Approval Probability
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Adjusted LOA
ML Risk
A/H5N1 · 3 trials · 2 indications
Seroconversion is defined as either 1) baseline HI titer \< 1:10 and a post-vaccination HI titer ≥ 1:40, or 2) baseline HI titer ≥ 1:10 and a minimum four-fold rise. Seroprotection is defined as a post-vaccination HI antibody titer ≥ 1:40. FDA/EMEA criterion for seroconversion was to meet or exceed 40%. FDA/EMEA criterion for seroprotection was to meet or exceed 70%.
Evaluate hemagglutination inhibition (HI) immune responses to two doses of 15μg A/H5N1 achieved in the antigen plus VEP group versus the antigen alone group (Group 3 vs. Group 2) at Day 42 using standard serological parameters (Geometric Mean Titer \[GMT\], Geometric Mean Fold Ratio \[GMFR\], seroconversion and seroprotection).
| Arm | Type | Description |
|---|---|---|
| Group 1: 30 µg HA, no LT patch | EXPERIMENTAL | A/H5N1 Vaccine 30 µg HA i.m. on Day 0 |
| Group 2: 30 µg HA + 50 µg LT patch | EXPERIMENTAL | A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0 |
| Group 3: 30 µg HA + 100 µg LT patch | EXPERIMENTAL | A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0 |
| Group 4: 45 µg HA, no LT patch | EXPERIMENTAL | A/H5N1 Vaccine 45 µg HA i.m. on Day 0 |
| Group 5: 45 µg HA + 50 µg LT patch | EXPERIMENTAL | A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0 |
| Group 6: 45 µg HA + 100 µg LT patch | EXPERIMENTAL | A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0 |
| Group 1 | EXPERIMENTAL | 3.8 mcg with AS03 adjuvant at D0 and 21 |
| Group 2 | EXPERIMENTAL | 15 mcg at D0 and 21 |
| Group 3 | EXPERIMENTAL | 15 mcg + 50 mcg VEP at D0 and 21 |
| Group 4 | EXPERIMENTAL | 30 mcg + 50 mcg VEP at D0 |
| Group 5 | EXPERIMENTAL | - |
| Group 6 | EXPERIMENTAL | - |
| Group 7 | EXPERIMENTAL | - |
| Group 8 | EXPERIMENTAL | - |
| Group 9 | EXPERIMENTAL | - |
| Group 10 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| A/H5N1 | BIOLOGICAL | A/H5N1 Low Dose |
| LT Adjuvant Patch | BIOLOGICAL | LT Adjuvant Patch Low Dose |
| A/H5N1 Antigen | BIOLOGICAL | A/H5N1 Antigen |
| Vaccine Enhancement Patch | DRUG | Vaccine Enhancement Patch |
| Placebo | BIOLOGICAL | Placebo (0.5ml); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21 |
Inclusion Criteria: * Healthy adult male or females 18 to 49 years of age (inclusive) * Signed Informed Consent * Women who are not post-menopausal or surgically sterile must have a negative serum or urine pregnancy test at screening and within 24 hours of vaccination with understanding (through in...
A/H5N1 is an investigational monoclonal antibody developed by Valneva SE for pandemic influenza and for use in healthy volunteers. It is being studied as a countermeasure against H5N1 influenza, the avian influenza strain that public health authorities consider a pandemic threat. It has not been approved for any indication.
A/H5N1 is developed by Valneva SE, a biopharmaceutical company listed under the ticker VALN. Valneva has sponsored the clinical studies of the asset, including the dose ranging and vaccine enhancement patch trials conducted in the United States, Austria, and Belgium.
A/H5N1 is in Phase 1 development. The program has completed two clinical trials, and no trials are currently active. The asset holds a FAST_TRACK designation from the FDA, which is intended to expedite review of drugs addressing serious conditions and unmet medical needs.
A/H5N1 has been studied in completed trials including NCT01353534, an open-label Phase 1 study of a vaccine enhancement patch given with two doses of H5N1 vaccine in 276 healthy adults in Austria and Belgium, and NCT00908687, a Phase 2 dose ranging study in 500 adults with pandemic influenza in the United States.
Across its completed clinical program, A/H5N1 has enrolled a total of 1,001 participants. The studies were randomized and controlled, with participants aged 18 years and older, and included healthy volunteers. The trials took place in the United States, Austria, and Belgium.