InfluenzaPhase 1NCT02883426
Evaluating the Safety and Immunogenicity of a Live Attenuated Virus Vaccine to Prevent Influenza H3N2v Disease
A Phase 1 study testing H3N2v MN 2010/AA ca live attenuated influenza vaccine (LAIV) and H3N2v inactivated subvirion influenza vaccine in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This study will evaluate the safety and immunogenicity of the H3N2v MN 2010/AA ca live attenuated influenza vaccine (H3N2v LAIV) in healthy children and adults, 6 to 26 years old. Read more about this study
- Who is it for?
- Ages 6 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- H3N2v MN 2010/AA ca live attenuated influenza vaccine (LAIV) and H3N2v inactivated subvirion influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 5 Jan 2017
- 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 6 to 26 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Males and non-pregnant females between 6 and 26 years of age inclusive.
- For children, presence of an adult caregiver who is in good health and able to understand and carry out the requirements
- General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator.
- Agree to storage of blood specimens for future research.
- Available for the duration of the trial.
- Willingness to participate in the study as evidenced by signing the informed consent document. Verbal assent will be obtained from minors 6 to 12 years of age and signed assent will be obtained from minors 13 and older.
- Female subjects of childbearing potential must agree to use effective birth control methods for the duration of the study (e.g., pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; intrauterine device; abstinence from heterosexual intercourse, surgical sterilization).
Who cannot join
- Anticipated direct routine [e.g. weekly or more frequent] contact with individuals younger than the designated age groups being studied as a result of household contact, occupation, or participation in day care with such individuals.
- Pregnancy as determined by a positive urine or serum human choriogonadotropin (β-HCG) test.
- Currently breast-feeding.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history or physical examination.
- Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, affects the ability of the subject to understand and cooperate with the study protocol.
- Other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol.
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- History of anaphylaxis.
- Allergy to oseltamivir as determined by subject report.
- Current diagnosis of asthma or reactive airway disease (within the past 2 years).
- Use of aspirin or salicylate-containing medications within 28 days prior to randomization or expected receipt through 28 days after final vaccination.
- History of Guillain-Barré Syndrome.
- Known history of HIV, hepatitis C, or active hepatitis B infection.
- Known immunodeficiency syndrome.
- Use of corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to vaccination.
- Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to study vaccination.
- Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study vaccination.
- Travel to the Southern Hemisphere within 14 days prior to study vaccination.
- Travel on a cruise ship within 14 days prior to study vaccination.
- Receipt of another investigational vaccine or drug within 30 days prior to study vaccination.
- Allergy to eggs or egg products, gentamicin, or gelatin.
- Chronic use of intranasal medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center (URMC), Vaccine Research Unit (Outpatient)
Rochester, New York, 14642
About this study
Official title: Evaluation of the Safety and Immunogenicity of Live Influenza A Vaccine H3N2v (6-2) AA ca Recombinant (A/Minnesota/11/2010 (H3N2v) x A/Ann Arbor/6/60 ca), a Live Attenuated Virus Vaccine Candidate for Prevention of Influenza H3N2v Disease
This study will evaluate the safety and immunogenicity of the H3N2v MN 2010/AA ca live attenuated influenza vaccine (H3N2v LAIV) in healthy children and adults, 6 to 26 years old.
Read the detailed description
The potential for widespread human disease due to the H3N2v influenza viruses is considerable. Infection with these viruses would most likely impact young children. This study will evaluate the safety and immunogenicity of the H3N2v MN 2010/AA ca live attenuated influenza vaccine (H3N2v LAIV) in healthy children and adults, 6 to 26 years old.
The study will enroll participants sequentially in four groups: Group 1 will include H3N2v seronegative adults ages 18-26 years; Group 2 will include H3N2v seropositive adolescents ages 13-17 years; Group 3 will include H3N2v seronegative adolescents ages 13-17 years; and Group 4 will include children ages 6 to 12 years, who will not be screened for H3N2v serostatus.
At study entry (Day 0), participants in Group 1 will receive one dose of H3N2v LAIV. Participants in Groups 2, 3, and 4 will be randomly assigned to receive two doses of either H3N2v LAIV or placebo, receiving the first dose on Day 0 and the second dose on Day 28. On Day 84, all participants will receive one dose of H3N2v IIV (an inactivated booster vaccine).
Participants will attend several additional study visits through Day 180. These visits may include a physical examination; respiratory examination; and collection of blood, urine, or nasal fluids.
- Conditions
- Influenza
- Being tested
- H3N2v MN 2010/AA ca live attenuated influenza vaccine (LAIV), H3N2v inactivated subvirion influenza vaccine, Placebo
- Keywords
- H3N2v Influenza Viruses
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H3N2v MN 2010/AA ca live attenuated influenza vaccine (LAIV)Biological
Also called H3N2v LAIV
Approximately 10^7.0 Fluorescent Focus Units (FFU) per 0.2 mL dose; administered intranasally
H3N2v inactivated subvirion influenza vaccineBiological
Also called H3N2v IIV
15 μg; administered intramuscularly
PlaceboBiological
Administered by nasal spray
| Study group | Role | What they receive |
|---|---|---|
| Group 1: H3N2v Seronegative Adults: H3N2v LAIV | Experimental | Participants will receive one dose of H3N2v LAIV on Day 0 (study entry). They will then receive one dose of H3N2v IIV on Day 84. Receives: Biological: H3N2v MN 2010/AA ca live attenuated influenza vaccine (LAIV); Biological: H3N2v inactivated subvirion influenza vaccine |
| Group 2: H3N2v Seropositive Adolescents: H3N2v LAIV | Experimental | Participants will receive two doses of H3N2v LAIV, the first dose on Day 0 (study entry) and the second dose on Day 28. They will then receive one dose of H3N2v IIV on Day 84. Receives: Biological: H3N2v MN 2010/AA ca live attenuated influenza vaccine (LAIV); Biological: H3N2v inactivated subvirion influenza vaccine |
| Group 2: H3N2v Seropositive Adolescents: Placebo | Placebo comparator | Participants will receive two doses of placebo, the first dose on Day 0 (study entry) and the second dose on Day 28. They will then receive one dose of H3N2v IIV on Day 84. Receives: Biological: H3N2v inactivated subvirion influenza vaccine; Biological: Placebo |
| Group 3: H3N2v Seronegative Adolescents: H3N2v LAIV | Experimental | Participants will receive two doses of H3N2v LAIV, the first dose on Day 0 (study entry) and the second dose on Day 28. They will then receive one dose of H3N2v IIV on Day 84. Receives: Biological: H3N2v MN 2010/AA ca live attenuated influenza vaccine (LAIV); Biological: H3N2v inactivated subvirion influenza vaccine |
| Group 3: H3N2v Seronegative Adolescents: Placebo | Placebo comparator | Participants will receive two doses of placebo, the first dose on Day 0 (study entry) and the second dose on Day 28. They will then receive one dose of H3N2v IIV on Day 84. Receives: Biological: H3N2v inactivated subvirion influenza vaccine; Biological: Placebo |
| Group 4: Children: H3N2v LAIV | Experimental | Participants will receive two doses of H3N2v LAIV, the first dose on Day 0 (study entry) and the second dose on Day 28. They will then receive one dose of H3N2v IIV on Day 84. Receives: Biological: H3N2v MN 2010/AA ca live attenuated influenza vaccine (LAIV); Biological: H3N2v inactivated subvirion influenza vaccine |
| Group 4: Children: Placebo | Placebo comparator | Participants will receive two doses of placebo, the first dose on Day 0 (study entry) and the second dose on Day 28. They will then receive one dose of H3N2v IIV on Day 84. Receives: Biological: H3N2v inactivated subvirion influenza vaccine; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of vaccine-related reactogenicity events (REs) that occur during the acute monitoring phase of the study
Measured: Measured through Day 180
Area under the curve of nasal virus shedding after each dose of vaccine
As assessed by liquid titration of nasal secretions on Madin Darby canine kidney (MDCK) cells at 33°C
Measured: Measured through Day 180
Development of serum antibody
Assessed by either hemagglutination inhibition (HAI) or microneutralization (MN) assays
Measured: Measured through Day 180
Secondary outcomes (1)
Development of a significant increase in nasal secretion hemagglutinin (HA)-specific antibody
Assessed by enzyme-linked immunosorbent assay (ELISA), luminex or microneutralization assay
Measured: Measured through Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startSep 2016
- Primary completion5 Jan 2017
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.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- John Treanor, M.D., Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883426
- Sponsor's protocol ID
- URMC 16-001
- Status last verified
- May 2018
- First submitted
- 25 Aug 2016
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Immunogenicity of Live Influenza A Vaccine H3N2v (6-2) AA ca Recombinant (A/Minnesota/11/2010 (H3N2v) x A/Ann Arbor/6/60 ca), a Live Attenuated Virus Vaccine Candidate for Prevention of Influenza H3N2v Disease
- ClinicalTrials.gov ID
- NCT02883426
- Acronym / sponsor ID
- URMC 16-001
- Conditions
- Influenza
- Keywords
- H3N2v Influenza Viruses
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Sep 2016
- Primary completion
- 5 Jan 2017 (actual)
- First posted
- 30 Aug 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.
This study will evaluate the safety and immunogenicity of the H3N2v MN 2010/AA ca live attenuated influenza vaccine (H3N2v LAIV) in healthy children and adults, 6 to 26 years old.
Detailed description
The potential for widespread human disease due to the H3N2v influenza viruses is considerable. Infection with these viruses would most likely impact young children. This study will evaluate the safety and immunogenicity of the H3N2v MN 2010/AA ca live attenuated influenza vaccine (H3N2v LAIV) in healthy children and adults, 6 to 26 years old.
The study will enroll participants sequentially in four groups: Group 1 will include H3N2v seronegative adults ages 18-26 years; Group 2 will include H3N2v seropositive adolescents ages 13-17 years; Group 3 will include H3N2v seronegative adolescents ages 13-17 years; and Group 4 will include children ages 6 to 12 years, who will not be screened for H3N2v serostatus.
At study entry (Day 0), participants in Group 1 will receive one dose of H3N2v LAIV. Participants in Groups 2, 3, and 4 will be randomly assigned to receive two doses of either H3N2v LAIV or placebo, receiving the first dose on Day 0 and the second dose on Day 28. On Day 84, all participants will receive one dose of H3N2v IIV (an inactivated booster vaccine).
Participants will attend several additional study visits through Day 180. These visits may include a physical examination; respiratory examination; and collection of blood, urine, or nasal fluids.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Group 1: H3N2v Seronegative Adults: H3N2v LAIV | Experimental | Biological: H3N2v MN 2010/AA ca live attenuated influenza vaccine (LAIV), Biological: H3N2v inactivated subvirion influenza vaccineParticipants will receive one dose of H3N2v LAIV on Day 0 (study entry). They will then receive one dose of H3N2v IIV on Day 84. |
| Group 2: H3N2v Seropositive Adolescents: H3N2v LAIV | Experimental | Biological: H3N2v MN 2010/AA ca live attenuated influenza vaccine (LAIV), Biological: H3N2v inactivated subvirion influenza vaccineParticipants will receive two doses of H3N2v LAIV, the first dose on Day 0 (study entry) and the second dose on Day 28. They will then receive one dose of H3N2v IIV on Day 84. |
| Group 2: H3N2v Seropositive Adolescents: Placebo | Placebo comparator | Biological: H3N2v inactivated subvirion influenza vaccine, Biological: PlaceboParticipants will receive two doses of placebo, the first dose on Day 0 (study entry) and the second dose on Day 28. They will then receive one dose of H3N2v IIV on Day 84. |
| Group 3: H3N2v Seronegative Adolescents: H3N2v LAIV | Experimental | Biological: H3N2v MN 2010/AA ca live attenuated influenza vaccine (LAIV), Biological: H3N2v inactivated subvirion influenza vaccineParticipants will receive two doses of H3N2v LAIV, the first dose on Day 0 (study entry) and the second dose on Day 28. They will then receive one dose of H3N2v IIV on Day 84. |
| Group 3: H3N2v Seronegative Adolescents: Placebo | Placebo comparator | Biological: H3N2v inactivated subvirion influenza vaccine, Biological: PlaceboParticipants will receive two doses of placebo, the first dose on Day 0 (study entry) and the second dose on Day 28. They will then receive one dose of H3N2v IIV on Day 84. |
| Group 4: Children: H3N2v LAIV | Experimental | Biological: H3N2v MN 2010/AA ca live attenuated influenza vaccine (LAIV), Biological: H3N2v inactivated subvirion influenza vaccineParticipants will receive two doses of H3N2v LAIV, the first dose on Day 0 (study entry) and the second dose on Day 28. They will then receive one dose of H3N2v IIV on Day 84. |
| Group 4: Children: Placebo | Placebo comparator | Biological: H3N2v inactivated subvirion influenza vaccine, Biological: PlaceboParticipants will receive two doses of placebo, the first dose on Day 0 (study entry) and the second dose on Day 28. They will then receive one dose of H3N2v IIV on Day 84. |
Who may qualify
- Ages
- 6 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Males and non-pregnant females between 6 and 26 years of age inclusive.
- For children, presence of an adult caregiver who is in good health and able to understand and carry out the requirements
- General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator.
- Agree to storage of blood specimens for future research.
- Available for the duration of the trial.
Key exclusion criteria (21 listed)
- Anticipated direct routine [e.g. weekly or more frequent] contact with individuals younger than the designated age groups being studied as a result of household contact, occupation, or participation in day care with such individuals.
- Pregnancy as determined by a positive urine or serum human choriogonadotropin (β-HCG) test.
- Currently breast-feeding.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history or physical examination.
- Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, affects the ability of the subject to understand and cooperate with the study protocol.
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 |
|---|---|---|
| H3N2v MN 2010/AA ca live attenuated influenza vaccine (LAIV)Also: H3N2v LAIVApproximately 10^7.0 Fluorescent Focus Units (FFU) per 0.2 mL dose; administered intranasally | Biological | Group 1: H3N2v Seronegative Adults: H3N2v LAIV, Group 2: H3N2v Seropositive Adolescents: H3N2v LAIV, Group 3: H3N2v Seronegative Adolescents: H3N2v LAIV, Group 4: Children: H3N2v LAIV |
| H3N2v inactivated subvirion influenza vaccineAlso: H3N2v IIV15 μg; administered intramuscularly | Biological | Group 1: H3N2v Seronegative Adults: H3N2v LAIV, Group 2: H3N2v Seropositive Adolescents: H3N2v LAIV, Group 2: H3N2v Seropositive Adolescents: Placebo, Group 3: H3N2v Seronegative Adolescents: H3N2v LAIV, Group 3: H3N2v Seronegative Adolescents: Placebo, Group 4: Children: H3N2v LAIV, Group 4: Children: Placebo |
| PlaceboAdministered by nasal spray | Biological | Group 2: H3N2v Seropositive Adolescents: Placebo, Group 3: H3N2v Seronegative Adolescents: Placebo, Group 4: Children: Placebo |
Primary outcome
Frequency of vaccine-related reactogenicity events (REs) that occur during the acute monitoring phase of the study
Time frame: Measured through Day 180
Area under the curve of nasal virus shedding after each dose of vaccine
Time frame: Measured through Day 180
As assessed by liquid titration of nasal secretions on Madin Darby canine kidney (MDCK) cells at 33°C
Development of serum antibody
Time frame: Measured through Day 180
Assessed by either hemagglutination inhibition (HAI) or microneutralization (MN) assays
1 secondary outcome
Development of a significant increase in nasal secretion hemagglutinin (HA)-specific antibody
Time frame: Measured through Day 180
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
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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.
John Treanor, M.D. principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing H3N2v MN 2010/AA ca live attenuated influenza vaccine (LAIV) and H3N2v inactivated subvirion influenza vaccine in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 21 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: stopped early, as of the sponsor's last update on 3 May 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 United States. 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?
The study was stopped early. Results are not available in the source record.
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?
Frequency of vaccine-related reactogenicity events (REs) that occur during the acute monitoring phase of the study (time frame: Measured through Day 180). The study lists 3 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 3 May 2018.