Phase I clinical evaluation of a synthetic oligosaccharide-protein conjugate vaccine against Haemophilus influenzae type b in human adult volunteers.
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.
Toraño
Gilda
G
Institute for Tropical Medicine Pedro Kouri, Autopista Novia del Mediodía, Km 6, La Lisa, Apdo 601, Marianao 13, Havana 11300, Cuba.
Toledo
Maria E
ME
Baly
Alberto
A
Fernandez-Santana
Violeta
V
Rodriguez
Francisco
F
Alvarez
Yunia
Y
Serrano
Teresita
T
Musachio
Alexis
A
Hernandez
Ibis
I
Hardy
Eugenio
E
Rodríguez
Arlene
A
Hernandez
Hector
H
Aguilar
Aristides
A
Sánchez
Raydel
R
Diaz
Manuel
M
Muzio
Verena
V
Dfana
Jorgelina
J
Rodríguez
Maria C
MC
Heynngnezz
Lazaro
L
Verez-Bencomo
Vicente
V
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
D000907:Antibodies, Bacterial; D018073:Haemophilus Vaccines; D007070:Immunoglobulin A; D007074:Immunoglobulin G; D007075:Immunoglobulin M; D018074:Vaccines, Conjugate