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Phase 2 Completed N=581 Randomized Quadruple-blind Prevention

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

Influenza · Healthy Volunteers
Source: ClinicalTrials.gov NCT05608005 ↗
Enrolled (actual)
581
Serious AEs
5.1%
Results posted
Feb 2025
Primary outcomePrimary: Geometric Mean of Hemagglutination Inhibition (HAI) Antibody (Ab) Titer at Day 22 — 5.74; 5.61; 5.28 titer

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Geometric Mean of Hemagglutination Inhibition (HAI) Antibody (Ab) Titer at Day 22
5.74; 5.61; 5.28
PRIMARY
Geometric Mean of Hemagglutination Inhibition Antibody Titer at Day 43
12.6; 13.4; 5.80
PRIMARY
Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 22
1.09; 1.05; 1.03
PRIMARY
Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 43
2.39; 2.52; 1.13
PRIMARY
Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 202
1.01; 0.966; 0.990
PRIMARY
Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 387
0.998; 0.976; 0.978
PRIMARY
Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 22
2.2; 0.4; 0.0
PRIMARY
Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 43
22.9; 22.9; 1.4
PRIMARY
Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 1
0.0; 0.9; 0.0
PRIMARY
Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 22
2.2; 0.9; 0.0
PRIMARY
Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 43
23.2; 23.4; 1.4
PRIMARY
Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 202
0.5; 0.0; 0.0
PRIMARY
Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 387
0.0; 0.0; 0.0
PRIMARY
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 1
3.4; 3.4; 1.3
PRIMARY
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 22
6.9; 6.5; 2.6
PRIMARY
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 43
46.9; 52.4; 9.7
PRIMARY
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 202
3.3; 2.4; 1.5
PRIMARY
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 387
3.0; 2.5; 0.0
PRIMARY
Geometric Mean of Neutralization Test (NT) Antibody Titer at Day 22
7.23; 6.85; 6.88
PRIMARY
Geometric Mean of Neutralization Test Antibody Titer at Day 43
26.8; 25.8; 11.5
PRIMARY
Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 22
1.21; 1.14; 1.09
PRIMARY
Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 43
4.51; 4.29; 1.86
PRIMARY
Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 202
1.20; 1.17; 0.856
PRIMARY
Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 387
1.20; 1.18; 0.909
PRIMARY
Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 22
10.0; 7.3; 7.9; 2.2; 2.2; 0.0
PRIMARY
Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 43
54.9; 55.8; 29.2; 35.7; 35.1; 11.1
PRIMARY
Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 22
22.2; 17.2; 18.4; 7.8; 6.0; 5.3
PRIMARY
Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 43
64.6; 71.4; 48.6; 51.1; 51.9; 26.4
PRIMARY
Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 1
14.2; 15.5; 18.4
PRIMARY
Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 22
26.8; 24.1; 26.3
PRIMARY
Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 43
69.6; 76.2; 54.2
PRIMARY
Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 202
25.7; 25.0; 6.1
PRIMARY
Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 387
24.1; 26.3; 8.2
SECONDARY
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
1; 0; 0
SECONDARY
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
53; 57; 8; 57; 56; 20
SECONDARY
Number of Participants With Unsolicited AEs
32; 39; 9
SECONDARY
Number of Participants With Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)
11; 12; 6; 1; 1; 0

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 con

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05608005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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