InfluenzaPhase 4NCT03101462
Live Attenuated Influenza Vaccine (LAIV) Versus Trivalent Inactivated Influenza Vaccine in Healthy Adults 18-49 Years
A Phase 4 study testing Inactivated Influenza Vaccine and Live Attenuated Influenza Vaccine in people with Influenza, run by St. Louis University.
Trial summary
This randomized, open-label, single-site study at Saint Louis University will enroll approximately 40 subjects who are healthy, 18 to 49 years old. Subjects will be randomized in a 1:1 fashion to receive either licensed trivalent FluMist containing (2010-2011 season appropriate), or licensed inactivated trivalent… 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?
- Inactivated Influenza Vaccine and Live Attenuated Influenza Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 24 Feb 2011to 9 Nov 2011
- Phase
- Phase 4
- 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
- Male or female age 18 to 49 years, inclusive, on the day of randomization (reached his or her 18th year birthday but not yet reached his or her 50th year birthday) at the time of the dose of study product
- Written informed consent and a locally required authorization (eg, HIPAA in the USA, ) obtained from the subject prior to performing any protocol-related procedures.
- Females of child-bearing potential, (ie, unless surgically sterile [eg, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy], has sterile male partner, is at least 1 year post-menopausal, or practices abstinence) must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, or use of a condom with spermicide by the sexual partner) for 30 days prior to the first dose of study product, and must agree to continue using such precautions for 60 days after the dose of vaccine due to a potential dose of live vaccine product. In addition, the subject must also have a negative urine or blood pregnancy test at screening and, if screening and Day 0 do not occur on the same day, a negative urine pregnancy test on the day of vaccination prior to randomization. Investigator judgment is required to assess a female subject's capability of pregnancy.
- Are in good health, as determined by vital signs, medical history to ensure any existing medical diagnoses or conditions are stable and not considered clinically significant by physician investigator, and targeted physical examination based on medical history.
- Able to complete follow-up period of 180 days post dose of vaccine as required by the protocol
- Subject available by telephone
- Able to understand and comply with the requirements of the protocol, as judged by the investigator
Who cannot join
- Any of the following would exclude the subject from participation in the study:
- Have an acute illness, including an oral temperature ≥ 100.4°F, within 3 days prior to vaccination.
- Participated in an investigational influenza vaccine study or had a known infection with "flu" since 2007 (confirmed by laboratory culture, including subtype of the influenza A virus (H1N1) investigational vaccines or illness).
- Previous vaccination against influenza in 2007, 2008, 2009 or 2010 with seasonal trivalent live or inactivated influenza vaccine (including H1N1 vaccines).
- Current or expected receipt of immunosuppressive medications (inhaled and topical corticosteroids are permitted) including corticosteroids (≥ 20 mg/day of prednisone equivalent given daily or on alternate days for ≥ 14 days) within a 30 day window around dose of study vaccine product Note: topical corticosteroids for uncomplicated dermatitis may be used throughout the study according to the judgment of the investigator; topical calcineurin inhibitors may be used in accordance with their package insert at entry and during study participation.
- Receipt of immunoglobulin or blood products within 90 days before randomization into the study or expected receipt during study participation
Show all 16Show fewer
- Received an experimental agent within 1 month prior to vaccination in this study or expect to receive an experimental agent during the active study period (prior to Day 60 after vaccination (Experimental agent includes: vaccine, biologic, device, or medication).
- Have received any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study or plan receipt of such vaccines within 60 days following the vaccination.
- Any known immunosuppressive condition or immune deficiency disease including known cancer illness or organ transplant
- Have known active HIV, Hepatitis B or Hepatitis C infection.
- Have a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol, thimerosal, gentamycin and chicken protein) or severe reactions to previous influenza vaccinations.
- History of Guillain-Barré syndrome
- Use of antiviral agents with activity against influenza virus (including amantadine, rimantadine, oseltamivir and zanamivir) within 30 days prior to dose of study vaccine products or anticipated use within 30 days after vaccination
- Breastfeeding woman
- History of alcohol or drug abuse that, in the opinion of the investigator, would affect the subject's safety or compliance with study
- Previous medical history, evidence of an intercurrent illness or any condition that, in the opinion of the investigator, would interfere with evaluation of the study vaccine products or interpretation of subject safety or that may compromise the safety of the subject in the study.
About this study
Official title: A Randomized, Open-Label, Study to Evaluate the Immunogenicity of One Dose of Live Attenuated Influenza Vaccine (LAIV) Compared to One Dose of Trivalent Inactivated Influenza Vaccine (IIV) in Adults 18-49 Years of Age
This randomized, open-label, single-site study at Saint Louis University will enroll approximately 40 subjects who are healthy, 18 to 49 years old. Subjects will be randomized in a 1:1 fashion to receive either licensed trivalent FluMist containing (2010-2011 season appropriate), or licensed inactivated trivalent influenza vaccine (2010-2011 season appropriate) so that approximately 20 subjects will be randomized to receive LAIV, and 20 will receive IIV.
Read the detailed description
This Phase IV, randomized, open-label, single-site study at Saint Louis University will enroll approximately 40 subjects who are healthy, 18 to 49 years old. Subjects will be randomized in a 1:1 fashion to receive either licensed inactivated influenza vaccine (IIV) (2010-2011 season appropriate) or licensed live attenuated influenza vaccine (LAIV) (2010-2011 season appropriate) so that approximately 20 subjects will be randomized to receive IIV, and 20 will receive LAIV. Subjects will receive 1 dose of IIV or LAIV in the Center for Vaccine Development on Day 0 and will return to the site on days 7 and 45 to assess immunogenicity. Subjects will be asked to report any serious adverse events. Blood samples and nasal washes for assessment of immune responses will be obtained at three time points: on Day 0 prior to dosing with IIV or LAIV, and at visits conducted 7 and 45-51 days post vaccination. The study will be conducted just prior to and during the influenza season. Subjects will receive a single dose of IIV or LAIV administered as instructed per package insert. Two contacts will be made with subjects, either telephone calls or e-mail, to collect serious adverse events only, one at Days 28-35, and one at approximately Days 180-190 to conclude the subject's participation. The duration of each subject's participation is approximately 6 months. The primary immune studies conducted with collected samples will include serum hemagglutinin inhibition (HAI) antibody titers, nasal wash influenza-specific secretory immunoglobulin A (IgA) responses, peripheral blood interferon gamma (IFN-γ) ELISPOT assays and peripheral blood carboxyfluorescein succinimidyl ester (CFSE) dilution/intracellular cytokine staining flow cytometric assays. In addition, frozen serum and peripheral blood mononuclear cells (PBMC) samples will be used in exploratory assays to determine the kinetics and nature of innate responses and the detailed molecular signatures of memory T cells induced by IIV and LAIV vaccinations. Investigators will be performing genome-wide expression studies, but will not perform DNA sequencing and will not send anything other than coded samples outside of Saint Louis University.
- Conditions
- Influenza
- Being tested
- Inactivated Influenza Vaccine, Live Attenuated Influenza Vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated Influenza VaccineBiological
Also called IIV
Live Attenuated Influenza VaccineBiological
Also called LAIV
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | One dose of 0.5 mL Licensed Inactivated Influenza Vaccine (IIV) on Day 0 Receives: Biological: Inactivated Influenza Vaccine |
| Group 2 | Active comparator | One dose of 0.5 mL Licensed Live Attenuated Influenza Vaccine (LAIV) on Day 0 Receives: Biological: Live Attenuated Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Antibody Responses
Geometric mean hemagglutination inhibition titers to three different influenza viruses
Measured: Day 0, Day 7, and Day 45
T-cell Responses
Number of Interferon gamma ELISPOT spot forming cells (SFC) per million Peripheral Blood Mononuclear Cells (PBMCs) were calculated.
Measured: Day 0, Day 7, and Day 45
Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation
Mean absolute numbers of CD4(+), Carboxyfluorescein succinimidyl ester [CFSE(low)] IFN-gamma(+), and T cells after activation with a specific antigen measured by flow cytometry
Measured: Day 0, Day 7, and Day 45
Secretory Immunoglobulin A (IgA) Responses
Influenza virus strain-specific nasal wash secretory immunoglobulin A (IgA) titers by ELISA was measured
Measured: Day 0 and Day 45
Hemagglutinin Immunoglobulin A (IgA) Responses
Hemagglutinin (HA) specific nasal wash secretory immunoglobulin A (IgA) of serum reactivity with HA bound to ELISA plates.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start24 Feb 2011
- Primary completion13 May 2011
- Study completion9 Nov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to one of two different groups to receive either licensed inactivated influenza vaccine (IIV) or licensed live attenuated influenza vaccine (LAIV) from the 2010-2011 season.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Collaborators
- MedImmune LLC
- Responsible party
- Principal investigator, Daniel Hoft, MD, PhD, St. Louis University
- Investigators
- Daniel F Hoft, MD, PhD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101462
- Sponsor's protocol ID
- 16354
- Status last verified
- Nov 2018
- First submitted
- 23 Mar 2017
- Last updated
- 6 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoft DF, Lottenbach KR, Blazevic A, Turan A, Blevins TP, Pacatte TP, Yu Y, Mitchell MC, Hoft SG, Belshe RB. Comparisons of the Humoral and Cellular Immune Responses Induced by Live Attenuated Influenza Vaccine and Inactivated Influenza Vaccine in Adults. Clin Vaccine Immunol. 2017 Jan 5;24(1):e00414-16. doi: 10.1128/CVI.00414-16. Print 2017 Jan.
PubMed 27847366
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Study to Evaluate the Immunogenicity of One Dose of Live Attenuated Influenza Vaccine (LAIV) Compared to One Dose of Trivalent Inactivated Influenza Vaccine (IIV) in Adults 18-49 Years of Age
- ClinicalTrials.gov ID
- NCT03101462
- Acronym / sponsor ID
- 16354
- Conditions
- Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Collaborators
- MedImmune LLC
- Study start
- 24 Feb 2011 (actual)
- Primary completion
- 13 May 2011 (actual)
- Study completion
- 9 Nov 2011 (actual)
- First posted
- 5 Apr 2017 (actual)
- Results
- Posted 6 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, open-label, single-site study at Saint Louis University will enroll approximately 40 subjects who are healthy, 18 to 49 years old. Subjects will be randomized in a 1:1 fashion to receive either licensed trivalent FluMist containing (2010-2011 season appropriate), or licensed inactivated trivalent influenza vaccine (2010-2011 season appropriate) so that approximately 20 subjects will be randomized to receive LAIV, and 20 will receive IIV.
Detailed description
This Phase IV, randomized, open-label, single-site study at Saint Louis University will enroll approximately 40 subjects who are healthy, 18 to 49 years old. Subjects will be randomized in a 1:1 fashion to receive either licensed inactivated influenza vaccine (IIV) (2010-2011 season appropriate) or licensed live attenuated influenza vaccine (LAIV) (2010-2011 season appropriate) so that approximately 20 subjects will be randomized to receive IIV, and 20 will receive LAIV. Subjects will receive 1 dose of IIV or LAIV in the Center for Vaccine Development on Day 0 and will return to the site on days 7 and 45 to assess immunogenicity. Subjects will be asked to report any serious adverse events. Blood samples and nasal washes for assessment of immune responses will be obtained at three time points: on Day 0 prior to dosing with IIV or LAIV, and at visits conducted 7 and 45-51 days post vaccination. The study will be conducted just prior to and during the influenza season. Subjects will receive a single dose of IIV or LAIV administered as instructed per package insert. Two contacts will be made with subjects, either telephone calls or e-mail, to collect serious adverse events only, one at Days 28-35, and one at approximately Days 180-190 to conclude the subject's participation. The duration of each subject's participation is approximately 6 months. The primary immune studies conducted with collected samples will include serum hemagglutinin inhibition (HAI) antibody titers, nasal wash influenza-specific secretory immunoglobulin A (IgA) responses, peripheral blood interferon gamma (IFN-γ) ELISPOT assays and peripheral blood carboxyfluorescein succinimidyl ester (CFSE) dilution/intracellular cytokine staining flow cytometric assays. In addition, frozen serum and peripheral blood mononuclear cells (PBMC) samples will be used in exploratory assays to determine the kinetics and nature of innate responses and the detailed molecular signatures of memory T cells induced by IIV and LAIV vaccinations. Investigators will be performing genome-wide expression studies, but will not perform DNA sequencing and will not send anything other than coded samples outside of Saint Louis University.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomized to one of two different groups to receive either licensed inactivated influenza vaccine (IIV) or licensed live attenuated influenza vaccine (LAIV) from the 2010-2011 season.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Biological: Inactivated Influenza VaccineOne dose of 0.5 mL Licensed Inactivated Influenza Vaccine (IIV) on Day 0 |
| Group 2 | Active comparator | Biological: Live Attenuated Influenza VaccineOne dose of 0.5 mL Licensed Live Attenuated Influenza Vaccine (LAIV) on Day 0 |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female age 18 to 49 years, inclusive, on the day of randomization (reached his or her 18th year birthday but not yet reached his or her 50th year birthday) at the time of the dose of study product
- Written informed consent and a locally required authorization (eg, HIPAA in the USA, ) obtained from the subject prior to performing any protocol-related procedures.
- Females of child-bearing potential, (ie, unless surgically sterile [eg, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy], has sterile male partner, is at least 1 year post-menopausal, or practices abstinence) must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, or use of a condom with spermicide by the sexual partner) for 30 days prior to the first dose of study product, and must agree to continue using such precautions for 60 days after the dose of vaccine due to a potential dose of live vaccine product. In addition, the subject must also have a negative urine or blood pregnancy test at screening and, if screening and Day 0 do not occur on the same day, a negative urine pregnancy test on the day of vaccination prior to randomization. Investigator judgment is required to assess a female subject's capability of pregnancy.
- Are in good health, as determined by vital signs, medical history to ensure any existing medical diagnoses or conditions are stable and not considered clinically significant by physician investigator, and targeted physical examination based on medical history.
- Able to complete follow-up period of 180 days post dose of vaccine as required by the protocol
Key exclusion criteria (16 listed)
- Have an acute illness, including an oral temperature ≥ 100.4°F, within 3 days prior to vaccination.
- Participated in an investigational influenza vaccine study or had a known infection with "flu" since 2007 (confirmed by laboratory culture, including subtype of the influenza A virus (H1N1) investigational vaccines or illness).
- Previous vaccination against influenza in 2007, 2008, 2009 or 2010 with seasonal trivalent live or inactivated influenza vaccine (including H1N1 vaccines).
- Current or expected receipt of immunosuppressive medications (inhaled and topical corticosteroids are permitted) including corticosteroids (≥ 20 mg/day of prednisone equivalent given daily or on alternate days for ≥ 14 days) within a 30 day window around dose of study vaccine product Note: topical corticosteroids for uncomplicated dermatitis may be used throughout the study according to the judgment of the investigator; topical calcineurin inhibitors may be used in accordance with their package insert at entry and during study participation.
- Receipt of immunoglobulin or blood products within 90 days before randomization into the study or expected receipt during study participation
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 |
|---|---|---|
| Inactivated Influenza VaccineAlso: IIV | Biological | Group 1 |
| Live Attenuated Influenza VaccineAlso: LAIV | Biological | Group 2 |
Primary outcome
Serum Antibody Responses
Time frame: Day 0, Day 7, and Day 45
Geometric mean hemagglutination inhibition titers to three different influenza viruses
T-cell Responses
Time frame: Day 0, Day 7, and Day 45
Number of Interferon gamma ELISPOT spot forming cells (SFC) per million Peripheral Blood Mononuclear Cells (PBMCs) were calculated.
Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation
Time frame: Day 0, Day 7, and Day 45
Mean absolute numbers of CD4(+), Carboxyfluorescein succinimidyl ester [CFSE(low)] IFN-gamma(+), and T cells after activation with a specific antigen measured by flow cytometry
Secretory Immunoglobulin A (IgA) Responses
Time frame: Day 0 and Day 45
Influenza virus strain-specific nasal wash secretory immunoglobulin A (IgA) titers by ELISA was measured
Hemagglutinin Immunoglobulin A (IgA) Responses
Time frame: Day 7
Hemagglutinin (HA) specific nasal wash secretory immunoglobulin A (IgA) of serum reactivity with HA bound to ELISA plates.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27847366Hoft DF, Lottenbach KR, Blazevic A, Turan A, Blevins TP, Pacatte TP, Yu Y, Mitchell MC, Hoft SG, Belshe RB. Comparisons of the Humoral and Cellular Immune Responses Induced by Live Attenuated Influenza Vaccine and Inactivated Influenza Vaccine in Adults. Clin Vaccine Immunol. 2017 Jan 5;24(1):e00414-16. doi: 10.1128/CVI.00414-16. Print 2017 Jan.
- Individual participant dataSharing planned: No
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.
Daniel F Hoft, MD, PhD principal investigator
St. Louis University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inactivated Influenza Vaccine and Live Attenuated Influenza Vaccine in people with Influenza, run by St. Louis University.
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 16 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 6 Mar 2019. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 6 Mar 2019). 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?
Serum Antibody Responses (time frame: Day 0, Day 7, and Day 45). The study lists 5 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 NCT03101462, 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 6 Mar 2019.