Trial Outcomes & Findings for Characterization of Tissue-Specific Immune Responses to Bronchoscopic Instillation of Mycobacterial Antigens Into the Human Lung (NCT NCT05027958)

Last Updated: 2025-11-06

Results Overview

Median difference in CD4 cell response to intrabronchial instillation of Tuberculin Purified Protein Derivative (PPD) using flow cytometry. The frequency of (Mycobacterium tuberculosis) Mtb-specific T cells was measured by intracellular cytokine staining for Interferon Gamma (IFNγ) and Tumor Necrosis Factor (TNF) after in vitro restimulation of Peripheral Blood Mononuclear Cells (PBMC) and Bronchoalveolar Lavage (BAL) cells with PPD or Mtb-derived peptide megapools.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

17 participants

Primary outcome timeframe

Day 5 and Day 21

Results posted on

2025-11-06

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1: Healthy Volunteer Participants With Confirmed Latent Tuberculosis Infection (LTBI) Healthy volunteer participants with confirmed Latent Tuberculosis Infection (LTBI) (TST positive and IGRA positive) receiving instillation dose of purified protein derivative (PPD) 0.5 tuberculin units (10 uL Tubersol® in 10 mL normal saline) into the right upper lobe of lung. Tuberculin Purified Protein Derivative: PPD administered through the airways to elicit the development of alveolar inflammation challenge dose of 0.5 TU	Arm 2: Healthy Volunteer Participants With Confirmed Non-Latent Tuberculosis Infection (LTBI) Healthy volunteer participants with confirmed non-Latent Tuberculosis Infection (LTBI) (TST negative and IGRA negative) receiving instillation dose of purified protein derivative (PPD) 0.5 tuberculin units (10 uL Tubersol® in 10 mL normal saline) into the right upper lobe of lung. Tuberculin Purified Protein Derivative: PPD administered through the airways to elicit the development of alveolar inflammation challenge dose of 0.5 TU
Overall Study STARTED	7	10
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: Healthy Volunteer Participants With Confirmed Latent Tuberculosis Infection (LTBI) Healthy volunteer participants with confirmed Latent Tuberculosis Infection (LTBI) (TST positive and IGRA positive) receiving instillation dose of purified protein derivative (PPD) 0.5 tuberculin units (10 uL Tubersol® in 10 mL normal saline) into the right upper lobe of lung. Tuberculin Purified Protein Derivative: PPD administered through the airways to elicit the development of alveolar inflammation challenge dose of 0.5 TU	Arm 2: Healthy Volunteer Participants With Confirmed Non-Latent Tuberculosis Infection (LTBI) Healthy volunteer participants with confirmed non-Latent Tuberculosis Infection (LTBI) (TST negative and IGRA negative) receiving instillation dose of purified protein derivative (PPD) 0.5 tuberculin units (10 uL Tubersol® in 10 mL normal saline) into the right upper lobe of lung. Tuberculin Purified Protein Derivative: PPD administered through the airways to elicit the development of alveolar inflammation challenge dose of 0.5 TU
Overall Study Lost to Follow-up	1	1
Overall Study Non-compliance (missed one or more study visits)	1	0
Overall Study Physician Decision	1	4
Overall Study Adverse Event	0	1

Baseline Characteristics

Characterization of Tissue-Specific Immune Responses to Bronchoscopic Instillation of Mycobacterial Antigens Into the Human Lung

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: Healthy Volunteer Participants With Confirmed Latent Tuberculosis Infection (LTBI) n=7 Participants Healthy volunteer participants with confirmed Latent Tuberculosis Infection (LTBI) (TST positive and IGRA positive) receiving instillation dose of purified protein derivative (PPD) 0.5 tuberculin units (10 uL Tubersol® in 10 mL normal saline) into the right upper lobe of lung. Tuberculin Purified Protein Derivative: PPD administered through the airways to elicit the development of alveolar inflammation challenge dose of 0.5 TU	Arm 2: Healthy Volunteer Participants With Confirmed Non-Latent Tuberculosis Infection (LTBI) n=10 Participants Healthy volunteer participants with confirmed non-Latent Tuberculosis Infection (LTBI) (TST negative and IGRA negative) receiving instillation dose of purified protein derivative (PPD) 0.5 tuberculin units (10 uL Tubersol® in 10 mL normal saline) into the right upper lobe of lung. Tuberculin Purified Protein Derivative: PPD administered through the airways to elicit the development of alveolar inflammation challenge dose of 0.5 TU	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=49 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=49 Participants	10 Participants n=50 Participants	17 Participants n=50 Participants
Age, Categorical >=65 years	0 Participants n=49 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants
Sex: Female, Male Female	4 Participants n=49 Participants	7 Participants n=50 Participants	11 Participants n=50 Participants
Sex: Female, Male Male	3 Participants n=49 Participants	3 Participants n=50 Participants	6 Participants n=50 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=49 Participants	0 Participants n=50 Participants	1 Participants n=50 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=49 Participants	10 Participants n=50 Participants	16 Participants n=50 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=49 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=49 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants
Race (NIH/OMB) Asian	0 Participants n=49 Participants	2 Participants n=50 Participants	2 Participants n=50 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=49 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants
Race (NIH/OMB) Black or African American	4 Participants n=49 Participants	1 Participants n=50 Participants	5 Participants n=50 Participants
Race (NIH/OMB) White	3 Participants n=49 Participants	7 Participants n=50 Participants	10 Participants n=50 Participants
Race (NIH/OMB) More than one race	0 Participants n=49 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=49 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants
Region of Enrollment United States	7 participants n=49 Participants	10 participants n=50 Participants	17 participants n=50 Participants

PRIMARY outcome

Timeframe: Day 5 and Day 21

Population: Cryo-recovery of cells obtained from one participant was unsuccessful; therefore, analysis could not be performed.

Outcome measures

Outcome measures
Measure	Arm 1: Healthy Volunteer Participants With Confirmed Latent Tuberculosis Infection (LTBI) n=4 Participants Healthy volunteer participants with confirmed Latent Tuberculosis Infection (LTBI) (TST positive and IGRA positive) receiving instillation dose of purified protein derivative (PPD) 0.5 tuberculin units (10 uL Tubersol® in 10 mL normal saline) into the right upper lobe of lung. Tuberculin Purified Protein Derivative: PPD administered through the airways to elicit the development of alveolar inflammation challenge dose of 0.5 TU	Arm 2: Healthy Volunteer Participants With Confirmed Non-Latent Tuberculosis Infection (LTBI) n=4 Participants Healthy volunteer participants with confirmed non-Latent Tuberculosis Infection (LTBI) (TST negative and IGRA negative) receiving instillation dose of purified protein derivative (PPD) 0.5 tuberculin units (10 uL Tubersol® in 10 mL normal saline) into the right upper lobe of lung. Tuberculin Purified Protein Derivative: PPD administered through the airways to elicit the development of alveolar inflammation challenge dose of 0.5 TU
Median Difference in CD4 Cell Response to Intrabronchial Instillation of Tuberculin Purified Protein Derivative (PPD) Day 5	5.26 % Antigen Specific T cells Interval 3.99 to 11.5	0.725 % Antigen Specific T cells Interval 0.462 to 1.74
Median Difference in CD4 Cell Response to Intrabronchial Instillation of Tuberculin Purified Protein Derivative (PPD) Day 21	29.9 % Antigen Specific T cells Interval 19.0 to 37.3	2.92 % Antigen Specific T cells Interval 1.98 to 4.16

SECONDARY outcome

Timeframe: Baseline (Up to -7 days prior to PPD instillation), Day 4 and Day 20

Median difference in the Standard Uptake Value (SUV) in the pulmonary parenchyma and thoracic lymph nodes with positron emission tomography combined with chest computed tomography (PET-CT)

Outcome measures

Outcome data not reported

Adverse Events

Arm 1: Healthy Volunteer Participants With Confirmed Latent Tuberculosis Infection (LTBI)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Arm 2: Healthy Volunteer Participants With Confirmed Non-Latent Tuberculosis Infection (LTBI)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Kevin P. Fennelly, M.D., MPH, ATSF

Division of Intramural Research, NHLBI

Phone: 301-385-0807

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Arm 1: Healthy Volunteer Participants With Confirmed Latent Tuberculosis Infection (LTBI) n=7 participants at risk Healthy volunteer participants with confirmed Latent Tuberculosis Infection (LTBI) (TST positive and IGRA positive) receiving instillation dose of purified protein derivative (PPD) 0.5 tuberculin units (10 uL Tubersol® in 10 mL normal saline) into the right upper lobe of lung. Tuberculin Purified Protein Derivative: PPD administered through the airways to elicit the development of alveolar inflammation challenge dose of 0.5 TU	Arm 2: Healthy Volunteer Participants With Confirmed Non-Latent Tuberculosis Infection (LTBI) n=10 participants at risk Healthy volunteer participants with confirmed non-Latent Tuberculosis Infection (LTBI) (TST negative and IGRA negative) receiving instillation dose of purified protein derivative (PPD) 0.5 tuberculin units (10 uL Tubersol® in 10 mL normal saline) into the right upper lobe of lung. Tuberculin Purified Protein Derivative: PPD administered through the airways to elicit the development of alveolar inflammation challenge dose of 0.5 TU
Cardiac disorders Sinus bradycardia	28.6% 2/7 • Number of events 2 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	0.00% 0/10 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Cardiac disorders Sinus tachycardia	14.3% 1/7 • Number of events 2 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	10.0% 1/10 • Number of events 2 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Eye disorders Red eyes	0.00% 0/7 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	10.0% 1/10 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Gastrointestinal disorders Nausea	28.6% 2/7 • Number of events 2 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	10.0% 1/10 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
General disorders Bruising	14.3% 1/7 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	0.00% 0/10 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
General disorders Chills	14.3% 1/7 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	0.00% 0/10 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
General disorders Edema face	0.00% 0/7 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	10.0% 1/10 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
General disorders Fatigue	14.3% 1/7 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	0.00% 0/10 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
General disorders Fever	14.3% 1/7 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	10.0% 1/10 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
General disorders Injection site reaction	14.3% 1/7 • Number of events 3 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	0.00% 0/10 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
General disorders Non-cardiac chest pain	14.3% 1/7 • Number of events 2 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	0.00% 0/10 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
General disorders Pain	14.3% 1/7 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	0.00% 0/10 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Injury, poisoning and procedural complications Bruising	28.6% 2/7 • Number of events 2 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	30.0% 3/10 • Number of events 5 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Injury, poisoning and procedural complications Injection site reaction	0.00% 0/7 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	10.0% 1/10 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Injury, poisoning and procedural complications Skin laceration	14.3% 1/7 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	0.00% 0/10 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Investigations Blood bicarbonate decreased	14.3% 1/7 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	0.00% 0/10 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Investigations Basophil count increased	14.3% 1/7 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	0.00% 0/10 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Investigations C-Reactive Protein increased	14.3% 1/7 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	10.0% 1/10 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Investigations Lymphocyte count decreased	0.00% 0/7 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	10.0% 1/10 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Metabolism and nutrition disorders Hyperglycemia	14.3% 1/7 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	0.00% 0/10 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/7 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	10.0% 1/10 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Nervous system disorders Dizziness	14.3% 1/7 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	0.00% 0/10 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Nervous system disorders Headache	28.6% 2/7 • Number of events 4 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	30.0% 3/10 • Number of events 4 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Nervous system disorders Hypersomnia	14.3% 1/7 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	0.00% 0/10 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Nervous system disorders Gag reflex	0.00% 0/7 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	10.0% 1/10 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Renal and urinary disorders Urinary retention	14.3% 1/7 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	0.00% 0/10 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Reproductive system and breast disorders Adnexal cystic mass	14.3% 1/7 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	0.00% 0/10 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Respiratory, thoracic and mediastinal disorders Cough	57.1% 4/7 • Number of events 11 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	50.0% 5/10 • Number of events 11 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Respiratory, thoracic and mediastinal disorders Dyspnea	14.3% 1/7 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	0.00% 0/10 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Respiratory, thoracic and mediastinal disorders Hoarseness	42.9% 3/7 • Number of events 6 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	30.0% 3/10 • Number of events 3 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Respiratory, thoracic and mediastinal disorders Nasal congestion	28.6% 2/7 • Number of events 4 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	0.00% 0/10 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Respiratory, thoracic and mediastinal disorders Productive cough	14.3% 1/7 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	0.00% 0/10 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Respiratory, thoracic and mediastinal disorders Bradypnea	14.3% 1/7 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	0.00% 0/10 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Respiratory, thoracic and mediastinal disorders Lung consolidations	0.00% 0/7 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	10.0% 1/10 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Respiratory, thoracic and mediastinal disorders Lung infiltrate	14.3% 1/7 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	0.00% 0/10 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Respiratory, thoracic and mediastinal disorders Paratracheal and suprahilar nodes	14.3% 1/7 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	0.00% 0/10 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Respiratory, thoracic and mediastinal disorders Tachypnea	14.3% 1/7 • Number of events 2 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	0.00% 0/10 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Respiratory, thoracic and mediastinal disorders Sore throat	57.1% 4/7 • Number of events 14 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	30.0% 3/10 • Number of events 8 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Respiratory, thoracic and mediastinal disorders Wheezing	28.6% 2/7 • Number of events 3 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	0.00% 0/10 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.
Skin and subcutaneous tissue disorders Purpura	14.3% 1/7 • Number of events 1 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.	0.00% 0/10 • 30 Days At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization via in person, telephone and or e-mail.