A Randomized Phase I Study of a Hepatitis B Antigen Combined With IMP321
Condition: Healthy
MeSH terms: Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single centre, three single administrations (Days 1, 29 and 57) at increasing doses
      of IMP321 (3, 10, 30 and 100 µg) in four cohorts of 12 subjects, single blind, randomized
      study.
    

Detailed description: 
      In each cohort, 8 subjects will receive the hepatitis B antigen (10 µg) with IMP321 at one
      dose, 2 subjects will receive the reference hepatitis B antigen (10 µg) alone with
      physiological saline and 2 subjects will receive the commercial vaccine Engerix B® (20 µg).

      Engerix B® will be administered intramuscularly. The other treatments will be administered
      subcutaneously.

      The four successive cohorts of volunteers will be:

      Cohort A:

        -  8 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with
           IMP321 (3 µg),

        -  2 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with
           physiological saline,

        -  2 subjects treated by the commercial hepatitis vaccine Engerix B® (20 µg HBsAg with
           alum).

      If the tolerability of this cohort is acceptable, the following cohort will be done.

      Cohort B:

        -  8 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with
           IMP321 (10 µg),

        -  2 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with
           Physiological saline,

        -  2 subjects treated by the commercial hepatitis vaccine Engerix B® (20 µg HBsAg with
           alum).

      If the tolerability of this cohort is acceptable, the following cohort will be done.

      Cohort C:

        -  8 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with
           IMP321 (30 µg),

        -  2 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with
           physiological saline,

        -  2 subjects treated by the commercial hepatitis vaccine Engerix B® (20 µg HBsAg with
           alum).

      If the tolerability of this cohort is acceptable, the following cohort will be done.

      Cohort D:

        -  8 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with
           IMP321 (100 µg),

        -  2 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with
           physiological saline

        -  2 subjects treated by the commercial hepatitis vaccine Engerix B® (20 µg HBsAg with
           alum).

      Blood samples will be collected on the morning of days 1, 29, 36, 57 and 85 for
      pharmacodynamic evaluation.

      Monitoring for the occurrence of adverse events (AE), changes in physical examination, vital
      signs (blood pressure, pulse rate, respiration), electrocardiograms (ECG) and clinical
      laboratory tests (biochemistry, haematology, urinalysis) will be performed before and after
      each dose of the study drug to assess safety and tolerability.
    

Intervention name(s): hepatitis B antigen (without alum) plus IMP321; hepatitis B antigen alone (without alum); Engerix B
Intervention type(s): Biological; Biological; Biological
Intervention description(s): hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with IMP321; hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with physiological saline; 20 µg hepatitis B antigen absorbed on alum
Other intervention name(s): CD223; hLAG-3Ig; LAG-3
Intervention MeSH terms: Aluminum sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Healthy volunteers; IMP321; Adjuvant; Pharmacodynamics