Trial Outcomes & Findings for Experimental Human Infection With Neisseria Gonorrhoeae (NCT NCT03840811)
NCT ID: NCT03840811
Last Updated: 2021-03-23
Results Overview
The competitive index (CI) is defined by the ratio of colony forming units (cfu) of the two strains recovered from urine cultures on the day of treatment (output) compared to the ratio of strains in the inoculum (input): CI = mutant cfu(output)/wild-type cfu(output) ÷ mutant cfu(input)/wild-type cfu(input). The CI is used to assess whether the fitness of a given mutant is different than that of wild-type, and CI as a ratio is compared to 1. If it's not significantly different than 1, then no significant difference in the fitness was observed. Mutant or wild-type cfu values of 0 were replaced by 1 in the calculation of competitive index. The assessment was performed in the MtrD trial mixed group.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
Baseline and the day of treatment, any day between Day 2 and Day 6
Results posted on
2021-03-23
Participant Flow
Males aged 18-\<36 years old, living in central North Carolina, in general good health with no history of sexually transmitted infection (STIs) were enrolled. Participants were enrolled between 23APR2017 and 10NOV2019.
Participant milestones
| Measure |
Mutant FA7537
Participants received a bacterial inoculum containing only the isogenic mtrD mutant N. gonorrhoeae strain.
Cefixime: Mandatory rescue therapy consisting of cefixime 400 mg orally in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation.
Ceftriaxone: Mandatory rescue therapy consisting of ceftriaxone 250 mg intramuscularly in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation.
Ciprofloxacin: Mandatory antibiotic treatment failure therapy: Ciprofloxacin 500 mg orally in a single dose: if the participant has a positie test of cure 1 week post initial antibiotic treatment.
Neisseria gonorrhoeae strain FA7537: 0.4 mL of a suspension containing 10\^5 - 10\^6 CFU of Neisseria gonorrhoeae, in phosphate-buffered saline, delivered to the anterior urethra through a No.8 pediatric French catheter.
|
Wild-type FA1090
Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain.
Cefixime: Mandatory rescue therapy consisting of cefixime 400 mg orally in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation.
Ceftriaxone: Mandatory rescue therapy consisting of ceftriaxone 250 mg intramuscularly in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation.
Ciprofloxacin: Mandatory antibiotic treatment failure therapy: Ciprofloxacin 500 mg orally in a single dose: if the participant has a positie test of cure 1 week post initial antibiotic treatment.
Neisseria gonorrhoeae strain FA1090 A26: 0.4 mL of a suspension containing 10\^5 - 10\^6 CFU of Neisseria gonorrhoeae, in phosphate-buffered saline, delivered to the anterior urethra through a No.8 pediatric French catheter.
|
Mixed FA1090/FA7537
Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic MtrD mutant and WT strain.
Cefixime: Mandatory rescue therapy consisting of cefixime 400 mg orally in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation.
Ceftriaxone: Mandatory rescue therapy consisting of ceftriaxone 250 mg intramuscularly in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation.
Ciprofloxacin: Mandatory antibiotic treatment failure therapy: Ciprofloxacin 500 mg orally in a single dose: if the participant has a positie test of cure 1 week post initial antibiotic treatment.
Neisseria gonorrhoeae strain FA1090 A26: 0.4 mL of a suspension containing 10\^5 - 10\^6 CFU of Neisseria gonorrhoeae, in phosphate-buffered saline, delivered to the anterior urethra through a No.8 pediatric French catheter.
Neisseria gonorrhoeae strain FA7537: 0.4 mL of a suspension containing 10\^5 - 10\^6 CFU of Neisseria gonorrhoeae, in phosphate-buffered saline, delivered to the anterior urethra through a No.8 pediatric French catheter.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
6
|
12
|
|
Overall Study
COMPLETED
|
9
|
6
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Mutant FA7537
Participants received a bacterial inoculum containing only the isogenic mtrD mutant N. gonorrhoeae strain.
Cefixime: Mandatory rescue therapy consisting of cefixime 400 mg orally in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation.
Ceftriaxone: Mandatory rescue therapy consisting of ceftriaxone 250 mg intramuscularly in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation.
Ciprofloxacin: Mandatory antibiotic treatment failure therapy: Ciprofloxacin 500 mg orally in a single dose: if the participant has a positie test of cure 1 week post initial antibiotic treatment.
Neisseria gonorrhoeae strain FA7537: 0.4 mL of a suspension containing 10\^5 - 10\^6 CFU of Neisseria gonorrhoeae, in phosphate-buffered saline, delivered to the anterior urethra through a No.8 pediatric French catheter.
|
Wild-type FA1090
Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain.
Cefixime: Mandatory rescue therapy consisting of cefixime 400 mg orally in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation.
Ceftriaxone: Mandatory rescue therapy consisting of ceftriaxone 250 mg intramuscularly in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation.
Ciprofloxacin: Mandatory antibiotic treatment failure therapy: Ciprofloxacin 500 mg orally in a single dose: if the participant has a positie test of cure 1 week post initial antibiotic treatment.
Neisseria gonorrhoeae strain FA1090 A26: 0.4 mL of a suspension containing 10\^5 - 10\^6 CFU of Neisseria gonorrhoeae, in phosphate-buffered saline, delivered to the anterior urethra through a No.8 pediatric French catheter.
|
Mixed FA1090/FA7537
Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic MtrD mutant and WT strain.
Cefixime: Mandatory rescue therapy consisting of cefixime 400 mg orally in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation.
Ceftriaxone: Mandatory rescue therapy consisting of ceftriaxone 250 mg intramuscularly in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation.
Ciprofloxacin: Mandatory antibiotic treatment failure therapy: Ciprofloxacin 500 mg orally in a single dose: if the participant has a positie test of cure 1 week post initial antibiotic treatment.
Neisseria gonorrhoeae strain FA1090 A26: 0.4 mL of a suspension containing 10\^5 - 10\^6 CFU of Neisseria gonorrhoeae, in phosphate-buffered saline, delivered to the anterior urethra through a No.8 pediatric French catheter.
Neisseria gonorrhoeae strain FA7537: 0.4 mL of a suspension containing 10\^5 - 10\^6 CFU of Neisseria gonorrhoeae, in phosphate-buffered saline, delivered to the anterior urethra through a No.8 pediatric French catheter.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
Experimental Human Infection With Neisseria Gonorrhoeae
Baseline characteristics by cohort
| Measure |
Mutant FA7537
n=9 Participants
Participants received a bacterial inoculum containing only the isogenic MtrD mutant N. gonorrhoeae strain.
|
Wild-type FA1090
n=6 Participants
Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain.
|
Mixed FA1090/FA7537
n=12 Participants
Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic MtrD mutant and WT strain.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
25.2 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
21.8 years
STANDARD_DEVIATION 2.8 • n=7 Participants
|
25.2 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
24.4 years
STANDARD_DEVIATION 4.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
27 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and the day of treatment, any day between Day 2 and Day 6Population: The evaluable population included participants who received a dose of N. gonorrhoeae within 1 log10 of the intended dose, reached an objective study endpoint (urethral discharge or day 6), and had a valid competitive index (the competitive index could not be calculated for participant who had a negative urine culture result on the day of treatment).
The competitive index (CI) is defined by the ratio of colony forming units (cfu) of the two strains recovered from urine cultures on the day of treatment (output) compared to the ratio of strains in the inoculum (input): CI = mutant cfu(output)/wild-type cfu(output) ÷ mutant cfu(input)/wild-type cfu(input). The CI is used to assess whether the fitness of a given mutant is different than that of wild-type, and CI as a ratio is compared to 1. If it's not significantly different than 1, then no significant difference in the fitness was observed. Mutant or wild-type cfu values of 0 were replaced by 1 in the calculation of competitive index. The assessment was performed in the MtrD trial mixed group.
Outcome measures
| Measure |
Mixed FA1090/FA7537
n=10 Participants
Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic MtrD mutant and WT strain.
|
Wild-type FA1090
Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain.
|
|---|---|---|
|
The Competitive Index of the Mutant Compared to Wild Type Proportion of Organisms With the Predicted Competitive Advantage Recovered From Urine and/or Urethral Swab Specimens From Infected Participants
|
15.11 ratio
Interval 0.01 to 78.93
|
—
|
PRIMARY outcome
Timeframe: day of infection, any day between Day 2 and Day 6Population: The evaluable population included participants who received a dose of N. gonorrhoeae within 1 log10 of the intended dose and reached an objective study endpoint (urethral discharge or day 6).
Infection is defined by a positive urine or urethral swab culture. The proportion of infected participants by Day 6 with N. gonorrhoeae was assessed in each trial by group among participants with non-competitive infections. Participants could become infected and received treatment any day before or on day 6.
Outcome measures
| Measure |
Mixed FA1090/FA7537
n=7 Participants
Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic MtrD mutant and WT strain.
|
Wild-type FA1090
n=6 Participants
Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain.
|
|---|---|---|
|
Proportion of Participants That Become Infected as Defined by a Positive Urine or Urethral Swab Culture Among Infections Initiated With Individual N. Gonorrhoeae Strains in Non-competitive Infections
|
0.86 proportion of participants
Interval 0.42 to 1.0
|
1.00 proportion of participants
Interval 0.54 to 1.0
|
PRIMARY outcome
Timeframe: day of infection, any day between Day 2 and Day 6Population: The evaluable population included participants who received a dose of N. gonorrhoeae within 1 log10 of the intended dose and reached an objective study endpoint (urethral discharge or day 6).
Infection is defined by a positive urine or urethral swab culture. The proportion of infected participants by Day 6 with N. gonorrhoeae was assessed in each trial among participants with infections initiated with mixed inocula. Participants could become infected and received treatment any day before or on day 6.
Outcome measures
| Measure |
Mixed FA1090/FA7537
n=11 Participants
Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic MtrD mutant and WT strain.
|
Wild-type FA1090
Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain.
|
|---|---|---|
|
Proportion of Participants That Become Infected as Defined by a Positive Urine or Urethral Swab Culture for Infections Initiated With Mixed Inocula
|
1.00 proportion of participants
Interval 0.72 to 1.0
|
—
|
SECONDARY outcome
Timeframe: Day 2 through the day of treatment, up to Day 6Population: The evaluable population included participants who received a dose of N. gonorrhoeae within 1 log10 of the intended dose and reached an objective study endpoint (urethral discharge or day 6).
The median time from inoculation to antibiotic treatment were calculated for each group.
Outcome measures
| Measure |
Mixed FA1090/FA7537
n=7 Participants
Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic MtrD mutant and WT strain.
|
Wild-type FA1090
n=6 Participants
Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain.
|
|---|---|---|
|
Median Time From Inoculation to Treatment Among Infected Participants by Day 6, by Strain, in Non-competitive Infections
|
3.0 days
Interval 1.0 to 5.0
|
3.0 days
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Day of occurrence, any day between Day 2 and Day 6Population: The evaluable population included participants who received a dose of N. gonorrhoeae within 1 log10 of the intended dose and reached an objective study endpoint (urethral discharge or day 6).
Bacteriuria is defined as Log10 cfu N. gonorrhoeae/mL urine sediment.
Outcome measures
| Measure |
Mixed FA1090/FA7537
n=7 Participants
Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic MtrD mutant and WT strain.
|
Wild-type FA1090
n=6 Participants
Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain.
|
|---|---|---|
|
Proportion of Participants With Occurrence of Bacteriuria in Non-competitive Infections, by Strain
|
0.86 proportion of participants
Interval 0.42 to 1.0
|
1.00 proportion of participants
Interval 0.54 to 1.0
|
SECONDARY outcome
Timeframe: Day of occurrence, any day between Day 2 and Day 6Population: The evaluable population included participants who received a dose of N. gonorrhoeae within 1 log10 of the intended dose and reached an objective study endpoint (urethral discharge or day 6).
Participants with any subjective symptoms or objective signs (observed urethral discharge) during period 01 (post-inoculation and before treatment which can occur on or before day 6) from the Solicited Events Form were captured.
Outcome measures
| Measure |
Mixed FA1090/FA7537
n=7 Participants
Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic MtrD mutant and WT strain.
|
Wild-type FA1090
n=6 Participants
Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain.
|
|---|---|---|
|
Proportion of Participants With Occurrence of Signs and Symptoms of Urethritis Attributable to Gonococcal Infection in Non-competitive Infections, by Strain
|
1.00 proportion of participants
Interval 0.59 to 1.0
|
1.00 proportion of participants
Interval 0.54 to 1.0
|
SECONDARY outcome
Timeframe: Day of occurrence, any day between Day 2 and Day 6Population: The evaluable population included participants who received a dose of N. gonorrhoeae within 1 log10 of the intended dose and reached an objective study endpoint (urethral discharge or day 6).
Urethritis is defined as \>= 5.8 Log10 WBC/mL urine sediment.
Outcome measures
| Measure |
Mixed FA1090/FA7537
n=7 Participants
Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic MtrD mutant and WT strain.
|
Wild-type FA1090
n=6 Participants
Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain.
|
|---|---|---|
|
Proportion of Participants With Occurrence of Urethritis in Non-competitive Infections
|
1.00 proportion of participants
Interval 0.59 to 1.0
|
1.00 proportion of participants
Interval 0.54 to 1.0
|
Adverse Events
Mutant FA7537
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Wild-type FA1090
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Mixed FA1090/FA7537
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mutant FA7537
n=9 participants at risk
Participants received a bacterial inoculum containing only the isogenic MtrD mutant N. gonorrhoeae strain.
|
Wild-type FA1090
n=6 participants at risk
Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain.
|
Mixed FA1090/FA7537
n=12 participants at risk
Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic MtrD mutant and WT strain.
|
|---|---|---|---|
|
Nervous system disorders
Tingling
|
0.00%
0/9 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
0.00%
0/6 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
8.3%
1/12 • Number of events 1 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
|
Reproductive system and breast disorders
Irritation or Itching
|
22.2%
2/9 • Number of events 2 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
0.00%
0/6 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
8.3%
1/12 • Number of events 1 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
|
Renal and urinary disorders
Dysuria
|
33.3%
3/9 • Number of events 3 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
50.0%
3/6 • Number of events 3 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
8.3%
1/12 • Number of events 1 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
|
Renal and urinary disorders
Urethral Discharge
|
0.00%
0/9 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
16.7%
1/6 • Number of events 1 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
0.00%
0/12 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
|
General disorders
Feverishness
|
11.1%
1/9 • Number of events 1 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
0.00%
0/6 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
0.00%
0/12 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
|
Reproductive system and breast disorders
Testicular Pain
|
11.1%
1/9 • Number of events 1 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
0.00%
0/6 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
16.7%
2/12 • Number of events 2 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
|
Renal and urinary disorders
Urinary Frequency
|
0.00%
0/9 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
0.00%
0/6 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
8.3%
1/12 • Number of events 1 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/9 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
16.7%
1/6 • Number of events 1 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
0.00%
0/12 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
0.00%
0/6 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
8.3%
1/12 • Number of events 1 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/9 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
16.7%
1/6 • Number of events 1 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
0.00%
0/12 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
|
Investigations
Heart Rate Irregular
|
11.1%
1/9 • Number of events 1 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
0.00%
0/6 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
0.00%
0/12 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
|
Nervous system disorders
Presyncope
|
0.00%
0/9 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
0.00%
0/6 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
8.3%
1/12 • Number of events 1 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
|
Immune system disorders
Seasonal Allergy
|
11.1%
1/9 • Number of events 1 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
0.00%
0/6 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
0.00%
0/12 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
|
Renal and urinary disorders
Urethritis Noninfective
|
0.00%
0/9 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
16.7%
1/6 • Number of events 1 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
8.3%
1/12 • Number of events 1 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
11.1%
1/9 • Number of events 1 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
0.00%
0/6 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
8.3%
1/12 • Number of events 1 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
0.00%
0/6 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
8.3%
1/12 • Number of events 1 • All adverse events that occurred from inoculation (Day 1) through the 2 week final follow-up phone call (Study Days 12-23) were reported.
The solicited and unsolicited AEs reported for the MtrD trial were summarized using MedDRA 22.1
|
Additional Information
Marcia M. Hobbs, PhD
University of North Carolina at Chapel Hill
Phone: (919) 843-6893
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60