Clinical trial NCT05608005: Study on Two Adjuvanted Dose Levels of Panblok H7+MF59 Compared for Immunogenicity and Safety With an Unadjuvanted Dose of Panblok H7 in Participants 18 Years of Age and Older
Official title: A Parallel-group, Phase I/II, Randomized, Modified Double-blind, 3-arm, Active Comparator, Multi-center, Prevention Study to Evaluate the Immunogenicity and Safety of Two Adjuvanted Dose Levels of Panblok H7+MF59 Influenza Vaccine Compared With an Unadjuvanted Dose of Panblok H7 in Participants 18 Years of Age and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Influenza
Healthy Volunteers
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2022-11-07
Enrollment: 581
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible participants (18-64 years of age and ≥65 years of age) will be randomized in a 3:3:1 ratio to receive 2 doses, 21 days apart, by intramuscular (IM) route of either Panblok H7+MF59 (dose 1), Panblok H7+MF59 (dose 2), or unadjuvanted Panblok H7 (dose 3) at D01.
Primary purpose: PREVENTION

Brief summary: VAM00001 is a Phase I/II, randomized, modified double-blind, multi-center study.

The purpose of this study is to compare 2 dose levels of Panblok H7 (dose 1 and dose 2 of rHA) with a standard squalene dose of adjuvant MF59 to Panblok H7 (dose 3) unadjuvanted in approximately 700 adult participants in order to select one dose formulation to be used for further clinical development. The randomization ratio will be 3:3:1 for Panblok H7 (dose 1) + MF59, Panblok H7 (dose 2) + MF59, and Panblok H7 (dose 3) unadjuvanted, respectively. Each study group will be stratified into the age groups 18-64 years and ≥ 65 years of age.

The study duration for each participant will be approximately 13 months.

Detailed description: The study duration for each participant will be approximately 13 months.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older on the day of inclusion
* Participants who are healthy as determined by medical evaluation including medical history and physical examination
* A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:

Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile.

OR Is of childbearing potential and agrees to use a highly effective contraceptive method or abstinence from at least 4 weeks prior to each study intervention administration until at least 12 weeks after the last study intervention administration.

* A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 24 hours before the first dose of study intervention
* Informed consent form has been signed and dated

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
* Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
* Thrombocytopenia or bleeding disorder contraindicating intramuscular injection based on investigator's judgement
* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion (1)

  (1) Chronic illness may include, but is not limited to, cardiac disorders, renal disorders, auto-immune disorders, diabetes, psychiatric disorders, or chronic infection
* Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of study intervention administration in the absence of therapy, and participants who have a history of neoplastic disease and who have been disease-free for ≥ 5 years)
* Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 100.4°F) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
* Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion
* Receipt of any vaccine in the 14 days preceding Visit 1 or planned receipt of any vaccine prior to Visit 3, except for seasonal flu vaccine, which may be received at least 2 weeks after Visit 2
* Previous vaccination against H7N9 with an investigational vaccine
* Receipt of immune globulins, blood or blood-derived products in the past 3 months
* Participation at the time of study enrollment (or in the 4 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
* Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
* Personal or family history of Guillain-Barré syndrome
* Self-reported seropositivity for Hepatitis B antigen or Hepatitis C

"The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial."

Primary outcomes:
measure: Geometric Mean of Hemagglutination Inhibition (HAI) Antibody (Ab) Titer at Day 22
timeFrame: Day 22
measure: Geometric Mean of Hemagglutination Inhibition Antibody Titer at Day 43
timeFrame: Day 43
measure: Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 22
timeFrame: Days 1 and 22
measure: Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 43
timeFrame: Days 1 and 43
measure: Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 202
timeFrame: Days 1 and 202
measure: Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 387
timeFrame: Days 1 and 387
measure: Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 22
timeFrame: Day 22
measure: Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 43
timeFrame: Day 43
measure: Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 1
timeFrame: Day 1
measure: Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 22
timeFrame: Day 22
measure: Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 43
timeFrame: Day 43
measure: Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 202
timeFrame: Day 202
measure: Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 387
timeFrame: Day 387
measure: Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 1
timeFrame: Day 1
measure: Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 22
timeFrame: Day 22
measure: Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 43
timeFrame: Day 43
measure: Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 202
timeFrame: Day 202
measure: Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 387
timeFrame: Day 387
measure: Geometric Mean of Neutralization Test (NT) Antibody Titer at Day 22
timeFrame: Day 22
measure: Geometric Mean of Neutralization Test Antibody Titer at Day 43
timeFrame: Day 43
measure: Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 22
timeFrame: Days 1 and 22
measure: Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 43
timeFrame: Days 1 and 43
measure: Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 202
timeFrame: Days 1 and 202
measure: Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 387
timeFrame: Days 1 and 387
measure: Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 22
timeFrame: Day 22
measure: Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 43
timeFrame: Day 43
measure: Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 22
timeFrame: Day 22
measure: Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 43
timeFrame: Day 43
measure: Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 1
timeFrame: Day 1
measure: Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 22
timeFrame: Day 22
measure: Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 43
timeFrame: Day 43
measure: Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 202
timeFrame: Day 202
measure: Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 387
timeFrame: Day 387
Secondary outcomes:
measure: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
timeFrame: Up to 30 minutes after each vaccination
measure: Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
timeFrame: Up to 7 days after each vaccination
measure: Number of Participants With Unsolicited AEs
timeFrame: Up to 21 days after each vaccination
measure: Number of Participants With Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)
timeFrame: From first dose vaccine administration (Day 1) until 12 months after the last dose administration, 387 days
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Centricity Research-Mesa Site Number : 8400006
state: Arizona
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research-Hallandale Beach Site Number : 8400026
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America Site Number : 8400024
state: Florida
city: Miami
country: United States
facility: Suncoast Research Associates, LLC Site Number : 8400008
state: Florida
city: Saint Augustine
country: United States
facility: St Johns Center for Clinical Research Site Number : 8400021
state: Florida
city: Atlanta
country: United States
facility: CenExel ACMR (Atlanta Center for Medical Research) Site Number : 8400022
state: Georgia
city: Valparaiso
country: United States
facility: Velocity Clinical Research Valparaiso Site Number : 8400007
state: Indiana
city: Metairie
country: United States
facility: Velocity Clinical Research Site Number : 8400027
state: Louisiana
city: Raleigh
country: United States
facility: M3 Wake Research Inc Site Number : 8400010
state: North Carolina
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians Site Number : 8400015
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians, Inc. Site Number : 8400002
state: Pennsylvania
city: Anderson
country: United States
facility: Velocity Clinical Research Anderson Site Number : 8400016
state: South Carolina
city: Chattanooga
country: United States
facility: WR-ClinSearch, LLC Site Number : 8400003
state: Tennessee
city: Austin
country: United States
facility: Velocity Clinical Research Site Number : 8400019
state: Texas
city: Salt Lake City
country: United States
facility: JBR Clinical Research Site Number : 8400005
state: Utah
city: Salt Lake City
country: United States
facility: Foothill Family Research-South Site Number : 8400009
state: Utah
Study officials:
affiliation: MCM Vaccines B.V.
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: