Clinical trial NCT05422326: 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
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2022-06-16
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Geometric Mean Titer (GMT) of hemagglutination inhibition (HI) antibodies against H5N6 strain
timeFrame: Day 1, Day 8, Day 22, Day 43
measure: Geometric Mean Fold Increase (GMFI) of HI antibodies against H5N6 strain
timeFrame: Day 1, Day 8, Day 22, Day 43
measure: Percentage of subjects with HI titers ≥1:40 against H5N6 strain
timeFrame: Day 1, Day 8, Day 22, Day 43
measure: Percentage of subjects with seroconversion against H5N6 strain
timeFrame: Day 8, Day 22, Day 43
Secondary outcomes:
measure: GMT of HI antibodies against H5N1 strain
timeFrame: Day 1, Day 8, Day 22, Day 43, Day 202
measure: GMFI of HI antibodies against H5N1 strain
timeFrame: Day 1, Day 8, Day 22, Day 43, Day 202
measure: Percentage of subjects with HI titers ≥1:40 against H5N1 strain
timeFrame: Day 1, Day 8, Day 22, Day 43, Day 202
measure: Percentage of subjects with seroconversion against H5N1 strain
timeFrame: Day 8, Day 22, Day 43, Day 202
measure: GMT of HI antibodies against H5N6 strain
timeFrame: Day 202
measure: GMFI of HI antibodies against H5N6 strain
timeFrame: Day 1, Day 202
measure: Percentage of subjects with HI titers ≥1:40 against H5N6 strain
timeFrame: Day 202
measure: Percentage of subjects with seroconversion against H5N6 strain
timeFrame: Day 202
measure: Frequency and severity of solicited local and systemic adverse events (AEs)
timeFrame: Day 1 through Day 7 and Day 22 through Day 28
measure: Frequency and severity of unsolicited AEs
timeFrame: Day 1 through Day 43
measure: Frequency and severity of serious AEs (SAEs), AEs leading to withdrawal, AEs of special interest (AESI) and medically attended AEs (MAAEs)
timeFrame: Day 1 through Day 202
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Optimal Research, LLC
state: Alabama
city: Tempe
country: United States
facility: Clinical Research Consortium Arizona
state: Arizona
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: Milford
country: United States
facility: Clinical Research Consulting, LLC
state: Connecticut
city: Clearwater
country: United States
facility: Innovative Research of West Florida, Inc.
state: Florida
city: Melbourne
country: United States
facility: Optimal Research, LLC
state: Florida
city: Chicago
country: United States
facility: Great Lakes Clinical Trials LLC
state: Illinois
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research, LLC
state: Missouri
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc
state: New York
city: Raleigh
country: United States
facility: PMG Research of Raleigh
state: North Carolina
city: Winston-Salem
country: United States
facility: AccellaCare
state: North Carolina
city: Columbus
country: United States
facility: Aventiv Research
state: Ohio
city: San Antonio
country: United States
facility: Biogenics Research Institute
state: Texas
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc/Foothill Family Clinic North
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc/Foothill Family Clinic South
state: Utah
city: South Jordan
country: United States
facility: J. Lewis Research, Inc/Jordan River Family Medicine
state: Utah
Study officials:
affiliation: Seqirus
name: Therapeutic Area Head
role: STUDY_CHAIR
References: