This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Right arrowReprints and Permissions
Right arrow Copyright Information
Right arrow Books from ASM Press
Right arrow MicrobeWorld
Citing Articles
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Toraño, G.
Right arrow Articles by Verez-Bencomo, V.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Toraño, G.
Right arrow Articles by Verez-Bencomo, V.

 Previous Article  |  Next Article 

Clinical and Vaccine Immunology, September 2006, p. 1052-1056, Vol. 13, No. 9
1071-412X/06/$08.00+0     doi:10.1128/CVI.00144-06
Copyright © 2006, American Society for Microbiology. All Rights Reserved.

Phase I Clinical Evaluation of a Synthetic Oligosaccharide-Protein Conjugate Vaccine against Haemophilus influenzae Type b in Human Adult Volunteers

Gilda Toraño,1 Maria E. Toledo,1* Alberto Baly,1 Violeta Fernandez-Santana,3 Francisco Rodriguez,1 Yunia Alvarez,1 Teresita Serrano,1 Alexis Musachio,2 Ibis Hernandez,1 Eugenio Hardy,2 Arlene Rodríguez,2 Hector Hernandez,2 Aristides Aguilar,2 Raydel Sánchez,1 Manuel Diaz,1 Verena Muzio,2 Jorgelina Dfana,1 Maria C. Rodríguez,3 Lazaro Heynngnezz,2 and Vicente Verez-Bencomo3

Institute for Tropical Medicine Pedro Kouri, Autopista Novia del Mediodía, Km 6, La Lisa, Apdo 601, Marianao 13, Havana 11300, Cuba,1 Center for Genetic Engineering and Biotechnology, Apdo 6162, Cubanacan, Playa, Havana 10600, Cuba,2 Center for the Study of Synthetic Antigens, Facultad de Química, Universidad de la Habana, Havana 10400, Cuba3

Received 16 April 2006/ Returned for modification 9 June 2006/ Accepted 14 July 2006

Since 1989, we have been involved in the development of a vaccine against Haemophilus influenzae type b. The new vaccine is based on the conjugation of synthetic oligosaccharides to tetanus toxoid. Our main goals have been (i) to verify the feasibility of using the synthetic antigen and (ii) to search for new production alternatives for this important infant vaccine. Overall, eight trials have already been conducted with adults, children (4 to 5 years old), and infants. We have described herein the details from the first two phase I clinical trials conducted with human adult volunteers under double blind, randomized conditions. The participants each received a single intramuscular injection to evaluate safety and initial immunogenicity. We have found an excellent safety profile and an antibody response similar to the one observed for the control vaccine.

* Corresponding author. Mailing address: Institute for Tropical Medicine Pedro Kouri, Autopista Novia del Mediodía, Km 6, La Lisa, Apdo 601, Marianao 13, Havana 11300, Cuba. Phone: 53 7 202 06 51. Fax: 53 7 204 60 51. E-mail: mariaeugenia{at}ipk.sld.cu.

Clinical and Vaccine Immunology, September 2006, p. 1052-1056, Vol. 13, No. 9
1071-412X/06/$08.00+0     doi:10.1128/CVI.00144-06
Copyright © 2006, American Society for Microbiology. All Rights Reserved.





Copyright © 2009 by the American Society for Microbiology.   For an alternate route to Journals.ASM.org, visit: http://intl-journals.asm.org | More Info»