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A/H5N1 Antigen

Phase 1

Healthy | Monoclonal antibody | Other |Valneva SE|Last Updated: Oct 18, 2012

Success Probability

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment276

FDA Designations

FAST_TRACK

Clinical trial landscape

A/H5N1 Antigen · 1 trial · 1 indication

Phase 1 1
NCT01353534Open-label Study to Assess Immunogenicity and Safety of a Vaccine Enhancement Patch When Administered With 2 Doses of H5N1 VaccineHealthy
COMPLETED276 Analytics
PHASE1COMPLETED
Open-label Study to Assess Immunogenicity and Safety of a Vaccine Enhancement Patch When Administered With 2 Doses of H5N1 Vaccine
Healthy
NCT01353534276
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Study Endpoints

Primary Endpoints

Evaluate hemagglutination inhibition (HI) immune responses
Day 42

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).

Secondary Endpoints

Safety of 15µg and 30µg IM A/H5N1 antigen administered with the 50µg VEP
8 months
Characterize HI immune responses
8 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTAL3.8 mcg with AS03 adjuvant at D0 and 21
Group 2EXPERIMENTAL15 mcg at D0 and 21
Group 3EXPERIMENTAL15 mcg + 50 mcg VEP at D0 and 21
Group 4EXPERIMENTAL30 mcg + 50 mcg VEP at D0

Interventions

NameTypeDescription
A/H5N1 AntigenBIOLOGICALA/H5N1 Antigen
Vaccine Enhancement PatchDRUGVaccine Enhancement Patch
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Eligibility Criteria

Age Range18 Years to 49 Years
SexALL
Healthy VolunteersYes
Study Sites5

Inclusion Criteria: * Healthy adult males or females 18-49 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 at all in-clinic visits with understanding to not become pregna...

Countries:AustriaBelgium
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Frequently asked questions about A/H5N1 Antigen

What is A/H5N1 used for?

A/H5N1 is an investigational vaccine being developed for pandemic influenza. It is intended for use in healthy adults to protect against the H5N1 influenza strain. The vaccine is currently in clinical development and has not been approved by the FDA.

Who makes A/H5N1?

A/H5N1 is being developed by Valneva SE, a biopharmaceutical company traded on the stock exchange under the ticker VALN. Valneva is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in healthy adult populations.

What phase is A/H5N1 in?

A/H5N1 is in Phase 2 clinical development. It has completed two clinical trials, including a Phase 1 dose-ranging study and a Phase 2 dose-ranging study. The vaccine has received Fast Track designation from the FDA, indicating it is being developed for a serious condition with unmet medical need.

What clinical trials is A/H5N1 in?

A/H5N1 has completed two clinical trials: NCT00532792, a Phase 1 dose-ranging study with an adjuvant patch enrolling 501 participants, and NCT00908687, a Phase 2 dose-ranging study enrolling 500 participants. Both trials were conducted in the United States and involved healthy adults aged 18 years and older.

Is A/H5N1 the same as an H5N1 vaccine?

A/H5N1 is a specific vaccine candidate targeting the H5N1 influenza strain, which has pandemic potential. It is being studied for use in healthy adults to prevent pandemic influenza. The vaccine is administered with an adjuvant patch to enhance immune response, as evaluated in clinical trials.