Immunogenicity and safety assessment of the Cuban recombinant hepatitis B vaccine in healthy adults

• Published in: Biologicals 2007-04, Vol.35 (2), p.115-122
• Main Authors: Estévez, Zurina Cinza, Betancourt, Arístides Aguilar, González, Verena Muzio, Baile, Nelvis Figueroa, Silva, Carmen Valenzuela, Bernal, Francisco Hernández, Arias, Eduardo Pentón, Fernández, Aurora Delhanty, Olazábal, Nelia Martin, Amaurys del Río Martín, Batista, Lester Leal, Ríos, Gloria Véliz, Hernández, Héctor Hernández, Hernández, Aracelis Blanco, Lugo, Evelyn Pérez, Joel de la Torre Cruz, Batista Marchec, Bertha L., Leovaldo Álvarez Falcón, Brito, Jannet Trujillo, León, Darién Ortega, Saura, Pedro López
• Format: Article
• Language: English
• Subjects: Adult; Antibody Formation; Clinical trial; Double-Blind Method; Female; Hepatitis B - prevention & control; Hepatitis B Vaccines - adverse effects; Hepatitis B Vaccines - immunology; Hepatitis B Vaccines - therapeutic use; Humans; Immunogenicity; Male; Middle Aged; Recombinant hepatitis B vaccine; Safety; Serologic Tests; Vaccination - adverse effects; Vaccines, Synthetic - adverse effects; Vaccines, Synthetic - immunology; Vaccines, Synthetic - therapeutic use
• ISSN: 1045-1056; 1095-8320
• DOI: 10.1016/j.biologicals.2006.06.001

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 μg 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.