Durability and Impact of the Seasonal Influenza Vaccine on H5 Induced B Cell Response

NCT03701061 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: IRB00100804U19AI090023
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a prospective single site exploratory study to examine the impact of Food and Drug Administration (FDA) approved seasonal flu vaccine on the immune responses of H5N1 vaccine previously received with or without the AS03 adjuvant.

Conditions

Influenza A Subtype H5N1 Infection

Keywords

Immune response

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Four-fold Increase in Stem-specific Antibody Titers (H5, Hemagglutinin Antibody) Against H5N1 at Day 29 After Vaccination With the Seasonal Influenza Vaccine Among All the Participants in Both Arms

  Antibody Titers (hemagglutinin inhibition antibody titers) are measured through immunologic assays from blood draw at Baseline (Day1) before study vaccination and are repeated on Day 29. Participants with four fold increase in titer levels will be recorded.

  Baseline (Day 1) before vaccination and Day 29 post vaccination

Secondary Outcomes (3)

• Number of Solicited (AE's) Grade 2 and Above at Day 8 After Vaccination With the Seasonal Influenza Vaccine Among the Participants in Both Arms

  up to Day 8 post vaccination

• Number of Unsolicited Adverse Events (AE's) Grade 2 and Above at Day 29 After Vaccination With the Seasonal Influenza Vaccine Among the Participants in Both Arms

  Up to Day 29 post vaccination

• Number of Serious Adverse Events at Day 365 Among the Participants in Both Arms

  Up to 365 days post vaccination

Study Arms (2)

Participants that received AS03 Adjuvant

EXPERIMENTAL

Subjects that participated in HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine with AS03 Adjuvant study are included in the study. Subjects will receive a single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent).

Biological: Seasonal Influenza Vaccine

Participants that did not receive AS03 Adjuvant

ACTIVE COMPARATOR

Subjects that participated in HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine without AS03 Adjuvant study are included in the study. Subjects will receive a single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent).

Biological: Seasonal Influenza Vaccine

Interventions

Seasonal Influenza Vaccine BIOLOGICAL

A single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent) will be administered to the subjects participated in HIPCVAX-010 Study

Also known as: Fluarix Quadrivalent

Participants that received AS03 Adjuvant

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participated in HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine with and without AS03 Adjuvant study.
• Capable of informed consent and provision of written informed consent before any study procedures.
• Capable of attending all study visits according to the study schedule.
• Are in good health, as determined by medical history and targeted physical exam related to this history.
• Female subjects of childbearing age must have a negative urine pregnancy test before study vaccination, and must use at least one form of contraception to avoid pregnancy for 28 days before and 28 days after Fluarix Quadrivalent administration.

You may not qualify if:

• Have an acute illness, including any fever (\> 100.4 F \[\> 38 degrees C\], regardless of the route) within 72 hours before vaccination.
• Have any acute or chronic medical condition that, in the opinion of the principal investigator, would make vaccination unsafe or interfere with the evaluation of immune response to study vaccination.
• Alcohol or drug abuse and psychiatric conditions that, in the opinion of the investigator, would preclude compliance with the trial or interpretation of safety or endpoint data.
• Have a suppressed immune system as a result of illness, immunosuppressive medication, chemotherapy, or radiation therapy within 3 years prior to study vaccination.
• Are pregnant or breastfeeding or plan to within one month of vaccination.
• Have taken oral or parenteral corticosteroids of any dose within 28 days before study vaccination.
• Have a known history of autoimmune disease.
• Have a history of Guillain-Barre Syndrome.
• Have a history of bleeding disorders.
• Have known hypersensitivity or allergy to any component of the vaccine, including egg and latex allergies, or history of anaphylaxis with influenza vaccine or vaccine component.
• Have received blood or blood products 3 months prior to study entry or expected to receive through 6 months after study entry.
• Have received any live virus vaccines within 4 weeks prior to study entry or expected receipt within 4 weeks after study entry.
• Have received any inactivated vaccine within 2 weeks or expected receipt within 2 weeks after study entry.
• Have received any experimental agents within 6 weeks prior to study or plan to through study duration.
• Have received the 2018-2019 influenza seasonal vaccine.

Sponsors & Collaborators

• Emory University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

The Hope Clinic of Emory University

Decatur, Georgia, 30030, United States

Location

Results Point of Contact

• Title: Nadine Rouphael
• Organization: Emory University

nroupha@emory.edu

404-712-1435

Study Officials

• Nadine Rouphael, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Prospective, Exploratory study with up to 50 subjects total, who previously participated in the HIPCVAX-010 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine with and without AS03 Adjuvant study

Study Record Dates

• First Submitted: October 6, 2018
• First Posted: October 9, 2018
• Study Start: October 11, 2018
• Primary Completion: February 28, 2019
• Study Completion: January 31, 2020
• Last Updated: March 11, 2020
• Results First Posted: March 11, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)