Open AccessPhase I Clinical Evaluation of a Synthetic Oligosaccharide-Protein Conjugate Vaccine against Haemophilus influenzae Type b in Human Adult Volunteers
Author(s) -
Gilda Toraño,
María Eugenia Toledo,
Alberto Baly,
Violeta Fernández-Santana,
Francisco Javier García Rodríguez,
Yunia Alvarez,
Teresita Serrano,
Alexis Musachio,
Ibis Hernández,
Eugenio Hardy,
Alina Martínez Rodríguez,
Héctor Hernández y Hernández,
A. Aguilar,
Raydel Martínez Sánchez,
Manuel Dı́az,
Verena Muzio,
Jorgelina Dfana,
M. C. Rodríguez,
Lázaro Heynngnezz,
Vicente Vérez-Bencomo
Publication year - 2006
Publication title -
clinical and vaccine immunology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.649
H-Index - 77
eISSN - 1556-6811
pISSN - 1556-679X
DOI - 10.1128/cvi.00144-06
Subject(s) - immunogenicity , toxoid , tetanus , medicine , haemophilus influenzae , conjugate vaccine , clinical trial , haemophilus , antibody , immunology , vaccine trial , vaccination , virology , microbiology and biotechnology , biology , bacteria , genetics , antibiotics
Since 1989, we have been involved in the development of a vaccine againstHaemophilus 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.