Trial Outcomes & Findings for Challenge Infection of Healthy Adult Volunteers With RSV A2 (NCT NCT03388645)
NCT ID: NCT03388645
Last Updated: 2020-12-03
Results Overview
Participants who had shedding of RSV as assessed by detection of RSV A2 in nasal wash by FilmArray multiplex polymerase chain reaction (PCR), by reverse transcriptase (RT)-quantitative PCR, or by quantitative viral culture.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
19 participants
Primary outcome timeframe
Daily from study Day 2 through day 10 after challenge with RSV A2
Results posted on
2020-12-03
Participant Flow
19 subjects were recruited; 7 were not dosed because they were either ineligible or did not start the study.
Participant milestones
| Measure |
Low Dose 10^6.3 PFU of RSV A2
Single intranasal dose of 10\^6.3 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
|
High Dose 10^7 PFU of RSV A2
Single intranasal dose of 10\^7 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
|
|---|---|---|
|
Low Dose RSV A2
STARTED
|
4
|
0
|
|
Low Dose RSV A2
COMPLETED
|
4
|
0
|
|
Low Dose RSV A2
NOT COMPLETED
|
0
|
0
|
|
High Dose RSV A2
STARTED
|
0
|
8
|
|
High Dose RSV A2
COMPLETED
|
0
|
7
|
|
High Dose RSV A2
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Challenge Infection of Healthy Adult Volunteers With RSV A2
Baseline characteristics by cohort
| Measure |
Low Dose 10^6.3 PFU of RSV A2
n=4 Participants
Single intranasal dose of 10\^6.3 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
|
High Dose 10^7 PFU of RSV A2
n=8 Participants
Single intranasal dose of 10\^7 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Daily from study Day 2 through day 10 after challenge with RSV A2Participants who had shedding of RSV as assessed by detection of RSV A2 in nasal wash by FilmArray multiplex polymerase chain reaction (PCR), by reverse transcriptase (RT)-quantitative PCR, or by quantitative viral culture.
Outcome measures
| Measure |
Low Dose 10^6.3 PFU of RSV A2
n=4 Participants
Single intranasal dose of 10\^6.3 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
|
High Dose 10^7 PFU of RSV A2
n=8 Participants
Single intranasal dose of 10\^7 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
|
|---|---|---|
|
Participants With Detectable RSV Shedding in Nasopharyngeal Wash
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Safety assessed continuously during the inpatient phase and at Day 28 and 56 during the outpatient phase of the studyParticipants who had one or more episodes of related, expected adverse events. Participants were evaluated for grades 1 to 3 adverse events. Only grade 1 adverse events were experienced.
Outcome measures
| Measure |
Low Dose 10^6.3 PFU of RSV A2
n=4 Participants
Single intranasal dose of 10\^6.3 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
|
High Dose 10^7 PFU of RSV A2
n=8 Participants
Single intranasal dose of 10\^7 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
|
|---|---|---|
|
Participants With Related, Expected Adverse Events After Challenge
Nasal congestion or rhinorrhea
|
3 Participants
|
2 Participants
|
|
Participants With Related, Expected Adverse Events After Challenge
Sore throat
|
2 Participants
|
4 Participants
|
|
Participants With Related, Expected Adverse Events After Challenge
Cough
|
0 Participants
|
3 Participants
|
|
Participants With Related, Expected Adverse Events After Challenge
Headache
|
2 Participants
|
0 Participants
|
|
Participants With Related, Expected Adverse Events After Challenge
Sinus congestion or pain
|
1 Participants
|
1 Participants
|
|
Participants With Related, Expected Adverse Events After Challenge
Fever 38°C to 39.4°C
|
0 Participants
|
0 Participants
|
|
Participants With Related, Expected Adverse Events After Challenge
Ear Pain
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Safety assessed continuously during the inpatient phase and at Day 28 and 56 during the outpatient phase of the studyParticipants who had one or more episodes of unrelated, expected adverse events. Participants were evaluated for grades 1 to 3 adverse events. Only grade 1 adverse events were experienced.
Outcome measures
| Measure |
Low Dose 10^6.3 PFU of RSV A2
n=4 Participants
Single intranasal dose of 10\^6.3 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
|
High Dose 10^7 PFU of RSV A2
n=8 Participants
Single intranasal dose of 10\^7 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
|
|---|---|---|
|
Participants With Unrelated Expected Adverse Events After Challenge
Nasal congestion or rhinorrhea
|
1 Participants
|
0 Participants
|
|
Participants With Unrelated Expected Adverse Events After Challenge
Headache
|
1 Participants
|
1 Participants
|
|
Participants With Unrelated Expected Adverse Events After Challenge
Cough
|
1 Participants
|
1 Participants
|
|
Participants With Unrelated Expected Adverse Events After Challenge
Sinus congestion or pain
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Safety assessed continuously during the inpatient phase and at Day 28 and 56 during the outpatient phase of the studyParticipants who had one or more episodes of related, unexpected adverse events. Related, unexpected adverse events are those that are not expected but are related to RSV A2 or of grade 4 severity and related to RSV A2. Only grade 1 adverse events were experienced.
Outcome measures
| Measure |
Low Dose 10^6.3 PFU of RSV A2
n=4 Participants
Single intranasal dose of 10\^6.3 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
|
High Dose 10^7 PFU of RSV A2
n=8 Participants
Single intranasal dose of 10\^7 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
|
|---|---|---|
|
Participants With Related, Unexpected Adverse Events After Challenge
Postnasal drip
|
1 Participants
|
0 Participants
|
|
Participants With Related, Unexpected Adverse Events After Challenge
Respiratory rate
|
1 Participants
|
0 Participants
|
|
Participants With Related, Unexpected Adverse Events After Challenge
Smell alteration
|
0 Participants
|
1 Participants
|
|
Participants With Related, Unexpected Adverse Events After Challenge
Sneezing
|
0 Participants
|
2 Participants
|
|
Participants With Related, Unexpected Adverse Events After Challenge
Alanine aminotransferase
|
1 Participants
|
0 Participants
|
|
Participants With Related, Unexpected Adverse Events After Challenge
Anxiety
|
1 Participants
|
0 Participants
|
|
Participants With Related, Unexpected Adverse Events After Challenge
Bradycardia
|
2 Participants
|
0 Participants
|
|
Participants With Related, Unexpected Adverse Events After Challenge
Chills
|
0 Participants
|
1 Participants
|
|
Participants With Related, Unexpected Adverse Events After Challenge
Fatigue
|
0 Participants
|
1 Participants
|
|
Participants With Related, Unexpected Adverse Events After Challenge
General discomfort
|
0 Participants
|
1 Participants
|
|
Participants With Related, Unexpected Adverse Events After Challenge
Taste alteration
|
0 Participants
|
1 Participants
|
|
Participants With Related, Unexpected Adverse Events After Challenge
Throat irritation
|
0 Participants
|
4 Participants
|
|
Participants With Related, Unexpected Adverse Events After Challenge
Watering eyes
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Safety assessed continuously during the inpatient phase and at Day 28 and 56 during the outpatient phase of the studyParticipants who had one or more episodes of unrelated, unexpected adverse events. Unrelated, unexpected adverse events are those that are not expected and are not related to RSV A2.
Outcome measures
| Measure |
Low Dose 10^6.3 PFU of RSV A2
n=4 Participants
Single intranasal dose of 10\^6.3 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
|
High Dose 10^7 PFU of RSV A2
n=8 Participants
Single intranasal dose of 10\^7 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
|
|---|---|---|
|
Participants With Unrelated, Unexpected Adverse Events After Challenge
Syncope
|
0 Participants
|
1 Participants
|
|
Participants With Unrelated, Unexpected Adverse Events After Challenge
Abdominal pain
|
0 Participants
|
1 Participants
|
|
Participants With Unrelated, Unexpected Adverse Events After Challenge
Bradycardia
|
1 Participants
|
2 Participants
|
|
Participants With Unrelated, Unexpected Adverse Events After Challenge
Bruising aminotransferase
|
1 Participants
|
0 Participants
|
|
Participants With Unrelated, Unexpected Adverse Events After Challenge
Cognitive disturbance
|
1 Participants
|
0 Participants
|
|
Participants With Unrelated, Unexpected Adverse Events After Challenge
Hemoglobin decreased
|
1 Participants
|
5 Participants
|
|
Participants With Unrelated, Unexpected Adverse Events After Challenge
Irritability
|
1 Participants
|
0 Participants
|
|
Participants With Unrelated, Unexpected Adverse Events After Challenge
Laceration
|
1 Participants
|
0 Participants
|
|
Participants With Unrelated, Unexpected Adverse Events After Challenge
Light headedness
|
0 Participants
|
2 Participants
|
|
Participants With Unrelated, Unexpected Adverse Events After Challenge
Low back pain
|
1 Participants
|
0 Participants
|
|
Participants With Unrelated, Unexpected Adverse Events After Challenge
Muscle soreness
|
0 Participants
|
1 Participants
|
|
Participants With Unrelated, Unexpected Adverse Events After Challenge
Nausea
|
1 Participants
|
0 Participants
|
|
Participants With Unrelated, Unexpected Adverse Events After Challenge
Neck pain
|
1 Participants
|
0 Participants
|
|
Participants With Unrelated, Unexpected Adverse Events After Challenge
Night sweats
|
1 Participants
|
0 Participants
|
|
Participants With Unrelated, Unexpected Adverse Events After Challenge
Pain
|
1 Participants
|
0 Participants
|
|
Participants With Unrelated, Unexpected Adverse Events After Challenge
Potassium decreased
|
0 Participants
|
1 Participants
|
|
Participants With Unrelated, Unexpected Adverse Events After Challenge
Tiredness
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Daily from study Day 2 through day 10 after RSV challengeParticipants who experienced mild to moderate upper respiratory illness in healthy volunteers challenged with RSV A2. All RSV illness qualified as mild illness.
Outcome measures
| Measure |
Low Dose 10^6.3 PFU of RSV A2
n=4 Participants
Single intranasal dose of 10\^6.3 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
|
High Dose 10^7 PFU of RSV A2
n=8 Participants
Single intranasal dose of 10\^7 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
|
|---|---|---|
|
Participants With Mild to Moderate Upper Respiratory Illness
|
2 Participants
|
1 Participants
|
Adverse Events
Low Dose 10^6.3 PFU of RSV A2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
High Dose 10^7 PFU of RSV A2
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Dose 10^6.3 PFU of RSV A2
n=4 participants at risk
Single intranasal dose of 10\^6.3 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
|
High Dose 10^7 PFU of RSV A2
n=8 participants at risk
Single intranasal dose of 10\^7 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
50.0%
2/4 • 56 days
|
25.0%
2/8 • 56 days
|
|
Eye disorders
Lacrimation increased
|
25.0%
1/4 • 56 days
|
0.00%
0/8 • 56 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • 56 days
|
12.5%
1/8 • 56 days
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • 56 days
|
0.00%
0/8 • 56 days
|
|
General disorders
Chills
|
0.00%
0/4 • 56 days
|
12.5%
1/8 • 56 days
|
|
General disorders
Discomfort
|
0.00%
0/4 • 56 days
|
12.5%
1/8 • 56 days
|
|
General disorders
Fatigue
|
0.00%
0/4 • 56 days
|
25.0%
2/8 • 56 days
|
|
General disorders
Pain
|
25.0%
1/4 • 56 days
|
0.00%
0/8 • 56 days
|
|
Injury, poisoning and procedural complications
Contusion
|
25.0%
1/4 • 56 days
|
0.00%
0/8 • 56 days
|
|
Injury, poisoning and procedural complications
Skin laceration
|
25.0%
1/4 • 56 days
|
0.00%
0/8 • 56 days
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
1/4 • 56 days
|
0.00%
0/8 • 56 days
|
|
Investigations
Blood potassium decreased
|
0.00%
0/4 • 56 days
|
12.5%
1/8 • 56 days
|
|
Investigations
Haemoglobin decreased
|
25.0%
1/4 • 56 days
|
50.0%
4/8 • 56 days
|
|
Investigations
Respiratory rate
|
25.0%
1/4 • 56 days
|
0.00%
0/8 • 56 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • 56 days
|
0.00%
0/8 • 56 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • 56 days
|
12.5%
1/8 • 56 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
25.0%
1/4 • 56 days
|
0.00%
0/8 • 56 days
|
|
Nervous system disorders
Cognitive disorder
|
25.0%
1/4 • 56 days
|
0.00%
0/8 • 56 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • 56 days
|
25.0%
2/8 • 56 days
|
|
Nervous system disorders
Headache
|
75.0%
3/4 • 56 days
|
12.5%
1/8 • 56 days
|
|
Nervous system disorders
Parosmia
|
0.00%
0/4 • 56 days
|
12.5%
1/8 • 56 days
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • 56 days
|
12.5%
1/8 • 56 days
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/4 • 56 days
|
12.5%
1/8 • 56 days
|
|
Psychiatric disorders
Anxiety
|
25.0%
1/4 • 56 days
|
0.00%
0/8 • 56 days
|
|
Psychiatric disorders
Irritability
|
25.0%
1/4 • 56 days
|
0.00%
0/8 • 56 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • 56 days
|
37.5%
3/8 • 56 days
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
50.0%
2/4 • 56 days
|
12.5%
1/8 • 56 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
75.0%
3/4 • 56 days
|
25.0%
2/8 • 56 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
50.0%
2/4 • 56 days
|
50.0%
4/8 • 56 days
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
25.0%
1/4 • 56 days
|
25.0%
2/8 • 56 days
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/4 • 56 days
|
25.0%
2/8 • 56 days
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/4 • 56 days
|
50.0%
4/8 • 56 days
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
25.0%
1/4 • 56 days
|
0.00%
0/8 • 56 days
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
25.0%
1/4 • 56 days
|
0.00%
0/8 • 56 days
|
Additional Information
Lesia Dropulic
National Institute of Allergy and Infectious Diseases
Phone: +1 301 496 7675
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place