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A Study to Evaluate Safety and Immunogenicity of One or Two Booster Vaccinations With H5N6 Influenza Vaccine in Adults Primed With H5N1 Influenza Vaccine or Unprimed

Primary Purpose

Influenza, Human, Influenza in Birds, Respiratory Tract Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aH5N6c on Day 1
aH5N6c on Day 22
Placebo on Day 22
Sponsored by
Seqirus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza, Human focused on measuring Influenza, Pandemic, Vaccine, H5N1, H5N6, Flu, MF59, Avian

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects who received 2 doses of aH5N1c vaccine or placebo in and completed the parent study V89_18 in the <65 years of age cohort.
  • Individuals who can comply with study procedures including follow-up.

Exclusion Criteria:

  • Females of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of contraceptive methods from at least 30 days prior to study entry and who do not plan to do so until at least 30 days after the last study vaccination.
  • Progressive, unstable or uncontrolled clinical conditions.
  • Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
  • Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
  • Abnormal function of the immune system.
  • History of any medical condition considered an adverse event of special interest (AESI).
  • Received immunoglobulins with immunomodulating effects or any blood products within 180 days prior to informed consent.
  • Subjects, who received an influenza H5 vaccine other than in the V89_18 parent study or have a history of H5 influenza infection prior to enrollment.
  • Received an investigational or non-registered medicinal product within 30 days prior to informed consent.
  • Individuals who received any other vaccines [except corona virus disease 2019 (COVID-19) vaccines] within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 28 days from the study vaccination.
  • Receipt of any COVID-19 vaccine within 7 days prior to enrollment or plan to receive any COVID-19 vaccine within 7 days from study vaccination.
  • Acute (severe) febrile illness.
  • A known history of Guillain-Barre Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis.

Sites / Locations

  • Optimal Research, LLC
  • Clinical Research Consortium Arizona
  • California Research Foundation
  • Clinical Research Consulting, LLC
  • Innovative Research of West Florida, Inc.
  • Optimal Research, LLC
  • Great Lakes Clinical Trials LLC
  • Heartland Research Associates, LLC
  • The Center for Pharmaceutical Research
  • Sundance Clinical Research, LLC
  • Rochester Clinical Research, Inc
  • PMG Research of Raleigh
  • AccellaCare
  • Aventiv Research
  • Biogenics Research Institute
  • J. Lewis Research, Inc/Foothill Family Clinic North
  • J. Lewis Research, Inc/Foothill Family Clinic South
  • J. Lewis Research, Inc/Jordan River Family Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 and have been randomized to receive two aH5N6c vaccinations, 3 weeks apart

Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 and have been randomized to receive an aH5N6c vaccination on Day 1 and saline placebo on Day 22

Eligible subjects who received placebo in the parent study V89_18 receive two aH5N6c vaccinations, 3 weeks apart.

Outcomes

Primary Outcome Measures

Geometric Mean Titer (GMT) of hemagglutination inhibition (HI) antibodies against H5N6 strain
GMT pre-vaccination, 1 and 3 weeks post-vaccination 1, and 3 weeks post-vaccination 2
Geometric Mean Fold Increase (GMFI) of HI antibodies against H5N6 strain
GMFI 1 and 3 weeks post-vaccination 1, and 3 weeks post-vaccination 2 compared to pre-vaccination (Day 1)
Percentage of subjects with HI titers ≥1:40 against H5N6 strain
Pre-vaccination, 1 and 3 weeks post-vaccination 1, and 3 weeks post-vaccination 2
Percentage of subjects with seroconversion against H5N6 strain
Seroconversion 1 and 3 weeks post-vaccination 1, and 3 weeks post-vaccination 2, defined as a ≥4-fold increase in HI titer post-vaccination in those with pre-vaccination titer ≥1:10, or a post-vaccination HI titer ≥1:40 for subjects with baseline titer <1:10

Secondary Outcome Measures

GMT of HI antibodies against H5N1 strain
GMT pre-vaccination, 1 and 3 weeks post-vaccination 1, and 3 weeks and 6 months post-vaccination 2
GMFI of HI antibodies against H5N1 strain
GMFI 1 and 3 weeks post-vaccination 1, and 3 weeks and 6 months post-vaccination 2 compared to pre-vaccination (Day 1)
Percentage of subjects with HI titers ≥1:40 against H5N1 strain
Pre-vaccination, 1 and 3 weeks post-vaccination 1, and 3 weeks and 6 months post-vaccination 2
Percentage of subjects with seroconversion against H5N1 strain
Seroconversion 1 and 3 weeks post-vaccination 1, and 3 weeks and 6 months post-vaccination 2, defined as a ≥4-fold increase in HI titer post-vaccination in those with pre-vaccination titer ≥1:10, or a post-vaccination HI titer ≥1:40 for subjects with baseline titer <1:10
GMT of HI antibodies against H5N6 strain
GMT 6 months post-vaccination 2
GMFI of HI antibodies against H5N6 strain
GMFI 6 months post-vaccination 2 compared to pre-vaccination (Day 1)
Percentage of subjects with HI titers ≥1:40 against H5N6 strain
6 months post-vaccination 2
Percentage of subjects with seroconversion against H5N6 strain
Seroconversion 6 months post-vaccination 2, defined as a ≥4-fold increase in HI titer post-vaccination in those with pre-vaccination titer ≥1:10, or a post-vaccination HI titer ≥1:40 for subjects with baseline titer <1:10
Frequency and severity of solicited local and systemic adverse events (AEs)
For 7 days following each vaccination
Frequency and severity of unsolicited AEs
For 3 weeks following each vaccination
Frequency and severity of serious AEs (SAEs), AEs leading to withdrawal, AEs of special interest (AESI) and medically attended AEs (MAAEs)
From vaccination until study completion

Full Information

First Posted
June 14, 2022
Last Updated
August 1, 2023
Sponsor
Seqirus
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1. Study Identification

Unique Protocol Identification Number
NCT05422326
Brief Title
A Study to Evaluate Safety and Immunogenicity of One or Two Booster Vaccinations With H5N6 Influenza Vaccine in Adults Primed With H5N1 Influenza Vaccine or Unprimed
Official Title
A Phase 2, Randomized, Study to Evaluate Safety and Immunogenicity of One or Two Heterologous Booster Vaccinations With an MF59-adjuvanted, Cell Culture-derived H5N6 Influenza Vaccine in Adults Primed With MF59-adjuvanted, Cell Culture-derived H5N1 Influenza Vaccine or Unprimed
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 18, 2022 (Actual)
Primary Completion Date
October 24, 2022 (Actual)
Study Completion Date
March 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seqirus

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a Phase 2, randomized, multi-center study in approximately 300 adults who received 2 doses of aH5N1c or placebo in and completed the parent study V89_18 in the <65 years of age cohort. The study investigates whether two priming doses of MF59-adjuvanted H5N1 cell culture-derived vaccine (aH5N1c) followed by one or two booster vaccinations with a MF59-adjuvanted H5N6 cell culture derived vaccine (aH5N6c) 3 weeks apart elicit immune responses to the antigens used for priming (H5N1) and boosting (H5N6) after first and second heterologous booster vaccination. Eligible subjects, who received 2 doses of aH5N1c in the parent study V89_18 are randomized in a 1:1 ratio to receive either two aH5N6c vaccinations, 3 weeks apart (group 1) or an aH5N6c vaccination on Day 1 and saline placebo on Day 22 (group 2). Eligible subjects, who received placebo in the parent study will receive two aH5N6c vaccinations, 3 weeks apart (group 3). After the second vaccine administration, subjects are monitored for approximately 6 months for safety and antibody persistence. The total study duration will be approximately 7 months per subject.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human, Influenza in Birds, Respiratory Tract Infections, Infections, Orthomyxoviridae Infections, RNA Virus Infections, Virus Diseases, Respiratory Tract Diseases
Keywords
Influenza, Pandemic, Vaccine, H5N1, H5N6, Flu, MF59, Avian

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Eligible subjects, who received 2 doses of aH5N1c in the parent study V89_18 are randomized in a 1:1 ratio to group 1 (two aH5N6c vaccinations, 3 weeks apart) or group 2 (aH5N6c vaccination and placebo, 3 weeks apart). Eligible subjects, who received placebo in the parent study are allocated to group 3 (two aH5N6c vaccinations, 3 weeks apart).
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 and have been randomized to receive two aH5N6c vaccinations, 3 weeks apart
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 and have been randomized to receive an aH5N6c vaccination on Day 1 and saline placebo on Day 22
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Eligible subjects who received placebo in the parent study V89_18 receive two aH5N6c vaccinations, 3 weeks apart.
Intervention Type
Biological
Intervention Name(s)
aH5N6c on Day 1
Intervention Description
MF59-adjuvanted cell-culture derived subunit inactivated monovalent A/H5N6 vaccine (aH5N6c) for intramuscular (IM) administration, containing 7.5 μg H5N6 hemagglutinin (HA) (A/Guangdong/18SF020/2018 (H5N6)-like) + 0.25 mL MF59 (approximately 0.5 mL total volume)
Intervention Type
Biological
Intervention Name(s)
aH5N6c on Day 22
Intervention Description
MF59-adjuvanted cell-culture derived subunit inactivated monovalent A/H5N6 vaccine (aH5N6c) for intramuscular (IM) administration, containing 7.5 μg H5N6 HA (A/Guangdong/18SF020/2018 (H5N6)-like) + 0.25 mL MF59 (approximately 0.5 mL total volume) given 3 weeks after the first aH5N6c vaccination
Intervention Type
Biological
Intervention Name(s)
Placebo on Day 22
Intervention Description
Saline placebo (sterile, 0.5 mL) given 3 weeks after the aH5N6c vaccination
Primary Outcome Measure Information:
Title
Geometric Mean Titer (GMT) of hemagglutination inhibition (HI) antibodies against H5N6 strain
Description
GMT pre-vaccination, 1 and 3 weeks post-vaccination 1, and 3 weeks post-vaccination 2
Time Frame
Day 1, Day 8, Day 22, Day 43
Title
Geometric Mean Fold Increase (GMFI) of HI antibodies against H5N6 strain
Description
GMFI 1 and 3 weeks post-vaccination 1, and 3 weeks post-vaccination 2 compared to pre-vaccination (Day 1)
Time Frame
Day 1, Day 8, Day 22, Day 43
Title
Percentage of subjects with HI titers ≥1:40 against H5N6 strain
Description
Pre-vaccination, 1 and 3 weeks post-vaccination 1, and 3 weeks post-vaccination 2
Time Frame
Day 1, Day 8, Day 22, Day 43
Title
Percentage of subjects with seroconversion against H5N6 strain
Description
Seroconversion 1 and 3 weeks post-vaccination 1, and 3 weeks post-vaccination 2, defined as a ≥4-fold increase in HI titer post-vaccination in those with pre-vaccination titer ≥1:10, or a post-vaccination HI titer ≥1:40 for subjects with baseline titer <1:10
Time Frame
Day 8, Day 22, Day 43
Secondary Outcome Measure Information:
Title
GMT of HI antibodies against H5N1 strain
Description
GMT pre-vaccination, 1 and 3 weeks post-vaccination 1, and 3 weeks and 6 months post-vaccination 2
Time Frame
Day 1, Day 8, Day 22, Day 43, Day 202
Title
GMFI of HI antibodies against H5N1 strain
Description
GMFI 1 and 3 weeks post-vaccination 1, and 3 weeks and 6 months post-vaccination 2 compared to pre-vaccination (Day 1)
Time Frame
Day 1, Day 8, Day 22, Day 43, Day 202
Title
Percentage of subjects with HI titers ≥1:40 against H5N1 strain
Description
Pre-vaccination, 1 and 3 weeks post-vaccination 1, and 3 weeks and 6 months post-vaccination 2
Time Frame
Day 1, Day 8, Day 22, Day 43, Day 202
Title
Percentage of subjects with seroconversion against H5N1 strain
Description
Seroconversion 1 and 3 weeks post-vaccination 1, and 3 weeks and 6 months post-vaccination 2, defined as a ≥4-fold increase in HI titer post-vaccination in those with pre-vaccination titer ≥1:10, or a post-vaccination HI titer ≥1:40 for subjects with baseline titer <1:10
Time Frame
Day 8, Day 22, Day 43, Day 202
Title
GMT of HI antibodies against H5N6 strain
Description
GMT 6 months post-vaccination 2
Time Frame
Day 202
Title
GMFI of HI antibodies against H5N6 strain
Description
GMFI 6 months post-vaccination 2 compared to pre-vaccination (Day 1)
Time Frame
Day 1, Day 202
Title
Percentage of subjects with HI titers ≥1:40 against H5N6 strain
Description
6 months post-vaccination 2
Time Frame
Day 202
Title
Percentage of subjects with seroconversion against H5N6 strain
Description
Seroconversion 6 months post-vaccination 2, defined as a ≥4-fold increase in HI titer post-vaccination in those with pre-vaccination titer ≥1:10, or a post-vaccination HI titer ≥1:40 for subjects with baseline titer <1:10
Time Frame
Day 202
Title
Frequency and severity of solicited local and systemic adverse events (AEs)
Description
For 7 days following each vaccination
Time Frame
Day 1 through Day 7 and Day 22 through Day 28
Title
Frequency and severity of unsolicited AEs
Description
For 3 weeks following each vaccination
Time Frame
Day 1 through Day 43
Title
Frequency and severity of serious AEs (SAEs), AEs leading to withdrawal, AEs of special interest (AESI) and medically attended AEs (MAAEs)
Description
From vaccination until study completion
Time Frame
Day 1 through Day 202

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects who received 2 doses of aH5N1c vaccine or placebo in and completed the parent study V89_18 in the <65 years of age cohort. Individuals who can comply with study procedures including follow-up. Exclusion Criteria: Females of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of contraceptive methods from at least 30 days prior to study entry and who do not plan to do so until at least 30 days after the last study vaccination. Progressive, unstable or uncontrolled clinical conditions. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. Abnormal function of the immune system. History of any medical condition considered an adverse event of special interest (AESI). Received immunoglobulins with immunomodulating effects or any blood products within 180 days prior to informed consent. Subjects, who received an influenza H5 vaccine other than in the V89_18 parent study or have a history of H5 influenza infection prior to enrollment. Received an investigational or non-registered medicinal product within 30 days prior to informed consent. Individuals who received any other vaccines [except corona virus disease 2019 (COVID-19) vaccines] within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 28 days from the study vaccination. Receipt of any COVID-19 vaccine within 7 days prior to enrollment or plan to receive any COVID-19 vaccine within 7 days from study vaccination. Acute (severe) febrile illness. A known history of Guillain-Barre Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Therapeutic Area Head
Organizational Affiliation
Seqirus
Official's Role
Study Chair
Facility Information:
Facility Name
Optimal Research, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35802
Country
United States
Facility Name
Clinical Research Consortium Arizona
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
California Research Foundation
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Clinical Research Consulting, LLC
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
Facility Name
Innovative Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Optimal Research, LLC
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32934
Country
United States
Facility Name
Great Lakes Clinical Trials LLC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
The Center for Pharmaceutical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Sundance Clinical Research, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Rochester Clinical Research, Inc
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
PMG Research of Raleigh
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
AccellaCare
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Aventiv Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Biogenics Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
J. Lewis Research, Inc/Foothill Family Clinic North
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
J. Lewis Research, Inc/Foothill Family Clinic South
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
J. Lewis Research, Inc/Jordan River Family Medicine
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

A Study to Evaluate Safety and Immunogenicity of One or Two Booster Vaccinations With H5N6 Influenza Vaccine in Adults Primed With H5N1 Influenza Vaccine or Unprimed

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