Healthy VolunteersPhase 1/2NCT02796001
Hallmarks of Protective Immunity in Sequential Rhinovirus Infections in Humans
A Phase 1/2 study testing human rhinovirus in people with Healthy Volunteers, run by University of Virginia at 1 site in United States.
Trial summary
The primary objective of this study is to assess the relationship between rhinovirus specific T-cell immunity and the human host response to primary rhinovirus challenge and subsequent secondary challenge with either homologous or heterologous rhinovirus serotypes. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- human rhinovirus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2017to 1 May 2020
- Phase
- Phase 1/2
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject must be 18-40 years of age
- Subject must read and sign a copy of the approved Consent Form
- Subject must have a serum neutralizing antibody titer of ≤1:2 to rhinovirus type 39 and rhinovirus type 16
- Female subjects must be using an effective birth control method.
- Total IgE <150 IU/ml.
Who cannot join
- Any clinically significant abnormalities of the upper respiratory tract
- Any clinically significant acute or chronic respiratory illness
- Any clinically significant bleeding tendency by history
- Hypertension that requires treatment with antihypertensive medications
- History of angina or other clinically significant cardiac disease
- Any upper respiratory infection or allergic rhinitis in the two weeks prior to the start of the study
Show all 12Show fewer
- Any medical condition that in the opinion of the Investigator is cause for exclusion from the study
- Use of any anti-inflammatory (steroids or NSAIDs) or cough/cold preparation in the 1 month prior to the study
- Regular use of tobacco in the last 6 months (ie. more than 2 days out of 7) or inability to refrain from smoking during the study
- Inability to refrain from the use of common cold therapies in the 5 days after each rhinovirus challenge.
- Participation in any other clinical drug trial in the month prior to the study
- Female subjects with a positive urine pregnancy screen.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
The primary objective of this study is to assess the relationship between rhinovirus specific T-cell immunity and the human host response to primary rhinovirus challenge and subsequent secondary challenge with either homologous or heterologous rhinovirus serotypes.
Read the detailed description
The primary objective of this study is to assess the relationship between RV-specific T-cell immunity and the human host response to primary RV challenge and subsequent secondary challenge with either homologous or heterologous RV serotypes. The overall hypothesis that will be addressed by the mechanistic studies in this proposal is that T helper (Th) and T follicular helper (Tfh) cells directed against conserved RV epitopes expand upon RV exposure and some of these cells persist as stable cross-reactive memory populations capable of displaying lineage-specific protective functions upon re-infection with related or unrelated strains of RV. The human specimens collected in this study will be analyzed with a variety of state-of-the-art techniques to provide an in depth description of T-cell responses to RV infection, and the correlation of these responses with viral infection, antibody responses, and illness. Beyond this objective, by using a systems biology approach, we aim to gain new insight into the role of diverse cell types involved in adaptive immunity to RV. .
- Conditions
- Healthy Volunteers
- Being tested
- human rhinovirus, no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human rhinovirusBiological
human rhinovirus
no interventionOther
4 volunteers were not re-challenged and did not participate in the second challenge
| Study group | Role | What they receive |
|---|---|---|
| RV16 infected volunteers re-challenged with RV16 | Active comparator | volunteers re-challenged with RV16 Receives: Biological: human rhinovirus |
| RV infected volunteers re-challenged with RV39 | Active comparator | volunteers re-challenged with RV39 Receives: Biological: human rhinovirus |
| RV infected not rechallenged | Other | Volunteers who were infected with RV16 and eligible for re-challenge but who were not re-challenged due to voluntary withdrawal (3) or removal for exclusion criteria Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virus Infection
Number infected after re-challenge with RV16 compared to RV39 as determined by virus isolation in cell culture or viral serology
Measured: Volunteers were cultured daily for detection of virus shedding for 5 days after the virus re-challenge and serum was collected for viral serology 4 weeks after virus re-challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study start25 Sep 2017
- Primary completion1 May 2020
- Study completion1 May 2020
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 (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Volunteers who were infected with RV16 by experimental challenge were eligible for participation by re-challenge with either RV16 or RV39 to assess the host response to homologous or heterologous rechallenge.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald B Turner, University of Virginia
- Investigators
- Ronald Turner, MD, Principal investigator, Univ of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796001
- Sponsor's protocol ID
- 16-0055
- Status last verified
- Jun 2022
- First submitted
- 7 Jun 2016
- Last updated
- 6 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Barone SM, Paul AG, Muehling LM, Lannigan JA, Kwok WW, Turner RB, Woodfolk JA, Irish JM. Unsupervised machine learning reveals key immune cell subsets in COVID-19, rhinovirus infection, and cancer therapy. Elife. 2021 Aug 5;10:e64653. doi: 10.7554/eLife.64653.
PubMed 34350827
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hallmarks of Protective Immunity in Sequential Rhinovirus Infections in Humans
- ClinicalTrials.gov ID
- NCT02796001
- Acronym / sponsor ID
- 16-0055
- Conditions
- Healthy Volunteers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Posted 6 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the relationship between rhinovirus specific T-cell immunity and the human host response to primary rhinovirus challenge and subsequent secondary challenge with either homologous or heterologous rhinovirus serotypes.
Detailed description
The primary objective of this study is to assess the relationship between RV-specific T-cell immunity and the human host response to primary RV challenge and subsequent secondary challenge with either homologous or heterologous RV serotypes. The overall hypothesis that will be addressed by the mechanistic studies in this proposal is that T helper (Th) and T follicular helper (Tfh) cells directed against conserved RV epitopes expand upon RV exposure and some of these cells persist as stable cross-reactive memory populations capable of displaying lineage-specific protective functions upon re-infection with related or unrelated strains of RV. The human specimens collected in this study will be analyzed with a variety of state-of-the-art techniques to provide an in depth description of T-cell responses to RV infection, and the correlation of these responses with viral infection, antibody responses, and illness. Beyond this objective, by using a systems biology approach, we aim to gain new insight into the role of diverse cell types involved in adaptive immunity to RV. .
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Volunteers who were infected with RV16 by experimental challenge were eligible for participation by re-challenge with either RV16 or RV39 to assess the host response to homologous or heterologous rechallenge.
| Arm | Type | Receives |
|---|---|---|
| RV16 infected volunteers re-challenged with RV16 | Active comparator | Biological: human rhinovirusvolunteers re-challenged with RV16 |
| RV infected volunteers re-challenged with RV39 | Active comparator | Biological: human rhinovirusvolunteers re-challenged with RV39 |
| RV infected not rechallenged | Other | Other: no interventionVolunteers who were infected with RV16 and eligible for re-challenge but who were not re-challenged due to voluntary withdrawal (3) or removal for exclusion criteria |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject must be 18-40 years of age
- Subject must read and sign a copy of the approved Consent Form
- Subject must have a serum neutralizing antibody titer of ≤1:2 to rhinovirus type 39 and rhinovirus type 16
- Female subjects must be using an effective birth control method.
- Total IgE <150 IU/ml.
Key exclusion criteria (12 listed)
- Any clinically significant abnormalities of the upper respiratory tract
- Any clinically significant acute or chronic respiratory illness
- Any clinically significant bleeding tendency by history
- Hypertension that requires treatment with antihypertensive medications
- History of angina or other clinically significant cardiac disease
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 |
|---|---|---|
| human rhinovirushuman rhinovirus | Biological | RV infected volunteers re-challenged with RV39, RV16 infected volunteers re-challenged with RV16 |
| no intervention4 volunteers were not re-challenged and did not participate in the second challenge | Other | RV infected not rechallenged |
Primary outcome
Virus Infection
Time frame: Volunteers were cultured daily for detection of virus shedding for 5 days after the virus re-challenge and serum was collected for viral serology 4 weeks after virus re-challenge
Number infected after re-challenge with RV16 compared to RV39 as determined by virus isolation in cell culture or viral serology
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34350827Barone SM, Paul AG, Muehling LM, Lannigan JA, Kwok WW, Turner RB, Woodfolk JA, Irish JM. Unsupervised machine learning reveals key immune cell subsets in COVID-19, rhinovirus infection, and cancer therapy. Elife. 2021 Aug 5;10:e64653. doi: 10.7554/eLife.64653.
- Individual participant dataSharing planned: Undecided
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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.
Ronald Turner, MD principal investigator
Univ of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing human rhinovirus in people with Healthy Volunteers, run by University of Virginia 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 5 inclusion and 12 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 6 Jun 2022. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 6 Jun 2022). 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?
Virus Infection (time frame: Volunteers were cultured daily for detection of virus shedding for 5 days after the virus re-challenge and serum was collected for viral serology 4 weeks after virus re-challenge). 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 NCT02796001, which also lists 1 linked publication.
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 6 Jun 2022.