Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    18-I-0039
Previous Study | Return to List | Next Study

Challenge Infection of Healthy Adult Volunteers With RSV A2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03388645
Recruitment Status : Completed
First Posted : January 3, 2018
Results First Posted : December 3, 2020
Last Update Posted : December 3, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Upper Respiratory Tract Infections
Interventions Biological: 10^6.3 PFU of RSV A2
Biological: 10^7 PFU of RSV A2
Enrollment 19
Recruitment Details 19 subjects were recruited; 7 were not dosed because they were either ineligible or did not start the study.
Pre-assignment Details  
Arm/Group Title Low Dose 10^6.3 PFU of RSV A2 High Dose 10^7 PFU of RSV A2
Hide Arm/Group Description 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 Single intranasal dose of 10^7 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
Period Title: Low Dose RSV A2
Started 4 0
Completed 4 0
Not Completed 0 0
Period Title: High Dose RSV A2
Started 0 8
Completed 0 7
Not Completed 0 1
Arm/Group Title Low Dose 10^6.3 PFU of RSV A2 High Dose 10^7 PFU of RSV A2 Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 4 8 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 8 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
8
 100.0%
12
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 8 participants 12 participants
Female
1
  25.0%
4
  50.0%
5
  41.7%
Male
3
  75.0%
4
  50.0%
7
  58.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 8 participants 12 participants
Hispanic or Latino
1
  25.0%
1
  12.5%
2
  16.7%
Not Hispanic or Latino
2
  50.0%
7
  87.5%
9
  75.0%
Unknown or Not Reported
1
  25.0%
0
   0.0%
1
   8.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 8 participants 12 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  12.5%
1
   8.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
2
  25.0%
2
  16.7%
White
3
  75.0%
5
  62.5%
8
  66.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  25.0%
0
   0.0%
1
   8.3%
1.Primary Outcome
Title Participants With Detectable RSV Shedding in Nasopharyngeal Wash
Hide Description 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.
Time Frame Daily from study Day 2 through day 10 after challenge with RSV A2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose 10^6.3 PFU of RSV A2 High Dose 10^7 PFU of RSV A2
Hide Arm/Group Description:
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
Single intranasal dose of 10^7 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
Overall Number of Participants Analyzed 4 8
Measure Type: Count of Participants
Unit of Measure: Participants
2
  50.0%
4
  50.0%
2.Primary Outcome
Title Participants With Related, Expected Adverse Events After Challenge
Hide Description Participants 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.
Time Frame Safety assessed continuously during the inpatient phase and at Day 28 and 56 during the outpatient phase of the study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose 10^6.3 PFU of RSV A2 High Dose 10^7 PFU of RSV A2
Hide Arm/Group Description:
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
Single intranasal dose of 10^7 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
Overall Number of Participants Analyzed 4 8
Measure Type: Count of Participants
Unit of Measure: Participants
Nasal congestion or rhinorrhea
3
  75.0%
2
  25.0%
Sore throat
2
  50.0%
4
  50.0%
Cough
0
   0.0%
3
  37.5%
Headache
2
  50.0%
0
   0.0%
Sinus congestion or pain
1
  25.0%
1
  12.5%
Fever 38°C to 39.4°C
0
   0.0%
0
   0.0%
Ear Pain
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Participants With Unrelated Expected Adverse Events After Challenge
Hide Description Participants 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.
Time Frame Safety assessed continuously during the inpatient phase and at Day 28 and 56 during the outpatient phase of the study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose 10^6.3 PFU of RSV A2 High Dose 10^7 PFU of RSV A2
Hide Arm/Group Description:
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
Single intranasal dose of 10^7 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
Overall Number of Participants Analyzed 4 8
Measure Type: Count of Participants
Unit of Measure: Participants
Nasal congestion or rhinorrhea
1
  25.0%
0
   0.0%
Headache
1
  25.0%
1
  12.5%
Cough
1
  25.0%
1
  12.5%
Sinus congestion or pain
0
   0.0%
1
  12.5%
4.Primary Outcome
Title Participants With Related, Unexpected Adverse Events After Challenge
Hide Description Participants 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.
Time Frame Safety assessed continuously during the inpatient phase and at Day 28 and 56 during the outpatient phase of the study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose 10^6.3 PFU of RSV A2 High Dose 10^7 PFU of RSV A2
Hide Arm/Group Description:
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
Single intranasal dose of 10^7 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
Overall Number of Participants Analyzed 4 8
Measure Type: Count of Participants
Unit of Measure: Participants
Alanine aminotransferase
1
  25.0%
0
   0.0%
Anxiety
1
  25.0%
0
   0.0%
Bradycardia
2
  50.0%
0
   0.0%
Chills
0
   0.0%
1
  12.5%
Fatigue
0
   0.0%
1
  12.5%
General discomfort
0
   0.0%
1
  12.5%
Postnasal drip
1
  25.0%
0
   0.0%
Respiratory rate
1
  25.0%
0
   0.0%
Smell alteration
0
   0.0%
1
  12.5%
Sneezing
0
   0.0%
2
  25.0%
Taste alteration
0
   0.0%
1
  12.5%
Throat irritation
0
   0.0%
4
  50.0%
Watering eyes
1
  25.0%
0
   0.0%
5.Primary Outcome
Title Participants With Unrelated, Unexpected Adverse Events After Challenge
Hide Description Participants 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.
Time Frame Safety assessed continuously during the inpatient phase and at Day 28 and 56 during the outpatient phase of the study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose 10^6.3 PFU of RSV A2 High Dose 10^7 PFU of RSV A2
Hide Arm/Group Description:
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
Single intranasal dose of 10^7 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
Overall Number of Participants Analyzed 4 8
Measure Type: Count of Participants
Unit of Measure: Participants
Abdominal pain
0
   0.0%
1
  12.5%
Bradycardia
1
  25.0%
2
  25.0%
Bruising aminotransferase
1
  25.0%
0
   0.0%
Cognitive disturbance
1
  25.0%
0
   0.0%
Hemoglobin decreased
1
  25.0%
5
  62.5%
Irritability
1
  25.0%
0
   0.0%
Laceration
1
  25.0%
0
   0.0%
Light headedness
0
   0.0%
2
  25.0%
Low back pain
1
  25.0%
0
   0.0%
Muscle soreness
0
   0.0%
1
  12.5%
Nausea
1
  25.0%
0
   0.0%
Neck pain
1
  25.0%
0
   0.0%
Night sweats
1
  25.0%
0
   0.0%
Pain
1
  25.0%
0
   0.0%
Potassium decreased
0
   0.0%
1
  12.5%
Syncope
0
   0.0%
1
  12.5%
Tiredness
0
   0.0%
1
  12.5%
6.Secondary Outcome
Title Participants With Mild to Moderate Upper Respiratory Illness
Hide Description Participants who experienced mild to moderate upper respiratory illness in healthy volunteers challenged with RSV A2. All RSV illness qualified as mild illness.
Time Frame Daily from study Day 2 through day 10 after RSV challenge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose 10^6.3 PFU of RSV A2 High Dose 10^7 PFU of RSV A2
Hide Arm/Group Description:
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
Single intranasal dose of 10^7 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
Overall Number of Participants Analyzed 4 8
Measure Type: Count of Participants
Unit of Measure: Participants
2
  50.0%
1
  12.5%
Time Frame 56 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low Dose 10^6.3 PFU of RSV A2 High Dose 10^7 PFU of RSV A2
Hide Arm/Group Description 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 Single intranasal dose of 10^7 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0
All-Cause Mortality
Low Dose 10^6.3 PFU of RSV A2 High Dose 10^7 PFU of RSV A2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/8 (0.00%) 
Hide Serious Adverse Events
Low Dose 10^6.3 PFU of RSV A2 High Dose 10^7 PFU of RSV A2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/8 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Low Dose 10^6.3 PFU of RSV A2 High Dose 10^7 PFU of RSV A2
Affected / at Risk (%) Affected / at Risk (%)
Total   4/4 (100.00%)   7/8 (87.50%) 
Cardiac disorders     
Bradycardia   2/4 (50.00%)  2/8 (25.00%) 
Eye disorders     
Lacrimation increased   1/4 (25.00%)  0/8 (0.00%) 
Gastrointestinal disorders     
Abdominal pain   0/4 (0.00%)  1/8 (12.50%) 
Nausea   1/4 (25.00%)  0/8 (0.00%) 
General disorders     
Chills   0/4 (0.00%)  1/8 (12.50%) 
Discomfort   0/4 (0.00%)  1/8 (12.50%) 
Fatigue   0/4 (0.00%)  2/8 (25.00%) 
Pain   1/4 (25.00%)  0/8 (0.00%) 
Injury, poisoning and procedural complications     
Contusion   1/4 (25.00%)  0/8 (0.00%) 
Skin laceration   1/4 (25.00%)  0/8 (0.00%) 
Investigations     
Alanine aminotransferase increased   1/4 (25.00%)  0/8 (0.00%) 
Blood potassium decreased   0/4 (0.00%)  1/8 (12.50%) 
Haemoglobin decreased   1/4 (25.00%)  4/8 (50.00%) 
Respiratory rate   1/4 (25.00%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain   1/4 (25.00%)  0/8 (0.00%) 
Myalgia   0/4 (0.00%)  1/8 (12.50%) 
Neck pain   1/4 (25.00%)  0/8 (0.00%) 
Nervous system disorders     
Cognitive disorder   1/4 (25.00%)  0/8 (0.00%) 
Dizziness   0/4 (0.00%)  2/8 (25.00%) 
Headache   3/4 (75.00%)  1/8 (12.50%) 
Parosmia   0/4 (0.00%)  1/8 (12.50%) 
Syncope   0/4 (0.00%)  1/8 (12.50%) 
Taste disorder   0/4 (0.00%)  1/8 (12.50%) 
Psychiatric disorders     
Anxiety   1/4 (25.00%)  0/8 (0.00%) 
Irritability   1/4 (25.00%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough   1/4 (25.00%)  3/8 (37.50%) 
Dysphonia   2/4 (50.00%)  1/8 (12.50%) 
Nasal congestion   3/4 (75.00%)  2/8 (25.00%) 
Oropharyngeal pain   2/4 (50.00%)  4/8 (50.00%) 
Sinus congestion   1/4 (25.00%)  2/8 (25.00%) 
Sneezing   0/4 (0.00%)  2/8 (25.00%) 
Throat irritation   0/4 (0.00%)  4/8 (50.00%) 
Upper-airway cough syndrome   1/4 (25.00%)  0/8 (0.00%) 
Skin and subcutaneous tissue disorders     
Night sweats   1/4 (25.00%)  0/8 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lesia Dropulic
Organization: National Institute of Allergy and Infectious Diseases
Phone: +1 301 496 7675
EMail: dropulicl@niaid.nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT03388645    
Other Study ID Numbers: 180039
18-I-0039
First Submitted: December 30, 2017
First Posted: January 3, 2018
Results First Submitted: November 12, 2020
Results First Posted: December 3, 2020
Last Update Posted: December 3, 2020