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

NCT05422326 | Completed Phase 2 FDA Drug

• 1 other identifier: V89_18E1
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 18

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

  Day 1, Day 8, Day 22, Day 43

• 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)

  Day 1, Day 8, Day 22, Day 43

• 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

  Day 1, Day 8, Day 22, Day 43

• 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

  Day 8, Day 22, Day 43

Secondary Outcomes (11)

• GMT of HI antibodies against H5N1 strain

  Day 1, Day 8, Day 22, Day 43, Day 202

• GMFI of HI antibodies against H5N1 strain

  Day 1, Day 8, Day 22, Day 43, Day 202

• Percentage of subjects with HI titers ≥1:40 against H5N1 strain

  Day 1, Day 8, Day 22, Day 43, Day 202

• Percentage of subjects with seroconversion against H5N1 strain

  Day 8, Day 22, Day 43, Day 202

• GMT of HI antibodies against H5N6 strain

  Day 202

Study Arms (3)

Group 1

EXPERIMENTAL

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

Biological: aH5N6c on Day 1; Biological: aH5N6c on Day 22

Group 2

EXPERIMENTAL

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

Biological: aH5N6c on Day 1; Biological: Placebo on Day 22

Group 3

EXPERIMENTAL

Eligible subjects who received placebo in the parent study V89\_18 receive two aH5N6c vaccinations, 3 weeks apart.

Biological: aH5N6c on Day 1; Biological: aH5N6c on Day 22

Interventions

aH5N6c on Day 1 BIOLOGICAL

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)

Group 1; Group 2; Group 3

aH5N6c on Day 22 BIOLOGICAL

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

Group 1; Group 3

Placebo on Day 22 BIOLOGICAL

Saline placebo (sterile, 0.5 mL) given 3 weeks after the aH5N6c vaccination

Group 2

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seqirus: lead

Study Sites (18)

Optimal Research, LLC

Huntsville, Alabama, 35802, United States

Location

Clinical Research Consortium Arizona

Tempe, Arizona, 85283, United States

Location

California Research Foundation

San Diego, California, 92103, United States

Location

Clinical Research Consulting, LLC

Milford, Connecticut, 06460, United States

Location

Innovative Research of West Florida, Inc.

Clearwater, Florida, 33756, United States

Location

Optimal Research, LLC

Melbourne, Florida, 32934, United States

Location

Great Lakes Clinical Trials LLC

Chicago, Illinois, 60640, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Location

The Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

Sundance Clinical Research, LLC

St Louis, Missouri, 63141, United States

Location

Rochester Clinical Research, Inc

Rochester, New York, 14609, United States

Location

PMG Research of Raleigh

Raleigh, North Carolina, 27609, United States

Location

AccellaCare

Winston-Salem, North Carolina, 27103, United States

Location

Aventiv Research

Columbus, Ohio, 43213, United States

Location

Biogenics Research Institute

San Antonio, Texas, 78229, United States

Location

J. Lewis Research, Inc/Foothill Family Clinic North

Salt Lake City, Utah, 84109, United States

Location

J. Lewis Research, Inc/Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States

Location

J. Lewis Research, Inc/Jordan River Family Medicine

South Jordan, Utah, 84095, United States

Location

MeSH Terms

Conditions

Influenza, Human; Influenza in Birds; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Condition Hierarchy (Ancestors)

Bird Diseases; Animal Diseases

Study Officials

• Therapeutic Area Head

  Seqirus

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 16, 2022
• Study Start: July 18, 2022
• Primary Completion: October 24, 2022
• Study Completion: March 24, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-08

Locations

US (18)