CMenB Vaccine
n=11 participants at risk
Participants will receive the 4CMenB (Bexsero) vaccine by an injection in the deltoid region of the upper arm or the higher front area on one side of the thigh at the enrollment visit (Day 0) and at week 5.
Meningococcal Group B Vaccine: All participants will receive the 4CMenB vaccine, 0.5 mL, at entry (Day 0) and at week 5.
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General disorders
injection site (left deltoid) pain
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72.7%
8/11 • Number of events 16 • From signing of Informed Consent until study completion, a total of up to 26 weeks.
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General disorders
Injection site (left deltoid) tenderness
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36.4%
4/11 • Number of events 7 • From signing of Informed Consent until study completion, a total of up to 26 weeks.
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General disorders
Injection site (left deltoid) erythema
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18.2%
2/11 • Number of events 2 • From signing of Informed Consent until study completion, a total of up to 26 weeks.
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General disorders
Injection site (left deltoid) induration
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18.2%
2/11 • Number of events 2 • From signing of Informed Consent until study completion, a total of up to 26 weeks.
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General disorders
Injection site (left deltoid) swelling
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9.1%
1/11 • Number of events 1 • From signing of Informed Consent until study completion, a total of up to 26 weeks.
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General disorders
Fatigue
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27.3%
3/11 • Number of events 4 • From signing of Informed Consent until study completion, a total of up to 26 weeks.
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General disorders
Subjective fever
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18.2%
2/11 • Number of events 2 • From signing of Informed Consent until study completion, a total of up to 26 weeks.
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General disorders
chills
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9.1%
1/11 • Number of events 1 • From signing of Informed Consent until study completion, a total of up to 26 weeks.
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Gastrointestinal disorders
Nausea
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18.2%
2/11 • Number of events 2 • From signing of Informed Consent until study completion, a total of up to 26 weeks.
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Gastrointestinal disorders
Abdominal pain
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9.1%
1/11 • Number of events 1 • From signing of Informed Consent until study completion, a total of up to 26 weeks.
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Gastrointestinal disorders
Gastroesophageal reflux
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9.1%
1/11 • Number of events 1 • From signing of Informed Consent until study completion, a total of up to 26 weeks.
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Nervous system disorders
Headache
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18.2%
2/11 • Number of events 5 • From signing of Informed Consent until study completion, a total of up to 26 weeks.
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Nervous system disorders
lightheadedness
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9.1%
1/11 • Number of events 1 • From signing of Informed Consent until study completion, a total of up to 26 weeks.
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General disorders
flushing
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9.1%
1/11 • Number of events 1 • From signing of Informed Consent until study completion, a total of up to 26 weeks.
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Infections and infestations
pharyngitis
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9.1%
1/11 • Number of events 1 • From signing of Informed Consent until study completion, a total of up to 26 weeks.
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Infections and infestations
cough and nasal congestion
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9.1%
1/11 • Number of events 1 • From signing of Informed Consent until study completion, a total of up to 26 weeks.
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Infections and infestations
upper respiratory tract infection
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9.1%
1/11 • Number of events 1 • From signing of Informed Consent until study completion, a total of up to 26 weeks.
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Surgical and medical procedures
wisdom teeth extraction
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9.1%
1/11 • Number of events 1 • From signing of Informed Consent until study completion, a total of up to 26 weeks.
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Additional Information
Joseph Duncan, MD, PhD
University of North Carolina at Chapel Hill
Phone: 919-966-2536
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place