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Study to Evaluate Safety and Immunogenicity of Different Priming and Booster Regimens With Adjuvanted H5N8 and/or H5N6 Influenza Vaccine in Adults

Primary Purpose

Influenza, Human, Infections, Respiratory Tract Infections

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aH5N8c on Day 1
aH5N6c on Day 1
aH5N8c on Day 22
aH5N6c on Day 22
aH5N8c on Day 202
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, Vaccine, MF59, Adjuvant, H5N8, H5N6, Pandemic, Avian

Eligibility Criteria

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

Inclusion Criteria: Individuals of ≥18 years of age on the day of informed consent. Individuals who or whose legally acceptable representative(s) have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. Individuals who can comply with study procedures including follow-up. Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method which they intend to use for at least 30 days before the first study vaccination and plan to do so until 2 months after the last study vaccination. Individuals must provide a baseline blood sample prior to randomization and vaccination. 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 2 months 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 resulting from: Clinical conditions. Systemic administration of corticosteroids at a dose ≥20 mg/day of prednisone (or equivalent) for more than 14 consecutive days within 90 days prior to informed consent. Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent. History of any medical condition considered an AESI. Received immunoglobulins with immunomodulating effects or any blood products within 180 days prior to informed consent. Individuals who previously received an H5 influenza vaccine or have a known history of H5 influenza infection prior to enrollment. Received an investigational or non-registered medicinal product within 30 days prior to informed consent or are unwilling to refuse participation in another clinical study at any time during the conduct of this study. Study personnel or immediate family or household member of study personnel. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the individual due to participation in the study. Individuals who received any other vaccines (with the exception of COVID-19 vaccines) within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from any of the 3 scheduled study vaccinations. Receipt of any (investigational or licensed) COVID-19 vaccine within 14 days (non-replicating vaccines) or 28 days (replicating vaccines) prior to enrollment or plan to receive any COVID-19 vaccine within 7 days from any of the 3 scheduled study vaccinations. A known history of Guillain-Barre Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis.

Sites / Locations

  • Cullman Clinical Trials
  • Lifeline Primary Care
  • Georgia Clinic
  • Velocity Clinical Research
  • Meridian Clinical Research
  • Meridian Clinical Research
  • Meridian Clinical Research
  • Medical Care LLC
  • Cope Family Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm A

Arm B

Arm C

Arm Description

Eligible subjects who have been randomized to receive aH5N8c on Day 1, Day 22 and Day 202

Eligible subjects who have been randomized to receive aH5N8c on Day 1, aH5N6c on Day 22, and aH5N8c on Day 202

Eligible subjects who have been randomized to receive aH5N6c on Day 1 and aH5N8c on Day 22 and Day 202

Outcomes

Primary Outcome Measures

Geometric mean titer (GMT) of hemagglutination inhibition (HI) antibodies against H5N8 strain - Day 1
GMT (HI) prevaccination
GMT of HI antibodies against H5N8 strain - Day 22
GMT (HI) 3 weeks post first priming vaccination
GMT of HI antibodies against H5N8 strain - Day 43
GMT (HI) 3 weeks post second priming vaccination
GMT of HI antibodies against H5N8 strain - Day 202
GMT (HI) pre booster vaccination
GMT of HI antibodies against H5N8 strain - Day 209
GMT (HI) 1 week post booster vaccination
GMT of HI antibodies against H5N8 strain - Day 223
GMT (HI) 3 weeks post booster vaccination
GMT of HI antibodies against H5N6 strain - Day 1
GMT (HI) prevaccination
GMT of HI antibodies against H5N6 strain - Day 22
GMT (HI) 3 weeks post first priming vaccination
GMT of HI antibodies against H5N6 strain - Day 43
GMT (HI) 3 weeks post second priming vaccination
GMT of HI antibodies against H5N6 strain - Day 202
GMT (HI) pre booster vaccination
GMT of HI antibodies against H5N6 strain - Day 223
GMT (HI) 3 weeks post booster vaccination
Geometric mean fold increase (GMFI) of HI antibodies against H5N8 strain - Day 22
GMFI (HI) 3 weeks post first priming vaccination compared to prevaccination
GMFI of HI antibodies against H5N8 strain - Day 43
GMFI (HI) 3 weeks post second priming vaccination compared to prevaccination
GMFI of HI antibodies against H5N8 strain - Day 209
GMFI (HI) 1 week post booster vaccination compared to pre booster vaccination
GMFI of HI antibodies against H5N8 strain - Day 223
GMFI (HI) 3 weeks post booster vaccination compared to pre booster vaccination
GMFI of HI antibodies against H5N6 strain - Day 22
GMFI (HI) 3 weeks post first priming vaccination compared to prevaccination
GMFI of HI antibodies against H5N6 strain - Day 43
GMFI (HI) 3 weeks post second priming vaccination compared to prevaccination
GMFI of HI antibodies against H5N6 strain - Day 223
GMFI (HI) 3 weeks post booster vaccination compared to pre booster vaccination
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 1
% ≥1:40 (HI) prevaccination
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 22
% ≥1:40 (HI) 3 weeks post first priming vaccination
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 43
% ≥1:40 (HI) 3 weeks post second priming vaccination
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 209
% ≥1:40 (HI) 1 week post booster vaccination
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 223
% ≥1:40 (HI) 3 weeks post booster vaccination
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 1
% ≥1:40 (HI) prevaccination
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 22
% ≥1:40 (HI) 3 weeks post first priming vaccination
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 43
% ≥1:40 (HI) 3 weeks post second priming vaccination
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 223
% ≥1:40 (HI) 3 weeks post booster vaccination
Percentages of subjects with seroconversion by HI against H5N8 strain - Day 22
% seroconversion (HI) 3 weeks post first priming vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with prevaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Percentages of subjects with seroconversion by HI against H5N8 strain - Day 43
% seroconversion (HI) 3 weeks post second priming vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Percentages of subjects with seroconversion by HI against H5N8 strain - Day 209
% seroconversion (HI) 1 week post booster vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Percentages of subjects with seroconversion by HI against H5N8 strain - Day 223
% seroconversion (HI) 3 weeks post booster vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Percentages of subjects with seroconversion by HI against H5N6 strain - Day 22
% seroconversion (HI) 3 weeks post first priming vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Percentages of subjects with seroconversion by HI against H5N6 strain - Day 43
% seroconversion (HI) 3 weeks post second priming vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Percentages of subjects with seroconversion by HI against H5N6 strain - Day 223
% seroconversion (HI) 3 weeks post booster vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10

Secondary Outcome Measures

Frequency and severity of solicited local and systemic adverse events (AEs)
For 7 consecutive days following each vaccination (ie, Day 1 through Day 7, Day 22 through Day 28, and Day 202 through 208, or until symptom resolution if ongoing at Day 7, Day 28 or Day 208 for a maximum of 14 days postvaccination).
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 first vaccination until study completion
GMT of HI antibodies against H5N8 strain - Persistence
GMT (HI) 6 months post 2nd priming vaccination and 6 months post booster vaccination
GMT of HI antibodies against H5N6 strain - Persistence
GMT (HI) 6 months post 2nd priming vaccination
GMFI of HI antibodies against H5N8 strain - Persistence
GMFI (HI) 6 months post 2nd priming vaccination compared to prevaccination (Day 1), and 6 months post booster vaccination compared to prevaccination (Day 1) and compared to pre booster vaccination (Day 202)
GMFI of HI antibodies against H5N6 strain - Persistence
GMFI (HI) 6 months post 2nd priming vaccination compared to prevaccination
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Persistence
% ≥1:40 (HI) 6 months post 2nd priming vaccination and 6 months post booster vaccination
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Persistence
% ≥1:40 (HI) 6 months post 2nd priming vaccination
Percentages of subjects with seroconversion by HI against H5N8 strain - Persistence
% seroconversion (HI) 6 months post 2nd priming vaccination and 6 months post booster vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Percentages of subjects with seroconversion by HI against H5N6 strain - Persistence
% seroconversion (HI) 6 months post 2nd priming vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
GMT of microneutralization (MN) antibodies against H5N8 strain
GMT (MN) prevaccination, 3 weeks post priming vaccinations, pre booster vaccination and 3 weeks post booster vaccination
GMT of MN antibodies against H5N6 strain
GMT (MN) prevaccination, 3 weeks post 2nd priming vaccination, pre booster vaccination and 3 weeks post booster vaccination
GMFI of MN antibodies against H5N8 strain
GMFI (MN) 3 weeks post priming vaccinations and 6 months post 2nd priming vaccination compared to prevaccination (Day 1), and 3 weeks post booster vaccination compared to pre booster vaccination (Day 202)
GMFI of MN antibodies against H5N6 strain
GMFI (MN) 3 weeks and 6 months post 2nd priming vaccination compared to prevaccination (Day 1), and 3 weeks post booster vaccination compared to pre booster vaccination (Day 202)
Percentages of subjects with MN titers ≥1:40 against H5N8 strain
% ≥1:40 (MN) prevaccination, 3 weeks post priming vaccinations, pre booster vaccination, and 3 weeks post booster vaccination
Percentages of subjects with MN titers ≥1:40 against H5N6 strain
% ≥1:40 (MN) prevaccination, 3 weeks post 2nd priming vaccination, pre booster vaccination, and 3 weeks post booster vaccination
Percentages of subjects with seroconversion by MN against H5N8 strain
% seroconversion (MN) 3 weeks post priming vaccinations, pre booster vaccination, and 3 weeks post booster vaccination, defined as a ≥4-fold increase in MN titer postvaccination for subjects with prevaccination titer ≥lower limit of quantification (LLOQ), or a postvaccination MN titer ≥4×LLOQ for subjects with prevaccination titer <LLOQ
Percentages of subjects with seroconversion by MN against H5N6 strain
% seroconversion (MN) 3 weeks post 2nd priming vaccination, pre booster vaccination, and 3 weeks post booster vaccination, defined as a ≥4-fold increase in MN titer postvaccination for subjects with prevaccination titer ≥lower limit of quantification (LLOQ), or a postvaccination MN titer ≥4×LLOQ for subjects with prevaccination titer <LLOQ

Full Information

First Posted
May 4, 2023
Last Updated
August 24, 2023
Sponsor
Seqirus
Collaborators
Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT05874713
Brief Title
Study to Evaluate Safety and Immunogenicity of Different Priming and Booster Regimens With Adjuvanted H5N8 and/or H5N6 Influenza Vaccine in Adults
Official Title
A Phase 2, Multi-Center, Randomized, Observer-Blind Study, to Evaluate Safety and Immunogenicity of Homologous or Heterologous Priming and Booster Vaccinations With H5N8 or H5N6 MF59-adjuvanted, Cell Culture-derived Influenza Vaccine in Healthy Subjects ≥18 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 7, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seqirus
Collaborators
Department of Health and Human Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This Phase 2, randomized, observer-blind clinical study is evaluating 3 different priming and booster regimens with MF59-adjuvanted H5N8 and/or H5N6 cell culture-derived influenza vaccine (aH5N8c; aH5N6c). Approximately 480 healthy adult subjects are to be randomized into 1 of 3 possible treatment groups, stratified by age group (18-64 years and ≥65 years) and by poultry worker status (yes/no). Each subject will receive a priming influenza vaccine injection on Day 1 and Day 22 and a booster vaccination on Day 202. Subjects will be followed up for approximately 6 months after the booster injection. The primary immunogenicity analysis is based on antibody responses against H5N8 and H5N6 as measured by hemagglutination inhibition (HI) assay on Day 1, Day 22, Day 29, Day 43, Day 202, Day 209 (H5N8 only), and Day 223.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human, Infections, Respiratory Tract Infections, Virus Diseases, Infection Viral
Keywords
Influenza, Vaccine, MF59, Adjuvant, H5N8, H5N6, Pandemic, Avian

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Eligible subjects are randomized in a 2:1:1 ratio to Treatment Arm A, B, or C, respectively, and will receive two priming doses of the allocated aH5N8c/aH5N6c vaccine 3 weeks apart, ie, at Day 1 and Day 22, and a booster dose of aH5N8c vaccine at Day 202.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
480 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Eligible subjects who have been randomized to receive aH5N8c on Day 1, Day 22 and Day 202
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Eligible subjects who have been randomized to receive aH5N8c on Day 1, aH5N6c on Day 22, and aH5N8c on Day 202
Arm Title
Arm C
Arm Type
Experimental
Arm Description
Eligible subjects who have been randomized to receive aH5N6c on Day 1 and aH5N8c on Day 22 and Day 202
Intervention Type
Biological
Intervention Name(s)
aH5N8c on Day 1
Intervention Description
MF59-adjuvanted cell-culture derived subunit inactivated monovalent A/H5N8 vaccine (aH5N8c) for intramuscular administration, containing intermediate dose H5N8 hemagglutinin + standard dose MF59 (approximately 0.5 mL total volume)
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 administration, containing intermediate dose H5N6 hemagglutinin + standard dose MF59 (approximately 0.5 mL total volume)
Intervention Type
Biological
Intervention Name(s)
aH5N8c on Day 22
Intervention Description
MF59-adjuvanted cell-culture derived subunit inactivated monovalent A/H5N8 vaccine (aH5N8c) for intramuscular administration, containing intermediate dose H5N8 hemagglutinin + standard dose 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 administration, containing intermediate dose H5N6 hemagglutinin + standard dose MF59 (approximately 0.5 mL total volume)
Intervention Type
Biological
Intervention Name(s)
aH5N8c on Day 202
Intervention Description
MF59-adjuvanted cell-culture derived subunit inactivated monovalent A/H5N8 vaccine (aH5N8c) for intramuscular administration, containing intermediate dose H5N8 hemagglutinin + standard dose MF59 (approximately 0.5 mL total volume)
Primary Outcome Measure Information:
Title
Geometric mean titer (GMT) of hemagglutination inhibition (HI) antibodies against H5N8 strain - Day 1
Description
GMT (HI) prevaccination
Time Frame
Day 1
Title
GMT of HI antibodies against H5N8 strain - Day 22
Description
GMT (HI) 3 weeks post first priming vaccination
Time Frame
Day 22
Title
GMT of HI antibodies against H5N8 strain - Day 43
Description
GMT (HI) 3 weeks post second priming vaccination
Time Frame
Day 43
Title
GMT of HI antibodies against H5N8 strain - Day 202
Description
GMT (HI) pre booster vaccination
Time Frame
Day 202
Title
GMT of HI antibodies against H5N8 strain - Day 209
Description
GMT (HI) 1 week post booster vaccination
Time Frame
Day 209
Title
GMT of HI antibodies against H5N8 strain - Day 223
Description
GMT (HI) 3 weeks post booster vaccination
Time Frame
Day 223
Title
GMT of HI antibodies against H5N6 strain - Day 1
Description
GMT (HI) prevaccination
Time Frame
Day 1
Title
GMT of HI antibodies against H5N6 strain - Day 22
Description
GMT (HI) 3 weeks post first priming vaccination
Time Frame
Day 22
Title
GMT of HI antibodies against H5N6 strain - Day 43
Description
GMT (HI) 3 weeks post second priming vaccination
Time Frame
Day 43
Title
GMT of HI antibodies against H5N6 strain - Day 202
Description
GMT (HI) pre booster vaccination
Time Frame
Day 202
Title
GMT of HI antibodies against H5N6 strain - Day 223
Description
GMT (HI) 3 weeks post booster vaccination
Time Frame
Day 223
Title
Geometric mean fold increase (GMFI) of HI antibodies against H5N8 strain - Day 22
Description
GMFI (HI) 3 weeks post first priming vaccination compared to prevaccination
Time Frame
Day 22
Title
GMFI of HI antibodies against H5N8 strain - Day 43
Description
GMFI (HI) 3 weeks post second priming vaccination compared to prevaccination
Time Frame
Day 43
Title
GMFI of HI antibodies against H5N8 strain - Day 209
Description
GMFI (HI) 1 week post booster vaccination compared to pre booster vaccination
Time Frame
Day 209
Title
GMFI of HI antibodies against H5N8 strain - Day 223
Description
GMFI (HI) 3 weeks post booster vaccination compared to pre booster vaccination
Time Frame
Day 223
Title
GMFI of HI antibodies against H5N6 strain - Day 22
Description
GMFI (HI) 3 weeks post first priming vaccination compared to prevaccination
Time Frame
Day 22
Title
GMFI of HI antibodies against H5N6 strain - Day 43
Description
GMFI (HI) 3 weeks post second priming vaccination compared to prevaccination
Time Frame
Day 43
Title
GMFI of HI antibodies against H5N6 strain - Day 223
Description
GMFI (HI) 3 weeks post booster vaccination compared to pre booster vaccination
Time Frame
Day 223
Title
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 1
Description
% ≥1:40 (HI) prevaccination
Time Frame
Day 1
Title
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 22
Description
% ≥1:40 (HI) 3 weeks post first priming vaccination
Time Frame
Day 22
Title
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 43
Description
% ≥1:40 (HI) 3 weeks post second priming vaccination
Time Frame
Day 43
Title
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 209
Description
% ≥1:40 (HI) 1 week post booster vaccination
Time Frame
Day 209
Title
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 223
Description
% ≥1:40 (HI) 3 weeks post booster vaccination
Time Frame
Day 223
Title
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 1
Description
% ≥1:40 (HI) prevaccination
Time Frame
Day 1
Title
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 22
Description
% ≥1:40 (HI) 3 weeks post first priming vaccination
Time Frame
Day 22
Title
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 43
Description
% ≥1:40 (HI) 3 weeks post second priming vaccination
Time Frame
Day 43
Title
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 223
Description
% ≥1:40 (HI) 3 weeks post booster vaccination
Time Frame
Day 223
Title
Percentages of subjects with seroconversion by HI against H5N8 strain - Day 22
Description
% seroconversion (HI) 3 weeks post first priming vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with prevaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Time Frame
Day 22
Title
Percentages of subjects with seroconversion by HI against H5N8 strain - Day 43
Description
% seroconversion (HI) 3 weeks post second priming vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Time Frame
Day 43
Title
Percentages of subjects with seroconversion by HI against H5N8 strain - Day 209
Description
% seroconversion (HI) 1 week post booster vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Time Frame
Day 209
Title
Percentages of subjects with seroconversion by HI against H5N8 strain - Day 223
Description
% seroconversion (HI) 3 weeks post booster vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Time Frame
Day 223
Title
Percentages of subjects with seroconversion by HI against H5N6 strain - Day 22
Description
% seroconversion (HI) 3 weeks post first priming vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Time Frame
Day 22
Title
Percentages of subjects with seroconversion by HI against H5N6 strain - Day 43
Description
% seroconversion (HI) 3 weeks post second priming vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Time Frame
Day 43
Title
Percentages of subjects with seroconversion by HI against H5N6 strain - Day 223
Description
% seroconversion (HI) 3 weeks post booster vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Time Frame
Day 223
Secondary Outcome Measure Information:
Title
Frequency and severity of solicited local and systemic adverse events (AEs)
Description
For 7 consecutive days following each vaccination (ie, Day 1 through Day 7, Day 22 through Day 28, and Day 202 through 208, or until symptom resolution if ongoing at Day 7, Day 28 or Day 208 for a maximum of 14 days postvaccination).
Time Frame
Day 1 through Day 7, Day 22 through Day 28, and Day 202 through 208
Title
Frequency and severity of unsolicited AEs
Description
For 3 weeks following each vaccination
Time Frame
Day 1 through Day 43 and Day 202 through Day 223
Title
Frequency and severity of serious AEs (SAEs), AEs leading to withdrawal, AEs of special interest (AESI), and medically attended AEs (MAAEs)
Description
From first vaccination until study completion
Time Frame
Day 1 through Day 382
Title
GMT of HI antibodies against H5N8 strain - Persistence
Description
GMT (HI) 6 months post 2nd priming vaccination and 6 months post booster vaccination
Time Frame
Day 202, Day 382
Title
GMT of HI antibodies against H5N6 strain - Persistence
Description
GMT (HI) 6 months post 2nd priming vaccination
Time Frame
Day 202
Title
GMFI of HI antibodies against H5N8 strain - Persistence
Description
GMFI (HI) 6 months post 2nd priming vaccination compared to prevaccination (Day 1), and 6 months post booster vaccination compared to prevaccination (Day 1) and compared to pre booster vaccination (Day 202)
Time Frame
Day 202, Day 382
Title
GMFI of HI antibodies against H5N6 strain - Persistence
Description
GMFI (HI) 6 months post 2nd priming vaccination compared to prevaccination
Time Frame
Day 202
Title
Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Persistence
Description
% ≥1:40 (HI) 6 months post 2nd priming vaccination and 6 months post booster vaccination
Time Frame
Day 202, Day 382
Title
Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Persistence
Description
% ≥1:40 (HI) 6 months post 2nd priming vaccination
Time Frame
Day 202
Title
Percentages of subjects with seroconversion by HI against H5N8 strain - Persistence
Description
% seroconversion (HI) 6 months post 2nd priming vaccination and 6 months post booster vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Time Frame
Day 202, Day 382
Title
Percentages of subjects with seroconversion by HI against H5N6 strain - Persistence
Description
% seroconversion (HI) 6 months post 2nd priming vaccination, defined as a ≥4-fold increase in HI titer postvaccination in those with pre-vaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with prevaccination titer <1:10
Time Frame
Day 202
Title
GMT of microneutralization (MN) antibodies against H5N8 strain
Description
GMT (MN) prevaccination, 3 weeks post priming vaccinations, pre booster vaccination and 3 weeks post booster vaccination
Time Frame
Day 1, Day 22, Day 43, Day 202, Day 223
Title
GMT of MN antibodies against H5N6 strain
Description
GMT (MN) prevaccination, 3 weeks post 2nd priming vaccination, pre booster vaccination and 3 weeks post booster vaccination
Time Frame
Day 1, Day 43, Day 202, Day 223
Title
GMFI of MN antibodies against H5N8 strain
Description
GMFI (MN) 3 weeks post priming vaccinations and 6 months post 2nd priming vaccination compared to prevaccination (Day 1), and 3 weeks post booster vaccination compared to pre booster vaccination (Day 202)
Time Frame
Day 22, Day 43, Day 202, Day 223
Title
GMFI of MN antibodies against H5N6 strain
Description
GMFI (MN) 3 weeks and 6 months post 2nd priming vaccination compared to prevaccination (Day 1), and 3 weeks post booster vaccination compared to pre booster vaccination (Day 202)
Time Frame
Day 43, Day 202, Day 223
Title
Percentages of subjects with MN titers ≥1:40 against H5N8 strain
Description
% ≥1:40 (MN) prevaccination, 3 weeks post priming vaccinations, pre booster vaccination, and 3 weeks post booster vaccination
Time Frame
Day 1, Day 22, Day 43, Day 202, Day 223
Title
Percentages of subjects with MN titers ≥1:40 against H5N6 strain
Description
% ≥1:40 (MN) prevaccination, 3 weeks post 2nd priming vaccination, pre booster vaccination, and 3 weeks post booster vaccination
Time Frame
Day 1, Day 43, Day 202, Day 223
Title
Percentages of subjects with seroconversion by MN against H5N8 strain
Description
% seroconversion (MN) 3 weeks post priming vaccinations, pre booster vaccination, and 3 weeks post booster vaccination, defined as a ≥4-fold increase in MN titer postvaccination for subjects with prevaccination titer ≥lower limit of quantification (LLOQ), or a postvaccination MN titer ≥4×LLOQ for subjects with prevaccination titer <LLOQ
Time Frame
Day 22, Day 43, Day 202, Day 209, Day 223
Title
Percentages of subjects with seroconversion by MN against H5N6 strain
Description
% seroconversion (MN) 3 weeks post 2nd priming vaccination, pre booster vaccination, and 3 weeks post booster vaccination, defined as a ≥4-fold increase in MN titer postvaccination for subjects with prevaccination titer ≥lower limit of quantification (LLOQ), or a postvaccination MN titer ≥4×LLOQ for subjects with prevaccination titer <LLOQ
Time Frame
Day 43, Day 202, Day 209, Day 223

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals of ≥18 years of age on the day of informed consent. Individuals who or whose legally acceptable representative(s) have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. Individuals who can comply with study procedures including follow-up. Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method which they intend to use for at least 30 days before the first study vaccination and plan to do so until 2 months after the last study vaccination. Individuals must provide a baseline blood sample prior to randomization and vaccination. 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 2 months 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 resulting from: Clinical conditions. Systemic administration of corticosteroids at a dose ≥20 mg/day of prednisone (or equivalent) for more than 14 consecutive days within 90 days prior to informed consent. Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent. History of any medical condition considered an AESI. Received immunoglobulins with immunomodulating effects or any blood products within 180 days prior to informed consent. Individuals who previously received an H5 influenza vaccine or have a known history of H5 influenza infection prior to enrollment. Received an investigational or non-registered medicinal product within 30 days prior to informed consent or are unwilling to refuse participation in another clinical study at any time during the conduct of this study. Study personnel or immediate family or household member of study personnel. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the individual due to participation in the study. Individuals who received any other vaccines (with the exception of COVID-19 vaccines) within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from any of the 3 scheduled study vaccinations. Receipt of any (investigational or licensed) COVID-19 vaccine within 14 days (non-replicating vaccines) or 28 days (replicating vaccines) prior to enrollment or plan to receive any COVID-19 vaccine within 7 days from any of the 3 scheduled study vaccinations. 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
Cullman Clinical Trials
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35055
Country
United States
Facility Name
Lifeline Primary Care
City
Lilburn
State/Province
Georgia
ZIP/Postal Code
30047
Country
United States
Facility Name
Georgia Clinic
City
Norcross
State/Province
Georgia
ZIP/Postal Code
30092
Country
United States
Facility Name
Velocity Clinical Research
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51106
Country
United States
Facility Name
Meridian Clinical Research
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Meridian Clinical Research
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
Meridian Clinical Research
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Facility Name
Medical Care LLC
City
Elizabethton
State/Province
Tennessee
ZIP/Postal Code
37643
Country
United States
Facility Name
Cope Family Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84010
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Study to Evaluate Safety and Immunogenicity of Different Priming and Booster Regimens With Adjuvanted H5N8 and/or H5N6 Influenza Vaccine in Adults

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