InfluenzaPhase 1/2NCT02746211
Influenza Challenge Study in Healthy Volunteers
A Phase 1/2 study testing High Titre Influenza virus, Medium - High Influenza virus and Medium Low Titre Influenza virus in people with Influenza, run by Hvivo at 1 site in United Kingdom.
Trial summary
A study to determine the infectious titre of an Influenza A (H1N1) (A/New Caledonia/20/99) virus for use in other Influenza challenge studies for the development of Influenza vaccines, antiviral agents and to better understand the host response to Influenza infection. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- High Titre Influenza virus, Medium - High Influenza virus and Medium Low Titre Influenza virus
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2008to Dec 2008
- Phase
- Phase 1/2
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 45 years, inclusive.
- Comprehension of the study requirements;availability for the required study period, ability to attend scheduled study visits, and willingness to participate in the inpatient challenge.
- Willingness to provide written consent for participation after reading the Consent Form and after having adequate opportunity to discuss the study with an investigator or qualified deputy.
- Good general health status as determined by a screening evaluation no greater than 45 days prior to the quarantine and challenge phase.
- For female subjects, provision of a history of reliable contraceptive practices [hysterectomy or bilateral tubal ligation, oral or implanted contraceptive use, intrauterine device, barrier method plus spermicide, history of a single male partner with vasectomy, or a history of abstinence deemed credible by the investigator(s)]. The provision of this history does NOT replace the requirement to perform, and obtain negative results in, pregnancy tests.
Who cannot join
- Presence of any significant acute or chronic, uncontrolled medical or psychiatric illness,
- Health care workers (including doctors, nurses, medical students and allied healthcare professionals) anticipated to have patient contact within two weeks of viral challenge. Healthcare workers who volunteer should not work with patients until 14 days after challenge or until their symptoms are fully resolved.
- Venous access deemed inadequate for the phlebotomy demands of the study.
- Positive serologic tests for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
- Evidence of drug abuse or a positive urine Class A drug or alcohol screen.
- Female subjects, who are known to be pregnant or who have a positive urine β-HCG detected prior to challenge.
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- Chronic use of any medication or other product (prescription or over-the-counter), for symptoms of rhinitis or nasal congestion or for any chronic nasopharyngeal complaint, or chronic use of any intranasal medication for any indication.
- Any history during adulthood of asthma of any etiology (chronic obstructive pulmonary disease), or any use of a bronchodilator or other asthma medication within adulthood.
- Smokers unwilling/unable to desist for the quarantine phase duration of the study.
- Subject is type I or type II diabetic.
- Subject is allergic to Gentamicin.
- Acute use of any medication or other product, prescription or over-the-counter, for symptoms of rhinitis or nasal congestion within seven (7) days prior to challenge. This includes any corticosteroid or beta agonist containing nasal spray.
- An Abnormal ECG deemed clinically relevant by the Investigator(s).
- Any anatomic or neurologic abnormality impairing the gag reflex or conducive to aspiration, or history suggestive of such a problem or any abnormality significantly altering the anatomy of the nose or nasopharynx.
- Receipt of systemic glucocorticoids (in a dose ≥5 mg prednisone daily or equivalent) within one month, or any other cytotoxic or immunosuppressive drug within six months prior to challenge.
- Receipt of any investigational drug within six (6) months prior to challenge, or prior participation in a clinical trial of any Influenza vaccine, or any investigational vaccine or experimental Influenza viral challenge delivered directly to the respiratory tract within 1 year prior to challenge.
- Presence of any febrile illness or symptoms of upper viral respiratory infection:
- existing on the day of challenge or between admission for Influenza challenge and administration of the challenge inoculum. (Such subjects may be re-evaluated for enrollment after resolution of the illness);
- within two (2) weeks prior to challenge or if challenge is set to occur during November, December, January, February, or March if there are any symptoms suggestive of viral respiratory infection occurring between screening and challenge.
- History of frequent epistaxis (nose bleeds).
- Presence of household member or close contact (for an additional two weeks after discharge from the isolation facility) who is: (a) less than 3 years of age; (b) any person with any known immunodeficiency; (c) any person receiving immunosuppressant medications; (d) any person undergoing or soon to undergo cancer chemotherapy within 28 days of challenge; (e) any person who has diagnosed emphysema or COPD, is elderly residing in a nursing home, or with severe lung disease or medical condition including but not exclusive to the conditions listed in Appendix 8; or (f) any person who has received a transplant (bone marrow or solid organ).
- Any laboratory test which is abnormal and which is deemed by the Investigator(s) to be clinically significant. (This includes blood chemistry, haematology, cardiac iso-enzymes, or urinalysis).
- Known IgA deficiency, immotile cilia syndrome, or Kartagener's syndrome.
- History of seasonal hay fever or a seasonal allergic rhinitis (SAR), including the use of symptomatic prescription only medication and non prescription medication.
- As a result of the medical interview, physical exam, or screening investigations, the Investigator(s) considers the subject unfit for the study.
- Those employed or immediate relatives of those employed at Retroscreen Virology or the study site.
- Receipt of a northern hemisphere seasonal influenza vaccine in the 2006/07/08 winter seasons.
- Receipt of any systemic chemotherapy agent at any time.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
hVIVO Services Ltd, QMB Bioenterprise building
London, e1 2ax
About this study
Official title: An Open Label Dose-Ranging Influenza Challenge Study in Healthy Volunteers
A study to determine the infectious titre of an Influenza A (H1N1) (A/New Caledonia/20/99) virus for use in other Influenza challenge studies for the development of Influenza vaccines, antiviral agents and to better understand the host response to Influenza infection.
Read the detailed description
The primary aim was to determine the infectious titre of an Influenza A (H1N1) (A/New Caledonia/20/99) virus for use in other Influenza challenge studies for the development of Influenza vaccines, antiviral agents and to better understand the host response to Influenza infection.
In addition, the safety of the inoculum, the virus shedding from the nasal mucosa following challenge with Influenza., changes in mRNA and protein expression from blood and nasal brush samples. were assessed Self reported symptoms following challenge were recorded. Samples were taken to facilitate validation of CMI and other immunologically relevant assays in development
Overall Trial Design:
For each group of subjects, quarantine, challenge phase, release from quarantine and decontamination occured concurrently at the designated study site throughout the challenge phase of the study.
The volunteers were be stratified into four groups depending on their intended challenge titre of virus:
High titre Medium-high titre Medium-low titre Low titre Influenza inoculation (nasal drops)
- Conditions
- Influenza
- Being tested
- High Titre Influenza virus, Medium - High Influenza virus, Medium Low Titre Influenza virus, Low titre
- Keywords
- immunology, pathogenicity
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Titre Influenza virusBiological
High Titre Influenza virus
Medium - High Influenza virusBiological
Medium - High Influenza virus
Medium Low Titre Influenza virusBiological
Medium Low Titre Influenza virus
Low titreBiological
Low titre
| Study group | Role | What they receive |
|---|---|---|
| High Titre Influenza virus | Experimental | High Titre Influenza virus Receives: Biological: High Titre Influenza virus |
| Medium - High Influenza virus | Experimental | Medium - High Influenza virus Receives: Biological: Medium - High Influenza virus |
| Medium Low Titre Influenza virus | Experimental | Medium Low Titre Influenza virus Receives: Biological: Medium Low Titre Influenza virus |
| Low titre Influenza Vaccine | Experimental | Low titre Influenza Vaccine Receives: Biological: Low titre |
What is being measured
The primary outcome is the main question the study is designed to answer.
The infection rate of an Influenza (A/New Caledonia/20/99) virus. in human volunteers
Measured: 14 days
Secondary outcomes (2)
Self Reported Symptoms
Volunteers complete a standardized diary card, rating there symptoms from 0 to 3. The total score for each day is reported.
Measured: 14 days
Virus Shedding from Nasal Mucosa
Nasal wash samples are taken daily and virus titre measured using tissue culture and reported in TCID50.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvivo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Lambkin-Williams, PhD, Principal investigator, 020 7756 1300
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746211
- Sponsor's protocol ID
- RIS-110 (DEE-CS-002)
- Status last verified
- Feb 2016
- First submitted
- 23 Feb 2016
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Only in anonymised form
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Dose-Ranging Influenza Challenge Study in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02746211
- Acronym / sponsor ID
- RIS-110 (DEE-CS-002)
- Conditions
- Influenza
- Keywords
- immunology, pathogenicity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- HvivoIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 21 Apr 2016 (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.
A study to determine the infectious titre of an Influenza A (H1N1) (A/New Caledonia/20/99) virus for use in other Influenza challenge studies for the development of Influenza vaccines, antiviral agents and to better understand the host response to Influenza infection.
Detailed description
The primary aim was to determine the infectious titre of an Influenza A (H1N1) (A/New Caledonia/20/99) virus for use in other Influenza challenge studies for the development of Influenza vaccines, antiviral agents and to better understand the host response to Influenza infection.
In addition, the safety of the inoculum, the virus shedding from the nasal mucosa following challenge with Influenza., changes in mRNA and protein expression from blood and nasal brush samples. were assessed Self reported symptoms following challenge were recorded. Samples were taken to facilitate validation of CMI and other immunologically relevant assays in development
Overall Trial Design:
For each group of subjects, quarantine, challenge phase, release from quarantine and decontamination occured concurrently at the designated study site throughout the challenge phase of the study.
The volunteers were be stratified into four groups depending on their intended challenge titre of virus:
High titre Medium-high titre Medium-low titre Low titre Influenza inoculation (nasal drops)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High Titre Influenza virus | Experimental | Biological: High Titre Influenza virusHigh Titre Influenza virus |
| Medium - High Influenza virus | Experimental | Biological: Medium - High Influenza virusMedium - High Influenza virus |
| Medium Low Titre Influenza virus | Experimental | Biological: Medium Low Titre Influenza virusMedium Low Titre Influenza virus |
| Low titre Influenza Vaccine | Experimental | Biological: Low titreLow titre Influenza Vaccine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18 to 45 years, inclusive.
- Comprehension of the study requirements;availability for the required study period, ability to attend scheduled study visits, and willingness to participate in the inpatient challenge.
- Willingness to provide written consent for participation after reading the Consent Form and after having adequate opportunity to discuss the study with an investigator or qualified deputy.
- Good general health status as determined by a screening evaluation no greater than 45 days prior to the quarantine and challenge phase.
- For female subjects, provision of a history of reliable contraceptive practices [hysterectomy or bilateral tubal ligation, oral or implanted contraceptive use, intrauterine device, barrier method plus spermicide, history of a single male partner with vasectomy, or a history of abstinence deemed credible by the investigator(s)]. The provision of this history does NOT replace the requirement to perform, and obtain negative results in, pregnancy tests.
Key exclusion criteria (28 listed)
- Presence of any significant acute or chronic, uncontrolled medical or psychiatric illness,
- Health care workers (including doctors, nurses, medical students and allied healthcare professionals) anticipated to have patient contact within two weeks of viral challenge. Healthcare workers who volunteer should not work with patients until 14 days after challenge or until their symptoms are fully resolved.
- Venous access deemed inadequate for the phlebotomy demands of the study.
- Positive serologic tests for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
- Evidence of drug abuse or a positive urine Class A drug or alcohol screen.
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 |
|---|---|---|
| High Titre Influenza virusHigh Titre Influenza virus | Biological | High Titre Influenza virus |
| Medium - High Influenza virusMedium - High Influenza virus | Biological | Medium - High Influenza virus |
| Medium Low Titre Influenza virusMedium Low Titre Influenza virus | Biological | Medium Low Titre Influenza virus |
| Low titreLow titre | Biological | Low titre Influenza Vaccine |
Primary outcome
The infection rate of an Influenza (A/New Caledonia/20/99) virus. in human volunteers
Time frame: 14 days
2 secondary outcomes
Self Reported Symptoms
Time frame: 14 days
Virus Shedding from Nasal Mucosa
Time frame: 14 days
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 21 Apr 2016.
- Individual participant dataSharing planned: Yes. Only in anonymised form
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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.
Robert Lambkin-Williams, PhD principal investigator
020 7756 1300
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 High Titre Influenza virus, Medium - High Influenza virus and Medium Low Titre Influenza virus in people with Influenza, run by Hvivo at 1 site in United Kingdom.
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 28 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 21 Apr 2016. 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 Kingdom. 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?
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?
The infection rate of an Influenza (A/New Caledonia/20/99) virus. in human volunteers (time frame: 14 days). 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 21 Apr 2016.