1. Immunogenicity and safety assessment of the Cuban recombinant hepatitis B vaccine in healthy adults.
- Author
-
Estévez ZC, Betancourt AA, Muzio González V, Baile NF, Silva CV, Bernal FH, Arias EP, Delhanty Fernández A, Olazábal NM, del Río Martín A, Batista LL, Véliz Ríos G, Hernández HH, Hernández AB, Lugo EP, de la Torre Cruz J, Batista Marchec BL, Falcón LA, Brito JT, León DO, and Saura PL
- Subjects
- Adult, Double-Blind Method, Female, Humans, Male, Middle Aged, Serologic Tests, Vaccines, Synthetic adverse effects, Vaccines, Synthetic immunology, Vaccines, Synthetic therapeutic use, Antibody Formation, Hepatitis B prevention & control, Hepatitis B Vaccines adverse effects, Hepatitis B Vaccines immunology, Hepatitis B Vaccines therapeutic use, Vaccination adverse effects
- 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.
- Published
- 2007
- Full Text
- View/download PDF