Phase I clinical evaluation of a synthetic oligosaccharide-protein conjugate vaccine against Haemophilus influenzae type b in human adult volunteers.

Autor: Toraño G; Institute for Tropical Medicine Pedro Kouri, Autopista Novia del Mediodía, Km 6, La Lisa, Apdo 601, Marianao 13, Havana 11300, Cuba., Toledo ME, Baly A, Fernandez-Santana V, Rodriguez F, Alvarez Y, Serrano T, Musachio A, Hernandez I, Hardy E, Rodríguez A, Hernandez H, Aguilar A, Sánchez R, Diaz M, Muzio V, Dfana J, Rodríguez MC, Heynngnezz L, Verez-Bencomo V
Jazyk: angličtina
Zdroj: Clinical and vaccine immunology : CVI [Clin Vaccine Immunol] 2006 Sep; Vol. 13 (9), pp. 1052-6.
DOI: 10.1128/CVI.00144-06
Abstrakt: 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.
Databáze: MEDLINE