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hepatitis B antigen plus IMP321 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | IMP321 |
| B | PLACEBO_COMPARATOR | Saline |
| C | ACTIVE_COMPARATOR | Engerix B |
| Name | Type | Description |
|---|---|---|
| hepatitis B antigen (without alum) plus IMP321 | BIOLOGICAL | hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with IMP321 |
| hepatitis B antigen alone (without alum) | BIOLOGICAL | hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with physiological saline |
| Engerix B | BIOLOGICAL | 20 µg hepatitis B antigen absorbed on alum |
Inclusion Criteria: * able to give a written informed consent ; * healthy male volunteers aged between 18 and 40 years and post-menopausal healthy women aged between 18 and 55 years; * with body mass index (weight/height²) in the range 18 to 30 kg/m²; * registered with the French Social Security in...
Hepatitis B antigen plus IMP321 is an investigational combination product developed by Immutep Limited. It pairs a hepatitis B antigen with IMP321, an antibody-based agent, and was studied as a vaccine-style combination in healthy adult volunteers rather than in patients with an active disease indication.
Hepatitis B antigen plus IMP321 is being developed by Immutep Limited, which trades under the ticker IMMP. Immutep is the sponsor associated with the clinical program for this combination, which has been evaluated in a single Phase 1 study conducted in France.
Hepatitis B antigen plus IMP321 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials of the combination are currently listed. It is an investigational product and has not been approved by the FDA for any use.
The combination was tested in trial NCT00354861, titled A Randomized Phase I Study of a Hepatitis B Antigen Combined With IMP321. The completed Phase 1 study enrolled 48 healthy volunteers in France, used a placebo-controlled design, and included randomization but was not double-blind.