Trial Outcomes & Findings for An Inflammatory Challenge Using Endotoxin (NCT NCT04310423)

NCT ID: NCT04310423

Last Updated: 2025-05-01

Results Overview

Alcohol Urge Questionnaire (AUQ) score is the primary outcome for the cue-reactivity paradigm. The AUQ is comprised of eight items rated on a 7-point Likert scale with items related to the subjective experience of alcohol craving. The minimum value is 8 and the maximum value is 56 with a higher score indicating greater subjective alcohol craving. Phasic craving for alcohol following alcohol cue exposure was assessed using the first and last items from the AUQ during an alcohol cue reactivity paradigm at baseline and at time of expected peak cytokine response (T2). This subscale of 2 items about desire to drink rated on a 7-point Likert scale provided a minimum possible value of 2 and a maximum value of 14, with higher values indicating a higher craving to drink alcohol. The investigators are primarily interested in whether low dose endotoxin increases cue-induced craving for alcohol in non-treatment-seeking heavy drinkers, relative to placebo.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: The cue-reactivity paradigm is conducted at baseline and at 2 hours post-infusion of placebo or low dose endotoxin during the experimental visit.
• Results posted on: 2025-05-01

Participant Flow

Screening procedures for participants were conducted from 2021 - 2023; therefore, given the COVID-19 pandemic, initial screening procedures were conducted via HIPAA-compliant telemedicine software. Following, participants completed a medical screening visit at the Clinical and Translational Research Center (CTRC) at UCLA. Following, participants completed the experimental visit at the CTRC and the UCLA Center for Cognitive Neuroscience (CCN).

Participants completed an initial and medical screening visit for eligibility prior to the randomization assignment.

Participant milestones

Measure	Placebo Matched to endotoxin Placebo: Matched to endotoxin	Endotoxin Bolus dose of endotoxin (0.8 ng/kg) Endotoxin: Bolus dose of 0.8 ng/kg
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Inflammatory Challenge Using Endotoxin

Baseline characteristics by cohort

Measure	Placebo n=10 Participants Matched to endotoxin Placebo: Matched to endotoxin	Endotoxin n=10 Participants Bolus dose of endotoxin (0.8 ng/kg) Endotoxin: Bolus dose of 0.8 ng/kg	Total n=20 Participants Total of all reporting groups
Age, Continuous	27.80 years STANDARD_DEVIATION 7.58 • n=5 Participants	30.30 years STANDARD_DEVIATION 6.53 • n=7 Participants	29.05 years STANDARD_DEVIATION 7.01 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants
Alcohol Use Disorder Identification Test	12.00 units on a scale STANDARD_DEVIATION 2.66 • n=5 Participants	13.30 units on a scale STANDARD_DEVIATION 6.18 • n=7 Participants	12.65 units on a scale STANDARD_DEVIATION 4.68 • n=5 Participants
Beck Depression Inventory - 2	7.40 score on a scale STANDARD_DEVIATION 6.28 • n=5 Participants	7.80 score on a scale STANDARD_DEVIATION 7.90 • n=7 Participants	7.60 score on a scale STANDARD_DEVIATION 6.95 • n=5 Participants
Body Mass Index	24.99 kg/m^2 STANDARD_DEVIATION 4.07 • n=5 Participants	27.25 kg/m^2 STANDARD_DEVIATION 3.72 • n=7 Participants	26.12 kg/m^2 STANDARD_DEVIATION 3.97 • n=5 Participants
Drinks per Drinking Day	4.58 drinks/drinking day STANDARD_DEVIATION 1.95 • n=5 Participants	4.12 drinks/drinking day STANDARD_DEVIATION 1.40 • n=7 Participants	4.35 drinks/drinking day STANDARD_DEVIATION 1.67 • n=5 Participants
Structured Clinical Interview for DSM-5 Alcohol Use Disorder Symptoms	4.20 symptoms STANDARD_DEVIATION 1.93 • n=5 Participants	4.10 symptoms STANDARD_DEVIATION 1.85 • n=7 Participants	4.15 symptoms STANDARD_DEVIATION 1.84 • n=5 Participants
Reward Relief Habit Drinking Scale Reward	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Reward Relief Habit Drinking Scale Relief	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Reward Relief Habit Drinking Scale Habit	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Years of Education	16.00 years STANDARD_DEVIATION 2.45 • n=5 Participants	16.90 years STANDARD_DEVIATION 2.13 • n=7 Participants	16.45 years STANDARD_DEVIATION 2.28 • n=5 Participants

PRIMARY outcome

Timeframe: The cue-reactivity paradigm is conducted at baseline and at 2 hours post-infusion of placebo or low dose endotoxin during the experimental visit.

Population: All randomized participants included in analysis.

Alcohol Urge Questionnaire (AUQ) score is the primary outcome for the cue-reactivity paradigm. The AUQ is comprised of eight items rated on a 7-point Likert scale with items related to the subjective experience of alcohol craving. The minimum value is 8 and the maximum value is 56 with a higher score indicating greater subjective alcohol craving. Phasic craving for alcohol following alcohol cue exposure was assessed using the first and last items from the AUQ during an alcohol cue reactivity paradigm at baseline and at time of expected peak cytokine response (T2). This subscale of 2 items about desire to drink rated on a 7-point Likert scale provided a minimum possible value of 2 and a maximum value of 14, with higher values indicating a higher craving to drink alcohol. The investigators are primarily interested in whether low dose endotoxin increases cue-induced craving for alcohol in non-treatment-seeking heavy drinkers, relative to placebo.

Outcome measures

Measure	Placebo n=10 Participants Matched to endotoxin Placebo: Matched to endotoxin	Endotoxin n=10 Participants Bolus dose of endotoxin (0.8 ng/kg) Endotoxin: Bolus dose of 0.8 ng/kg
Cue-induced Craving Baseline	4.5004 score on a scale Standard Error 0.9622	7.9081 score on a scale Standard Error 0.9604
Cue-induced Craving Two Hours Post-Baseline	4.5004 score on a scale Standard Error 0.9622	5.6178 score on a scale Standard Error 0.9858

PRIMARY outcome

Timeframe: The POMS will be completed at 5 timepoints during the experimental visit. Specifically, negative mood will be assessed at baseline (prior to infusion) and 1 hour, 2 hours, 3 hours, and 4 hours post-infusion of placebo or low dose endotoxin.

Population: All participants were included in the analysis.

The Profile of Mood States (POMS) is a self-report questionnaire that measures dimensions of mood. Four items from the POMS were summed to calculate the negative mood subscale. The items included "discouraged," downhearted," "uneasy," and "anxious." Participants rated the extent that they felt items "right now" on a scale from 0-4, with higher scores indicating more endorsement of the items. Items were summed to calculate negative mood subscale with the score ranging from 0-16, with higher scores indicating higher negative mood. The investigators were interested in whether low dose endotoxin would increase negative mood as compared to placebo.

Outcome measures

Measure	Placebo n=10 Participants Matched to endotoxin Placebo: Matched to endotoxin	Endotoxin n=10 Participants Bolus dose of endotoxin (0.8 ng/kg) Endotoxin: Bolus dose of 0.8 ng/kg
Change in Negative Mood Baseline	0.60 score on a scale Standard Error 0.27	0.80 score on a scale Standard Error 0.36
Change in Negative Mood One Hour Post-Baseline	0.50 score on a scale Standard Error 0.34	0.90 score on a scale Standard Error 0.43
Change in Negative Mood Two Hours Post-Baseline	0.50 score on a scale Standard Error 0.27	0.90 score on a scale Standard Error 0.31
Change in Negative Mood Three Hours Post-Baseline	1.70 score on a scale Standard Error 0.88	1.70 score on a scale Standard Error 0.72
Change in Negative Mood Four Hours Post-Baseline	0.90 score on a scale Standard Error 0.53	1.70 score on a scale Standard Error 0.79

SECONDARY outcome

Timeframe: The RRS will be completed at 2 timepoints during the experimental visit. Specifically, reward responsiveness will be assessed at baseline (prior to infusion) and 2 hours post-infusion of placebo or low dose endotoxin.

Population: All participants included in analysis; participants completed RRS at baseline and two-hours post-baseline (T2).

The Reward Responsiveness Scale (RRS) measures self-report reward responsiveness. The RRS scale consists of 8 items on a 4-point scale, with the sum total score of items ranging from 8-32, where higher scores indicate higher reward responsiveness. The measure was completed electronically. The investigators are interested in whether low dose endotoxin will decrease reward responsiveness as compared to placebo.

Outcome measures

Measure	Placebo n=10 Participants Matched to endotoxin Placebo: Matched to endotoxin	Endotoxin n=10 Participants Bolus dose of endotoxin (0.8 ng/kg) Endotoxin: Bolus dose of 0.8 ng/kg
Change in Reward Responsiveness RRS Baseline	25.60 scores on scale Standard Error 1.11	26.20 scores on scale Standard Error 0.98
Change in Reward Responsiveness RRS Two Hours Post-Baseline	25.50 scores on scale Standard Error 1.27	26.22 scores on scale Standard Error 1.24

SECONDARY outcome

Timeframe: The PRT will be completed at 2 timepoints during the experimental visit. Specifically, reward responsiveness will be assessed at baseline (prior to infusion) and 2 hours post-infusion of placebo or low dose endotoxin.

Population: All participants included in analysis; participants completed PRT at baseline and two-hours post-baseline (T2).

The Probabilistic Reward Task (PRT) is a signal detection learning task that assesses reward learning from which two subscales were derived: logd is a measure of discriminability, or how difficult it is for the subjects to discriminate between the signals, while logb is a measure of response bias, or subjects' preference for the response paired with the more frequent reward. Higher logd values indicate a better ability to discriminate between reward signals (logd=1⁄2 log(Richcorrect*Leancorrect)/(Richincorrect*Leanincorrect)). Higher logb values indicate better reward sensitivity (logb=1⁄2 log(Richcorrect*Leanincorrect)/(Richincorrect*Leancorrect)). The range of possible logb and logd subscale values is between -2.48 to 2.48. The measure was completed electronically. The investigators are interested in whether low dose endotoxin will decrease reward responsiveness as compared to placebo.

Outcome measures

Measure	Placebo n=10 Participants Matched to endotoxin Placebo: Matched to endotoxin	Endotoxin n=10 Participants Bolus dose of endotoxin (0.8 ng/kg) Endotoxin: Bolus dose of 0.8 ng/kg
Change in Reward Responsiveness PRT logd Baseline	1.46 scores on task Standard Error 0.13	1.29 scores on task Standard Error 0.16
Change in Reward Responsiveness PRT logd Two Hours Post-Basleine	1.98 scores on task Standard Error 0.33	1.27 scores on task Standard Error 0.16
Change in Reward Responsiveness PRT logb Baseline	-0.07 scores on task Standard Error 0.03	0.16 scores on task Standard Error 0.05
Change in Reward Responsiveness PRT logb Two Hours Post-Baseline	0.31 scores on task Standard Error 0.38	0.20 scores on task Standard Error 0.04

SECONDARY outcome

Timeframe: The fMRI scan will be completed during the experimental visit. Specifically, participants will undergo the neuroimaging scan at 3 hours post-infusion of placebo or low dose endotoxin.

Population: All participants included in analysis. The outcome measure data below indicates the voxel size of significant clusters identified in which individuals who received placebo had greater activation for alcohol beverages compared to non-alcohol beverages than those who received endotoxin. Therefore, only one Arm/Group is reported, as the neuroimaging analyses used FSL software wherein the outcome is the identification of these significant clusters.

The fMRI scan will include a cue-reactivity paradigm in which participants will view images of alcoholic beverages, non-alcoholic beverages, negative images, and fixation cross. Participants will be asked to rate their alcohol craving before the scan and after each cue block. The investigators are interested in determining the effects of endotoxin on neural alcohol cue-reactivity. An alcohol beverage > non-alcohol beverage contrast was specified in the first-level model for each subject, and FSL's FLAME 1 was used to conduct group-level analyses (endotoxin vs. placebo) to identify significant brain clusters in which individuals who received placebo had greater activation for alcohol beverages compared to non-alcohol beverages than those who received endotoxin. Outcome measure below indicates the voxel size of said significant clusters.

Outcome measures

Measure	Placebo n=20 Participants Matched to endotoxin Placebo: Matched to endotoxin	Endotoxin Bolus dose of endotoxin (0.8 ng/kg) Endotoxin: Bolus dose of 0.8 ng/kg
Effect on Neural Alcohol Cue-reactivity Left Postcentral Gyrus Significant Cluster	3190 Voxels	—
Effect on Neural Alcohol Cue-reactivity Right Thalamus Significant Cluster	1942 Voxels	—
Effect on Neural Alcohol Cue-reactivity Left Inferior Temporal Gyrus Cluster	931 Voxels	—
Effect on Neural Alcohol Cue-reactivity Left/Right Precuneus Cluster	920 Voxels	—
Effect on Neural Alcohol Cue-reactivity Right Precentral Gyrus	518 Voxels	—

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Endotoxin

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=10 participants at risk Matched to endotoxin Placebo: Matched to endotoxin	Endotoxin n=10 participants at risk Bolus dose of endotoxin (0.8 ng/kg) Endotoxin: Bolus dose of 0.8 ng/kg
Immune system disorders Fever	0.00% 0/10 • Adverse event data were collected throughout the study duration from 2021-2023. Adverse event information was collected during 4-hour inflammatory challenge and then for one week following the challenge. FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" was used to inform adverse events. Stopping criteria was met if there was emergence of an SAE or more than 1 Grade 3 (severe) adverse event at least possibly related to endotoxin.	20.0% 2/10 • Number of events 2 • Adverse event data were collected throughout the study duration from 2021-2023. Adverse event information was collected during 4-hour inflammatory challenge and then for one week following the challenge. FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" was used to inform adverse events. Stopping criteria was met if there was emergence of an SAE or more than 1 Grade 3 (severe) adverse event at least possibly related to endotoxin.
Immune system disorders Nausea	0.00% 0/10 • Adverse event data were collected throughout the study duration from 2021-2023. Adverse event information was collected during 4-hour inflammatory challenge and then for one week following the challenge. FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" was used to inform adverse events. Stopping criteria was met if there was emergence of an SAE or more than 1 Grade 3 (severe) adverse event at least possibly related to endotoxin.	40.0% 4/10 • Number of events 4 • Adverse event data were collected throughout the study duration from 2021-2023. Adverse event information was collected during 4-hour inflammatory challenge and then for one week following the challenge. FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" was used to inform adverse events. Stopping criteria was met if there was emergence of an SAE or more than 1 Grade 3 (severe) adverse event at least possibly related to endotoxin.
Immune system disorders Shivering	0.00% 0/10 • Adverse event data were collected throughout the study duration from 2021-2023. Adverse event information was collected during 4-hour inflammatory challenge and then for one week following the challenge. FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" was used to inform adverse events. Stopping criteria was met if there was emergence of an SAE or more than 1 Grade 3 (severe) adverse event at least possibly related to endotoxin.	70.0% 7/10 • Number of events 7 • Adverse event data were collected throughout the study duration from 2021-2023. Adverse event information was collected during 4-hour inflammatory challenge and then for one week following the challenge. FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" was used to inform adverse events. Stopping criteria was met if there was emergence of an SAE or more than 1 Grade 3 (severe) adverse event at least possibly related to endotoxin.
Immune system disorders Fatigue	50.0% 5/10 • Number of events 5 • Adverse event data were collected throughout the study duration from 2021-2023. Adverse event information was collected during 4-hour inflammatory challenge and then for one week following the challenge. FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" was used to inform adverse events. Stopping criteria was met if there was emergence of an SAE or more than 1 Grade 3 (severe) adverse event at least possibly related to endotoxin.	70.0% 7/10 • Number of events 7 • Adverse event data were collected throughout the study duration from 2021-2023. Adverse event information was collected during 4-hour inflammatory challenge and then for one week following the challenge. FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" was used to inform adverse events. Stopping criteria was met if there was emergence of an SAE or more than 1 Grade 3 (severe) adverse event at least possibly related to endotoxin.
Immune system disorders Shortness of Breath	0.00% 0/10 • Adverse event data were collected throughout the study duration from 2021-2023. Adverse event information was collected during 4-hour inflammatory challenge and then for one week following the challenge. FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" was used to inform adverse events. Stopping criteria was met if there was emergence of an SAE or more than 1 Grade 3 (severe) adverse event at least possibly related to endotoxin.	20.0% 2/10 • Number of events 2 • Adverse event data were collected throughout the study duration from 2021-2023. Adverse event information was collected during 4-hour inflammatory challenge and then for one week following the challenge. FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" was used to inform adverse events. Stopping criteria was met if there was emergence of an SAE or more than 1 Grade 3 (severe) adverse event at least possibly related to endotoxin.
Immune system disorders Muscle Pain	10.0% 1/10 • Number of events 2 • Adverse event data were collected throughout the study duration from 2021-2023. Adverse event information was collected during 4-hour inflammatory challenge and then for one week following the challenge. FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" was used to inform adverse events. Stopping criteria was met if there was emergence of an SAE or more than 1 Grade 3 (severe) adverse event at least possibly related to endotoxin.	40.0% 4/10 • Number of events 4 • Adverse event data were collected throughout the study duration from 2021-2023. Adverse event information was collected during 4-hour inflammatory challenge and then for one week following the challenge. FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" was used to inform adverse events. Stopping criteria was met if there was emergence of an SAE or more than 1 Grade 3 (severe) adverse event at least possibly related to endotoxin.
Immune system disorders Arm Rash	0.00% 0/10 • Adverse event data were collected throughout the study duration from 2021-2023. Adverse event information was collected during 4-hour inflammatory challenge and then for one week following the challenge. FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" was used to inform adverse events. Stopping criteria was met if there was emergence of an SAE or more than 1 Grade 3 (severe) adverse event at least possibly related to endotoxin.	10.0% 1/10 • Number of events 1 • Adverse event data were collected throughout the study duration from 2021-2023. Adverse event information was collected during 4-hour inflammatory challenge and then for one week following the challenge. FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" was used to inform adverse events. Stopping criteria was met if there was emergence of an SAE or more than 1 Grade 3 (severe) adverse event at least possibly related to endotoxin.
Immune system disorders Hypertension	0.00% 0/10 • Adverse event data were collected throughout the study duration from 2021-2023. Adverse event information was collected during 4-hour inflammatory challenge and then for one week following the challenge. FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" was used to inform adverse events. Stopping criteria was met if there was emergence of an SAE or more than 1 Grade 3 (severe) adverse event at least possibly related to endotoxin.	10.0% 1/10 • Number of events 1 • Adverse event data were collected throughout the study duration from 2021-2023. Adverse event information was collected during 4-hour inflammatory challenge and then for one week following the challenge. FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" was used to inform adverse events. Stopping criteria was met if there was emergence of an SAE or more than 1 Grade 3 (severe) adverse event at least possibly related to endotoxin.
Immune system disorders Headache	20.0% 2/10 • Number of events 2 • Adverse event data were collected throughout the study duration from 2021-2023. Adverse event information was collected during 4-hour inflammatory challenge and then for one week following the challenge. FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" was used to inform adverse events. Stopping criteria was met if there was emergence of an SAE or more than 1 Grade 3 (severe) adverse event at least possibly related to endotoxin.	20.0% 2/10 • Number of events 2 • Adverse event data were collected throughout the study duration from 2021-2023. Adverse event information was collected during 4-hour inflammatory challenge and then for one week following the challenge. FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" was used to inform adverse events. Stopping criteria was met if there was emergence of an SAE or more than 1 Grade 3 (severe) adverse event at least possibly related to endotoxin.
Immune system disorders Lightheadedness	0.00% 0/10 • Adverse event data were collected throughout the study duration from 2021-2023. Adverse event information was collected during 4-hour inflammatory challenge and then for one week following the challenge. FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" was used to inform adverse events. Stopping criteria was met if there was emergence of an SAE or more than 1 Grade 3 (severe) adverse event at least possibly related to endotoxin.	10.0% 1/10 • Number of events 1 • Adverse event data were collected throughout the study duration from 2021-2023. Adverse event information was collected during 4-hour inflammatory challenge and then for one week following the challenge. FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" was used to inform adverse events. Stopping criteria was met if there was emergence of an SAE or more than 1 Grade 3 (severe) adverse event at least possibly related to endotoxin.
Immune system disorders Low Back Pain	0.00% 0/10 • Adverse event data were collected throughout the study duration from 2021-2023. Adverse event information was collected during 4-hour inflammatory challenge and then for one week following the challenge. FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" was used to inform adverse events. Stopping criteria was met if there was emergence of an SAE or more than 1 Grade 3 (severe) adverse event at least possibly related to endotoxin.	10.0% 1/10 • Number of events 1 • Adverse event data were collected throughout the study duration from 2021-2023. Adverse event information was collected during 4-hour inflammatory challenge and then for one week following the challenge. FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" was used to inform adverse events. Stopping criteria was met if there was emergence of an SAE or more than 1 Grade 3 (severe) adverse event at least possibly related to endotoxin.
Immune system disorders Injection Site Pain	20.0% 2/10 • Number of events 2 • Adverse event data were collected throughout the study duration from 2021-2023. Adverse event information was collected during 4-hour inflammatory challenge and then for one week following the challenge. FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" was used to inform adverse events. Stopping criteria was met if there was emergence of an SAE or more than 1 Grade 3 (severe) adverse event at least possibly related to endotoxin.	10.0% 1/10 • Number of events 1 • Adverse event data were collected throughout the study duration from 2021-2023. Adverse event information was collected during 4-hour inflammatory challenge and then for one week following the challenge. FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" was used to inform adverse events. Stopping criteria was met if there was emergence of an SAE or more than 1 Grade 3 (severe) adverse event at least possibly related to endotoxin.

Additional Information

Dr. Lara Ray

University of California, Los Angeles

Phone: 310-794-5383

Email: lararay@psych.ucla.edu

Results disclosure agreements

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