Evaluating the Safety and Immunogenicity of a Live Attenuated Virus Vaccine to Prevent Influenza H3N2v Disease
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
1 other identifier
interventional
1
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2016
CompletedFirst Posted
Study publicly available on registry
August 30, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2017
CompletedMay 3, 2018
May 1, 2018
4 months
August 25, 2016
May 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Frequency of vaccine-related reactogenicity events (REs) that occur during the acute monitoring phase of the study
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 through Day 180
Development of serum antibody
Assessed by either hemagglutination inhibition (HAI) or microneutralization (MN) assays
Measured through Day 180
Secondary Outcomes (1)
Development of a significant increase in nasal secretion hemagglutinin (HA)-specific antibody
Measured through Day 180
Study Arms (7)
Group 1: H3N2v Seronegative Adults: H3N2v LAIV
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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 COMPARATORParticipants 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
EXPERIMENTALParticipants 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 COMPARATORParticipants 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
EXPERIMENTALParticipants 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 COMPARATORParticipants 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.
Interventions
Approximately 10\^7.0 Fluorescent Focus Units (FFU) per 0.2 mL dose; administered intranasally
15 μg; administered intramuscularly
Administered by nasal spray
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rochester Medical Center (URMC), Vaccine Research Unit (Outpatient)
Rochester, New York, 14642, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Treanor, M.D.
University of Rochester
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2016
First Posted
August 30, 2016
Study Start
September 1, 2016
Primary Completion
January 5, 2017
Last Updated
May 3, 2018
Record last verified: 2018-05