InfluenzaPhase 1NCT04106817
Single Ascending Dose Challenge Study to Determine Safety and Reactogenicity of an Influenza Challenge Virus
A Phase 1 study testing Live, wild-type A/California/H1N1 2009 influenza virus in people with Influenza, run by WCCT Global.
Trial summary
This is a non-controlled, open-label, single-center, dose-escalation study to determine the safety, infectivity, and immune responses elicited from of the potential influenza virus challenge strain. 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?
- Live, wild-type A/California/H1N1 2009 influenza virus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 19 Jan 2015to 10 Aug 2015
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, as determined by medical history, physical examination, vital signs, echocardiogram, 12-lead ECG, and clinical safety laboratory examinations at baseline, as determined by the Investigator.
- Absent or low levels of detectable pre-existing antibodies to influenza virus subtypes, including as a minimum the challenge strain, as determined by an HAI titer of ≤10 prior to challenge.
- Non-smoker (no smoking within the last year and a history of less than 10 packs per year total) and agree to not use tobacco products during participation in the study.
- Female subjects of childbearing potential must:
- Not be breastfeeding
- Have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1
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- Will use oral, implantable, transdermal, or injectable contraceptives for 30 days prior to administration of the A/California/H1N1 2009 virus until the follow-up visit is performed.
- Use another reliable form of contraception approved by the Investigator (eg, intrauterine device, female condom, diaphragm with spermicide, cervical cap, use of condom by the sexual partner or a sterile sexual partner) from the time of screening until the follow-up visit is performed.
- Female subjects not of childbearing potential must:
- Be at least 1 year post-menopausal, or
- Be surgically sterile
- Male subjects able to father a child and sexually active with a female of childbearing potential, must agree to use a double barrier method of birth control (eg, condom with spermicidal foam, cream gel) and to not donate sperm during the study, from the day of enrollment until the Day 60 (±3) follow-up visit. If the female partner is using an effective method of contraception, a single barrier method of birth control for the male is acceptable.
- Comprehension of the study requirements, expressed availability for the required study period, and ability to be quarantined for up to 10 days and to attend the scheduled follow up visit.
- Negative alcohol and urine drug screening tests prior to entering quarantine.
- Being willing to adhere to the prohibitions and restrictions specified in this protocol
Who cannot join
- Prior receipt of any influenza vaccine within the previous 2 years.
- Significant adulthood history of seasonal hay fever or a seasonal allergic rhinitis or perennial allergic rhinitis or chronic or nasal or sinus condition such as chronic sinusitis.
- Abnormal nasal structure including septal deviation and nasal polyps, or surgery to the nose or nasopharynx within 6 months of signing the informed consent form or recent (within the last 6 months) history of frequent or prolonged episodes of epistaxis.
- Suffering from asthma, bronchiectasis, emphysema, chronic obstructive pulmonary disease or any other chronic lung disease. A history of childhood asthma before the age of 12 is acceptable provided the subject is asymptomatic without treatment. Subjects with a single episode of wheezing after age 12 (lasting less than 8 weeks) can be included at the investigator's discretion.
- A female who is pregnant or who is breast feeding
- Diastolic BP, systolic BP or, pulse not consistent with normal vital signs, based on investigator judgment.
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- Current use or use of intranasal corticosteroids within the last 30 days prior to the administration of the investigational virus product (Study Day 1).
- Presence of significant uncontrolled medical, neurological or psychiatric illness (acute or chronic) as assessed by the Investigator. This includes, but is not limited to, institution of new surgical or medical treatment for a chronic condition), or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed on Day -1 prior to challenge.
- Positive serology for HIV-1 or HIV-2, or HBsAg or HCV antibodies.
- Cancer or treatment for cancer, within 5 years, excluding basal cell carcinoma of the skin, which is allowed.
- Presence of immunosuppression or any medical condition that may be associated with impaired immune responsiveness, including, but not limited to, diabetes mellitus inflammatory bowel disease.
- Presently receiving (or history of receiving) or during the preceding 3-month period prior to screening, any medications or other treatments that may adversely affect the immune system such as allergy injections, immune globulin, interferon, immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable) azathioprine or mercaptopurine. Topical corticosteroids except intranasal will be allowed. Use of intranasal corticosteroids within the last 30 days prior to the administration of the investigational virus product (Study Day 1) is prohibited.
- Chronic condition requiring prescription or over-the-counter medicine, with the exception of vitamins.
- Anticipated presence of a household contact with documented severe immunosuppression (as defined by CD4 < 200/mm³ or an absolute neutrophil count < 1500/mm³), either as a result of disease and/or therapy.
- Anticipated presence of a household contact aged ≤ 5 years, aged > 64 years, or a pregnant contact within 2 weeks following challenge.
- Current professional activity as a caregiver or healthcare worker who will return to work within 2 weeks following challenge.
- History of anaphylactic type reaction to egg or egg protein, adverse reaction to oseltamivir, a previous severe allergic reaction with generalized uticaria, angioedema, or anaphylaxis
- History of Guillain-Barre syndrome
- History of drug or chemical abuse in the year before the study.
- Receipt of any investigational virus product or nonregistered drug within the 30 days prior to challenge or currently enrolled in any investigational drug study or intends to enroll in such a study within the ensuing study period.
- Receipt of blood or blood products 6 months prior to challenge or planned administration during the study period.
- Blood donation in the last 26 weeks.
- Acute disease within 72 hours prior to challenge, defined as the presence of a moderate or severe illness with or without fever (as determined by the Investigator through medical history and physical examination), or presence of a fever ≥ 38ºC oral.
- Elevated white cell count above 10.5 x 109/L or an absolute neutrophil count above 7.5 x 109/L.
- Any condition that, in the opinion of the Investigator, might interfere with the primary study objective.
- Drinks more than 1200 mL (or 5 cups of 240 mL per cup) of tea/coffee/cocoa/cola or other caffeinated beverage per day more than one day per week in the 2 weeks before screening.
About this study
Official title: A Phase I, Open-label, Ascending Dose Study to Determine the Safety and Reactogenicity of a Wild Type Seasonal A/California/ H1N1 2009 Influenza Challenge Virus in Healthy Volunteers, Following a Single Intranasal Administration
This is a non-controlled, open-label, single-center, dose-escalation study to determine the safety, infectivity, and immune responses elicited from of the potential influenza virus challenge strain. The study objective is to determine the dose with the optimal safety profile and infectivity rate of the viral challenge strain in healthy volunteers for use in subsequent challenge intervention studies to test potential influenza vaccines and/or therapeutics.
- Conditions
- Influenza
- Being tested
- Live, wild-type A/California/H1N1 2009 influenza virus
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live, wild-type A/California/H1N1 2009 influenza virusBiological
Live, wild type influenza A virus that was inoculated and manufactured in allantoic fluid of SPF embryonated hen eggs
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 1:10 dilution of neat virus (0.25mL of 1:10 dilution per nostril of neat virus; approximate quantity 3.5 x 10^6TCID50/dose) Receives: Biological: Live, wild-type A/California/H1N1 2009 influenza virus |
| Cohort 2 | Experimental | 1:5 dilution of neat virus (0.25mL of 1:5 dilution per nostril of neat virus; approximate quantity 7 x 10^6TCID50/dose) Receives: Biological: Live, wild-type A/California/H1N1 2009 influenza virus |
| Cohort 3 | Experimental | 1:10 dilution of neat virus (0.5mL of 1:10 dilution per nostril of neat virus; approximate quantity 7 x 10^6TCID50/dose) Receives: Biological: Live, wild-type A/California/H1N1 2009 influenza virus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Shedding
Number of participants with viral shedding, assessed from nasopharyngeal swabs using RT-PCR and cell culture assay
Measured: Day 9
Seroconversion
Greater than or equal to 4-fold rise in HAI titer by study Day 60 relative to baseline
Measured: Day 60
Secondary outcomes (1)
Number and Severity of AEs
The number of AEs in each Cohort rated as mild, moderate, or severe intensity
Measured: Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start19 Jan 2015
- Primary completion10 Aug 2015
- Study completion10 Aug 2015
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.
- 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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- WCCT Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stanford University, National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106817
- Sponsor's protocol ID
- WCCTG 14-01
- Status last verified
- Jan 2020
- First submitted
- 24 Sep 2019
- Last updated
- 14 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Ascending Dose Study to Determine the Safety and Reactogenicity of a Wild Type Seasonal A/California/ H1N1 2009 Influenza Challenge Virus in Healthy Volunteers, Following a Single Intranasal Administration
- ClinicalTrials.gov ID
- NCT04106817
- Acronym / sponsor ID
- WCCTG 14-01
- Conditions
- Influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- WCCT GlobalIndustry (pharma, biotech, devices)
- Collaborators
- Stanford University, National Institutes of Health (NIH)
- Study start
- 19 Jan 2015 (actual)
- Primary completion
- 10 Aug 2015 (actual)
- Study completion
- 10 Aug 2015 (actual)
- First posted
- 27 Sep 2019 (actual)
- Results
- Posted 19 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-controlled, open-label, single-center, dose-escalation study to determine the safety, infectivity, and immune responses elicited from of the potential influenza virus challenge strain. The study objective is to determine the dose with the optimal safety profile and infectivity rate of the viral challenge strain in healthy volunteers for use in subsequent challenge intervention studies to test potential influenza vaccines and/or therapeutics.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: Live, wild-type A/California/H1N1 2009 influenza virus1:10 dilution of neat virus (0.25mL of 1:10 dilution per nostril of neat virus; approximate quantity 3.5 x 10^6TCID50/dose) |
| Cohort 2 | Experimental | Biological: Live, wild-type A/California/H1N1 2009 influenza virus1:5 dilution of neat virus (0.25mL of 1:5 dilution per nostril of neat virus; approximate quantity 7 x 10^6TCID50/dose) |
| Cohort 3 | Experimental | Biological: Live, wild-type A/California/H1N1 2009 influenza virus1:10 dilution of neat virus (0.5mL of 1:10 dilution per nostril of neat virus; approximate quantity 7 x 10^6TCID50/dose) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Healthy, as determined by medical history, physical examination, vital signs, echocardiogram, 12-lead ECG, and clinical safety laboratory examinations at baseline, as determined by the Investigator.
- Absent or low levels of detectable pre-existing antibodies to influenza virus subtypes, including as a minimum the challenge strain, as determined by an HAI titer of ≤10 prior to challenge.
- Non-smoker (no smoking within the last year and a history of less than 10 packs per year total) and agree to not use tobacco products during participation in the study.
- Female subjects of childbearing potential must:
- Female subjects not of childbearing potential must:
Key exclusion criteria (26 listed)
- Prior receipt of any influenza vaccine within the previous 2 years.
- Significant adulthood history of seasonal hay fever or a seasonal allergic rhinitis or perennial allergic rhinitis or chronic or nasal or sinus condition such as chronic sinusitis.
- Abnormal nasal structure including septal deviation and nasal polyps, or surgery to the nose or nasopharynx within 6 months of signing the informed consent form or recent (within the last 6 months) history of frequent or prolonged episodes of epistaxis.
- Suffering from asthma, bronchiectasis, emphysema, chronic obstructive pulmonary disease or any other chronic lung disease. A history of childhood asthma before the age of 12 is acceptable provided the subject is asymptomatic without treatment. Subjects with a single episode of wheezing after age 12 (lasting less than 8 weeks) can be included at the investigator's discretion.
- A female who is pregnant or who is breast feeding
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 |
|---|---|---|
| Live, wild-type A/California/H1N1 2009 influenza virusLive, wild type influenza A virus that was inoculated and manufactured in allantoic fluid of SPF embryonated hen eggs | Biological | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Viral Shedding
Time frame: Day 9
Number of participants with viral shedding, assessed from nasopharyngeal swabs using RT-PCR and cell culture assay
Seroconversion
Time frame: Day 60
Greater than or equal to 4-fold rise in HAI titer by study Day 60 relative to baseline
1 secondary outcome
Number and Severity of AEs
Time frame: Day 60
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Live, wild-type A/California/H1N1 2009 influenza virus in people with Influenza, run by WCCT Global.
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 26 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 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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 19 Nov 2019). 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?
Viral Shedding (time frame: Day 9). The study lists 2 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 14 Jan 2020.