tetano
Editor, Senior Moderator
* Oxford Journals
* Medicine
* Journal of Infectious Diseases
* Volume203, Issue12
* Pp. 1719-1728.
Combined, Concurrent, and Sequential Administration of Seasonal Influenza and MF59-Adjuvanted A/H5N1 Vaccines: A Phase II Randomized, Controlled Trial of Immunogenicity and Safety in Healthy Adults
1. Pio Lopez1,
2. Yolanda Caicedo1,
3. Alexandra Sierra1,
4. Sandrine Tilman2,
5. Angelika Banzhoff3 and
6. Ralf Clemens4
1.
1Centros de Estudios Infectologia Pedi?trica, Cali, Colombia; and Novartis Vaccines and Diagnostics
2.
2Amsterdam, the Netherlands
3.
3Marburg, Germany
4.
4Siena, Italy
1. Correspondence: Angelika Banzhoff, MD, PhD, Novartis Vaccines and Diagnostics, Emil von Behring Strasse 76, 35041 Marburg, Germany (e-mail: angelika.banzhoff{at}novartis.com).
Next Section
Abstract
Objective. We performed a phase II randomized, controlled, open-label, single-center study (Centros de Estudios de Infectolog?a Pedi?trica, Colombia) to examine the feasibility of combined administration of seasonal and MF59-adjuvanted A/H5N1 influenza vaccines using extemporaneous mixing or simultaneous administration.
Methods. The primary objective of the study was to assess the immunogenicity of seasonal influenza and A/H5N1 vaccines using European licensure criteria (Committee for Medicinal Products for Human Use [CHMP]); the secondary objective was to assess vaccine reactogenicity and safety.
Results. In 401 healthy 18?40-year-old subjects, both vaccines were immunogenic in all settings; the vaccine for seasonal influenza met all CHMP criteria, unaffected by coadministration of A/H5N1 vaccine in separate or mixed injections. Likewise, the immunogenicity of A/H5N1 vaccine was unaffected by seasonal influenza vaccination, with hemagglutination inhibition seroprotection rates of 28%?40% after 1 dose and 67%?80% after 2 doses, sufficient to meet CHMP criteria. Solicited local and systemic adverse events were mainly mild to moderate. No vaccine-related serious adverse events were reported during the study period.
Conclusions. These data demonstrate that seasonal and MF59-adjuvanted A/H5N1 influenza vaccines can be given as a mixed injection or by simultaneous separate injections without affecting immunogenicity or safety, supporting the feasibility of incorporating prepandemic MF59-adjuvanted A/H5N1 vaccines into seasonal influenza vaccination programs and the development of tetravalent influenza vaccines, including pandemic strains.
Clinical Trials Registration. NCT00481065.
http://jid.oxfordjournals.org/content/203/12/1719.full
* Medicine
* Journal of Infectious Diseases
* Volume203, Issue12
* Pp. 1719-1728.
Combined, Concurrent, and Sequential Administration of Seasonal Influenza and MF59-Adjuvanted A/H5N1 Vaccines: A Phase II Randomized, Controlled Trial of Immunogenicity and Safety in Healthy Adults
1. Pio Lopez1,
2. Yolanda Caicedo1,
3. Alexandra Sierra1,
4. Sandrine Tilman2,
5. Angelika Banzhoff3 and
6. Ralf Clemens4
1.
1Centros de Estudios Infectologia Pedi?trica, Cali, Colombia; and Novartis Vaccines and Diagnostics
2.
2Amsterdam, the Netherlands
3.
3Marburg, Germany
4.
4Siena, Italy
1. Correspondence: Angelika Banzhoff, MD, PhD, Novartis Vaccines and Diagnostics, Emil von Behring Strasse 76, 35041 Marburg, Germany (e-mail: angelika.banzhoff{at}novartis.com).
Next Section
Abstract
Objective. We performed a phase II randomized, controlled, open-label, single-center study (Centros de Estudios de Infectolog?a Pedi?trica, Colombia) to examine the feasibility of combined administration of seasonal and MF59-adjuvanted A/H5N1 influenza vaccines using extemporaneous mixing or simultaneous administration.
Methods. The primary objective of the study was to assess the immunogenicity of seasonal influenza and A/H5N1 vaccines using European licensure criteria (Committee for Medicinal Products for Human Use [CHMP]); the secondary objective was to assess vaccine reactogenicity and safety.
Results. In 401 healthy 18?40-year-old subjects, both vaccines were immunogenic in all settings; the vaccine for seasonal influenza met all CHMP criteria, unaffected by coadministration of A/H5N1 vaccine in separate or mixed injections. Likewise, the immunogenicity of A/H5N1 vaccine was unaffected by seasonal influenza vaccination, with hemagglutination inhibition seroprotection rates of 28%?40% after 1 dose and 67%?80% after 2 doses, sufficient to meet CHMP criteria. Solicited local and systemic adverse events were mainly mild to moderate. No vaccine-related serious adverse events were reported during the study period.
Conclusions. These data demonstrate that seasonal and MF59-adjuvanted A/H5N1 influenza vaccines can be given as a mixed injection or by simultaneous separate injections without affecting immunogenicity or safety, supporting the feasibility of incorporating prepandemic MF59-adjuvanted A/H5N1 vaccines into seasonal influenza vaccination programs and the development of tetravalent influenza vaccines, including pandemic strains.
Clinical Trials Registration. NCT00481065.
http://jid.oxfordjournals.org/content/203/12/1719.full