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Comparison of Three Licensed Influenza Vaccines

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ClinicalTrials.gov Identifier: NCT03068949
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : March 3, 2017
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
John Treanor, University of Rochester

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.

Condition or disease Intervention/treatment Phase
Influenza Biological: FluBlok Biological: Fluzone Biological: FluCelVax Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Comparison of CD4 T Cell Induction and Antibody Responses Between a Pure Hemagglutinin Influenza Vaccine (rHA, Protein Sciences Corp) and Licensed Subvirion Influenza Vaccine Made in Eggs (Sanofi) or Cell Culture (Novartis) in Healthy Adults.
Actual Study Start Date : October 28, 2015
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: FluBlok Biological: FluBlok
FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly
Active Comparator: Fluzone Biological: Fluzone
Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly
Active Comparator: FluCelVax Biological: FluCelVax
FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly



Primary Outcome Measures :
  1. The percent increase of CD4 cells per mL of blood. [ Time Frame: Baseline to Day 7 ]
    CD4 T cell reactivity to pools of unique, conserved, and total pHA peptides derived from the pH1N1 HA (hemagglutinin) , as well as H3, influenza B HA, NP (neuraminidase), and M1 peptides will be quantified using cytokine Elispot. The number of CD4 cells will be correlated with the antibody titer as measured by HAI.

  2. The percent increase of CD4 cells per mL of Blood. [ Time Frame: Baseline to Day 7 ]
    CD4 T cell reactivity to pools of unique, conserved, and total pHA peptides derived from the pH1N1 HA, as well as H3, influenza B HA, NP, and M1 peptides will be quantified using flow cytometry assays.


Secondary Outcome Measures :
  1. Change in Serum HAI antibody defined as the highest dilution resulting in complete inhibition of hemagglutination [ Time Frame: Baseline to Day 7 ]
    This is an exploratory objective: Serum hemagglutination-inhibition (HAI). HAI will be performed in microtiter format using turkey RBCs (red blood cells) and egg-grown, betapropriolactone-inactivated A/California/07/09 virus as antigen. The titer of antibody will be defined as the highest dilution resulting in complete inhibition of hemagglutination. Sera will be treated with receptor-destroying enzyme and heat inactivated prior to testing at an initial starting dilution of 1:4. Sera with no detectable HAI titer will be assigned a titer of 1:2 for calculation purposes. Serum antibody titers will be correlated with CD4 cells measured by ELISPOT.

  2. Number of participants with increased antibody specificity of cloned plasmablasts [ Time Frame: Day 7 to Day 28 ]
    This is an exploratory objective: Peripheral Blood Mononuclear Cells (PBMC) will be obtained before and on day 7 and 28 after vaccine and evaluated for B-cell responses. B cell responses will be evaluated by memory cell assay.

  3. Ratio of B cells reactive with the HA stalk versus the globular head. [ Time Frame: Day 7 to Day 28 ]
    This is an exploratory objective: Peripheral Blood Mononuclear Cells (PBMC) will be obtained before and on day 7 and 28 after vaccine and evaluated for B-cell responses. B cell responses will be evaluated by antibody secreting cell assay.

  4. Number of participants with increased RNA transcripts [ Time Frame: Baseline to Day 3 ]
    This is an exploratory objective: Whole blood will be collected in PaxGene tubes and the early innate response will be assessed by RNASeq analysis of the transcriptome.



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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Aged between 18 and 49 years of age (inclusive).
  2. 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.
  3. Female subjects of childbearing potential must have a negative pregnancy test (urine or serum) within 24 hours prior to vaccination.
  4. 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.
  5. The subject is able to understand and comply with the planned study procedures, including being available for all study visits.
  6. The subject has provided informed consent prior to any study procedures.
  7. Subjects who have not received seasonal flu vaccine for the current year.

Exclusion Criteria

  1. Subject report of known hypersensitivity to allergy to components of the study vaccine or other components of the study vaccine.
  2. Subject report of known latex allergy
  3. Subject report of a history of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines.
  4. Subject report of a history of Guillain-Barre syndrome within 6 weeks of receipt of a previous influenza vaccine.
  5. 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.
  6. 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.
  7. 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.
  8. 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).
  9. The subject received immunoglobulin or another blood product within the 3 months prior to enrollment in this study.
  10. 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.
  11. 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.
  12. 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.
  13. 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.
  14. 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.
  15. Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years.
  16. The subject has a diagnosis of schizophrenia, bi-polar disease, or other severe (disabling) chronic psychiatric diagnosis, or is receiving psychiatric drugs. Subjects who are receiving a single antidepressant drug and are stable for at least 3 months prior to enrollment without decompensation are allowed enrollment into the study.
  17. The subject has a history of alcohol or drug abuse in the 5 years prior to enrollment.
  18. The subject has a known human immunodeficiency virus, hepatitis B, or hepatitis C infection.
  19. The subject has any condition that the principal investigator (PI) believes may interfere with successful completion of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068949


Contacts
Contact: Doreen M. Francis, R.N. 585-275-3473 doreen_francis@urmc.rochester.edu

Locations
United States, New York
University of Rochester Medical Center, Vaccine Research Unit Room 3-5000 Recruiting
Rochester, New York, United States, 14642
Contact: John J. Treanor, MD    585-275-5871    john_treanor@urmc.rochester.edu   
Principal Investigator: John J. Treanor, MD         
Sponsors and Collaborators
University of Rochester
National Institutes of Health (NIH)

Responsible Party: John Treanor, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT03068949     History of Changes
Other Study ID Numbers: 59331
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared with the CEIRS (Centers of Excellence for Influenza Research and Surveillance) network

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs