AzTrials
AzTrials

InfluenzaPhase 1NCT01719783

Reactogenicity, Safety, and Immunogenicity of a Live Monovalent H5N2 Influenza Vaccine

A Phase 1 study testing LAIV H5N2 in people with Influenza, run by PATH at 1 site in Russia.

Completed

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

Official record
Search all trials

Trial summary

To evaluate the safety profile of two intranasal doses of LAIV A/17/turkey/Turkey/05/133 (H5N2) in healthy adults. Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
LAIV H5N2
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteRussia
Study dates
Sep 2012to Jan 2013
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 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Legal male or female adult 18 through 49 years of age at the enrollment visit.
  • Literate and willing to provide written informed consent.
  • Free of obvious health problems, as established by the medical history and screening evaluations, including physical examination.
  • Capable and willing to complete diary cards and willing to return for all follow-up visits
  • Willing to comply with the rules of the isolation unit (including willing and able to take oseltamivir influenza antiviral medication, should that be recommended by a study physician).
  • For females, willing to take reliable birth control measures throughout the entire period of participation in the study.

Who cannot join

  • Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during the period of this study.
  • Receipt of any non-study vaccine within four weeks prior to enrollment or refusal to postpone receipt of such vaccines until four weeks after study completion.
  • Practice of nasal irrigation on a regular basis within the past six months or has engaged in nasal irrigation within two weeks prior to enrollment.
  • Recent history of frequent nose bleeds (>5 within the past year).
  • Clinically relevant abnormal paranasal anatomy.
  • Recent history (within the past month) of rhino or sinus surgery, or surgery for any traumatic injury of the nose.
Show all 28Show fewer
  • Current or recent (within two weeks of enrollment) acute respiratory illness with or without fever.
  • Other acute illness at the time of study enrollment.
  • Receipt of immune globulin or other blood products within three months prior to study enrollment or planned receipt of such products during the period of subject participation in the study.
  • Chronic administration (defined as more than 14 consecutively-prescribed days) of immunosuppressants or other immune-modulating therapy within six months prior to study enrollment. (For corticosteroids, this means prednisone or equivalent, 0.5 mg per kg per day; topical steroids are allowed, exclusive of nasal.)
  • Participation in any previous trial of any H5 or H7 containing influenza vaccine.
  • History of asthma.
  • Hypersensitivity after previous administration of any influenza vaccine.
  • History of wheezing after past receipt of any live influenza vaccine.
  • Other adverse event (AE) following immunization, at least possibly related to previous receipt of any influenza vaccine.
  • Suspected or known hypersensitivity to any of the study vaccine components, including chicken or egg protein.
  • Seasonal (autumnal) hypersensitivity to the natural environment.
  • Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, metabolic, neurologic, psychiatric or renal functional abnormality, as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives. Subjects with physical examination findings or clinical laboratory screening results which would be graded 2 or higher on the AE severity grading scale (see Attachments) will be excluded from entry into the study and will be excluded from receipt of dose two of study vaccine or placebo.
  • History of leukemia or any other blood or solid organ cancer.
  • History of thrombocytopenic purpura or known bleeding disorder.
  • History of seizures.
  • Known or suspected immunosuppressive or immunodeficient condition of any kind, including HIV infection.
  • Known chronic hepatitis B (HBV) or hepatitis C (HCV) infection.
  • Known tuberculosis infection or evidence of previous tuberculosis exposure.
  • History of chronic alcohol abuse and/or illegal drug use.
  • Claustrophobia or sociophobia.
  • Pregnancy or lactation. (A negative pregnancy test will be required before administration of study vaccine or placebo for all women of childbearing potential.)
  • Any condition that, in the opinion of the investigator, would increase the health risk to the subject if he/she participates in the study or would interfere with the evaluation of the study objectives

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Research Institute of Influenza

    Saint Petersburg, 197376

Other trials in Russia

About this study

Official title: Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/Turkey/Turkey/05/133 (H5N2) Influenza Vaccine

To evaluate the safety profile of two intranasal doses of LAIV A/17/turkey/Turkey/05/133 (H5N2) in healthy adults.

Conditions
Influenza
Being tested
LAIV H5N2, Placebo
Keywords
influenza, vaccine, pandemic
Medical subject headings
Influenza, Human

What participants receive

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

  • LAIV H5N2Biological

    Also called A/17/turkey/Turkey/05/133(H5N2)live influenza vaccine

    2 doses provided intranasally

  • PlaceboOther

    2 doses of placebo provided intranasally

Study groups in NCT01719783
Study groupRoleWhat they receive
LAIV H5N2ExperimentalTwo doses of live monovalent influenza vaccine A/17/turkey/Turkey/05/133 ( live monovalent (LAIV H5N2) given intranasally
Receives: Biological: LAIV H5N2
PlaceboPlacebo comparatortwo doses of placebo solution intranasal
Receives: Other: Placebo

What is being measured

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

  1. Adverse Events by Severity

    Occurrence of participants with adverse events associated with intranasal administration, by worst grade of severity

    Measured: 6 days

Secondary outcomes (10)

  1. Number/Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI)

    Defined as a four-fold or greater antibody rise in titer from pre-vaccination level.

    HAI = hemagglutination-inhibition, conducted using World Health Organization (WHO)-recommended protocols.

    Measured: 28 days (Dose 1) and 56 days (Dose 2)

  2. Number/Percentage of Subjects With Serum Neutralizing Antibodies

    Defined as a four-fold or greater antibody rise in titer from pre-vaccination level.

    Measured by microneutralization assay in Madin-Darby canine kidney cells (MDCK).

    Measured: 28 days (Dose 1) and 56 days (Dose 2)

  3. Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin A (IgA)

    IgA = immunoglobulin class A antibodies Determined using ELISA using whole purified H5N2

    Measured: 28 days (Dose 1) and 56 days (Dose 2)

  4. Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin G (IgG)

    Determined using ELISA using whole purified H5N2.

    Measured: 28 days (Dose 1) and 56 days (Dose 2)

  5. Number/Percentage of Subjects With Seroconversion for Secretory IgA

    IgA antibodies from the nasal mucosa detected in nasal wick specimens. Determined using ELISA using whole purified H5N2

    Measured: 28 days (Dose 1) and 56 days (Dose 2)

  6. Number/Percentage of Subjects With Seroconversion for IgA in Saliva

    IgA = Immunoglobulin Class A antibodies. Determined using ELISA using whole purified H5N2.

    Measured: 28 days (Dose 1) and 56 days (Dose 2)

  7. Number/Percentage of Vaccinated Participants Shedding Influenza Virus After First Dose

    Nasal swabs were collected and used for Reverse transcription polymerase chain reaction (rRTPCR) assays to detect shedding of influenza virus for days 1-6 of the study.

    Measured: 6 days post-vaccination

  8. Number/Percentage of Vaccinated Participants Shedding Influenza Virus After Second Dose

    Nasal swabs were collected and used for Reverse transcription polymerase chain reaction (rRTPCR) assays to detect shedding of influenza virus for days 29-34 of the study (6 days after the second vaccination).

    Measured: 6 days post-vaccination

  9. Geometric Mean Titers for Serum HAI Antibodies

    Geometric mean titers for serum hemagglutination inhibition antibodies

    Measured: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

  10. Geometric Mean Titers (GMT) for Serum Neutralizing Antibodies

    Geometric mean titers for serum neutralizing antibodies measured by microneutralization assay

    Measured: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Timeline

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

  1. First posted1 Nov 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionJan 2013
  4. Study completionJan 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
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01719783
Sponsor's protocol ID
LAIV-H5N2-01
Status last verified
Nov 2018
First submitted
26 Oct 2012
Last updated
28 Nov 2018
Data monitoring committee
Yes

Publications

  • Kiseleva I, Dubrovina I, Fedorova E, Larionova N, Isakova-Sivak I, Bazhenova E, Pisareva M, Kuznetsova V, Flores J, Rudenko L. Genetic stability of live attenuated vaccines against potentially pandemic influenza viruses. Vaccine. 2015 Dec 8;33(49):7008-14. doi: 10.1016/j.vaccine.2015.09.050. Epub 2015 Oct 2.

    PubMed 26432909

  • Rudenko L, Kiseleva I, Stukova M, Erofeeva M, Naykhin A, Donina S, Larionova N, Pisareva M, Krivitskaya V, Flores J; Russian LAIV Trial Study Group. Clinical testing of pre-pandemic live attenuated A/H5N2 influenza candidate vaccine in adult volunteers: results from a placebo-controlled, randomized double-blind phase I study. Vaccine. 2015 Sep 22;33(39):5110-7. doi: 10.1016/j.vaccine.2015.08.019. Epub 2015 Aug 19.

    PubMed 26296497

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LAIV H5N2 in people with Influenza, run by PATH at 1 site in Russia.

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 6 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 28 Nov 2018. 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 Russia. 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. Some participants in this study may receive a placebo. 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 28 Nov 2018). 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?

Adverse Events by Severity (time frame: 6 days). 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 NCT01719783, 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 28 Nov 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in