title: Immunogenicity and safety assessment of the Cuban recombinant hepatitis B vaccine in healthy adults.
abstract: Manufactures of biotechnological/biological products (including vaccines) frequently make changes to manufacturing processes of products both during development and after approval. In our case, a non-inferiority bridging study was carried out to demonstrate that changes in the production plant facilities of Cuban recombinant hepatitis B vaccine, Heberbiovac HB, did not affect the safety and immunogenicity of the vaccine. This controlled, randomized, doubled-blinded trial included 501 volunteers, aged between 20 and 64, who were given three doses of vaccine (20 microg HBsAg/mL) at month 0, 1, and 2. Four lots were evaluated (three corresponding to the new production facilities and a control one produced in the older facilities). One month after the third dose, were observed protective levels of anti-HBsAg in 97% of the subjects that concluded the study with a geometric mean antibody titer (GMT) of 931.18 IU/L. Normal values of body mass index (BMI), the younger ages, and being a female, were significantly related to a good antibody response. The vaccine was well tolerated. Pain at the injection site was the most commonly reported symptom. We conclude that Heberbiovac HB vaccine maintains its characteristics after the modifications carried out in the production plant facilities and both, lot obtained in previous facilities and in the new ones, are comparable in terms of safety and immunogenicity.
authors.affiliation: Centre for Genetic Engineering and Biotechnology, Ave 31 e/158 y 190, P.O. Box 6162, 10600 Havana, Cuba. zurina.cinza@cigb.edu.cu
authors.forename: Zurina Cinza
authors.initials: ZC
authors.lastname: Estévez
authors.forename: Arístides Aguilar
authors.initials: AA
authors.lastname: Betancourt
authors.forename: Verena
authors.initials: V
authors.lastname: Muzio González
authors.forename: Nelvis Figueroa
authors.initials: NF
authors.lastname: Baile
authors.forename: Carmen Valenzuela
authors.initials: CV
authors.lastname: Silva
authors.forename: Francisco Hernández
authors.initials: FH
authors.lastname: Bernal
authors.forename: Eduardo Pentón
authors.initials: EP
authors.lastname: Arias
authors.forename: Aurora
authors.initials: A
authors.lastname: Delhanty Fernández
authors.forename: Nelia Martin
authors.initials: NM
authors.lastname: Olazábal
authors.forename: Amaurys
authors.initials: A
authors.lastname: del Río Martín
authors.forename: Lester Leal
authors.initials: LL
authors.lastname: Batista
authors.forename: Gloria
authors.initials: G
authors.lastname: Véliz Ríos
authors.forename: Héctor Hernández
authors.initials: HH
authors.lastname: Hernández
authors.forename: Aracelis Blanco
authors.initials: AB
authors.lastname: Hernández
authors.forename: Evelyn Pérez
authors.initials: EP
authors.lastname: Lugo
authors.forename: Joel
authors.initials: J
authors.lastname: de la Torre Cruz
authors.forename: Bertha L
authors.initials: BL
authors.lastname: Batista Marchec
authors.forename: Leovaldo Alvarez
authors.initials: LA
authors.lastname: Falcón
authors.forename: Jannet Trujillo
authors.initials: JT
authors.lastname: Brito
authors.forename: Darién Ortega
authors.initials: DO
authors.lastname: León
authors.forename: Pedro López
authors.initials: PL
authors.lastname: Saura
mesh_terms: D000328:Adult; D000917:Antibody Formation; D004311:Double-Blind Method; D005260:Female; D006509:Hepatitis B / Q000517:prevention & control*; D017325:Hepatitis B Vaccines / Q000009:adverse effects* / Q000276:immunology* / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012698:Serologic Tests; D014611:Vaccination / Q000009:adverse effects*; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use
chemical_list: D017325:Hepatitis B Vaccines; D014614:Vaccines, Synthetic