Upper Respiratory Tract InfectionsPhase 1NCT03388645
Challenge Infection of Healthy Adult Volunteers With RSV A2
A Phase 1 study testing 10^6.3 PFU of RSV A2 and 10^7 PFU of RSV A2 in people with Upper Respiratory Tract Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: One of the main causes of respiratory infections in children and adults is RSV. This stands for respiratory syncytial virus. Healthy adults usually get a cold when they get an infection with RSV. They generally recover without any problems. But some infections can be life-threatening. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infections
- What is being tested?
- 10^6.3 PFU of RSV A2 and 10^7 PFU of RSV A2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2018to 6 Dec 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-50 years inclusive.
- General good health, without significant medical illness, physical exam findings, or significant laboratory abnormalities as determined by the investigator.
- Willingness to stay confined to the inpatient unit for required study duration.
- Willingness to have samples stored for future research.
- Subjects must be of non-childbearing potential (e.g., surgically sterilized (bilateral oophorectomy, bilateral tubal ligation, hysterectomy) or, if of child-bearing potential and sexually active with a partner who can get them pregnant, must have in place an effective method of contraception for at least 30 days prior to administration of the challenge virus and until 30 days after challenge virus
- administration:
Show all 11Show fewer
- intrauterine device (IUD) or equivalent
- hormonal contraceptives (e.g., consistent, continuous use of contraceptive pill, patch, ring, implant, or injection)
- ---if participant uses contraceptive pill, patch, or ring, they must also use a barrier method at the time of potentially reproductive sexual activity (e.g., (male/female condom, cap, or diaphragm) plus spermicide)
- be in a monogamous relationship with a partner who has undergone a vasectomy at least 180 days prior to first dose of study agent
- A plaque reduction RSV neutralization titer < 8.0 log(2).
Who cannot join
- Subject who was previously challenged with RSV A2.
- Female subject who is pregnant or lactating OR planning to become pregnant from 30 days prior to inoculation through 30 days after inoculation.
- Presence of self-reported or medically documented significant medical condition(s) including but not limited to:
- -Respiratory disease (e.g., chronic obstructive pulmonary disease, emphysema, rhinitis, sinusitis) in adulthood, and additionally:
- --A history of asthma within the past 5 years, or a current diagnosis of asthma or reactive airway disease associated with
- exercise, seasonal hay fever or allergic rhinitis
Show all 31Show fewer
- --Presence of any febrile illness or symptoms suggestive of a respiratory infection within 2 weeks prior to inoculation.
- Any significant abnormality of the nose or nasopharynx, including recurrent epistaxis within 90 days prior to viral inoculation or nasal or sinus surgery within 180 days prior to viral inoculation.
- Chronic cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease).
- Chronic neurological or neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures).
- Ongoing malignancy.
- Chronic medical condition requiring close medical follow-up or hospitalization during the past 5 years (e.g., diabetes mellitus, renal dysfunction, hemoglobinopathy, autoimmune disease).
- An immunodeficiency.
- Use of systemic corticosteroids exceeding 10 mg/day of prednisone equivalent and nasal steroid preparations or immunosuppressive drugs within 30 days before inoculation and within 60 days after. Low dose topical steroid preparations used for a discrete period of time are permitted.
- Inhaled bronchodilator or inhaled steroid use within the last 360 days or use after upper respiratory tract infections.
- Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the study protocol.
- Complete blood count (CBC), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine values or other screening labs or tests (e.g. electrocardiogram (EKG), chest x-ray (CXR)) are outside of the NIH Department of Laboratory Medicine normal reference range and deemed clinically significant by the PI.
- Positive FDA-approved HIV test obtained during screening procedures.
- Positive serology for hepatitis C virus obtained during screening period.
- Presence of hepatitis B surface antigen obtained during screening period.
- A smoker of tobacco products or a routine marijuana smoker currently or in the past year.
- Current alcohol abuse or addiction.
- Current illicit drug abuse or addiction.
- Receipt of a licensed vaccine within 30 days prior to RSV A2 inoculation and planned vaccination within 60 days after inoculation..
- Receipt of blood or blood-derived products (including immunoglobulin) within 180 days prior to viral inoculation. Receipt of packed red blood cells given for an emergent indication in an otherwise healthy person, and not required as ongoing treatment, is not exclusionary.
- Receipt of an investigational agent or vaccine within 90 days prior to scheduled RSV A2 inoculation and planned receipt within 60 days after inoculation.
- A body mass index (BMI) less than or equal to 18.5 or greater than or equal to 37.0.
- A medical, occupational, or family problem that would preclude the participant from complying with all study requirements.
- Shares household, works closely with, or has routine contact with a child (children) < 5 years of age or with immunocompromised individual(s), adult(s) with significant cardiopulmonary disease or asthma, institutionalized persons or persons with functional disability, or any other individual that, in the judgment of the PI, might be at increased risk for complications if exposed to RSV.
- Deprived of freedom by an administrative or court order or in an emergency setting.
- Any condition that in the opinion of the PI would jeopardize the safety or rights of a person participating in the trial or would render the person unable to comply with the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
One of the main causes of respiratory infections in children and adults is RSV. This stands for respiratory syncytial virus. Healthy adults usually get a cold when they get an infection with RSV. They generally recover without any problems. But some infections can be life-threatening. Researchers want to study RSV infection in a safe, controlled setting in healthy adults to help develop new treatments.
Read more
Objective:
To test the safety of a high dose of RSV A2 by spraying the virus into the nose, and studying how the body responds.
Eligibility:
Healthy adults ages 18-50
Design:
Participants will be screened during 2 screening visits with:
- Medical interview
- Physical exam
- Blood and nasal samples
- Chest X-ray (chest radiograph)
- Participants will have a heart test. Sticky patches on the body will detect heart electrical activity.
- Pulmonary function test (PFT). They will blow into a machine to measure airflow.
- Urine tests for pregnancy or drug use.
Participants will be admitted to the hospital before they get RSV A2.
Participants will get a single dose of RSV A2 as two sprays, one into each nostril.
Participants will stay in the hospital under isolation for as long as it takes the body to clear RSV A2 from nasal fluids. This can take as long as 14 days or more.
Participants cannot take any cold medicine to try to feel better.
Every day, participants will:
- Answer questions about their symptoms
- Have nasal washes and/or nasal swabs collected
- Have a physical exam
Participants will have blood drawn most days.
After discharge, participants will keep a health diary.
Participants will have 2 follow-up visits at 1 month and 2 months after receiving the RSV A2 dose. A history and physical examination, a blood draw, and nasal wash and swab will be performed.
Read the detailed description
Respiratory syncytial virus (RSV) is the leading cause of pediatric lower respiratory tract infection. RSV also causes lower respiratory tract disease in the elderly and life-threatening disease in immunocompromised hosts. An RSV monoclonal antibody (palivizumab) is currently available for passive immunoprophylaxis in high-risk infants. Vaccines and antiviral agents are under development for the treatment and prevention of RSV, but none are licensed. The ability to challenge healthy volunteers with RSV could rapidly facilitate efficacy studies of future antivirals and vaccines. In addition, challenge studies would provide critical information on viral pathogenesis, including types of cells infected, mucosal and systemic immune response, and alterations in respiratory microbiota. Clinical trial material for human challenge studies has been prepared from live recombinant (complementary DNA-derived) RSV of subgroup A (RSV A2).
This study will be a phase 1 study in healthy adult male and non-pregnant female subjects 18 years to 50 years of age. The main purpose of the trial is to define the safety profile, determine the frequency of RSV shedding in nasal wash, estimate RSV illness rates, and study immune responses in subjects given 1 dose of 10^7 PFU of RSV A2 challenge virus using a nasal atomizer. If RSV A2 is found to be sufficiently infectious in adults, then it may be used as a challenge virus in future studies evaluating antivirals or the protective efficacy of RSV vaccines, or in studies of the immunopathogenesis of RSV infection.
Subjects will be admitted to the NIH Clinical Center and receive a single intranasal dose of 10^6.3 PFU or 107 PFU of RSV A2. Subjects will remain at the Clinical Center for approximately 9-14 days after challenge infection undergoing sequential clinical evaluations. Research specimens, nasal washes and blood, will be collected for various research assays. Subjects will be discharged when their daily nasal wash RSV result is negative for two days in a row, and they do not have any signs or symptoms suggestive of possible RSV-associated lower respiratory tract disease. Subjects will return for follow-up evaluation 28 and 56 days after viral challenge.
- Conditions
- Upper Respiratory Tract Infections
- Being tested
- 10^6.3 PFU of RSV A2, 10^7 PFU of RSV A2
- Keywords
- RSV Shedding, Immune Responses, Neutralizing Antibody Titer, Upper Respiratory Tract Infection
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10^6.3 PFU of RSV A2Biological
Each adult volunteer will receive a single intranasal inoculation of 10^6.3 PFU of RSV A2 administered with a nasal atomizer with subsequent sampling of nasal fluids and blood draws.
10^7 PFU of RSV A2Biological
Each adult volunteer will receive a single intranasal inoculation of 10^7 PFU of RSV A2 administered with a nasal atomizer with subsequent sampling of nasal fluids and blood draws.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose 10^6.3 PFU of RSV A2 | Experimental | 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 Receives: Biological: 10^6.3 PFU of RSV A2 |
| High Dose 10^7 PFU of RSV A2 | Experimental | Single intranasal dose of 10^7 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0 Receives: Biological: 10^7 PFU of RSV A2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Detectable RSV Shedding in Nasopharyngeal Wash
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.
Measured: Daily from study Day 2 through day 10 after challenge with RSV A2
Participants With Related, Expected Adverse Events After Challenge
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.
Measured: Safety assessed continuously during the inpatient phase and at Day 28 and 56 during the outpatient phase of the study
Participants With Unrelated Expected Adverse Events After Challenge
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.
Measured: Safety assessed continuously during the inpatient phase and at Day 28 and 56 during the outpatient phase of the study
Participants With Related, Unexpected Adverse Events After Challenge
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.
Measured: Safety assessed continuously during the inpatient phase and at Day 28 and 56 during the outpatient phase of the study
Participants With Unrelated, Unexpected Adverse Events After Challenge
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.
Measured: Safety assessed continuously during the inpatient phase and at Day 28 and 56 during the outpatient phase of the study
Secondary outcomes (1)
Participants With Mild to Moderate Upper Respiratory Illness
Participants who experienced mild to moderate upper respiratory illness in healthy volunteers challenged with RSV A2. All RSV illness qualified as mild illness.
Measured: Daily from study Day 2 through day 10 after RSV challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start20 Feb 2018
- Primary completion15 Nov 2019
- Study completion6 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Upper Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lesia K Dropulic, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388645
- Sponsor's protocol ID
- 180039
- Other IDs
- 18-I-0039
- Status last verified
- 6 Dec 2019
- First submitted
- 30 Dec 2017
- Last updated
- 3 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
DeVincenzo JP, Whitley RJ, Mackman RL, Scaglioni-Weinlich C, Harrison L, Farrell E, McBride S, Lambkin-Williams R, Jordan R, Xin Y, Ramanathan S, O'Riordan T, Lewis SA, Li X, Toback SL, Lin SL, Chien JW. Oral GS-5806 activity in a respiratory syncytial virus challenge study. N Engl J Med. 2014 Aug 21;371(8):711-22. doi: 10.1056/NEJMoa1401184.
PubMed 25140957Hall CB, Long CE, Schnabel KC. Respiratory syncytial virus infections in previously healthy working adults. Clin Infect Dis. 2001 Sep 15;33(6):792-6. doi: 10.1086/322657. Epub 2001 Aug 21.
PubMed 11512084Lee FE, Walsh EE, Falsey AR, Betts RF, Treanor JJ. Experimental infection of humans with A2 respiratory syncytial virus. Antiviral Res. 2004 Sep;63(3):191-6. doi: 10.1016/j.antiviral.2004.04.005.
PubMed 15451187
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Challenge Infection of Healthy Adult Volunteers With RSV A2
- ClinicalTrials.gov ID
- NCT03388645
- Acronym / sponsor ID
- 180039
- Conditions
- Upper Respiratory Tract Infections
- Keywords
- RSV Shedding, Immune Responses, Neutralizing Antibody Titer, Upper Respiratory Tract Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 6 Dec 2019 (actual)
- First posted
- 3 Jan 2018 (actual)
- Results
- Posted 3 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
One of the main causes of respiratory infections in children and adults is RSV. This stands for respiratory syncytial virus. Healthy adults usually get a cold when they get an infection with RSV. They generally recover without any problems. But some infections can be life-threatening. Researchers want to study RSV infection in a safe, controlled setting in healthy adults to help develop new treatments.
Objective:
To test the safety of a high dose of RSV A2 by spraying the virus into the nose, and studying how the body responds.
Eligibility:
Healthy adults ages 18-50
Design:
Participants will be screened during 2 screening visits with:
- Medical interview
- Physical exam
- Blood and nasal samples
- Chest X-ray (chest radiograph)
- Participants will have a heart test. Sticky patches on the body will detect heart electrical activity.
- Pulmonary function test (PFT). They will blow into a machine to measure airflow.
- Urine tests for pregnancy or drug use.
Participants will be admitted to the hospital before they get RSV A2.
Participants will get a single dose of RSV A2 as two sprays, one into each nostril.
Participants will stay in the hospital under isolation for as long as it takes the body to clear RSV A2 from nasal fluids. This can take as long as 14 days or more.
Participants cannot take any cold medicine to try to feel better.
Every day, participants will:
- Answer questions about their symptoms
- Have nasal washes and/or nasal swabs collected
- Have a physical exam
Participants will have blood drawn most days.
After discharge, participants will keep a health diary.
Participants will have 2 follow-up visits at 1 month and 2 months after receiving the RSV A2 dose. A history and physical examination, a blood draw, and nasal wash and swab will be performed.
Detailed description
Respiratory syncytial virus (RSV) is the leading cause of pediatric lower respiratory tract infection. RSV also causes lower respiratory tract disease in the elderly and life-threatening disease in immunocompromised hosts. An RSV monoclonal antibody (palivizumab) is currently available for passive immunoprophylaxis in high-risk infants. Vaccines and antiviral agents are under development for the treatment and prevention of RSV, but none are licensed. The ability to challenge healthy volunteers with RSV could rapidly facilitate efficacy studies of future antivirals and vaccines. In addition, challenge studies would provide critical information on viral pathogenesis, including types of cells infected, mucosal and systemic immune response, and alterations in respiratory microbiota. Clinical trial material for human challenge studies has been prepared from live recombinant (complementary DNA-derived) RSV of subgroup A (RSV A2).
This study will be a phase 1 study in healthy adult male and non-pregnant female subjects 18 years to 50 years of age. The main purpose of the trial is to define the safety profile, determine the frequency of RSV shedding in nasal wash, estimate RSV illness rates, and study immune responses in subjects given 1 dose of 10^7 PFU of RSV A2 challenge virus using a nasal atomizer. If RSV A2 is found to be sufficiently infectious in adults, then it may be used as a challenge virus in future studies evaluating antivirals or the protective efficacy of RSV vaccines, or in studies of the immunopathogenesis of RSV infection.
Subjects will be admitted to the NIH Clinical Center and receive a single intranasal dose of 10^6.3 PFU or 107 PFU of RSV A2. Subjects will remain at the Clinical Center for approximately 9-14 days after challenge infection undergoing sequential clinical evaluations. Research specimens, nasal washes and blood, will be collected for various research assays. Subjects will be discharged when their daily nasal wash RSV result is negative for two days in a row, and they do not have any signs or symptoms suggestive of possible RSV-associated lower respiratory tract disease. Subjects will return for follow-up evaluation 28 and 56 days after viral challenge.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose 10^6.3 PFU of RSV A2 | Experimental | Biological: 10^6.3 PFU of RSV A2Single 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 | Experimental | Biological: 10^7 PFU of RSV A2Single intranasal dose of 10^7 plaque forming units (PFU) of respiratory syncytial virus A2 (RSV A2) using a nasal atomizer on Day 0 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- ---if participant uses contraceptive pill, patch, or ring, they must also use a barrier method at the time of potentially reproductive sexual activity (e.g., (male/female condom, cap, or diaphragm) plus spermicide)
Key exclusion criteria (31 listed)
- Subject who was previously challenged with RSV A2.
- Female subject who is pregnant or lactating OR planning to become pregnant from 30 days prior to inoculation through 30 days after inoculation.
- Presence of self-reported or medically documented significant medical condition(s) including but not limited to:
- -Respiratory disease (e.g., chronic obstructive pulmonary disease, emphysema, rhinitis, sinusitis) in adulthood, and additionally:
- --A history of asthma within the past 5 years, or a current diagnosis of asthma or reactive airway disease associated with
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10^6.3 PFU of RSV A2Each adult volunteer will receive a single intranasal inoculation of 10^6.3 PFU of RSV A2 administered with a nasal atomizer with subsequent sampling of nasal fluids and blood draws. | Biological | Low Dose 10^6.3 PFU of RSV A2 |
| 10^7 PFU of RSV A2Each adult volunteer will receive a single intranasal inoculation of 10^7 PFU of RSV A2 administered with a nasal atomizer with subsequent sampling of nasal fluids and blood draws. | Biological | High Dose 10^7 PFU of RSV A2 |
Primary outcome
Participants With Detectable RSV Shedding in Nasopharyngeal Wash
Time frame: Daily from study Day 2 through day 10 after challenge with RSV A2
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.
Participants With Related, Expected Adverse Events After Challenge
Time frame: Safety assessed continuously during the inpatient phase and at Day 28 and 56 during the outpatient phase of the study
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.
Participants With Unrelated Expected Adverse Events After Challenge
Time frame: Safety assessed continuously during the inpatient phase and at Day 28 and 56 during the outpatient phase of the study
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.
Participants With Related, Unexpected Adverse Events After Challenge
Time frame: Safety assessed continuously during the inpatient phase and at Day 28 and 56 during the outpatient phase of the study
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.
Participants With Unrelated, Unexpected Adverse Events After Challenge
Time frame: Safety assessed continuously during the inpatient phase and at Day 28 and 56 during the outpatient phase of the study
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.
1 secondary outcome
Participants With Mild to Moderate Upper Respiratory Illness
Time frame: Daily from study Day 2 through day 10 after RSV challenge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25140957DeVincenzo JP, Whitley RJ, Mackman RL, Scaglioni-Weinlich C, Harrison L, Farrell E, McBride S, Lambkin-Williams R, Jordan R, Xin Y, Ramanathan S, O'Riordan T, Lewis SA, Li X, Toback SL, Lin SL, Chien JW. Oral GS-5806 activity in a respiratory syncytial virus challenge study. N Engl J Med. 2014 Aug 21;371(8):711-22. doi: 10.1056/NEJMoa1401184.
- Background: PubMed 11512084Hall CB, Long CE, Schnabel KC. Respiratory syncytial virus infections in previously healthy working adults. Clin Infect Dis. 2001 Sep 15;33(6):792-6. doi: 10.1086/322657. Epub 2001 Aug 21.
- Background: PubMed 15451187Lee FE, Walsh EE, Falsey AR, Betts RF, Treanor JJ. Experimental infection of humans with A2 respiratory syncytial virus. Antiviral Res. 2004 Sep;63(3):191-6. doi: 10.1016/j.antiviral.2004.04.005.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lesia K Dropulic, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 10^6.3 PFU of RSV A2 and 10^7 PFU of RSV A2 in people with Upper Respiratory Tract Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants With Detectable RSV Shedding in Nasopharyngeal Wash (time frame: Daily from study Day 2 through day 10 after challenge with RSV A2). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03388645, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.