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

NCT05608005 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: VAM00001U1111-1256-9115
• Study Type: interventional
• Target: 581
• Locations: 1 country
• Sites: 16

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.

Conditions

Influenza; Healthy Volunteers

Outcome Measures

Primary Outcomes (33)

• Geometric Mean of Hemagglutination Inhibition (HAI) Antibody (Ab) Titer at Day 22

  The HAI antibody was measured by hemagglutination inhibition using horse red blood cells (HIH) measurement method. The 95% confidence interval (CI) was based on the Student t-distribution of log10-transformed values.

  Day 22

• Geometric Mean of Hemagglutination Inhibition Antibody Titer at Day 43

  The HAI antibody was measured by HIH measurement method. The 95% CI was based on the Student t-distribution of log10-transformed values.

  Day 43

• Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 22

  The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.

  Days 1 and 22

• Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 43

  The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.

  Days 1 and 43

• Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 202

  The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.

  Days 1 and 202

• Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 387

  The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.

  Days 1 and 387

• Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 22

  The seroconversion was defined as titer \<10 on Day 1 and post-injection titer \>=40 on Day 22 or Day 43; or defined as titer \>=10 on Day 1 and a \>=4-fold increase in titer on Day 22 or Day 43. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

  Day 22

• Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 43

  The seroconversion was defined as titer \<10 on Day 1 and post-injection titer \>=40 on Day 22 or Day 43; or defined as titer \>=10 on Day 1 and a \>=4-fold increase in titer on Day 22 or Day 43. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

  Day 43

• Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 1

  The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

  Day 1

• Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 22

  The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

  Day 22

• Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 43

  The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

  Day 43

• Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 202

  The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

  Day 202

• Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 387

  The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

  Day 387

• Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 1

  The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

  Day 1

• Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 22

  The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

  Day 22

• Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 43

  The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

  Day 43

• Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 202

  The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

  Day 202

• Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 387

  The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

  Day 387

• Geometric Mean of Neutralization Test (NT) Antibody Titer at Day 22

  The NT antibody was measured by seroneutralization (SN) measurement method. The 95% CI was based on the Student t-distribution of log10-transformed values.

  Day 22

• Geometric Mean of Neutralization Test Antibody Titer at Day 43

  The NT antibody was measured by SN measurement method. The 95% CI was based on the Student t-distribution of log10-transformed values.

  Day 43

• Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 22

  The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.

  Days 1 and 22

• Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 43

  The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.

  Days 1 and 43

• Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 202

  The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.

  Days 1 and 202

• Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 387

  The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.

  Days 1 and 387

• Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 22

  The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

  Day 22

• Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 43

  The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

  Day 43

• Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 22

  The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

  Day 22

• Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 43

  The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

  Day 43

• Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 1

  The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

  Day 1

• Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 22

  The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

  Day 22

• Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 43

  The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

  Day 43

• Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 202

  The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

  Day 202

• Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 387

  The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

  Day 387

Secondary Outcomes (4)

• Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)

  Up to 30 minutes after each vaccination

• Number of Participants With Solicited Injection Site Reactions and Systemic Reactions

  Up to 7 days after each vaccination

• Number of Participants With Unsolicited AEs

  Up to 21 days after each vaccination

• Number of Participants With Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)

  From first dose vaccine administration (Day 1) until 12 months after the last dose administration, 387 days

Study Arms (3)

Group 1

EXPERIMENTAL

2 doses, 21 days apart, of Panblok H7 dose 1 + MF59

Biological: Panblok + MF59 Dose 1

Group 2

EXPERIMENTAL

2 doses, 21 days apart, of Panblok H7 dose 2 + MF59

Biological: Panblok + MF59 Dose 2

Group 3

ACTIVE COMPARATOR

2 doses, 21 days apart, of Panblok H7 dose 3 unadjuvanted

Biological: Unadjuvanted Panblok Dose 3

Interventions

Panblok + MF59 Dose 1 BIOLOGICAL

Pharmaceutical form: suspension for injection Route of administration: intramuscular

Group 1

Panblok + MF59 Dose 2 BIOLOGICAL

Pharmaceutical form: suspension for injection Route of administration: intramuscular

Group 2

Unadjuvanted Panblok Dose 3 BIOLOGICAL

Pharmaceutical form: liquid for injection Route of administration: intramuscular

Group 3

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (16)

Centricity Research-Mesa Site Number : 8400006

Mesa, Arizona, 85206, United States

Location

Velocity Clinical Research-Hallandale Beach Site Number : 8400026

Hallandale, Florida, 33009, United States

Location

Research Centers of America Site Number : 8400024

Hollywood, Florida, 33024, United States

Location

Suncoast Research Associates, LLC Site Number : 8400008

Miami, Florida, 33173, United States

Location

St Johns Center for Clinical Research Site Number : 8400021

Saint Augustine, Florida, 32086, United States

Location

CenExel ACMR (Atlanta Center for Medical Research) Site Number : 8400022

Atlanta, Georgia, 30331, United States

Location

Velocity Clinical Research Valparaiso Site Number : 8400007

Valparaiso, Indiana, 46383, United States

Location

Velocity Clinical Research Site Number : 8400027

Metairie, Louisiana, 70006, United States

Location

M3 Wake Research Inc Site Number : 8400010

Raleigh, North Carolina, 27612, United States

Location

Preferred Primary Care Physicians Site Number : 8400015

Pittsburgh, Pennsylvania, 15236, United States

Location

Preferred Primary Care Physicians, Inc. Site Number : 8400002

Pittsburgh, Pennsylvania, 15243, United States

Location

Velocity Clinical Research Anderson Site Number : 8400016

Anderson, South Carolina, 29621, United States

Location

WR-ClinSearch, LLC Site Number : 8400003

Chattanooga, Tennessee, 37421, United States

Location

Velocity Clinical Research Site Number : 8400019

Austin, Texas, 78759, United States

Location

JBR Clinical Research Site Number : 8400005

Salt Lake City, Utah, 84107, United States

Location

Foothill Family Research-South Site Number : 8400009

Salt Lake City, Utah, 84121, United States

Location

Related Links

• VAM00001 Plain Language Results Summary

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi Pasteur

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  MCM Vaccines B.V.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Modified double-blind: * Investigators and study staff who conduct the safety assessment, laboratory personnel who analyze the blood samples, Sponsor's personnel and study Team members, and the participant will not know which study dose is administered * Only the study staff who prepare and administer the study intervention and are not involved with the safety evaluation will know which study dose is administered
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Model Details: 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.

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: November 7, 2022
• Study Start: November 3, 2022
• Primary Completion: February 18, 2023
• Study Completion: February 13, 2024
• Last Updated: September 24, 2025
• Results First Posted: February 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (16)