InfluenzaPhase 1NCT02480101
Reactogenicity, Safety and Immunogenicity of a LAIV H7N9 Influenza Vaccine
A Phase 1 study testing H7N9 live influenza vaccine in people with Influenza, run by Research Institute of Influenza, Russia.
Trial summary
This is a single centre phase I, double-blind placebo-controlled study to assess reactogenicity, safety and immunogenicity of a live monovalent A/17/Anhui/2013/61 (H7N9) influenza vaccine in healthy male and female adults, 18 through 49 years of age . 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?
- H7N9 live influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Apr 2015
- 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 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.
- A signed 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 through day 56.
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 (more than 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 29Show 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 H7 or H5 containing influenza vaccine.
- History of bronchial asthma.
- Hypersensitivity and allergy reactions after previous administration of any vaccine.
- History of wheezing after past receipt of any live influenza vaccine.
- Other AE following immunization (body temperature more than 40°C, collapse, non-febrile seizures, anaphylaxis), at least possibly related to previous receipt of any vaccine (not only influenza).
- 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 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 HBV or 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.
- Allergic, including anaphylactic, reactions to the introduction of any vaccines in the subject's medical history (not only flu vaccine).
About this study
Official title: Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/Anhui/2013/61 (H7N9) Influenza Vaccine
This is a single centre phase I, double-blind placebo-controlled study to assess reactogenicity, safety and immunogenicity of a live monovalent A/17/Anhui/2013/61 (H7N9) influenza vaccine in healthy male and female adults, 18 through 49 years of age .
- Conditions
- Influenza
- Being tested
- H7N9 live influenza vaccine, 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.
H7N9 live influenza vaccineBiological
Also called LAIV H7N9
H7N9 live influenza vaccine
PlaceboBiological
Lyophilized purified allantoic fluid of chicken embryos with stabilizers
| Study group | Role | What they receive |
|---|---|---|
| H7N9 LAIV | Active comparator | H7N9 live influenza vaccine Receives: Biological: H7N9 live influenza vaccine |
| Placebo | Placebo comparator | Lyophilized purified allantoic fluid of chicken embryos with stabilizers Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate reactions
Immediate reactions occurring within two hours of administration of any dose, measured as observed by study staff or reported by the subject to study staff
Measured: 2 hours
Solicited adverse events
Adverse events commonly associated with intranasal vaccination (solicited local and systemic reactions), measured as observed by study staff or reported by the subject to study staff
Measured: Greater than two hours after administration of any dose of study vaccine or placebo through 6 days following any dose
Changes from baseline in laboratory findings
Abnormal laboratory findings from blood and urine specimens
Measured: Days 3, 6 and 34
Serious adverse events (SAEs)
All SAEs during 56 days, as observed by study staff, reported by the subject to study staff, or noted by the subject on a diary card, including abnormal laboratory findings from blood specimens collected on Days 28 (pre-vaccination) and 56
Measured: 4 weeks of receipt of any dose
Secondary outcomes (3)
Immune responses
Immune responses was parameterized as the proportion of subjects with at least a four-fold rise after each dose from baseline or as the mean titer after each dose in any of the following:
- Serum hemagglutination inhibition (HAI) antibodies
- Serum neutralizing antibodies
- Serum immunoglobulin class A (IgA) or immunoglobulin class G (IgG) antibodies measured by enzyme-linked immunosorbent assay (ELISA)
- Secretory IgA antibodies from the nasal mucosa detected in nasal wick specimens using ELISA
- Secretory IgA antibodies in saliva specimens using ELISA
Measured: Days 0, 28 and 56
Virus shedding
Virus shedding with virus detected by real-time reverse transcriptase polymerase chain reaction rRTPCR in nasal swabs at any time point (at day of vaccination and daily during hospitalization).
Measured: Days 0-6 after each dose
Virus stability
Virus stability (virus detected and sequenced after inoculation into chicken eggs)
Measured: Days 0-6 after each dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Institute of Influenza, Russia
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, Institute of Experimental Medicine, Russia
- Responsible party
- Principal investigator, Oleg Kiselev, Research Institute of Influenza, Russia
- Investigators
- Larisa G Rudenko, MD PhD DSc, Study chair, Institute of Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480101
- Sponsor's protocol ID
- LAIV-H7N9-01
- Status last verified
- Jun 2015
- First submitted
- 16 Jun 2015
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rudenko L, Isakova-Sivak I, Naykhin A, Kiseleva I, Stukova M, Erofeeva M, Korenkov D, Matyushenko V, Sparrow E, Kieny MP. H7N9 live attenuated influenza vaccine in healthy adults: a randomised, double-blind, placebo-controlled, phase 1 trial. Lancet Infect Dis. 2016 Mar;16(3):303-10. doi: 10.1016/S1473-3099(15)00378-3. Epub 2015 Dec 8.
PubMed 26673391
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/Anhui/2013/61 (H7N9) Influenza Vaccine
- ClinicalTrials.gov ID
- NCT02480101
- Acronym / sponsor ID
- LAIV-H7N9-01
- Conditions
- Influenza
- Keywords
- influenza vaccine pandemic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Research Institute of Influenza, RussiaUniversity, hospital or other
- Collaborators
- World Health Organization, Institute of Experimental Medicine, Russia
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 24 Jun 2015 (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.
This is a single centre phase I, double-blind placebo-controlled study to assess reactogenicity, safety and immunogenicity of a live monovalent A/17/Anhui/2013/61 (H7N9) influenza vaccine in healthy male and female adults, 18 through 49 years of age .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| H7N9 LAIV | Active comparator | Biological: H7N9 live influenza vaccineH7N9 live influenza vaccine |
| Placebo | Placebo comparator | Biological: PlaceboLyophilized purified allantoic fluid of chicken embryos with stabilizers |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Legal male or female adult 18 through 49 years of age at the enrollment visit.
- Literate and willing to provide written informed consent.
- A signed 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
Key exclusion criteria (29 listed)
- 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 (more than 5 within the past year).
- Clinically relevant abnormal paranasal anatomy.
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 |
|---|---|---|
| H7N9 live influenza vaccineAlso: LAIV H7N9H7N9 live influenza vaccine | Biological | H7N9 LAIV |
| PlaceboLyophilized purified allantoic fluid of chicken embryos with stabilizers | Biological | Placebo |
Primary outcome
Immediate reactions
Time frame: 2 hours
Immediate reactions occurring within two hours of administration of any dose, measured as observed by study staff or reported by the subject to study staff
Solicited adverse events
Time frame: Greater than two hours after administration of any dose of study vaccine or placebo through 6 days following any dose
Adverse events commonly associated with intranasal vaccination (solicited local and systemic reactions), measured as observed by study staff or reported by the subject to study staff
Changes from baseline in laboratory findings
Time frame: Days 3, 6 and 34
Abnormal laboratory findings from blood and urine specimens
Serious adverse events (SAEs)
Time frame: 4 weeks of receipt of any dose
All SAEs during 56 days, as observed by study staff, reported by the subject to study staff, or noted by the subject on a diary card, including abnormal laboratory findings from blood specimens collected on Days 28 (pre-vaccination) and 56
3 secondary outcomes
Immune responses
Time frame: Days 0, 28 and 56
Virus shedding
Time frame: Days 0-6 after each dose
Virus stability
Time frame: Days 0-6 after each dose
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 24 Jun 2015.
- Derived from this study: PubMed 26673391Rudenko L, Isakova-Sivak I, Naykhin A, Kiseleva I, Stukova M, Erofeeva M, Korenkov D, Matyushenko V, Sparrow E, Kieny MP. H7N9 live attenuated influenza vaccine in healthy adults: a randomised, double-blind, placebo-controlled, phase 1 trial. Lancet Infect Dis. 2016 Mar;16(3):303-10. doi: 10.1016/S1473-3099(15)00378-3. Epub 2015 Dec 8.
Related trials for Influenza
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
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.
Larisa G Rudenko, MD PhD DSc study chair
Institute of Experimental Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing H7N9 live influenza vaccine in people with Influenza, run by Research Institute of Influenza, 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 7 inclusion and 29 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 24 Jun 2015. 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. 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?
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?
Immediate reactions (time frame: 2 hours). The study lists 4 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 NCT02480101, 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 24 Jun 2015.