Respiratory Syncytial Virus InfectionsPhase 1NCT03624790
Inpatient Challenge Study of rRSV A/Maryland/001/11, a Human Respiratory Syncytial Virus Challenge Strain, Administered to Healthy Adult Volunteers
A Phase 1 study testing rRSV A/Maryland/001/11 in people with Respiratory Syncytial Virus Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, infectivity and replication, and immunogenicity of a recombinant respiratory syncytial virus (rRSV A/Maryland/001/11) challenge virus administered intranasally to healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- rRSV A/Maryland/001/11
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2018to 24 Oct 2024
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-pregnant adults between 18 years and 50 years of age, inclusive.
- General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator.
- Demonstrates comprehension of the protocol procedures and knowledge of RSV illness by passing a written comprehension examination (pass grade greater than or equal to 70%).
- Available for the duration of the trial.
- Willingness to participate in the study and stay confined to the inpatient unit for the required duration as evidenced by signing the informed consent document.
- Participants with childbearing potential must agree to have used effective birth control methods beginning at least one month prior to challenge, and continuing with 'per label/fully effective use' for the chosen method for the duration of the study, from amongst these:
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- pharmacologic/hormonal contraceptives, including oral, parenteral, subcutaneous, and transcutaneous delivery;
- condoms or diaphragm with spermicide;
- intrauterine device;
- absolute abstinence from heterosexual intercourse as a matter of normal preferred lifestyle;
- or must be surgically sterile, or must be 50 years of age AND have had no menses at all for at least one full year.
- All participants of childbearing potential must provide samples for urine and serum pregnancy testing prior to enrollment, prior to challenge, as well as a statement of menstrual history, at each study contact throughout the study, and report if they may be pregnant immediately.
- Willingness to refrain from blood and plasma donation for 1 year after study enrollment.
- Willingness to refrain from receiving licensed or investigational vaccines or other investigational products from the day of enrollment until Study Day 56.
- Willingness to follow admission and isolation requirements for the indicated duration per protocol.
Who cannot join
- Subject who was previously challenged with RSV in any study, or previously participated in an RSV vaccine study.
- Any subject who 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. Pregnancy is determined by a positive test for human chorionic gonadotropin (β-HCG test).
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies.
- 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 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.
- Presence of any febrile illness or symptoms suggestive of a respiratory infection within 2 weeks prior to inoculation.
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- Use of systemic or nasal steroid preparations or immunosuppressive drugs within 30 days prior to challenge. Topical steroid preparations are permitted.
- Inhaled bronchodilator or inhaled steroid use within the last year or use after upper respiratory tract infections within the last 5 years.
- Current or past (in the last 4 weeks) use of i.n. medications (including steroids, decongestants, or hormonal medications), or planning to use them within 28 days of study challenge
- Positive urine drug toxicology test for the presence of amphetamine, barbiturates, opiates, phencyclidine, benzodiazepines, methadone or cocaine metabolites.
- Evidence of current alcohol or illicit drug abuse or addiction.
- Other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol.
- History of anaphylaxis.
- Positive enzyme-linked immunosorbent assay (ELISA) and confirmatory tests for human immunodeficiency virus (HIV).
- Positive ELISA and confirmatory test (e.g., recombinant immunoblot assay) for hepatitis C virus (HCV).
- Positive hepatitis B virus surface antigen (HBsAg) by ELISA.
- Known immunodeficiency syndrome.
- Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to inoculation with RSV challenge and planned receipt within 56 days after challenge.
- History of surgical splenectomy.
- Receipt of blood or blood-derived products (including immunoglobulin [Ig]) within 6 months prior to study inoculation.
- Current routine (at least once weekly) smoking or vaping of a tobacco product or marijuana.
- The decision to exclude a potential subject is determined by medical history and a clinician's clinical judgment based on the physical examination.
- Receipt of any investigational vaccine or drug within 28 days prior or planned use within 56 days after study inoculation.
- Body mass index (BMI) less than 18.5 or greater than 37.5.
- Shared household, works closely with, or has routine contact with a child (children) less than 2 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 Principal Investigator (PI), might be at increased risk for complications if exposed to RSV.
- Any significant abnormality of the nose or nasopharynx, including recurrent epistaxis and including nasal or sinus surgery.
- History of Bell's palsy.
- Unwillingness to have nasopharyngeal (NP) swabs, nasal wash, or blood samples saved for future respiratory virus research.
- Serum RSV neutralizing antibody titers greater than or equal to 320.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
About this study
Official title: Phase I, Open Label, Inpatient Challenge Study of rRSV A/Maryland/001/11, a Human Respiratory Syncytial Virus Challenge Strain, Administered to Healthy Adult Volunteers
The purpose of this study is to evaluate the safety, infectivity and replication, and immunogenicity of a recombinant respiratory syncytial virus (rRSV A/Maryland/001/11) challenge virus administered intranasally to healthy adults.
Read the detailed description
This study will evaluate the safety, infectivity and replication, and immunogenicity of a recombinant respiratory syncytial virus (rRSV A/Maryland/001/11) challenge virus administered intranasally to healthy adults.
Participants will be admitted to the inpatient isolation unit and will receive a single dose of 10^5 plaque forming units (PFUs) of rRSV A/Maryland/001/11, delivered intranasally on Day 0. Participants will be enrolled outside of the RSV season between April 1 and October 31.
Participants will remain in the inpatient isolation unit for a minimum of 8 days after the challenge and will be discharged after two RSV reverse transcription polymerase chain reaction (RT-PCR) results lower than 3 Log10 genome equivalents per mL of nasal wash.
Upon discharge from the inpatient unit, participants will attend outpatient visits on Days 10 (if previously discharged), 28, and 56. These study visits may include physical examinations, blood collection, and nasal washes. At 6 months, there will be a follow-up phone contact to assess for any new chronic conditions or serious health events/hospitalizations.
Volunteers in Cohort 1 received a dose of 10^5 PFU, consistent with similar RSV challenge studies done previously. Cohort 2 will be conducted as an extension of Cohort 1 to extend the safety and infectivity evaluation, and will also receive a single dose of 10^5 PFU rRSV A/Maryland/001/11 challenge.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- rRSV A/Maryland/001/11
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rRSV A/Maryland/001/11Biological
10^5 PFU; delivered intranasally
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: rRSV A/Maryland/001/11 | Experimental | Participants will receive a single dose of rRSV A/Maryland/001/11 at study entry (Day 0). Receives: Biological: rRSV A/Maryland/001/11 |
| Cohort 2: rRSV A/Maryland/001/11 | Experimental | Participants will receive a single dose of rRSV A/Maryland/001/11 at study entry (Day 0). Receives: Biological: rRSV A/Maryland/001/11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of challenge virus-related solicited signs and symptoms
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017
Measured: Measured through Day 56
Severity of challenge virus-related solicited signs and symptoms
Graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017
Measured: Measured through Day 56
Frequency of adverse events (AEs)
Graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017
Measured: Measured through Day 56
Severity of AEs
Graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017
Measured: Measured through Day 56
Number of participants infected with rRSV A/Maryland/001/11 challenge virus
Defined as recovery of challenge virus from nasal wash, and/or detection of virus in nasal wash by real-time reverse transcription polymerase chain reaction (rRT-PCR), and/or a greater than or equal to 2.5-fold rise in serum neutralizing antibody titer to RSV
Measured: Measured through Day 56
Nasal wash virus titers of challenge virus shed
Measured by plaque titration and rRT-PCR
Measured: Measured through Day 56
Number of days challenge virus was shed
Measured by plaque titration and rRT-PCR
Measured: Measured through Day 56
Titer of serum immunoglobulin G (IgG) antibodies to the RSV F protein
Measured by enzyme-linked immunosorbent assay (ELISA)
Measured: Measured through Day 56
Change in serum neutralizing antibody titer to RSV
Measured by plaque reduction assay
Measured: Measured through Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start31 Jul 2018
- Primary completion24 Oct 2024
- Study completion24 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kawsar Talaat, MD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624790
- Sponsor's protocol ID
- CIR 320
- Status last verified
- Feb 2025
- First submitted
- 7 Aug 2018
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open Label, Inpatient Challenge Study of rRSV A/Maryland/001/11, a Human Respiratory Syncytial Virus Challenge Strain, Administered to Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT03624790
- Acronym / sponsor ID
- CIR 320
- Conditions
- Respiratory Syncytial Virus Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 10 Aug 2018 (actual)
- 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.
The purpose of this study is to evaluate the safety, infectivity and replication, and immunogenicity of a recombinant respiratory syncytial virus (rRSV A/Maryland/001/11) challenge virus administered intranasally to healthy adults.
Detailed description
This study will evaluate the safety, infectivity and replication, and immunogenicity of a recombinant respiratory syncytial virus (rRSV A/Maryland/001/11) challenge virus administered intranasally to healthy adults.
Participants will be admitted to the inpatient isolation unit and will receive a single dose of 10^5 plaque forming units (PFUs) of rRSV A/Maryland/001/11, delivered intranasally on Day 0. Participants will be enrolled outside of the RSV season between April 1 and October 31.
Participants will remain in the inpatient isolation unit for a minimum of 8 days after the challenge and will be discharged after two RSV reverse transcription polymerase chain reaction (RT-PCR) results lower than 3 Log10 genome equivalents per mL of nasal wash.
Upon discharge from the inpatient unit, participants will attend outpatient visits on Days 10 (if previously discharged), 28, and 56. These study visits may include physical examinations, blood collection, and nasal washes. At 6 months, there will be a follow-up phone contact to assess for any new chronic conditions or serious health events/hospitalizations.
Volunteers in Cohort 1 received a dose of 10^5 PFU, consistent with similar RSV challenge studies done previously. Cohort 2 will be conducted as an extension of Cohort 1 to extend the safety and infectivity evaluation, and will also receive a single dose of 10^5 PFU rRSV A/Maryland/001/11 challenge.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: rRSV A/Maryland/001/11 | Experimental | Biological: rRSV A/Maryland/001/11Participants will receive a single dose of rRSV A/Maryland/001/11 at study entry (Day 0). |
| Cohort 2: rRSV A/Maryland/001/11 | Experimental | Biological: rRSV A/Maryland/001/11Participants will receive a single dose of rRSV A/Maryland/001/11 at study entry (Day 0). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Non-pregnant adults between 18 years and 50 years of age, inclusive.
- General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator.
- Demonstrates comprehension of the protocol procedures and knowledge of RSV illness by passing a written comprehension examination (pass grade greater than or equal to 70%).
- Available for the duration of the trial.
- Willingness to participate in the study and stay confined to the inpatient unit for the required duration as evidenced by signing the informed consent document.
Key exclusion criteria (29 listed)
- Subject who was previously challenged with RSV in any study, or previously participated in an RSV vaccine study.
- Any subject who 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. Pregnancy is determined by a positive test for human chorionic gonadotropin (β-HCG test).
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies.
- 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 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.
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 |
|---|---|---|
| rRSV A/Maryland/001/1110^5 PFU; delivered intranasally | Biological | Cohort 1: rRSV A/Maryland/001/11, Cohort 2: rRSV A/Maryland/001/11 |
Primary outcome
Frequency of challenge virus-related solicited signs and symptoms
Time frame: Measured through Day 56
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017
Severity of challenge virus-related solicited signs and symptoms
Time frame: Measured through Day 56
Graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017
Frequency of adverse events (AEs)
Time frame: Measured through Day 56
Graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017
Severity of AEs
Time frame: Measured through Day 56
Graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017
Number of participants infected with rRSV A/Maryland/001/11 challenge virus
Time frame: Measured through Day 56
Defined as recovery of challenge virus from nasal wash, and/or detection of virus in nasal wash by real-time reverse transcription polymerase chain reaction (rRT-PCR), and/or a greater than or equal to 2.5-fold rise in serum neutralizing antibody titer to RSV
Nasal wash virus titers of challenge virus shed
Time frame: Measured through Day 56
Measured by plaque titration and rRT-PCR
Number of days challenge virus was shed
Time frame: Measured through Day 56
Measured by plaque titration and rRT-PCR
Titer of serum immunoglobulin G (IgG) antibodies to the RSV F protein
Time frame: Measured through Day 56
Measured by enzyme-linked immunosorbent assay (ELISA)
Change in serum neutralizing antibody titer to RSV
Time frame: Measured through Day 56
Measured by plaque reduction assay
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 7 Feb 2025.
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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.
Kawsar Talaat, MD principal investigator
Johns Hopkins Bloomberg School of Public Health
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 rRSV A/Maryland/001/11 in people with Respiratory Syncytial Virus 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 15 inclusion and 29 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 7 Feb 2025. 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?
Frequency of challenge virus-related solicited signs and symptoms (time frame: Measured through Day 56). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2025.