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Influenza APhase 1NCT02014870

Safety and Reactogenicity of a H1N1 Influenza Challenge Virus in Healthy Volunteers

A Phase 1 study testing 1:1000 Live wild-type A/California/H1N1 2009, 1:100 Live wild-type A/California/H1N1 2009 and 1:10 Live wild-type A/California/H1N1 2009 in people with Influenza A, run by Immune Targeting Systems Ltd at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective is to determine the dose level of live, wild-type A/California/ H1N1 2009 virus that has an appropriate safety and illness/infectivity profile to be used as an influenza virus, challenge strain in future intervention studies. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Influenza A
What is being tested?
1:1000 Live wild-type A/California/H1N1 2009, 1:100 Live wild-type A/California/H1N1 2009 and 1:10 Live wild-type A/California/H1N1 2009
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteBelgium
Study dates
Jun 2013to Oct 2013
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male or female aged 18-45 years inclusive.
  • Able to give written informed consent to participate.
  • Healthy, as determined by medical history, physical examination, vital signs, 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 titre of ≤ 10 prior to challenge.
  • Non-habitual smoker (habitual smokers are persons who smoke more than 4 cigarettes or other tobacco products on a weekly basis) and agree to not use tobacco products during participation in the study.
  • Females should fulfil one of the following criteria:
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  • At least one year post-menopausal;
  • Surgically sterile;
  • 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 (e.g., 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.
  • Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1.
  • 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 for 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.
  • Suffering from asthma, bronchiectasis, emphysema, chronic obstructive pulmonary disease or any other chronic lung disease.
  • Pregnant or who is breast feeding.
  • Diastolic BP < 50 or > 90 mmHg, a systolic BP < 100 or > 150 mmHg, a pulse < 50 or > 100 bpm after resting for 5 min.
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  • Current use or use within the last 7 days of intranasal corticosteroids.
  • 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 3 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.
  • 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 age 5 years or younger, within 2 weeks following challenge.
  • Anticipated presence of a household contact age 65 years or older, within 2 weeks following challenge.
  • Current professional activity as a carer or healthcare workers who will return to work within 2 weeks following challenge.
  • Anticipated presence of a pregnant household contact, within 2 weeks following challenge.
  • History of anaphylactic type reaction to egg or egg protein.
  • History of Guillain-Barré 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 enrol 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 12 weeks.
  • Acute disease within 72 h 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.
  • Habitual smoker (habitual smokers are persons who smoke more than 4 cigarettes or other tobacco products on a weekly basis).

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • SGS Life Sciences

    Antwerp

Other trials in Belgium

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

The primary objective is to determine the dose level of live, wild-type A/California/ H1N1 2009 virus that has an appropriate safety and illness/infectivity profile to be used as an influenza virus, challenge strain in future intervention studies.

Illness parameters were collected by subject symptom scores as well as by physical examination. Virus parameters were measured by PCR and cell culture assay (performed by VisMederi srl).

Conditions
Influenza A
Being tested
1:1000 Live wild-type A/California/H1N1 2009, 1:100 Live wild-type A/California/H1N1 2009, 1:10 Live wild-type A/California/H1N1 2009
Keywords
Influenza, Vaccine, Virus, H1N1, Challenge, Vismederi
Medical subject headings
Influenza, Human, Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1:1000 Live wild-type A/California/H1N1 2009Other

    Also called virus

    1:1000 dilution of neat virus

  • 1:100 Live wild-type A/California/H1N1 2009Other

    Also called Virus

    1:100 dilution of neat virus

  • 1:10 Live wild-type A/California/H1N1 2009Other

    Also called Virus

    1:10 dilution of neat virus

Study groups in NCT02014870
Study groupRoleWhat they receive
Cohort 1Experimental1:1000 dilution of neat virus
Receives: Other: 1:1000 Live wild-type A/California/H1N1 2009
Cohort 2Experimental1:100 dilution of neat virus
Receives: Other: 1:100 Live wild-type A/California/H1N1 2009
Cohort 3Experimental1:10 dilution of neat virus
Receives: Other: 1:10 Live wild-type A/California/H1N1 2009

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety

    Frequency and severity of treatment-emergent adverse events as a measure of which dose of H1N1 challenge virus is safe for future intervention studies

    Measured: Day 1 - 29

  2. Infectivity

    Frequency and severity of influenza signs and symptoms experienced and incidence of laboratory confirmed infections, as a measure of which dose of H1N1 virus induces an appropriate level of illness/ infectivity for future intervention studies

    Measured: Day 1- 8

Secondary outcomes (3)

  1. Kinetics

    Record influenza signs, symptoms, and viral load/shedding over time to assess kinetics of infection

    Measured: Day 1 -8

  2. Immunology

    Assess immunological responses over the study period, including

    1. humoral immune response to challenge virus;
    2. cell mediated immune responses to virus proteins, including those specific for ITS' influenza A vaccine peptides;

    Measured: Day 1 - 29

  3. Biomarkers

    investigate gene expression to explore potential markers of influenza A infection that may be used in future intervention studies and, as such, determine mechanisms of vaccine efficacy

    Measured: Day 1 -29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionOct 2013
  4. Study completionOct 2013

Resources

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
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02014870
Sponsor's protocol ID
H1N1_CS_01
Other IDs
2013-002503-34
Status last verified
Dec 2013
First submitted
5 Dec 2013
Last updated
18 Dec 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Muller J, Parizotto E, Antrobus R, Francis J, Bunce C, Stranks A, Nichols M, McClain M, Hill AVS, Ramasamy A, Gilbert SC. Development of an objective gene expression panel as an alternative to self-reported symptom scores in human influenza challenge trials. J Transl Med. 2017 Jun 8;15(1):134. doi: 10.1186/s12967-017-1235-3.

    PubMed 28595644

  • Watson JM, Francis JN, Mesens S, Faiman GA, Makin J, Patriarca P, Treanor JJ, Georges B, Bunce CJ. Characterisation of a wild-type influenza (A/H1N1) virus strain as an experimental challenge agent in humans. Virol J. 2015 Feb 3;12:13. doi: 10.1186/s12985-015-0240-5.

    PubMed 25645025

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 1:1000 Live wild-type A/California/H1N1 2009, 1:100 Live wild-type A/California/H1N1 2009 and 1:10 Live wild-type A/California/H1N1 2009 in people with Influenza A, run by Immune Targeting Systems Ltd at 1 site in Belgium.

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 14 inclusion and 27 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 18 Dec 2013. 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 Belgium. 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?

Safety (time frame: Day 1 - 29). 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?

On the ClinicalTrials.gov record for NCT02014870, 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 18 Dec 2013.

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