Upper Respiratory Tract InfectionPhase 1NCT02484417
Respiratory Syncytial Virus Human Challenge in Healthy Adult Volunteers
A Phase 1 study testing RSV A2 in people with Upper Respiratory Tract Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: Respiratory syncytial virus (RSV) can cause respiratory infections. Some of these can be life-threatening, especially in young children, the elderly, and people with weak immune systems. Researchers want to study RSV infection in a hospital setting in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Upper Respiratory Tract Infection
- What is being tested?
- RSV A2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2015to 10 Aug 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-50 years.
- 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 (i.e., either 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, then they must be 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:
- intrauterine device (IUD) or equivalent
Show all 9Show fewer
- hormonal contraceptives (e.g., consistent, continuous use of contraceptive pill, patch, ring, implant or injection)
- if participant uses contraceptive pill, patch or ring, two methods of contraception are required; a barrier method is to be used 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 6 months prior to first dose of study agent.
Who cannot join
- The presence of any one of the following criteria is sufficient to exclude a prospective subject from enrolling in this study:
- Female subject is pregnant or lactating OR planning to become pregnant in the timeframe that begins 30 days prior to the inoculation and ends 30 days after inoculation.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, hematologic, rheumatologic, endocrine, autoimmune, or renal disease.
- Complete blood count (CBC), AST, ALT, or creatinine values are both outside of the NIH Department of Laboratory Medicine normal reference range and deemed clinically significant by the PI.
- 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.
- A medical, occupational, or family problem as a result of alcohol or illicit drug use during the past 12 months.
Show all 25Show fewer
- Routine smoker of a tobacco product or marijuana currently or in the past year.
- Current alcohol abuse or addiction.
- Current illicit drug abuse or addiction.
- Presence of any febrile illness or symptoms suggestive of a viral respiratory infection within 2 weeks prior to inoculation accompanied by a positive multiplex FilmArray PCR performed on nasal wash.
- Use of corticosteroids (including nasal preparations) or immunosuppressive drugs within 30 days before inoculation.
- A history of asthma within the past 10 years, or a current diagnosis of asthma or reactive airway disease associated with exercise, seasonal hay fever or allergic rhinitis.
- Positive FDA-approved HIV test result prior to inoculation.
- Positive serology for hepatitis C virus within 6 months prior to inoculation.
- Presence of hepatitis B surface antigen within 6 months prior to inoculation.
- A known immunodeficiency syndrome.
- Receipt of a licensed vaccine within 4 weeks prior to viral inoculation.
- Receipt of blood or blood-derived products (including immunoglobulin) within 6 months 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 (for example packed red blood cells emergently given during an elective surgery).
- Receipt of another investigational agent within 3 months prior to viral inoculation.
- Individual with body mass index (BMI) less than or equal to 18.5 or greater than or equal to 37.5.
- Any significant abnormality of the nose or nasopharynx, including recurrent epistaxis within 3 months prior to viral inoculation.
- Nasal or sinus surgery within 6 months prior to viral inoculation.
- Shares household, works closely with, or has routine contact with a child (children) < 5 years of age or with immunocompromised individual(s), adults with significant cardiopulmonary disease, persons with significant asthma, institutionalized elderly or elderly 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 principal investigator (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
Official title: A Phase I Study of Respiratory Syncytial Virus Human Challenge in Healthy Adult Volunteers
Background:
- Respiratory syncytial virus (RSV) can cause respiratory infections. Some of these can be life-threatening, especially in young children, the elderly, and people with weak immune systems. Researchers want to study RSV infection in a hospital setting in healthy adults. They want to use what they learn to test new treatments or vaccines in the future.
Read more
Objectives:
- To study how the body responds to RSV.
Eligibility:
- Healthy volunteers ages 18-50
Design:
- Participants will be screened under another protocol.
- Participants will have:
- Medical history
- Physical exams
- EKG. Heart rhythm is measured with small sticky patches on the chest, arms, and legs.
- Chest x-ray
- Pulmonary function tests. This measures how much air a person can move into and out of the lungs.
- Blood and urine tests
- Nasal washes and/or nasal swabs. For the wash, the nose will be rinsed with a sterile liquid. For the swab, the inside of the nostril will be rubbed with a cotton swab.
- Participants will have two, possibly three, follow-up outpatient visits, approximately 1, 2 and 6 months after receiving the dose of RSV.
- Participants will stay in the hospital under isolation for 7 or more days after getting the virus.
- The average stay is 10 days. Participants cannot leave the isolation unit. They cannot have visitors.
- The virus should cause a mild to medium cold.
- Participants will fill out a symptom card every day in the hospital and for 1 month after.
- Participants will have 2 follow-up visits, 28 and 56 days after leaving the hospital.
- Female participants who are sexually active must remain abstinent or use an effective form of birth control for 1 month before and after getting the virus.
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 purpose of the trial is to define safety profiles and estimate illness rates for subjects given 2 different doses of RSV A2 challenge virus. If RSV A2 is found to be sufficiently infectious in adults, then it may be used as a challenge virus in future studies evaluating the protective efficacy of RSV vaccines or antivirals and in studies of pathogenesis of RSV.
Subjects will be admitted to the NIH Clinical Center and receive a single intranasal dose of RSV A2 at either 10^5 or 10^6.3 PFU. Subjects will remain at the Clinical Center for approximately 9-12 days for clinical evaluation. Research procedures conducted on blood and nasal swab and wash samples will include lymphocyte phenotyping, cytokine analysis, transcriptosome profiling, RSV-specific immunoglobin analysis (circulating IgG and nasal secretory IgA), quantitative viral titers and viral culture, and nasal microbiome analysis. Subjects will be discharged when their NP wash RSV results are negative for two consecutive days and they do not have any signs or symptoms suggestive of possible RSV-associated lower respiratory tract disease. Subjects will return for followup evaluation 28 and 56 days after viral challenge.
- Conditions
- Upper Respiratory Tract Infection
- Being tested
- RSV A2
- Keywords
- Neutralizing Antibody, Viral Shedding, Challenge, RSV, Healthy Volunteer
- 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.
RSV A2Biological
Intranasal inoculation of healthy volunteers with 10^5 or 10^6.3 plaque forming units (PFU) of RSV A2.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: RSV A2 10^5 PFU/dose | Experimental | Challenge 4 subjects with low dose and proceed to larger cohort after safety review. Receives: Biological: RSV A2 |
| Cohort 2: RSV A2 10^5 PFU/dose | Experimental | Challenge 12 subjects with the low dose and proceed to high dose after safety review. Receives: Biological: RSV A2 |
| Cohort 3: RSV A2 10^6.3 PFU/dose | Experimental | Challenge 12 subjects with the high dose Receives: Biological: RSV A2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection and assessment of expected and unexpected AEs.
Safety
Measured: Safety will be assessed continuously during inpatient and outpatient phases of the study through Day 56
Secondary outcomes (3)
RSV challenge associated viral shedding from nasal secretions: viral titer onset, duration, peak, and AUC
Viral shedding detected in nasal wash
Measured: Viral shedding was assessed daily during the inpatient phase starting on day 2 following virus inoculation through day of discharge
RSV challenge associated immune responses: neutralizing antibody and immune cell phenotyping
Antibody and T cell responses
Measured: Immune responses were assessed on days -1, 1, 7, and 10 during inpatient stay. Immune response were also examined during outpatient visits on day 28, day 56, and day 180.
RSV challenge associated clinical disease: frequency of upper respiratory infection, symptom score, and mucous weights
RSV Illness
Measured: Clinical signs and symptoms were assessed daily during the inpatient phase. Interim history and physical was performed during outpatient visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study start21 Jul 2015
- Primary completion10 Aug 2016
- Study completion10 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Upper Respiratory Tract InfectionStudies 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
- 32 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jeffrey I Cohen, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484417
- Sponsor's protocol ID
- 150148
- Other IDs
- 15-I-0148
- Status last verified
- 4 Mar 2026
- First submitted
- 25 Jun 2015
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Lee 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 15451187DeVincenzo JP, Wilkinson T, Vaishnaw A, Cehelsky J, Meyers R, Nochur S, Harrison L, Meeking P, Mann A, Moane E, Oxford J, Pareek R, Moore R, Walsh E, Studholme R, Dorsett P, Alvarez R, Lambkin-Williams R. Viral load drives disease in humans experimentally infected with respiratory syncytial virus. Am J Respir Crit Care Med. 2010 Nov 15;182(10):1305-14. doi: 10.1164/rccm.201002-0221OC. Epub 2010 Jul 9.
PubMed 20622030
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Respiratory Syncytial Virus Human Challenge in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02484417
- Acronym / sponsor ID
- 150148
- Conditions
- Upper Respiratory Tract Infection
- Keywords
- Neutralizing Antibody, Viral Shedding, Challenge, RSV, Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 21 Jul 2015 (actual)
- Primary completion
- 10 Aug 2016 (actual)
- Study completion
- 10 Aug 2016 (actual)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Respiratory syncytial virus (RSV) can cause respiratory infections. Some of these can be life-threatening, especially in young children, the elderly, and people with weak immune systems. Researchers want to study RSV infection in a hospital setting in healthy adults. They want to use what they learn to test new treatments or vaccines in the future.
Objectives:
- To study how the body responds to RSV.
Eligibility:
- Healthy volunteers ages 18-50
Design:
- Participants will be screened under another protocol.
- Participants will have:
- Medical history
- Physical exams
- EKG. Heart rhythm is measured with small sticky patches on the chest, arms, and legs.
- Chest x-ray
- Pulmonary function tests. This measures how much air a person can move into and out of the lungs.
- Blood and urine tests
- Nasal washes and/or nasal swabs. For the wash, the nose will be rinsed with a sterile liquid. For the swab, the inside of the nostril will be rubbed with a cotton swab.
- Participants will have two, possibly three, follow-up outpatient visits, approximately 1, 2 and 6 months after receiving the dose of RSV.
- Participants will stay in the hospital under isolation for 7 or more days after getting the virus.
- The average stay is 10 days. Participants cannot leave the isolation unit. They cannot have visitors.
- The virus should cause a mild to medium cold.
- Participants will fill out a symptom card every day in the hospital and for 1 month after.
- Participants will have 2 follow-up visits, 28 and 56 days after leaving the hospital.
- Female participants who are sexually active must remain abstinent or use an effective form of birth control for 1 month before and after getting the virus.
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 purpose of the trial is to define safety profiles and estimate illness rates for subjects given 2 different doses of RSV A2 challenge virus. If RSV A2 is found to be sufficiently infectious in adults, then it may be used as a challenge virus in future studies evaluating the protective efficacy of RSV vaccines or antivirals and in studies of pathogenesis of RSV.
Subjects will be admitted to the NIH Clinical Center and receive a single intranasal dose of RSV A2 at either 10^5 or 10^6.3 PFU. Subjects will remain at the Clinical Center for approximately 9-12 days for clinical evaluation. Research procedures conducted on blood and nasal swab and wash samples will include lymphocyte phenotyping, cytokine analysis, transcriptosome profiling, RSV-specific immunoglobin analysis (circulating IgG and nasal secretory IgA), quantitative viral titers and viral culture, and nasal microbiome analysis. Subjects will be discharged when their NP wash RSV results are negative for two consecutive days and they do not have any signs or symptoms suggestive of possible RSV-associated lower respiratory tract disease. Subjects will return for followup 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: RSV A2 10^5 PFU/dose | Experimental | Biological: RSV A2Challenge 4 subjects with low dose and proceed to larger cohort after safety review. |
| Cohort 2: RSV A2 10^5 PFU/dose | Experimental | Biological: RSV A2Challenge 12 subjects with the low dose and proceed to high dose after safety review. |
| Cohort 3: RSV A2 10^6.3 PFU/dose | Experimental | Biological: RSV A2Challenge 12 subjects with the high dose |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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, two methods of contraception are required; a barrier method is to be used 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 6 months prior to first dose of study agent.
Key exclusion criteria (25 listed)
- The presence of any one of the following criteria is sufficient to exclude a prospective subject from enrolling in this study:
- Female subject is pregnant or lactating OR planning to become pregnant in the timeframe that begins 30 days prior to the inoculation and ends 30 days after inoculation.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, hematologic, rheumatologic, endocrine, autoimmune, or renal disease.
- Complete blood count (CBC), AST, ALT, or creatinine values are both outside of the NIH Department of Laboratory Medicine normal reference range and deemed clinically significant by the PI.
- 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.
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 |
|---|---|---|
| RSV A2Intranasal inoculation of healthy volunteers with 10^5 or 10^6.3 plaque forming units (PFU) of RSV A2. | Biological | Cohort 1: RSV A2 10^5 PFU/dose, Cohort 2: RSV A2 10^5 PFU/dose, Cohort 3: RSV A2 10^6.3 PFU/dose |
Primary outcome
Collection and assessment of expected and unexpected AEs.
Time frame: Safety will be assessed continuously during inpatient and outpatient phases of the study through Day 56
Safety
3 secondary outcomes
RSV challenge associated viral shedding from nasal secretions: viral titer onset, duration, peak, and AUC
Time frame: Viral shedding was assessed daily during the inpatient phase starting on day 2 following virus inoculation through day of discharge
RSV challenge associated immune responses: neutralizing antibody and immune cell phenotyping
Time frame: Immune responses were assessed on days -1, 1, 7, and 10 during inpatient stay. Immune response were also examined during outpatient visits on day 28, day 56, and day 180.
RSV challenge associated clinical disease: frequency of upper respiratory infection, symptom score, and mucous weights
Time frame: Clinical signs and symptoms were assessed daily during the inpatient phase. Interim history and physical was performed during outpatient visits.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- 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.
- Background: PubMed 20622030DeVincenzo JP, Wilkinson T, Vaishnaw A, Cehelsky J, Meyers R, Nochur S, Harrison L, Meeking P, Mann A, Moane E, Oxford J, Pareek R, Moore R, Walsh E, Studholme R, Dorsett P, Alvarez R, Lambkin-Williams R. Viral load drives disease in humans experimentally infected with respiratory syncytial virus. Am J Respir Crit Care Med. 2010 Nov 15;182(10):1305-14. doi: 10.1164/rccm.201002-0221OC. Epub 2010 Jul 9.
- 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.
Jeffrey I Cohen, 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 RSV A2 in people with Upper Respiratory Tract Infection, 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 9 inclusion and 25 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 10 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Collection and assessment of expected and unexpected AEs. (time frame: Safety will be assessed continuously during inpatient and outpatient phases of the study through Day 56). 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 NCT02484417, which also lists 2 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 10 Mar 2026.