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Pandemic Influenza Vaccine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | There will be 12 subjects in Group 1 that will receive 10e8 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d). |
| Group 2 | EXPERIMENTAL | There will be 12 subjects in Group 2 that will receive 10e9 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d). |
| Group 3 | EXPERIMENTAL | There will be 12 subjects in Group 3 that will receive 10e10 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d). |
| Experimental: Group 4 | PLACEBO_COMPARATOR | There will be 12 subjects in Group 4 that will receive a placebo consisting of buffer administered via intranasal spray on day 0 and day 28 (+/- 4d). |
| Name | Type | Description |
|---|---|---|
| Pandemic Influenza Vaccine | BIOLOGICAL | Undetermined |
| Placebo | BIOLOGICAL | - |
Inclusion Criteria: * Healthy males and females in good general health, 19-49 years of age * Subjects must provide written consent * Willing to participate through study completion * Willing to undergo nasal washes and swabs and provide urine and blood samples per protocol for safety and immunogeni...
It is an investigational vaccine developed to protect against Influenza A Subtype H5N1 Infection, a pandemic influenza strain. It is designed for preventive immunization in healthy adults rather than for treating existing infection. The vaccine is being developed by Altimmune, Inc. and has been studied in a Phase 1 clinical trial.
Altimmune, Inc., which trades under the ticker ALT, is the developer of this pandemic influenza vaccine candidate. The company is responsible for its clinical development program, including the completed Phase 1 study conducted in the United States.
The Pandemic Influenza Vaccine is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. It is an investigational product and has not been approved by the FDA for any indication.
The vaccine has been evaluated in a single Phase 1 trial, NCT00755703, titled Safety and Immunogenicity Study of Adenovirus-vectored, Intranasal Pandemic Influenza Vaccine. The trial enrolled 48 healthy volunteers aged 19 years and older in the United States. It was randomized, double-blind, and placebo-controlled, and it is now completed.
The Pandemic Influenza Vaccine is administered intranasally, based on the title of its completed Phase 1 trial. It is an adenovirus-vectored vaccine candidate, meaning it uses a modified adenovirus to deliver influenza genetic material. This approach is intended to stimulate an immune response against Influenza A Subtype H5N1.