Live Attenuated Influenza Vaccine (LAIV) Versus Trivalent Inactivated Influenza Vaccine in Healthy Adults 18-49 Years

NCT03101462 | Completed Phase 4 Results DMC

• 1 other identifier: 16354
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief 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 influenza vaccine (2010-2011 season appropriate) so that approximately 20 subjects will be randomized to receive LAIV, and 20 will receive IIV.

Conditions

Influenza

Outcome Measures

Primary Outcomes (5)

• Serum Antibody Responses

  Geometric mean hemagglutination inhibition titers to three different influenza viruses

  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.

  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

  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

  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.

  Day 7

Study Arms (2)

Group 1

ACTIVE COMPARATOR

One dose of 0.5 mL Licensed Inactivated Influenza Vaccine (IIV) on Day 0

Biological: Inactivated Influenza Vaccine

Group 2

ACTIVE COMPARATOR

One dose of 0.5 mL Licensed Live Attenuated Influenza Vaccine (LAIV) on Day 0

Biological: Live Attenuated Influenza Vaccine

Interventions

Inactivated Influenza Vaccine BIOLOGICAL

Also known as: IIV

Group 1

Live Attenuated Influenza Vaccine BIOLOGICAL

Also known as: LAIV

Group 2

Eligibility Criteria

• Age: 18 Years - 49 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• St. Louis University: lead
• MedImmune LLC: collaborator

Related Publications (1)

• 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.

  PMID: 27847366 BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Daniel F. Hoft, MD, PhD
• Organization: Saint Louis University

daniel.hoft@health.slu.edu

314-977-5500

Study Officials

• Daniel F Hoft, MD, PhD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Infectious Diseases, Allergy & Immunology

Model Details: 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.

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: April 5, 2017
• Study Start: February 24, 2011
• Primary Completion: May 13, 2011
• Study Completion: November 9, 2011
• Last Updated: March 6, 2019
• Results First Posted: March 6, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share