Trial Outcomes & Findings for Experimental Human Infection With Neisseria Gonorrhoeae (LptA Trial) (NCT NCT04870138)

NCT ID: NCT04870138

Last Updated: 2021-12-02

Results Overview

Infection defined as reported symptoms of urethritis, including urethral discharge or dysuria, plus presence of gram-negative intracellular diplococci in a urethral swab smear. The proportion of infected participants by Day 5 with N. gonorrhoeae was assessed by group among participants with non-competitive infections. Participants could become infected and received treatment any day before or on day 5.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 16 participants
• Primary outcome timeframe: Day of infection, any day between Day 1 and Day 5
• Results posted on: 2021-12-02

Participant Flow

Males aged 18-<36 years old, living in central North Carolina, in general good health with no history of sexually transmitted infections (STIs) were enrolled. Participants were enrolled between 10MAR2013 and 26APR2015.

Participant milestones

Measure	Mutant FA7527 - LptA Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Neisseria gonorrhoeae strain FA7527: 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. Mandatory rescue therapy consisting of ceftriaxone 250 mg intramuscularly in a single dose; or Ciprofloxacin 500 mg orally in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation.	Wild-type FA1090 A25 Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Neisseria gonorrhoeae strain FA1090 A25: 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. Mandatory rescue therapy consisting of ceftriaxone 250 mg intramuscularly in a single dose; or Ciprofloxacin 500 mg orally in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation.	Mixed FA7527/FA1090 A25 Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Neisseria gonorrhoeae strains FA7527 and FA1090 A25: 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. Mandatory rescue therapy consisting of ceftriaxone 250 mg intramuscularly in a single dose; or Ciprofloxacin 500 mg orally in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation.
Overall Study STARTED	5	5	6
Overall Study COMPLETED	5	5	6
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Experimental Human Infection With Neisseria Gonorrhoeae (LptA Trial)

Baseline characteristics by cohort

Measure	Mutant FA7527 - LptA n=5 Participants Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Wild-type FA1090 n=5 Participants Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Mixed FA7527/FA1090 n=6 Participants Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Total n=16 Participants Total of all reporting groups
Age, Continuous	24.3 Years STANDARD_DEVIATION 2.6 • n=5 Participants	22.1 Years STANDARD_DEVIATION 2.3 • n=7 Participants	24.9 Years STANDARD_DEVIATION 3.3 • n=5 Participants	23.8 Years STANDARD_DEVIATION 2.9 • 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	5 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	16 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	14 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	1 Participants n=7 Participants	0 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	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	10 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	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants	16 participants n=4 Participants

PRIMARY outcome

Timeframe: Day of infection, any day between Day 1 and Day 5

Population: All participants inoculated with a dose of N. gonorrhoeae within 1 log10 of the intended dose and reached an objective study endpoint (symptoms of urethritis or day 5)

Infection defined as reported symptoms of urethritis, including urethral discharge or dysuria, plus presence of gram-negative intracellular diplococci in a urethral swab smear. The proportion of infected participants by Day 5 with N. gonorrhoeae was assessed by group among participants with non-competitive infections. Participants could become infected and received treatment any day before or on day 5.

Outcome measures

Measure	Mutant FA7527 - LptA n=5 Participants Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Wild-type FA1090 A25 n=5 Participants Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Mixed FA7527/FA1090 A25 Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
The Proportion of Participants That Become Infected With Individual N. Gonorrhoeae Strains in Non-competitive Infections	0.80 proportion of participants Interval 0.28 to 0.99	1.00 proportion of participants Interval 0.47 to 1.0	—

PRIMARY outcome

Timeframe: Day of infection, any day between Day 1 and Day 5

Population: All participants inoculated with a dose of N. gonorrhoeae within 1 log10 of the intended dose and reached an objective study endpoint (symptoms of urethritis or day 5).

Infection defined as reported symptoms of urethritis, including urethral discharge or dysuria, plus presence of gram-negative intracellular diplococci in a urethral swab smear. Participants could become infected and received treatment any day before or on day 5.

Outcome measures

Measure	Mutant FA7527 - LptA n=6 Participants Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Wild-type FA1090 A25 Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Mixed FA7527/FA1090 A25 Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
The Proportion of Participants That Become Infected With Mixed Inoculum	0.83 proportion of participants Interval 0.36 to 1.0	—	—

PRIMARY outcome

Timeframe: Baseline (Day 0) and the day of infection (any day between Day 1 and Day 5)

Population: All participants inoculated with a dose of N. gonorrhoeae within 1 log10 of the intended dose and reached an objective study endpoint (symptoms of urethritis or day 5).

Infection defined as reported symptoms of urethritis, including urethral discharge or dysuria, plus presence of gram-negative intracellular diplococci in a urethral swab smear. Participants could become infected and received treatment any day before or on day 5.

Outcome measures

Measure	Mutant FA7527 - LptA n=5 Participants Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Wild-type FA1090 A25 Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Mixed FA7527/FA1090 A25 Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
The Proportion of Wild Type (WT) Organisms Recovered From Urine and Urethral Swab Specimens From Individual Subjects Infected With Mixed Inoculum	1.0 proportion of WT organisms recovered Standard Deviation 0.0	—	—

SECONDARY outcome

Timeframe: Screening Visit (Day -30 to Day -1), Treatment Visit (Day 1 to Day 5), and Follow-Up Visit (3 to 7 days following Treatment Visit)

Population: All participants in the single-strain infection groups, consisting of the Mutant FA7527 - LptA group and Wild-type FA1090 A25 group, with EGF Cytokine outcomes specified in Description.

EGF Cytokine levels in peripheral blood collected from subjects were measured at the screening visit, during experimental infection and at the follow-up visit. Only cytokines detected during the treatment visit upon experimental infection or day 5 in > 50% of peripheral blood samples are included. Cytokine outcome values reported below the limit of quantitation are assigned 1/2 the lower limit of quantitation for calculation of mean values; limits of 95% confidence intervals are bounded by 1/2 the lower limit of quantitation and the upper limit of quantitation for each cytokine.

Outcome measures

Measure	Mutant FA7527 - LptA n=5 Participants Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Wild-type FA1090 A25 n=5 Participants Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Mixed FA7527/FA1090 A25 Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
EGF Cytokine Levels in Peripheral Blood Screening Visit	85.0 pg/mL Interval 1.8 to 189.6	33.5 pg/mL Interval 1.8 to 82.6	—
EGF Cytokine Levels in Peripheral Blood Treatment Visit	42.6 pg/mL Interval 2.9 to 82.3	29.6 pg/mL Interval 1.8 to 73.1	—
EGF Cytokine Levels in Peripheral Blood Follow-Up Visit	37.9 pg/mL Interval 1.8 to 79.2	42.9 pg/mL Interval 1.8 to 92.5	—

SECONDARY outcome

Timeframe: Screening Visit (Day -30 to Day -1), Treatment Visit (Day 1 to Day 5), and Follow-Up Visit (3 to 7 days following Treatment Visit)

Population: All participants in the single-strain infection groups, consisting of the Mutant FA7527 - LptA group and Wild-type FA1090 A25 group, with Eotaxin Cytokine outcomes specified in Description.

Eotaxin cytokine levels in peripheral blood collected from subjects were measured at the screening visit, during experimental infection and at the follow-up visit. Only cytokines detected during the treatment visit upon experimental infection or day 5 in > 50% of peripheral blood samples are included. Cytokine outcome values reported below the limit of quantitation are assigned 1/2 the lower limit of quantitation for calculation of mean values; limits of 95% confidence intervals are bounded by 1/2 the lower limit of quantitation and the upper limit of quantitation for each cytokine.

Outcome measures

Measure	Mutant FA7527 - LptA n=5 Participants Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Wild-type FA1090 A25 n=5 Participants Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Mixed FA7527/FA1090 A25 Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
Eotaxin Cytokine Levels in Peripheral Blood Screening Visit	351.9 pg/mL Interval 91.6 to 612.2	267.4 pg/mL Interval 162.9 to 371.9	—
Eotaxin Cytokine Levels in Peripheral Blood Treatment Visit	422.7 pg/mL Interval 25.7 to 819.7	247.3 pg/mL Interval 25.9 to 468.7	—
Eotaxin Cytokine Levels in Peripheral Blood Follow-Up Visit	407.1 pg/mL Interval 1.5 to 840.8	218.3 pg/mL Interval 69.5 to 367.1	—

SECONDARY outcome

Timeframe: Screening Visit (Day -30 to Day -1), Treatment Visit (Day 1 to Day 5), and Follow-Up Visit (3 to 7 days following Treatment Visit)

Population: All participants in the single-strain infection groups, consisting of the Mutant FA7527 - LptA group and Wild-type FA1090 A25 group, with G-CSF Cytokine outcomes specified in Description.

G-CSF Cytokine levels in peripheral blood collected from subjects were measured at the screening visit, during experimental infection and at the follow-up visit. Only cytokines detected during the treatment visit upon experimental infection or day 5 in > 50% of peripheral blood samples are included. Cytokine outcome values reported below the limit of quantitation are assigned 1/2 the lower limit of quantitation for calculation of mean values; limits of 95% confidence intervals are bounded by 1/2 the lower limit of quantitation and the upper limit of quantitation for each cytokine.

Outcome measures

Measure	Mutant FA7527 - LptA n=5 Participants Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Wild-type FA1090 A25 n=5 Participants Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Mixed FA7527/FA1090 A25 Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
G-CSF Cytokine Levels in Peripheral Blood Screening Visit	32.5 pg/mL Interval 1.8 to 74.5	81.6 pg/mL Interval 1.8 to 258.7	—
G-CSF Cytokine Levels in Peripheral Blood Treatment Visit	37.8 pg/mL Interval 8.5 to 67.1	91.4 pg/mL Interval 1.8 to 293.1	—
G-CSF Cytokine Levels in Peripheral Blood Follow-Up Visit	19.2 pg/mL Interval 1.8 to 54.5	72.9 pg/mL Interval 1.8 to 207.7	—

SECONDARY outcome

Timeframe: Screening Visit (Day -30 to Day -1), Treatment Visit (Day 1 to Day 5), and Follow-Up Visit (3 to 7 days following Treatment Visit)

Population: All participants in the single-strain infection groups, consisting of the Mutant FA7527 - LptA group and Wild-type FA1090 A25 group, with Fractalkine Cytokine outcomes specified in Description.

Fractalkine Cytokine levels in peripheral blood collected from subjects were measured at the screening visit, during experimental infection and at the follow-up visit. Only cytokines detected during the treatment visit upon experimental infection or day 5 in > 50% of peripheral blood samples are included. Cytokine outcome values reported below the limit of quantitation are assigned 1/2 the lower limit of quantitation for calculation of mean values; limits of 95% confidence intervals are bounded by 1/2 the lower limit of quantitation and the upper limit of quantitation for each cytokine.

Outcome measures

Measure	Mutant FA7527 - LptA n=5 Participants Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Wild-type FA1090 A25 n=5 Participants Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Mixed FA7527/FA1090 A25 Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
Fractalkine Cytokine Levels in Peripheral Blood Screening Visit	202.2 pg/mL Interval 43.5 to 440.0	761.8 pg/mL Interval 43.5 to 1912.4	—
Fractalkine Cytokine Levels in Peripheral Blood Treatment Visit	248.3 pg/mL Interval 43.5 to 512.6	762.9 pg/mL Interval 43.5 to 1989.2	—
Fractalkine Cytokine Levels in Peripheral Blood Follow-Up Visit	222.2 pg/mL Interval 43.5 to 471.4	853.7 pg/mL Interval 43.5 to 2234.9	—

SECONDARY outcome

Timeframe: Screening Visit (Day -30 to Day -1), Treatment Visit (Day 1 to Day 5), and Follow-Up Visit (3 to 7 days following Treatment Visit)

Population: All participants in the single-strain infection groups, consisting of the Mutant FA7527 - LptA group and Wild-type FA1090 A25 group, with GRO Cytokine outcomes specified in Description.

GRO Cytokine levels in peripheral blood collected from subjects were measured at the screening visit, during experimental infection and at the follow-up visit. Only cytokines detected during the treatment visit upon experimental infection or day 5 in > 50% of peripheral blood samples are included. Cytokine outcome values reported below the limit of quantitation are assigned 1/2 the lower limit of quantitation for calculation of mean values; limits of 95% confidence intervals are bounded by 1/2 the lower limit of quantitation and the upper limit of quantitation for each cytokine.

Outcome measures

Measure	Mutant FA7527 - LptA n=5 Participants Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Wild-type FA1090 A25 n=5 Participants Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Mixed FA7527/FA1090 A25 Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
GRO Cytokine Levels in Peripheral Blood Screening Visit	1003.9 pg/mL Interval 297.2 to 1710.6	433.5 pg/mL Interval 63.9 to 803.1	—
GRO Cytokine Levels in Peripheral Blood Treatment Visit	436.4 pg/mL Interval 253.7 to 619.1	507.3 pg/mL Interval 297.0 to 717.6	—
GRO Cytokine Levels in Peripheral Blood Follow-Up Visit	403.1 pg/mL Interval 201.4 to 604.8	605.5 pg/mL Interval 354.4 to 856.6	—

SECONDARY outcome

Timeframe: Screening Visit (Day -30 to Day -1), Treatment Visit (Day 1 to Day 5), and Follow-Up Visit (3 to 7 days following Treatment Visit)

Population: All participants in the single-strain infection groups, consisting of the Mutant FA7527 - LptA group and Wild-type FA1090 A25 group, with IL-1RA Cytokine outcomes specified in Description.

IL-1RA Cytokine levels in peripheral blood collected from subjects were measured at the screening visit, during experimental infection and at the follow-up visit. Only cytokines detected during the treatment visit upon experimental infection or day 5 in > 50% of peripheral blood samples are included. Cytokine outcome values reported below the limit of quantitation are assigned 1/2 the lower limit of quantitation for calculation of mean values; limits of 95% confidence intervals are bounded by 1/2 the lower limit of quantitation and the upper limit of quantitation for each cytokine.

Outcome measures

Measure	Mutant FA7527 - LptA n=5 Participants Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Wild-type FA1090 A25 n=5 Participants Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Mixed FA7527/FA1090 A25 Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
IL-1RA Cytokine Levels in Peripheral Blood Screening Visit	145.6 pg/mL Interval 1.9 to 446.0	104.5 pg/mL Interval 1.9 to 319.4	—
IL-1RA Cytokine Levels in Peripheral Blood Treatment Visit	144.0 pg/mL Interval 1.9 to 401.4	94.0 pg/mL Interval 1.9 to 277.2	—
IL-1RA Cytokine Levels in Peripheral Blood Follow-Up Visit	106.2 pg/mL Interval 1.9 to 293.6	97.7 pg/mL Interval 1.9 to 289.1	—

SECONDARY outcome

Timeframe: Screening Visit (Day -30 to Day -1), Treatment Visit (Day 1 to Day 5), and Follow-Up Visit (3 to 7 days following Treatment Visit)

Population: All participants in the single-strain infection groups, consisting of the Mutant FA7527 - LptA group and Wild-type FA1090 A25 group, with IL-8 Cytokine outcomes specified in Description.

IL-8 Cytokine levels in peripheral blood collected from subjects were measured at the eligibility testing visit, during experimental infection and at the follow-up visit. Only cytokines detected during experimental infection in > 50% of peripheral blood samples are included. Cytokine outcome values reported below the limit of quantitation are assigned 1/2 the lower limit of quantitation for calculation of mean values; limits of 95% confidence intervals are bounded by 1/2 the lower limit of quantitation and the upper limit of quantitation for each cytokine.

Outcome measures

Measure	Mutant FA7527 - LptA n=5 Participants Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Wild-type FA1090 A25 n=5 Participants Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Mixed FA7527/FA1090 A25 Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
IL-8 Cytokine Levels in Peripheral Blood Screening Visit	17.3 pg/mL Interval 1.6 to 37.7	22.1 pg/mL Interval 1.6 to 67.3	—
IL-8 Cytokine Levels in Peripheral Blood Treatment Visit	23.0 pg/mL Interval 5.5 to 40.5	21.6 pg/mL Interval 1.6 to 66.2	—
IL-8 Cytokine Levels in Peripheral Blood Follow-Up Visit	18.0 pg/mL Interval 1.6 to 37.4	21.2 pg/mL Interval 1.6 to 62.7	—

SECONDARY outcome

Timeframe: Screening Visit (Day -30 to Day -1), Treatment Visit (Day 1 to Day 5), and Follow-Up Visit (3 to 7 days following Treatment Visit)

Population: All participants in the single-strain infection groups, consisting of the Mutant FA7527 - LptA group and Wild-type FA1090 A25 group, with IP-10 Cytokine outcomes specified in Description.

IP-10 Cytokine levels in peripheral blood collected from subjects were measured at the screening visit, during experimental infection and at the follow-up visit. Only cytokines detected during the treatment visit upon experimental infection or day 5 in > 50% of peripheral blood samples are included. Cytokine outcome values reported below the limit of quantitation are assigned 1/2 the lower limit of quantitation for calculation of mean values; limits of 95% confidence intervals are bounded by 1/2 the lower limit of quantitation and the upper limit of quantitation for each cytokine.

Outcome measures

Measure	Mutant FA7527 - LptA n=5 Participants Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Wild-type FA1090 A25 n=5 Participants Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Mixed FA7527/FA1090 A25 Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
IP-10 Cytokine Levels in Peripheral Blood Screening Visit	630.8 pg/mL Interval 200.2 to 1061.4	598.4 pg/mL Interval 1.7 to 1212.6	—
IP-10 Cytokine Levels in Peripheral Blood Treatment Visit	781.0 pg/mL Interval 549.0 to 1013.0	790.3 pg/mL Interval 37.9 to 1542.7	—
IP-10 Cytokine Levels in Peripheral Blood Follow-Up Visit	516.0 pg/mL Interval 338.2 to 693.8	361.9 pg/mL Interval 103.9 to 619.9	—

SECONDARY outcome

Timeframe: Screening Visit (Day -30 to Day -1), Treatment Visit (Day 1 to Day 5), and Follow-Up Visit (3 to 7 days following Treatment Visit)

Population: All participants in the single-strain infection groups, consisting of the Mutant FA7527 - LptA group and Wild-type FA1090 A25 group, with MCP-10 Cytokine outcomes specified in Description.

MCP-1 Cytokine levels in peripheral blood collected from subjects were measured at the eligibility testing visit, during experimental infection and at the follow-up visit. Only cytokines detected during experimental infection in > 50% of peripheral blood samples are included. Cytokine outcome values reported below the limit of quantitation are assigned 1/2 the lower limit of quantitation for calculation of mean values; limits of 95% confidence intervals are bounded by 1/2 the lower limit of quantitation and the upper limit of quantitation for each cytokine.

Outcome measures

Measure	Mutant FA7527 - LptA n=5 Participants Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Wild-type FA1090 A25 n=5 Participants Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Mixed FA7527/FA1090 A25 Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
MCP-1 Cytokine Levels in Peripheral Blood Screening Visit	428.0 pg/mL Interval 216.0 to 640.0	339.7 pg/mL Interval 181.5 to 497.9	—
MCP-1 Cytokine Levels in Peripheral Blood Treatment Visit	563.0 pg/mL Interval 434.7 to 691.3	271.7 pg/mL Interval 199.4 to 344.0	—
MCP-1 Cytokine Levels in Peripheral Blood Follow-Up Visit	379.2 pg/mL Interval 219.7 to 538.7	284.1 pg/mL Interval 168.3 to 399.9	—

SECONDARY outcome

Timeframe: Screening Visit (Day -30 to Day -1), Treatment Visit (Day 1 to Day 5), and Follow-Up Visit (3 to 7 days following Treatment Visit)

Population: All participants in the single-strain infection groups, consisting of the Mutant FA7527 - LptA group and Wild-type FA1090 A25 group, with MIP-1Beta Cytokine outcomes specified in Description.

MIP-1Beta Cytokine levels in peripheral blood collected from subjects were measured at the screening visit, during experimental infection and at the follow-up visit. Only cytokines detected during the treatment visit upon experimental infection or day 5 in > 50% of peripheral blood samples are included. Cytokine outcome values reported below the limit of quantitation are assigned 1/2 the lower limit of quantitation for calculation of mean values; limits of 95% confidence intervals are bounded by 1/2 the lower limit of quantitation and the upper limit of quantitation for each cytokine.

Outcome measures

Measure	Mutant FA7527 - LptA n=5 Participants Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Wild-type FA1090 A25 n=5 Participants Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Mixed FA7527/FA1090 A25 Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
MIP-1Beta Cytokine Levels in Peripheral Blood Screening Visit	45.4 pg/mL Interval 1.3 to 95.4	42.9 pg/mL Interval 1.3 to 139.2	—
MIP-1Beta Cytokine Levels in Peripheral Blood Treatment Visit	48.4 pg/mL Interval 9.2 to 87.6	37.8 pg/mL Interval 1.3 to 127.9	—
MIP-1Beta Cytokine Levels in Peripheral Blood Follow-Up Visit	39.4 pg/mL Interval 1.3 to 82.0	36.0 pg/mL Interval 1.3 to 122.0	—

SECONDARY outcome

Timeframe: Screening Visit (Day -30 to Day -1), Treatment Visit (Day 1 to Day 5), and Follow-Up Visit (3 to 7 days following Treatment Visit)

Population: All participants in the single-strain infection groups, consisting of the Mutant FA7527 - LptA group and Wild-type FA1090 A25 group, with VEGF Cytokine outcomes specified in Description.

VEGF Cytokine levels in peripheral blood collected from subjects were measured at the screening visit, during experimental infection and at the follow-up visit. Only cytokines detected during the treatment visit upon experimental infection or day 5 in > 50% of peripheral blood samples are included. Cytokine outcome values reported below the limit of quantitation are assigned 1/2 the lower limit of quantitation for calculation of mean values; limits of 95% confidence intervals are bounded by 1/2 the lower limit of quantitation and the upper limit of quantitation for each cytokine.

Outcome measures

Measure	Mutant FA7527 - LptA n=5 Participants Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Wild-type FA1090 A25 n=5 Participants Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Mixed FA7527/FA1090 A25 Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
VEGF Cytokine Levels in Peripheral Blood Screening Visit	321.1 pg/mL Interval 44.0 to 744.5	480.7 pg/mL Interval 44.0 to 1466.2	—
VEGF Cytokine Levels in Peripheral Blood Treatment Visit	340.3 pg/mL Interval 44.0 to 706.8	376.7 pg/mL Interval 44.0 to 1235.9	—
VEGF Cytokine Levels in Peripheral Blood Follow-Up Visit	334.1 pg/mL Interval 44.0 to 745.3	409.9 pg/mL Interval 44.0 to 1310.9	—

SECONDARY outcome

Timeframe: Screening Visit (Day -30 to Day -1), Treatment Visit (Day 1 to Day 5), and Follow-Up Visit (3 to 7 days following Treatment Visit)

Population: All participants in the single-strain infection groups, consisting of the Mutant FA7527 - LptA group and Wild-type FA1090 A25 group, with EGF Cytokine outcomes specified in Description.

EGF Cytokine levels in urine collected from subjects were measured at the screening visit, during experimental infection and at the follow-up visit. Only cytokines detected during the treatment visit upon experimental infection or day 5 in > 50% of both the urine and peripheral blood samples are included. Cytokine outcome values reported below the limit of quantitation are assigned 1/2 the lower limit of quantitation for calculation of mean values; limits of 95% confidence intervals are bounded by 1/2 the lower limit of quantitation and the upper limit of quantitation for each cytokine. Only the cytokines measured in both the urine and peripheral blood samples are included. Cytokine outcome values reported below the limit of detection are excluded.

Outcome measures

Measure	Mutant FA7527 - LptA n=5 Participants Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Wild-type FA1090 A25 n=5 Participants Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Mixed FA7527/FA1090 A25 Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
EGF Cytokine Levels in Urine Screening Visit	7333.2 pg/mL Interval 4942.2 to 8525.2	6600.9 pg/mL Interval 3086.1 to 8525.2	—
EGF Cytokine Levels in Urine Treatment Visit	7358.1 pg/mL Interval 4270.2 to 8525.2	8325.2 pg/mL Interval 7786.5 to 8525.2	—
EGF Cytokine Levels in Urine Follow-Up Visit	7358.1 pg/mL Interval 4270.2 to 8525.2	8490.4 pg/mL Interval 8393.5 to 8525.2	—

SECONDARY outcome

Timeframe: Screening Visit (Day -30 to Day -1), Treatment Visit (Day 1 to Day 5), and Follow-Up Visit (3 to 7 days following Treatment Visit)

Population: All participants in the single-strain infection groups, consisting of the Mutant FA7527 - LptA group and Wild-type FA1090 A25 group, with Eotaxin Cytokine outcomes specified in Description.

Eotaxin Cytokine levels in urine collected from subjects were measured at the screening visit, during experimental infection and at the follow-up visit. Only cytokines detected during the treatment visit upon experimental infection or day 5 in > 50% of both the urine and peripheral blood samples are included. Cytokine outcome values reported below the limit of quantitation are assigned 1/2 the lower limit of quantitation for calculation of mean values; limits of 95% confidence intervals are bounded by 1/2 the lower limit of quantitation and the upper limit of quantitation for each cytokine. Only the cytokines measured in both the urine and peripheral blood samples are included. Cytokine outcome values reported below the limit of detection are excluded.

Outcome measures

Measure	Mutant FA7527 - LptA n=5 Participants Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Wild-type FA1090 A25 n=5 Participants Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Mixed FA7527/FA1090 A25 Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
Eotaxin Cytokine Levels in Urine Screening Visit	5.2 pg/mL Interval 1.7 to 37.7	2.7 pg/mL Interval 1.0 to 4.4	—
Eotaxin Cytokine Levels in Urine Treatment Visit	5.9 pg/mL Interval 1.7 to 10.6	5.4 pg/mL Interval 1.7 to 11.0	—
Eotaxin Cytokine Levels in Urine Follow-Up Visit	7.1 pg/mL Interval 1.7 to 13.9	2.2 pg/mL Interval 1.7 to 3.5	—

SECONDARY outcome

Timeframe: Screening Visit (Day -30 to Day -1), Treatment Visit (Day 1 to Day 5), and Follow-Up Visit (3 to 7 days following Treatment Visit)

Population: All participants in the single-strain infection groups, consisting of the Mutant FA7527 - LptA group and Wild-type FA1090 A25 group, with G-CSF Cytokine outcomes specified in Description.

G-CSF Cytokine levels in urine collected from subjects were measured at the screening visit, during experimental infection and at the follow-up visit. Only cytokines detected during the treatment visit upon experimental infection or day 5 in > 50% of both the urine and peripheral blood samples are included. Cytokine outcome values reported below the limit of quantitation are assigned 1/2 the lower limit of quantitation for calculation of mean values; limits of 95% confidence intervals are bounded by 1/2 the lower limit of quantitation and the upper limit of quantitation for each cytokine. Only the cytokines measured in both the urine and peripheral blood samples are included. Cytokine outcome values reported below the limit of detection are excluded.

Outcome measures

Measure	Mutant FA7527 - LptA n=5 Participants Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Wild-type FA1090 A25 n=5 Participants Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Mixed FA7527/FA1090 A25 Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
G-CSF Cytokine Levels in Urine Screening Visit	16.6 pg/mL Interval 3.3 to 29.9	25.6 pg/mL Interval 1.5 to 64.4	—
G-CSF Cytokine Levels in Urine Treatment Visit	113.1 pg/mL Interval 16.5 to 209.7	207.1 pg/mL Interval 34.3 to 380.0	—
G-CSF Cytokine Levels in Urine Follow-Up Visit	18.3 pg/mL Interval 2.0 to 34.6	9.5 pg/mL Interval 1.5 to 21.5	—

SECONDARY outcome

Timeframe: Screening Visit (Day -30 to Day -1), Treatment Visit (Day 1 to Day 5), and Follow-Up Visit (3 to 7 days following Treatment Visit)

Population: All participants in the single-strain infection groups, consisting of the Mutant FA7527 - LptA group and Wild-type FA1090 A25 group, with Fractalkine Cytokine outcomes specified in Description.

Fractalkine Cytokine levels in urine collected from subjects were measured at the screening visit, during experimental infection and at the follow-up visit. Only cytokines detected during the treatment visit upon experimental infection or day 5 in > 50% of both the urine and peripheral blood samples are included. Cytokine outcome values reported below the limit of quantitation are assigned 1/2 the lower limit of quantitation for calculation of mean values; limits of 95% confidence intervals are bounded by 1/2 the lower limit of quantitation and the upper limit of quantitation for each cytokine. Only the cytokines measured in both the urine and peripheral blood samples are included. Cytokine outcome values reported below the limit of detection are excluded.

Outcome measures

Measure	Mutant FA7527 - LptA n=5 Participants Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Wild-type FA1090 A25 n=5 Participants Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Mixed FA7527/FA1090 A25 Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
Fractalkine Cytokine Levels in Urine Screening Visit	137.2 pg/mL Interval 8.4 to 383.8	58.5 pg/mL Interval 8.4 to 134.8	—
Fractalkine Cytokine Levels in Urine Treatment Visit	57.0 pg/mL Interval 35.1 to 78.9	71.0 pg/mL Interval 48.1 to 93.9	—
Fractalkine Cytokine Levels in Urine Follow-Up Visit	75.5 pg/mL Interval 20.8 to 130.2	86.9 pg/mL Interval 46.9 to 126.9	—

SECONDARY outcome

Timeframe: Screening Visit (Day -30 to Day -1), Treatment Visit (Day 1 to Day 5), and Follow-Up Visit (3 to 7 days following Treatment Visit)

Population: All participants in the single-strain infection groups, consisting of the Mutant FA7527 - LptA group and Wild-type FA1090 A25 group, with GRO Cytokine outcomes specified in Description.

GRO Cytokine levels in urine collected from subjects were measured at the screening visit, during experimental infection and at the follow-up visit. Only cytokines detected during the treatment visit upon experimental infection or day 5 in > 50% of both the urine and peripheral blood samples are included. Cytokine outcome values reported below the limit of quantitation are assigned 1/2 the lower limit of quantitation for calculation of mean values; limits of 95% confidence intervals are bounded by 1/2 the lower limit of quantitation and the upper limit of quantitation for each cytokine. Only the cytokines measured in both the urine and peripheral blood samples are included. Cytokine outcome values reported below the limit of detection are excluded.

Outcome measures

Measure	Mutant FA7527 - LptA n=5 Participants Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Wild-type FA1090 A25 n=5 Participants Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Mixed FA7527/FA1090 A25 Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
GRO Cytokine Levels in Urine Screening Visit	13.8 pg/mL Interval 1.6 to 37.1	3.5 pg/mL Interval 1.6 to 7.6	—
GRO Cytokine Levels in Urine Treatment Visit	54.7 pg/mL Interval 8.4 to 101.0	224.6 pg/mL Interval 1.6 to 567.9	—
GRO Cytokine Levels in Urine Follow-Up Visit	28.9 pg/mL Interval 1.6 to 77.3	4.0 pg/mL Interval 1.6 to 9.0	—

SECONDARY outcome

Timeframe: Screening Visit (Day -30 to Day -1), Treatment Visit (Day 1 to Day 5), and Follow-Up Visit (3 to 7 days following Treatment Visit)

Population: All participants in the single-strain infection groups, consisting of the Mutant FA7527 - LptA group and Wild-type FA1090 A25 group, with IL-1RA Cytokine outcomes specified in Description.

IL-1RA Cytokine levels in urine collected from subjects were measured at the screening visit, during experimental infection and at the follow-up visit. Only cytokines detected during the treatment visit upon experimental infection or day 5 in > 50% of both the urine and peripheral blood samples are included. Cytokine outcome values reported below the limit of quantitation are assigned 1/2 the lower limit of quantitation for calculation of mean values; limits of 95% confidence intervals are bounded by 1/2 the lower limit of quantitation and the upper limit of quantitation for each cytokine. Only the cytokines measured in both the urine and peripheral blood samples are included. Cytokine outcome values reported below the limit of detection are excluded.

Outcome measures

Measure	Mutant FA7527 - LptA n=5 Participants Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Wild-type FA1090 A25 n=5 Participants Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Mixed FA7527/FA1090 A25 Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
IL-1RA Cytokine Levels in Urine Screening Visit	210.9 pg/mL Interval 1.6 to 597.4	44.9 pg/mL Interval 1.6 to 102.9	—
IL-1RA Cytokine Levels in Urine Treatment Visit	205.2 pg/mL Interval 60.1 to 350.3	72.1 pg/mL Interval 35.5 to 108.7	—
IL-1RA Cytokine Levels in Urine Follow-Up Visit	138.8 pg/mL Interval 1.6 to 312.3	64.1 pg/mL Interval 14.1 to 114.1	—

SECONDARY outcome

Timeframe: Screening Visit (Day -30 to Day -1), Treatment Visit (Day 1 to Day 5), and Follow-Up Visit (3 to 7 days following Treatment Visit)

Population: All participants in the single-strain infection groups, consisting of the Mutant FA7527 - LptA group and Wild-type FA1090 A25 group, with IL-8 Cytokine outcomes specified in Description.

IL-8 Cytokine levels in urine collected from subjects were measured at the screening visit, during experimental infection and at the follow-up visit. Only cytokines detected during the treatment visit upon experimental infection or day 5 in > 50% of both the urine and peripheral blood samples are included. Cytokine outcome values reported below the limit of quantitation are assigned 1/2 the lower limit of quantitation for calculation of mean values; limits of 95% confidence intervals are bounded by 1/2 the lower limit of quantitation and the upper limit of quantitation for each cytokine. Only the cytokines measured in both the urine and peripheral blood samples are included. Cytokine outcome values reported below the limit of detection are excluded.

Outcome measures

Measure	Mutant FA7527 - LptA n=5 Participants Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Wild-type FA1090 A25 n=5 Participants Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Mixed FA7527/FA1090 A25 Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
IL-8 Cytokine Levels in Urine Screening Visit	1.6 pg/mL Interval 1.6 to 1.6	1.6 pg/mL Interval 1.6 to 1.6	—
IL-8 Cytokine Levels in Urine Treatment Visit	35.3 pg/mL Interval 1.6 to 79.3	32.9 pg/mL Interval 6.7 to 59.1	—
IL-8 Cytokine Levels in Urine Follow-Up Visit	6.3 pg/mL Interval 1.6 to 19.4	1.6 pg/mL Interval 1.6 to 1.6	—

SECONDARY outcome

Timeframe: Screening Visit (Day -30 to Day -1), Treatment Visit (Day 1 to Day 5), and Follow-Up Visit (3 to 7 days following Treatment Visit)

Population: All participants in the single-strain infection groups, consisting of the Mutant FA7527 - LptA group and Wild-type FA1090 A25 group, with IP-10 Cytokine outcomes specified in Description.

IP-10 Cytokine levels in urine collected from subjects were measured at the screening visit, during experimental infection and at the follow-up visit. Only cytokines detected during the treatment visit upon experimental infection or day 5 in > 50% of both the urine and peripheral blood samples are included. Cytokine outcome values reported below the limit of quantitation are assigned 1/2 the lower limit of quantitation for calculation of mean values; limits of 95% confidence intervals are bounded by 1/2 the lower limit of quantitation and the upper limit of quantitation for each cytokine. Only the cytokines measured in both the urine and peripheral blood samples are included. Cytokine outcome values reported below the limit of detection are excluded.

Outcome measures

Measure	Mutant FA7527 - LptA n=5 Participants Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Wild-type FA1090 A25 n=5 Participants Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Mixed FA7527/FA1090 A25 Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
IP-10 Cytokine Levels in Urine Screening Visit	64.5 pg/mL Interval 1.6 to 130.7	23.4 pg/mL Interval 1.6 to 69.6	—
IP-10 Cytokine Levels in Urine Treatment Visit	387.8 pg/mL Interval 1.6 to 789.2	411.4 pg/mL Interval 1.6 to 961.1	—
IP-10 Cytokine Levels in Urine Follow-Up Visit	177.8 pg/mL Interval 1.6 to 501.8	23.7 pg/mL Interval 1.6 to 63.5	—

SECONDARY outcome

Timeframe: Screening Visit (Day -30 to Day -1), Treatment Visit (Day 1 to Day 5), and Follow-Up Visit (3 to 7 days following Treatment Visit)

Population: All participants in the single-strain infection groups, consisting of the Mutant FA7527 - LptA group and Wild-type FA1090 A25 group, with MCP-1 Cytokine outcomes specified in Description.

MCP-1 Cytokine levels in urine collected from subjects were measured at the screening visit, during experimental infection and at the follow-up visit. Only cytokines detected during the treatment visit upon experimental infection or day 5 in > 50% of both the urine and peripheral blood samples are included. Cytokine outcome values reported below the limit of quantitation are assigned 1/2 the lower limit of quantitation for calculation of mean values; limits of 95% confidence intervals are bounded by 1/2 the lower limit of quantitation and the upper limit of quantitation for each cytokine. Only the cytokines measured in both the urine and peripheral blood samples are included. Cytokine outcome values reported below the limit of detection are excluded.

Outcome measures

Measure	Mutant FA7527 - LptA n=5 Participants Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Wild-type FA1090 A25 n=5 Participants Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Mixed FA7527/FA1090 A25 Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
MCP-1 Cytokine Levels in Urine Screening Visit	757.7 pg/mL Interval 1.6 to 1939.5	113.0 pg/mL Interval 1.6 to 263.3	—
MCP-1 Cytokine Levels in Urine Treatment Visit	622.5 pg/mL Interval 1.6 to 1802.0	233.9 pg/mL Interval 1.6 to 494.8	—
MCP-1 Cytokine Levels in Urine Follow-Up Visit	491.7 pg/mL Interval 1.6 to 1284.5	137.9 pg/mL Interval 83.4 to 192.4	—

SECONDARY outcome

Timeframe: Screening Visit (Day -30 to Day -1), Treatment Visit (Day 1 to Day 5), and Follow-Up Visit (3 to 7 days following Treatment Visit)

Population: All participants in the single-strain infection groups, consisting of the Mutant FA7527 - LptA group and Wild-type FA1090 A25 group, with MIP-1Beta Cytokine outcomes specified in Description.

MIP-1Beta Cytokine levels in urine collected from subjects were measured at the screening visit, during experimental infection and at the follow-up visit. Only cytokines detected during the treatment visit upon experimental infection or day 5 in > 50% of both the urine and peripheral blood samples are included. Cytokine outcome values reported below the limit of quantitation are assigned 1/2 the lower limit of quantitation for calculation of mean values; limits of 95% confidence intervals are bounded by 1/2 the lower limit of quantitation and the upper limit of quantitation for each cytokine. Only the cytokines measured in both the urine and peripheral blood samples are included. Cytokine outcome values reported below the limit of detection are excluded.

Outcome measures

Measure	Mutant FA7527 - LptA n=5 Participants Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Wild-type FA1090 A25 n=5 Participants Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Mixed FA7527/FA1090 A25 Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
MIP-1Beta Cytokine Levels in Urine Screening Visit	2.1 pg/mL Interval 1.6 to 3.4	1.6 pg/mL Interval 1.6 to 1.6	—
MIP-1Beta Cytokine Levels in Urine Treatment Visit	16.6 pg/mL Interval 1.6 to 41.4	22.0 pg/mL Interval 1.6 to 66.7	—
MIP-1Beta Cytokine Levels in Urine Follow-Up Visit	1.6 pg/mL Interval 1.6 to 1.6	1.6 pg/mL Interval 1.6 to 1.6	—

SECONDARY outcome

Timeframe: Screening Visit (Day -30 to Day -1), Treatment Visit (Day 1 to Day 5), and Follow-Up Visit (3 to 7 days following Treatment Visit)

Population: All participants in the single-strain infection groups, consisting of the Mutant FA7527 - LptA group and Wild-type FA1090 A25 group, with VEGF Cytokine outcomes specified in Description.

VEGF Cytokine levels in urine collected from subjects were measured at the screening visit, during experimental infection and at the follow-up visit. Only cytokines detected during the treatment visit upon experimental infection or day 5 in > 50% of both the urine and peripheral blood samples are included. Cytokine outcome values reported below the limit of quantitation are assigned 1/2 the lower limit of quantitation for calculation of mean values; limits of 95% confidence intervals are bounded by 1/2 the lower limit of quantitation and the upper limit of quantitation for each cytokine. Only the cytokines measured in both the urine and peripheral blood samples are included. Cytokine outcome values reported below the limit of detection are excluded.

Outcome measures

Measure	Mutant FA7527 - LptA n=5 Participants Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Wild-type FA1090 A25 n=5 Participants Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.	Mixed FA7527/FA1090 A25 Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain. Mandatory rescue therapy in a single dose, on participant request, at the onset of symptoms or on the 5th study day after inoculation.
VEGF Cytokine Levels in Urine Screening Visit	104.9 pg/mL Interval 9.2 to 242.5	45.3 pg/mL Interval 9.2 to 106.3	—
VEGF Cytokine Levels in Urine Treatment Visit	171.8 pg/mL Interval 9.2 to 399.6	111.3 pg/mL Interval 9.2 to 226.4	—
VEGF Cytokine Levels in Urine Follow-Up Visit	185.1 pg/mL Interval 9.2 to 430.4	71.8 pg/mL Interval 9.2 to 171.3	—

SECONDARY outcome

Timeframe: Day 1 through Day 5

Population: All participants in the single-strain infection groups, consisting of the Mutant FA7527 - LptA group and Wild-type FA1090 A25 group. Samples obtained were not adequate for analysis with current testing methods

RNA-seq is the standard method for measuring bacterial gene expression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 through Day 5

Population: All participants that received bacterial inoculum. Samples obtained were not adequate for analysis with current testing methods

RNA-seq is the standard method for measuring bacterial gene expression.

Outcome measures

Outcome data not reported

Adverse Events

Mutant FA7527

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Wild-type FA1090 A25

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Mixed FA7527/FA1090 A25

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Mutant FA7527 n=5 participants at risk Participants received a bacterial inoculum containing only the isogenic LptA mutant N. gonorrhoeae strain.	Wild-type FA1090 A25 n=5 participants at risk Participants received a bacterial inoculum containing only the wild-type (WT) N. gonorrhoeae strain.	Mixed FA7527/FA1090 A25 n=6 participants at risk Participants received a bacterial inoculum containing a mixture of equivalent numbers the isogenic LptA mutant and WT strain.
Gastrointestinal disorders Diarrhoea	0.00% 0/5 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1	0.00% 0/5 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1	16.7% 1/6 • Number of events 1 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1
General disorders Instillation Site Pain	0.00% 0/5 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1	0.00% 0/5 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1	16.7% 1/6 • Number of events 1 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1
Investigations Blood Pressure Increased	40.0% 2/5 • Number of events 2 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1	0.00% 0/5 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1	16.7% 1/6 • Number of events 1 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/5 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1	20.0% 1/5 • Number of events 1 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1	0.00% 0/6 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1
Nervous system disorders Headache	20.0% 1/5 • Number of events 1 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1	0.00% 0/5 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1	0.00% 0/6 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1
Nervous system disorders Tingling	0.00% 0/5 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1	0.00% 0/5 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1	33.3% 2/6 • Number of events 2 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1
Renal and urinary disorders Dysuria	40.0% 2/5 • Number of events 2 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1	40.0% 2/5 • Number of events 2 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1	16.7% 1/6 • Number of events 1 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1
Renal and urinary disorders Glycosuria	20.0% 1/5 • Number of events 1 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1	0.00% 0/5 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1	0.00% 0/6 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1
Renal and urinary disorders Hematuria	0.00% 0/5 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1	0.00% 0/5 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1	16.7% 1/6 • Number of events 1 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1
Renal and urinary disorders Urethral Discharge	60.0% 3/5 • Number of events 3 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1	100.0% 5/5 • Number of events 5 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1	83.3% 5/6 • Number of events 6 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1
Renal and urinary disorders Urethritis	20.0% 1/5 • Number of events 1 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1	0.00% 0/5 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1	0.00% 0/6 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1
Reproductive system and breast disorders Irritation or Itching	0.00% 0/5 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1	20.0% 1/5 • Number of events 1 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1	33.3% 2/6 • Number of events 2 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1
Respiratory, thoracic and mediastinal disorders Postnasal Drip	0.00% 0/5 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1	20.0% 1/5 • Number of events 1 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1	0.00% 0/6 • All AEs that occurred within the experimental infection trial period including inoculation and one week after the follow-up visit were reported. Events noted through a telephone call approximately 7 days after the follow-up visit to assess potential AEs were also reported. The unsolicited AEs were summarized using MedDRA 15.1. The solicited AEs were assessed using MedDRA 22.1

Additional Information

Marcia M. Hobbs, PhD

University of North Carolina at Chapel Hill

Phone: 919-843-6893

Email: mmhobbs@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60