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Ad4-H5-Vtn · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | three vaccinations of 10\^7vp Ad4-H5-Vtn or placebo |
| Cohort 2 | EXPERIMENTAL | three vaccinations of the 10\^8vp Ad4-H5-Vtn or placebo |
| Cohort 3 | EXPERIMENTAL | three vaccinations of 10\^9 Ad4-H5-Vtn or placebo |
| Cohort 4 | EXPERIMENTAL | three vaccinations of 10\^10 Ad4-H5-Vtn or placebo |
| Cohort 5 | EXPERIMENTAL | three vaccinations of 10\^11 Ad4-H5-Vtn or placebo |
| Name | Type | Description |
|---|---|---|
| Placebo | OTHER | enteric coated capsule containing no vaccine virus |
| Ad4-H5-Vtn | BIOLOGICAL | a live, replication-competent, recombinant Ad4 virus expressing the HA of H5N1 influenza (A/Vietnam/1194/2004) in an enteric capsule for oral administration |
| Sanofi Pasteur Influenza Virus Vaccine, H5N1 | BIOLOGICAL | Single administration of a heterologous boost given to volunteers 3 to 15 months following their last vaccination with Ad4-H5-Vtn or placebo. |
Inclusion Criteria: * Healthy adults and their healthy adult household contacts. Exclusion Criteria: * Healthcare workers who have direct contact with patients who are immunodeficient, are HIV-positive, have an unstable medical condition, or are under the age of 18. * Childcare workers who have d...
Ad4-H5-Vtn is an investigational vaccine being developed for bird flu, also known as avian influenza H5N1. It is designed to prevent infection caused by the H5N1 influenza virus. The vaccine is currently in Phase 1 clinical development and is not yet approved for use.
Ad4-H5-Vtn is being developed by Emergent BioSolutions Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol EBS. The company is conducting clinical trials to evaluate the safety and immunogenicity of this investigational vaccine for bird flu.
Ad4-H5-Vtn is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. A Phase 1 trial has been completed, and the vaccine remains in early-stage clinical testing for bird flu.
Ad4-H5-Vtn has been studied in one completed Phase 1 clinical trial, identified as NCT01006798. This trial evaluated the safety and immunogenicity of the vaccine in 166 healthy volunteers in the United States. The trial was randomized, double-blind, and controlled.
Ad4-H5-Vtn is a replication-competent adenovirus type 4-vectored vaccine. It uses a modified adenovirus to deliver genetic material encoding the H5N1 influenza virus hemagglutinin protein, stimulating an immune response against bird flu. The vaccine is designed to elicit protective immunity without causing disease.
Ad4-H5-Vtn is a distinct investigational vaccine specifically designed for avian influenza H5N1. It is not the same as seasonal flu vaccines or other licensed bird flu vaccines. Its unique adenovirus-vectored platform differentiates it from conventional egg-based or cell-based influenza vaccines.