Immunogenicity and safety assessment of the Cuban recombinant hepatitis B vaccine in healthy adults.
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.
Estévez
Zurina Cinza
ZC
Centre for Genetic Engineering and Biotechnology, Ave 31 e/158 y 190, P.O. Box 6162, 10600 Havana, Cuba. zurina.cinza@cigb.edu.cu
Betancourt
Arístides Aguilar
AA
Muzio González
Verena
V
Baile
Nelvis Figueroa
NF
Silva
Carmen Valenzuela
CV
Bernal
Francisco Hernández
FH
Arias
Eduardo Pentón
EP
Delhanty Fernández
Aurora
A
Olazábal
Nelia Martin
NM
del Río Martín
Amaurys
A
Batista
Lester Leal
LL
Véliz Ríos
Gloria
G
Hernández
Héctor Hernández
HH
Hernández
Aracelis Blanco
AB
Lugo
Evelyn Pérez
EP
de la Torre Cruz
Joel
J
Batista Marchec
Bertha L
BL
Falcón
Leovaldo Alvarez
LA
Brito
Jannet Trujillo
JT
León
Darién Ortega
DO
Saura
Pedro López
PL
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
D017325:Hepatitis B Vaccines; D014614:Vaccines, Synthetic