Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine With and Without Adjuvant System 03 (AS03)

Summary

This study will compare the different immune responses to Influenza A (H5N1) Virus Monovalent Vaccine with and without the AS03 adjuvant. The Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant vaccine is approved for use for adults to protect against flu caused by the A/H5N1 "bird flu" virus in Europe but none of the vaccines to be used in the study are approved for use in the United States. The results of this study will help researchers learn about better ways to vaccinate people against the H5N1 flu.

Timeline

Start

2013-07

Primary completion

2015-02

Completion

2015-11

Outcome

Met primary endpoint

registry With AS03 Adjuvant vs Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv; p = 0.0039; ANOVA NCT01910519 ↗

Publications

• Wimmers F, Donato M, Kuo A, Ashuach T, Gupta S, Li C, Dvorak M, Foecke MH, Chang SE, Hagan T, De Jong SE, Maecker HT, van der Most R, Cheung P, Cortese M, Bosinger SE, Davis M, Rouphael N, Subramaniam S, Yosef N, Utz PJ, Khatri P, Pulendran B. The single-cell epigenomic and transcriptional landscape of immunity to influenza vaccination. Cell. 2021 Jul 22;184(15):3915-3935.e21. doi: 10.1016/j.cell.2021.05.039. Epub 2021 Jun 25.

Drugs

Indications