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Completed

NCT Number: NCT05874713

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

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.

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Key information

Conditions

Influenza, Human Infection Viral Infections Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cullman Clinical Trials, Cullman, Alabama, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

aH5N8c on Day 1

Biological

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)

aH5N6c on Day 1

Biological

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)

aH5N8c on Day 22

Biological

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)

aH5N6c on Day 22

Biological

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)

aH5N8c on Day 202

Biological

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 outcomes

  1. Geometric mean titer (GMT) of hemagglutination inhibition (HI) antibodies against H5N8 strain - Day 1

    Time frame: Day 1

    GMT (HI) prevaccination

  2. GMT of HI antibodies against H5N8 strain - Day 22

    Time frame: Day 22

    GMT (HI) 3 weeks post first priming vaccination

  3. GMT of HI antibodies against H5N8 strain - Day 43

    Time frame: Day 43

    GMT (HI) 3 weeks post second priming vaccination

  4. GMT of HI antibodies against H5N8 strain - Day 202

    Time frame: Day 202

    GMT (HI) pre booster vaccination

  5. GMT of HI antibodies against H5N8 strain - Day 209

    Time frame: Day 209

    GMT (HI) 1 week post booster vaccination

  6. GMT of HI antibodies against H5N8 strain - Day 223

    Time frame: Day 223

    GMT (HI) 3 weeks post booster vaccination

  7. GMT of HI antibodies against H5N6 strain - Day 1

    Time frame: Day 1

    GMT (HI) prevaccination

  8. GMT of HI antibodies against H5N6 strain - Day 22

    Time frame: Day 22

    GMT (HI) 3 weeks post first priming vaccination

  9. GMT of HI antibodies against H5N6 strain - Day 43

    Time frame: Day 43

    GMT (HI) 3 weeks post second priming vaccination

  10. GMT of HI antibodies against H5N6 strain - Day 202

    Time frame: Day 202

    GMT (HI) pre booster vaccination

  11. GMT of HI antibodies against H5N6 strain - Day 223

    Time frame: Day 223

    GMT (HI) 3 weeks post booster vaccination

  12. Geometric mean fold increase (GMFI) of HI antibodies against H5N8 strain - Day 22

    Time frame: Day 22

    GMFI (HI) 3 weeks post first priming vaccination compared to prevaccination

  13. GMFI of HI antibodies against H5N8 strain - Day 43

    Time frame: Day 43

    GMFI (HI) 3 weeks post second priming vaccination compared to prevaccination

  14. GMFI of HI antibodies against H5N8 strain - Day 209

    Time frame: Day 209

    GMFI (HI) 1 week post booster vaccination compared to pre booster vaccination

  15. GMFI of HI antibodies against H5N8 strain - Day 223

    Time frame: Day 223

    GMFI (HI) 3 weeks post booster vaccination compared to pre booster vaccination

  16. GMFI of HI antibodies against H5N6 strain - Day 22

    Time frame: Day 22

    GMFI (HI) 3 weeks post first priming vaccination compared to prevaccination

  17. GMFI of HI antibodies against H5N6 strain - Day 43

    Time frame: Day 43

    GMFI (HI) 3 weeks post second priming vaccination compared to prevaccination

  18. GMFI of HI antibodies against H5N6 strain - Day 223

    Time frame: Day 223

    GMFI (HI) 3 weeks post booster vaccination compared to pre booster vaccination

  19. Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 1

    Time frame: Day 1

    % ≥1:40 (HI) prevaccination

  20. Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 22

    Time frame: Day 22

    % ≥1:40 (HI) 3 weeks post first priming vaccination

  21. Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 43

    Time frame: Day 43

    % ≥1:40 (HI) 3 weeks post second priming vaccination

  22. Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 209

    Time frame: Day 209

    % ≥1:40 (HI) 1 week post booster vaccination

  23. Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Day 223

    Time frame: Day 223

    % ≥1:40 (HI) 3 weeks post booster vaccination

  24. Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 1

    Time frame: Day 1

    % ≥1:40 (HI) prevaccination

  25. Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 22

    Time frame: Day 22

    % ≥1:40 (HI) 3 weeks post first priming vaccination

  26. Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 43

    Time frame: Day 43

    % ≥1:40 (HI) 3 weeks post second priming vaccination

  27. Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Day 223

    Time frame: Day 223

    % ≥1:40 (HI) 3 weeks post booster vaccination

  28. Percentages of subjects with seroconversion by HI against H5N8 strain - Day 22

    Time frame: 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

  29. Percentages of subjects with seroconversion by HI against H5N8 strain - Day 43

    Time frame: 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

  30. Percentages of subjects with seroconversion by HI against H5N8 strain - Day 209

    Time frame: 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

  31. Percentages of subjects with seroconversion by HI against H5N8 strain - Day 223

    Time frame: 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

  32. Percentages of subjects with seroconversion by HI against H5N6 strain - Day 22

    Time frame: 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

  33. Percentages of subjects with seroconversion by HI against H5N6 strain - Day 43

    Time frame: 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

  34. Percentages of subjects with seroconversion by HI against H5N6 strain - Day 223

    Time frame: 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 outcomes

  1. Frequency and severity of solicited local and systemic adverse events (AEs)

    Time frame: Day 1 through Day 7, Day 22 through Day 28, and Day 202 through 208

    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).

  2. Frequency and severity of unsolicited AEs

    Time frame: Day 1 through Day 43 and Day 202 through Day 223

    For 3 weeks following each vaccination

  3. Frequency and severity of serious AEs (SAEs), AEs leading to withdrawal, AEs of special interest (AESI), and medically attended AEs (MAAEs)

    Time frame: Day 1 through Day 382

    From first vaccination until study completion

  4. GMT of HI antibodies against H5N8 strain - Persistence

    Time frame: Day 202, Day 382

    GMT (HI) 6 months post 2nd priming vaccination and 6 months post booster vaccination

  5. GMT of HI antibodies against H5N6 strain - Persistence

    Time frame: Day 202

    GMT (HI) 6 months post 2nd priming vaccination

  6. GMFI of HI antibodies against H5N8 strain - Persistence

    Time frame: Day 202, Day 382

    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)

  7. GMFI of HI antibodies against H5N6 strain - Persistence

    Time frame: Day 202

    GMFI (HI) 6 months post 2nd priming vaccination compared to prevaccination

  8. Percentages of subjects with HI titers ≥1:40 against H5N8 strain - Persistence

    Time frame: Day 202, Day 382

    % ≥1:40 (HI) 6 months post 2nd priming vaccination and 6 months post booster vaccination

  9. Percentages of subjects with HI titers ≥1:40 against H5N6 strain - Persistence

    Time frame: Day 202

    % ≥1:40 (HI) 6 months post 2nd priming vaccination

  10. Percentages of subjects with seroconversion by HI against H5N8 strain - Persistence

    Time frame: Day 202, Day 382

    % 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

  11. Percentages of subjects with seroconversion by HI against H5N6 strain - Persistence

    Time frame: Day 202

    % 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

  12. GMT of microneutralization (MN) antibodies against H5N8 strain

    Time frame: Day 1, Day 22, Day 43, Day 202, Day 223

    GMT (MN) prevaccination, 3 weeks post priming vaccinations, pre booster vaccination and 3 weeks post booster vaccination

  13. GMT of MN antibodies against H5N6 strain

    Time frame: Day 1, Day 43, Day 202, Day 223

    GMT (MN) prevaccination, 3 weeks post 2nd priming vaccination, pre booster vaccination and 3 weeks post booster vaccination

  14. GMFI of MN antibodies against H5N8 strain

    Time frame: Day 22, Day 43, Day 202, Day 223

    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)

  15. GMFI of MN antibodies against H5N6 strain

    Time frame: Day 43, Day 202, Day 223

    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)

  16. Percentages of subjects with MN titers ≥1:40 against H5N8 strain

    Time frame: Day 1, Day 22, Day 43, Day 202, Day 223

    % ≥1:40 (MN) prevaccination, 3 weeks post priming vaccinations, pre booster vaccination, and 3 weeks post booster vaccination

  17. Percentages of subjects with MN titers ≥1:40 against H5N6 strain

    Time frame: Day 1, Day 43, Day 202, Day 223

    % ≥1:40 (MN) prevaccination, 3 weeks post 2nd priming vaccination, pre booster vaccination, and 3 weeks post booster vaccination

  18. Percentages of subjects with seroconversion by MN against H5N8 strain

    Time frame: Day 22, Day 43, Day 202, Day 209, Day 223

    % 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

  19. Percentages of subjects with seroconversion by MN against H5N6 strain

    Time frame: Day 43, Day 202, Day 209, Day 223

    % 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

Sponsors and collaborators

Lead sponsor

Seqirus

Industry

Collaborators

  • Biomedical Advanced Research and Development Authority

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 25, 2023
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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