A synthetic conjugate polysaccharide vaccine against Haemophilus influenzae type b.
Glycoconjugate vaccines provide effective prophylaxis against bacterial infections. To date, however, no commercial vaccine has been available in which the key carbohydrate antigens are produced synthetically. We describe the large-scale synthesis, pharmaceutical development, and clinical evaluation of a conjugate vaccine composed of a synthetic capsular polysaccharide antigen of Haemophilus influenzae type b (Hib). The vaccine was evaluated in clinical trials in Cuba and showed long-term protective antibody titers that compared favorably to licensed products prepared with the Hib polysaccharide extracted from bacteria. This demonstrates that access to synthetic complex carbohydrate-based vaccines is feasible and provides a basis for further development of similar approaches for other human pathogens.
Verez-Bencomo
V
V
Center for the Study of Synthetic Antigens, Facultad de Química, Universidad de la Habana, Ciudad Habana, Cuba, 10400. vicente@fq.uh.cu
Fernández-Santana
V
V
Hardy
Eugenio
E
Toledo
Maria E
ME
Rodríguez
Maria C
MC
Heynngnezz
Lazaro
L
Rodriguez
Arlene
A
Baly
Alberto
A
Herrera
Luis
L
Izquierdo
Mabel
M
Villar
Annette
A
Valdés
Yury
Y
Cosme
Karelia
K
Deler
Mercedes L
ML
Montane
Manuel
M
Garcia
Ernesto
E
Ramos
Alexis
A
Aguilar
Aristides
A
Medina
Ernesto
E
Toraño
Gilda
G
Sosa
Iván
I
Hernandez
Ibis
I
Martínez
Raydel
R
Muzachio
Alexis
A
Carmenates
Ania
A
Costa
Lourdes
L
Cardoso
Félix
F
Campa
Concepción
C
Diaz
Manuel
M
Roy
René
R
D000328:Adult; D000907:Antibodies, Bacterial / Q000096:biosynthesis / Q000097:blood; D002675:Child, Preschool; D004311:Double-Blind Method; D006001:Glycoconjugates / Q000276:immunology; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000138:chemical synthesis* / Q000276:immunology*; D019741:Haemophilus influenzae type b / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D007074:Immunoglobulin G / Q000097:blood; D007223:Infant; D011134:Polysaccharides / Q000138:chemical synthesis* / Q000276:immunology* / Q000302:isolation & purification; D011135:Polysaccharides, Bacterial / Q000276:immunology* / Q000302:isolation & purification; D013745:Tetanus Toxoid / Q000276:immunology; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000276:immunology
D000907:Antibodies, Bacterial; D006001:Glycoconjugates; D018073:Haemophilus Vaccines; D007074:Immunoglobulin G; D011134:Polysaccharides; D011135:Polysaccharides, Bacterial; D013745:Tetanus Toxoid; D018074:Vaccines, Conjugate; C008984:polyribitol phosphate