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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05874713
Other study ID # V205_01
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date June 7, 2023
Est. completion date October 2024

Study information

Verified date May 2024
Source Seqirus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 480
Est. completion date October 2024
Est. primary completion date April 25, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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: 1. Clinical conditions. 2. 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. 3. 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.

Study Design


Intervention

Biological:
aH5N8c on Day 1
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
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
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
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
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)

Locations

Country Name City State
United States Velocity Clinical Research Baton Rouge Louisiana
United States Cope Family Medicine Bountiful Utah
United States Cullman Clinical Trials Cullman Alabama
United States Medical Care LLC Elizabethton Tennessee
United States Velocity Clinical Research Grand Island Nebraska
United States Lifeline Primary Care Lilburn Georgia
United States Georgia Clinic Norcross Georgia
United States Velocity Clinical Research Norfolk Nebraska
United States Velocity Clinical Research Sioux City Iowa

Sponsors (2)

Lead Sponsor Collaborator
Seqirus Biomedical Advanced Research and Development Authority

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Geometric mean titer (GMT) of hemagglutination inhibition (HI) antibodies against H5N8 strain - Day 1 GMT (HI) prevaccination Day 1
Primary GMT of HI antibodies against H5N8 strain - Day 22 GMT (HI) 3 weeks post first priming vaccination Day 22
Primary GMT of HI antibodies against H5N8 strain - Day 43 GMT (HI) 3 weeks post second priming vaccination Day 43
Primary GMT of HI antibodies against H5N8 strain - Day 202 GMT (HI) pre booster vaccination Day 202
Primary GMT of HI antibodies against H5N8 strain - Day 209 GMT (HI) 1 week post booster vaccination Day 209
Primary GMT of HI antibodies against H5N8 strain - Day 223 GMT (HI) 3 weeks post booster vaccination Day 223
Primary GMT of HI antibodies against H5N6 strain - Day 1 GMT (HI) prevaccination Day 1
Primary GMT of HI antibodies against H5N6 strain - Day 22 GMT (HI) 3 weeks post first priming vaccination Day 22
Primary GMT of HI antibodies against H5N6 strain - Day 43 GMT (HI) 3 weeks post second priming vaccination Day 43
Primary GMT of HI antibodies against H5N6 strain - Day 202 GMT (HI) pre booster vaccination Day 202
Primary GMT of HI antibodies against H5N6 strain - Day 223 GMT (HI) 3 weeks post booster vaccination Day 223
Primary Geometric mean fold increase (GMFI) of HI antibodies against H5N8 strain - Day 22 GMFI (HI) 3 weeks post first priming vaccination compared to prevaccination Day 22
Primary GMFI of HI antibodies against H5N8 strain - Day 43 GMFI (HI) 3 weeks post second priming vaccination compared to prevaccination Day 43
Primary GMFI of HI antibodies against H5N8 strain - Day 209 GMFI (HI) 1 week post booster vaccination compared to pre booster vaccination Day 209
Primary GMFI of HI antibodies against H5N8 strain - Day 223 GMFI (HI) 3 weeks post booster vaccination compared to pre booster vaccination Day 223
Primary GMFI of HI antibodies against H5N6 strain - Day 22 GMFI (HI) 3 weeks post first priming vaccination compared to prevaccination Day 22
Primary GMFI of HI antibodies against H5N6 strain - Day 43 GMFI (HI) 3 weeks post second priming vaccination compared to prevaccination Day 43
Primary GMFI of HI antibodies against H5N6 strain - Day 223 GMFI (HI) 3 weeks post booster vaccination compared to pre booster vaccination Day 223
Primary Percentages of subjects with HI titers =1:40 against H5N8 strain - Day 1 % =1:40 (HI) prevaccination Day 1
Primary Percentages of subjects with HI titers =1:40 against H5N8 strain - Day 22 % =1:40 (HI) 3 weeks post first priming vaccination Day 22
Primary Percentages of subjects with HI titers =1:40 against H5N8 strain - Day 43 % =1:40 (HI) 3 weeks post second priming vaccination Day 43
Primary Percentages of subjects with HI titers =1:40 against H5N8 strain - Day 209 % =1:40 (HI) 1 week post booster vaccination Day 209
Primary Percentages of subjects with HI titers =1:40 against H5N8 strain - Day 223 % =1:40 (HI) 3 weeks post booster vaccination Day 223
Primary Percentages of subjects with HI titers =1:40 against H5N6 strain - Day 1 % =1:40 (HI) prevaccination Day 1
Primary Percentages of subjects with HI titers =1:40 against H5N6 strain - Day 22 % =1:40 (HI) 3 weeks post first priming vaccination Day 22
Primary Percentages of subjects with HI titers =1:40 against H5N6 strain - Day 43 % =1:40 (HI) 3 weeks post second priming vaccination Day 43
Primary Percentages of subjects with HI titers =1:40 against H5N6 strain - Day 223 % =1:40 (HI) 3 weeks post booster vaccination Day 223
Primary 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 Day 22
Primary 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 Day 43
Primary 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 Day 209
Primary 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 Day 223
Primary 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 Day 22
Primary 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 Day 43
Primary 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 Day 223
Secondary 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). Day 1 through Day 7, Day 22 through Day 28, and Day 202 through 208
Secondary Frequency and severity of unsolicited AEs For 3 weeks following each vaccination Day 1 through Day 43 and Day 202 through Day 223
Secondary 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 Day 1 through Day 382
Secondary GMT of HI antibodies against H5N8 strain - Persistence GMT (HI) 6 months post 2nd priming vaccination and 6 months post booster vaccination Day 202, Day 382
Secondary GMT of HI antibodies against H5N6 strain - Persistence GMT (HI) 6 months post 2nd priming vaccination Day 202
Secondary 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) Day 202, Day 382
Secondary GMFI of HI antibodies against H5N6 strain - Persistence GMFI (HI) 6 months post 2nd priming vaccination compared to prevaccination Day 202
Secondary 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 Day 202, Day 382
Secondary Percentages of subjects with HI titers =1:40 against H5N6 strain - Persistence % =1:40 (HI) 6 months post 2nd priming vaccination Day 202
Secondary 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 Day 202, Day 382
Secondary 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 Day 202
Secondary 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 Day 1, Day 22, Day 43, Day 202, Day 223
Secondary 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 Day 1, Day 43, Day 202, Day 223
Secondary 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) Day 22, Day 43, Day 202, Day 223
Secondary 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) Day 43, Day 202, Day 223
Secondary 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 Day 1, Day 22, Day 43, Day 202, Day 223
Secondary 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 Day 1, Day 43, Day 202, Day 223
Secondary 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 Day 22, Day 43, Day 202, Day 209, Day 223
Secondary 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 Day 43, Day 202, Day 209, Day 223
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