Vaccination with a Hybrid 1 (H1) fusion protein combined with a liposomal adjuvant (CAF01) induced antigen specific T-cells 3 years post vaccination in a human clinical trial. (VAC7P.971)
| Autor: | Dawn Henson, Jaap van Dissel, Simone Joosten, Andrew Graves, Søren Hoff, Darius Soonawala, Corine Prines, Birgit Thierry-Carstensen, Lars Andreasen, Adriette de Visser, Else Agger, Tom Ottenhoff, Ingrid Kromann, Peter Andersen, David Hokey |
|---|---|
| Rok vydání: | 2014 |
| Předmět: | |
| Zdroj: | The Journal of Immunology. 192:141.16-141.16 |
| ISSN: | 1550-6606 0022-1767 |
| Popis: | Approximately one third of the world’s population is infected with Mycobacterium tuberculosis. Developing novel vaccines to protect against pulmonary tuberculosis is a public health priority. In this study, a Hybrid 1 (H1) subunit vaccine containing a recombinant fusion protein of Ag85B and ESAT-6 was paired with a two-component CAF01 liposomal adjuvant system developed and manufactured by Statens Serum Institut. A phase I clinical study was performed to evaluate H1:CAF01 in healthy non-BCG vaccinated adult male and female subjects between the ages of 18 and 55 years old. The subjects were randomized into four groups including H1 alone or H1 with 125/25µg, 313/125µg or 625/125µg CAF01 and were vaccinated on study days 0 and 56. PBMCs harvested approximately 150 weeks post vaccination were used to assess antigen specific responses by a 13-color intracellular cytokine staining assay. Vaccination with H1:CAF01 resulted in statistically significant Ag85B-specific CD4 polyfunctional CD154+ T cells compared to H1 alone. ESAT-6 stimulation resulted in detection of CD4 polyfunctional CD154+ T cells responses that were not elevated to a statistically significant extent compared to H1 alone. This is the first demonstration of the persistence of an antigen-specific cellular immune response up to 3 years after vaccination in a clinical trial using H1:CAF01 vaccination. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|