Clinical trial NCT05975840: Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Astrakhan/3212/2020 Like (H5N8) Virus Vaccine With AS03 Adjuvant System in Medically Stable Adults
Official title: A Phase I/II Observer-blind, Randomized, Multi-center Trial to Evaluate the Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Astrakhan/3212/2020 Like (H5N8) Virus Vaccine With AS03 Adjuvant System (Referred to as Q-Pan H5N8), Given as a Two-dose Series to Adults 18 to 64 Years of Age and 65 Years of Age and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Influenza, Human
Keywords: Influenza
Safety
Immunogenicity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2023-08-04
Enrollment: 518
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the safety and immunogenicity of different formulations of monovalent Influenza A/Astrakhan/3212/2020-like virus vaccine with AS03 adjuvant system in adults greater than or equal to (\>=)18 years of age.


Eligibility criteria: Inclusion Criteria:

* Medically stable participants as established by medical history and clinical examination before entering into the study.
* A male or female \>=18 years of age at the time of signing consent form.
* Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study specific procedure.
* Female participants of childbearing potential or non-childbearing potential may be enrolled in the study if specific criteria are met.

Exclusion Criteria:

* Current diagnosis or history of autoimmune disorder(s) except hypothyroidism due to Hashimoto's thyroiditis.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
* Clinically significant acute or chronic pulmonary, cardiovascular, hepatic, or renal disease that appears uncontrolled or untreated, as determined by history or physical examination.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history, physical examination, or abnormalities in screening blood tests.
* Recurrent history of or uncontrolled neurological disorders or seizures.
* History of Guillain-Barré syndrome.
* Diagnosed with cancer, or treatment for cancer within 3 years.

  * Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
  * Persons with a history of histologically confirmed basal cell carcinoma of the skin successfully treated with local excision only, are accepted and are eligible, but other histologic types of skin cancer are exclusionary.
  * Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylaxis are eligible.
* Documented human immunodeficiency virus-positive participants.
* Bedridden participants.
* Personal or family history of narcolepsy.
* Food and Drug Administration (FDA) toxicity Grade 2, or greater, laboratory tests at Screening.
* Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
* Use of any investigational or non-registered product other than the study vaccine during the period beginning 30 days before the first dose of study vaccine (Day -29 to Day 1), or planned use during the entire study period.
* Use of public health emergency vaccines like coronavirus disease 2019 (COVID-19), Monkey pox (mpox) etc. These can be given at any time, but there should a gap of 2 - weeks before a dose of study vaccine can be given.
* Use of any licensed vaccines: prior to receipt of the study vaccine and continuing up to 3 weeks after receiving the dose 2 of study vaccine.
* Administration of long-acting immune-modifying drugs at any time during the study period.
* Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine dose and through the entire study period. For corticosteroids, this will mean prednisone equivalent \>=20 milligrams/day for 14 days or a total of \>=280 mg of prednisone equivalent dose in any 14-day period. Inhaled and topical steroids are allowed.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months after completion of the vaccination series.
* History of/or current drug/alcohol abuse.
* Any study personnel or their immediate dependents, family, or household member.
* Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non investigational vaccine/product.

Primary outcomes:
measure: Hemagglutination-inhibiting (HI) Antibody Titers Against Vaccine-homologous H5N8
timeFrame: At Day 43
measure: Geometric Mean Fold Rise (GMFR) of Serum HI Antibody Titers Against Vaccine-homologous H5N8
timeFrame: At Day 43
measure: Number of Seroprotected (SP) Participants for HI Antibody Titers
timeFrame: At Day 43
measure: Number of Participants Reporting Each Solicited Administration Site Event Following Dose 1
timeFrame: 7 days (Day 1 to Day 7) following dose 1
measure: Number of Participants Reporting Each Solicited Administration Site Event Following Dose 2
timeFrame: 7 days (Day 22 to Day 28) following dose 2
measure: Number of Participants Reporting Each Solicited Systemic Event Following Dose 1
timeFrame: 7 days (Day 1 to Day 7) following dose 1
measure: Number of Participants Reporting Each Solicited Systemic Event Following Dose 2
timeFrame: 7 days (Day 22 to Day 28) following dose 2
measure: Number of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1
timeFrame: 7 days (Day 1 to Day 7) following dose 1
measure: Number of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2
timeFrame: 7 days (Day 22 to Day 28) following dose 2
measure: Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1
timeFrame: 7 days (Day 1 to Day 7) following dose 1
measure: Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2
timeFrame: 7 days (Day 22 to Day 28) following dose 2
measure: Number of Participants Reporting Unsolicited AEs Following Dose 1
timeFrame: 21 days (Day 1 to Day 22) following dose 1
measure: Number of Participants Reporting Unsolicited AEs Following Dose 2
timeFrame: 21 days (Day 22 to Day 43) following dose 2
measure: Number of Participants Reporting Unsolicited Medically Attended Adverse Events (MAEs) Following Dose 1
timeFrame: 21 days (Day 1 to Day 22) following dose 1
measure: Number of Participants Reporting Unsolicited MAEs Following Dose 2
timeFrame: 21 days (Day 22 to Day 43) following dose 2
measure: Number of Participants Reporting Unsolicited MAEs up to 6 Months Post Dose 2 (Administered on Day 22)
timeFrame: Up to 6 months post dose 2 (administered on Day 22)
measure: Number of Participants Reporting Serious Adverse Events (SAEs) up to Day 43
timeFrame: From Day 1 to Day 43
measure: Number of Participants Reporting SAEs up to 6 Months Post Dose 2 (Administered on Day 22)
timeFrame: Day 1 to 6 months post dose 2 (administered on Day 22)
measure: Number of Participants Reporting Potential Immune-mediated Diseases (pIMDs) up to Day 43
timeFrame: From Day 1 to Day 43
measure: Number of Participants Reporting pIMDs up to 6 Months Post Dose 2 (Administered on Day 22)
timeFrame: Day 1 to 6 months post dose 2 (administered on Day 22)
Secondary outcomes:
measure: HI Antibody Titers Against Vaccine-homologous H5N8
timeFrame: Day 1, Day 22, and 6 months post dose 2 (administered on Day 22)
measure: GMFR of Serum HI Antibody Titers Against Vaccine-homologous H5N8
timeFrame: At Day 22, and 6 months post dose 2 (administered on Day 22)
measure: Number of Seroprotected Participants for HI Antibody Titers
timeFrame: At Day 1, Day 22, and 6 months post dose 2 (administered on Day 22)
measure: Number of Seroconverted Participants for HI Antibody Titers
timeFrame: At Day 22, Day 43 and 6 months post dose 2 (administered on Day 22)
measure: Microneutralization (MN) Antibody Titers for a Subset of Participants
timeFrame: At Day 1, Day 22, and 6 months post dose 2 (administered on Day 22)
measure: Number of Seropositive Participants for MN Antibody Titers for a Subset of Participants
timeFrame: At Day 1, Day 22, and 6 months post dose 2 (administered on Day 22)
measure: Number of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of Participants
timeFrame: At Day 22, Day 43, and 6 months post dose 2 (administered on Day 22)
Other outcomes:
Locations:
city: Anniston
country: United States
facility: GSK Investigational Site
state: Alabama
city: Mobile
country: United States
facility: GSK Investigational Site
state: Alabama
city: Tempe
country: United States
facility: GSK Investigational Site
state: Arizona
city: Chula Vista
country: United States
facility: GSK Investigational Site
state: California
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Santa Ana
country: United States
facility: GSK Investigational Site
state: California
city: Pembroke Pines
country: United States
facility: GSK Investigational Site
state: Florida
city: Chamblee
country: United States
facility: GSK Investigational Site
state: Georgia
city: Meridian
country: United States
facility: GSK Investigational Site
state: Idaho
city: El Dorado
country: United States
facility: GSK Investigational Site
state: Kansas
city: Lenexa
country: United States
facility: GSK Investigational Site
state: Kansas
city: Lexington
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Metairie
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Anderson
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Knoxville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Boerne
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Tomball
country: United States
facility: GSK Investigational Site
state: Texas
city: Norfolk
country: United States
facility: GSK Investigational Site
state: Virginia
Study officials:
References: