title: Phase I clinical evaluation of a synthetic oligosaccharide-protein conjugate vaccine against Haemophilus influenzae type b in human adult volunteers.
abstract: 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.
authors.affiliation: Institute for Tropical Medicine Pedro Kouri, Autopista Novia del Mediodía, Km 6, La Lisa, Apdo 601, Marianao 13, Havana 11300, Cuba.
authors.forename: Gilda
authors.initials: G
authors.lastname: Toraño
authors.forename: Maria E
authors.initials: ME
authors.lastname: Toledo
authors.forename: Alberto
authors.initials: A
authors.lastname: Baly
authors.forename: Violeta
authors.initials: V
authors.lastname: Fernandez-Santana
authors.forename: Francisco
authors.initials: F
authors.lastname: Rodriguez
authors.forename: Yunia
authors.initials: Y
authors.lastname: Alvarez
authors.forename: Teresita
authors.initials: T
authors.lastname: Serrano
authors.forename: Alexis
authors.initials: A
authors.lastname: Musachio
authors.forename: Ibis
authors.initials: I
authors.lastname: Hernandez
authors.forename: Eugenio
authors.initials: E
authors.lastname: Hardy
authors.forename: Arlene
authors.initials: A
authors.lastname: Rodríguez
authors.forename: Hector
authors.initials: H
authors.lastname: Hernandez
authors.forename: Aristides
authors.initials: A
authors.lastname: Aguilar
authors.forename: Raydel
authors.initials: R
authors.lastname: Sánchez
authors.forename: Manuel
authors.initials: M
authors.lastname: Diaz
authors.forename: Verena
authors.initials: V
authors.lastname: Muzio
authors.forename: Jorgelina
authors.initials: J
authors.lastname: Dfana
authors.forename: Maria C
authors.initials: MC
authors.lastname: Rodríguez
authors.forename: Lazaro
authors.initials: L
authors.lastname: Heynngnezz
authors.forename: Vicente
authors.initials: V
authors.lastname: Verez-Bencomo
mesh_terms: D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D000918:Antibody Specificity; D004311:Double-Blind Method; D004797:Enzyme-Linked Immunosorbent Assay; D006192:Haemophilus Infections / Q000276:immunology / Q000517:prevention & control*; D018073:Haemophilus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D019741:Haemophilus influenzae type b / Q000276:immunology*; D006801:Humans; D007070:Immunoglobulin A / Q000276:immunology; D007074:Immunoglobulin G / Q000276:immunology; D007075:Immunoglobulin M / Q000276:immunology; D008297:Male; D012189:Retrospective Studies; D015610:Serum Bactericidal Test; D018074:Vaccines, Conjugate
chemical_list: D000907:Antibodies, Bacterial; D018073:Haemophilus Vaccines; D007070:Immunoglobulin A; D007074:Immunoglobulin G; D007075:Immunoglobulin M; D018074:Vaccines, Conjugate