Comparison of Three Licensed Influenza Vaccines

NCT03068949 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 59331272201400005C-P00019-9999-4
• Study Type: interventional
• Target: 413
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate in detail the way that the immune system responds to three different kinds of flu shots that are licensed in the United States.

Conditions

Influenza

Outcome Measures

Primary Outcomes (10)

• Mean Change of HAI Serum Antibody Titers to A/California/07/09 (H1N1)

  Mean change of HAI serum antibody titers to A/California/07/09 (H1N1) using serum hemagglutination-inhibition (HAI) assay.

  Day 0 to Day 28

• Mean Change of HAI Serum Antibody Titers to A/Michigan/45/2015 (H1N1)

  Mean Change of HAI Serum Antibody Titers to A/Michigan/45/2015 (H1N1) using serum hemagglutination-inhibition (HAI) assay.

  Day 0 to Day 28

• Mean Change of HAI Serum Antibody Titers to A/Switzerland/9715293/13 (H3N2)

  Mean Change of HAI Serum Antibody Titers to A/Switzerland/9715293/13 (H3N2)

  Day 0 to Day 28

• Mean Change of MN Serum Antibody Titers to A/California/07/09 (H1N1)

  Mean Change of MN Serum Antibody Titers to A/California/07/09 (H1N1) using Microneutralization (MN) assay.

  Day 0 to Day 28

• Mean Change of MN Serum Antibody Titers to A/Michigan/45/2015 (H1N1)

  Mean Change of MN Serum Antibody Titers to A/Michigan/45/2015 (H1N1) using Microneutralization (MN) assay.

  Day 0 to Day 28

• Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From pH1N1 HA

  Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from pH1N1 HA using cytokine Elispot

  Day 0 to Day 14

• Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From H3 HA

  Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from H3 HA using cytokine Elispot

  Day 0 to Day 14

• Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From Influenza B HA

  Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from influenza B HA using cytokine Elispot.

  Day 0 to Day 14

• Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From NP

  Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from NP using cytokine Elispot.

  Day 0 to Day 14

• Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From M1

  Mean change in CD4 T cells reactivity to pools of total pHA peptides derived from M1 using cytokine Elispot.

  Day 0 to Day 14

Study Arms (4)

FluBlok

ACTIVE COMPARATOR

FluBlok 0.5 mL given IM X1

Biological: FluBlok

Fluzone

ACTIVE COMPARATOR

Fluzone 0.5 mL given IM X1

Biological: Fluzone

FluCelVax

ACTIVE COMPARATOR

FluCelVax 0.5 mL given IM X 1

Biological: FluCelVax

Fluzone HD

ACTIVE COMPARATOR

Fluzone HD 0.5 mL given IM X1

Biological: Fluzone HD

Interventions

FluBlok BIOLOGICAL

FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly

FluBlok

Fluzone BIOLOGICAL

Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly

Fluzone

FluCelVax BIOLOGICAL

FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly

FluCelVax

Fluzone HD BIOLOGICAL

Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly

Fluzone HD

Eligibility Criteria

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

You may qualify if:

• Aged between 18 and 49 years of age (inclusive).
• Female subjects must fulfill one of the following: (i) not able to bear children because she has been surgically sterilized (tubal ligation or hysterectomy) or (ii) agrees to practice effective methods of contraception that may include, but are not limited to abstinence, barrier methods, monogamous relationship with vasectomized partner, birth control pills, patches, hormonal shots or hormonal implants, NuvaRing and IUDs (intrauterine devices), from 30 days prior to study enrollment through 30 days following receipt of the last dose of vaccine.
• Female subjects of childbearing potential must have a negative pregnancy test (urine or serum) within 24 hours prior to vaccination.
• The subject must be in good health, as determined by: vital signs (heart rate \>55 to \<100 bpm; blood pressure: systolic ≥ 90 mm Hg and ≤150 mm Hg; diastolic ≤ 90 mm Hg; oral temperature \<100.0ºF); medical history; and targeted physical examination, when necessary, based on medical history. Stable medical condition is defined as: no recent increase in prescription medication, dose, or frequency of medication in the last 3 months and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months.
• The subject is able to understand and comply with the planned study procedures, including being available for all study visits.
• The subject has provided informed consent prior to any study procedures.
• Subjects who have not received seasonal flu vaccine for the current year.

You may not qualify if:

• Subject report of known hypersensitivity to allergy to components of the study vaccine or other components of the study vaccine.
• Subject report of known latex allergy
• Subject report of a history of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines.
• Subject report of a history of Guillain-Barre syndrome within 6 weeks of receipt of a previous influenza vaccine.
• The subject is a woman who is pregnant or breastfeeding or intends to become pregnant during the study period between enrollment and 30 days following receipt of vaccine.
• The subject is immunosuppressed as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.
• The subject has an active neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematological malignancy. For this criterion, "active" is defined as having received treatment within the past 5 years.
• The subject has long-term (greater than 2 weeks) use of oral or parenteral steroids, or high-dose inhaled steroids (\>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed).
• The subject received immunoglobulin or another blood product within the 3 months prior to enrollment in this study.
• The subject has received an inactivated vaccine within the 2 weeks or a live vaccine within the 4 weeks prior to enrollment in this study or plans to receive another vaccine within the next 28 days.
• The subject has an acute or chronic medical condition that, in the opinion of the investigator or appropriate sub-investigator, would render vaccination unsafe or would interfere with the evaluation of responses. These conditions include any acute or chronic medical disease or conditions defined as persisting for 3 months (defines ad 90 days) or longer, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses of the subject's successful completion of the study.
• Subjects with an active infection or that has an acute illness or an oral temperature greater than 99.9F (37.7C) within 3 days prior to enrollment or vaccination. Subjects who had an acute illness that was treated symptoms resolved are eligible to enroll as long as treatment is completed and symptoms resolved \> 3 days prior to enrollment.
• The subject is currently participating or plans to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication) or has received an experimental agent within 1 month prior to enrollment in this study, or expects to receive another experimental agent during participation in this study, or intends to donate blood during the study period.
• The subject has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
• Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years.

Sponsors & Collaborators

• University of Rochester: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Rochester Medical Center, Vaccine Research Unit Room 3-5000

Rochester, New York, 14642, United States

Location

Related Publications (1)

• Gouma S, Zost SJ, Parkhouse K, Branche A, Topham DJ, Cobey S, Hensley SE. Comparison of Human H3N2 Antibody Responses Elicited by Egg-Based, Cell-Based, and Recombinant Protein-Based Influenza Vaccines During the 2017-2018 Season. Clin Infect Dis. 2020 Sep 12;71(6):1447-1453. doi: 10.1093/cid/ciz996.

  PMID: 31598646 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

FluBlok; 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: Dr. Angela Branche
• Organization: University of Rochester

angela_branche@urmc.rochester.edu

5852750526

Study Officials

• Angela Branche, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: March 3, 2017
• Study Start: October 28, 2015
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2021
• Last Updated: November 30, 2021
• Results First Posted: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12 months
• Access Criteria: Broad Access

Locations

US (1)