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Research Paper
Safety and immunogenicity of a combined hepatitis B virus-Haemophilus influenzae type B vaccine comprising a synthetic antigen in healthy adults
Arístides Aguilar Betancourt, Carlos Alberto González-Delgado, Z. Cinza-Estévez, Jesus Martínez-Cabrera , Gloria Véliz-Ríos, Regis Alemán-Zaldívar , M.I. Alonso-Martínez, M. Lago-Baños, N. Puble Alvarez, A. Delahanty Fernandez, A.I. Juvier Madrazo, D. Ortega León, L. Olivera Ruano, A. Correa Fernández, D. Abreu Reyes, E. Soto Mestre, M.V. Pérez Pérez, N. Figueroa Baile, L. Hernandez Pérez, A. Rodríguez Silva, E. Martínez Díaz, N.S. Expósito, G.E. Guillén Nieto and Verena L. Muzio González
volume 4 | issue 1
january/february 2008Pages: 54 - 59
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The combined HB-Hib vaccine candidate Hebervac HB-Hib® (CIGB, La Habana), comprising recombinant HBsAg and tetanus toxoid conjugate synthetic PRP antigens has shown to be highly immunogenic in animal models. A phase I open, controlled, randomized clinical trial was carried out to assess the safety and immunogenicity profile of this bivalent vaccine in 25 healthy adults who were positive for antibody to HBsAg (anti-HBs). The trial was performed according to Good Clinical Practices and Guidelines. Volunteers were randomly allocated to receive the combined vaccine or simultaneous administration of HB vaccine Heberbiovac-HB® and Hib vaccine QuimiHib® (CIGB, La Habana). All individuals were intramuscularly immunized with a unique dose of 10 µg HBsAg plus 10 µg conjugated synthetic PRP. Adverse events were actively recorded after vaccine administration. Total anti-HBs and IgG anti-PRP antibody titers were evaluated using commercial ELISA kits at baseline and 30 days post-vaccination. The combined vaccine candidate was safe and well tolerated. The most common adverse reactions were local pain, febricula, fever and local erythema. These reactions were all mild in intensity and resolved without medical treatment. Adverse events were mostly reported during the first 6 - 72 hours post-vaccination. There were no serious adverse events during the study. No severe or unexpected events were either recorded during the trial. The combined vaccine elicited an anti-HBs and anti-PRP booster response in 100% of subjects at day 30 of the immunization schedule. Anti-HBs and anti-PRP antibody levels had at least a two-fold increase compared to baseline sera. Even more, anti-HBs antibody titer showed a four-fold increase in 100% of volunteers in the study group. The results indicate that the combined HB-Hib vaccine produces increased antibody levels in healthy adults who have previously been exposed to these two antigens. To our knowledge, this is the first demonstration of safety and immunogenicity for a combined vaccine comprising recombinant HBV and synthetic Hib antigens. The present results support phase I-II clinical trial in the target population, two months old healthy infants.
Authors
Arístides Aguilar Betancourt
Vaccine Division, Vaccine Clinical Trials Dept., Center for Genetic Engineering and Biotechnology, Ciudad Habana, Cuba
Carlos Alberto González-Delgado
National Center for Toxicology; CENATOX
Z. Cinza-Estévez
Vaccine Division; Vaccine Clinical Trials Department; Center for Genetic Engineering and Biotechnology; Habana, Cuba
Jesus Martínez-Cabrera
National Center for Toxicology, CENATOX
Gloria Véliz-Ríos
Vaccine Division; Vaccine Clinical Trials Department; Center for Genetic Engineering and Biotechnology; Habana, Cuba
Regis Alemán-Zaldívar
Vaccine Division; Vaccine Clinical Trials Department; Center for Genetic Engineering and Biotechnology; Habana, Cuba
M.I. Alonso-Martínez
"Carlos J. Finlay" University Hospital; Havana City, Cuba
M. Lago-Baños
"Carlos J. Finlay" University Hospital; Havana City, Cuba
N. Puble Alvarez
Carlos J. Finlay University Hospital; Havana, Cuba
A. Delahanty Fernandez
National Center of Immunoassays; CIE; Havana, Cuba
A.I. Juvier Madrazo
National Center of Immunoassays; CIE; Havana, Cuba
D. Ortega León
National Center of Immunoassays; CIE; Havana, Cuba
L. Olivera Ruano
National Center for Toxicology; CENATOX
A. Correa Fernández
National Center for Toxicology; CENATOX
D. Abreu Reyes
Carlos J. Finlay University Hospital, Havana, Cuba
E. Soto Mestre
National Center for Toxicology; CENATOX
M.V. Pérez Pérez
Carlos J. Finlay University Hospital; Havana, Cuba
N. Figueroa Baile
Vaccine Division; Vaccine Clinical Trials Department; Center for Genetic Engineering and Biotechnology; Habana, Cuba
L. Hernandez Pérez
Vaccine Division; Vaccine Clinical Trials Department; Center for Genetic Engineering and Biotechnology; Habana, Cuba
A. Rodríguez Silva
Vaccine Division; Vaccine Clinical Trials Department; Center for Genetic Engineering and Biotechnology; Habana, Cuba
E. Martínez Díaz
Vaccine Division; Vaccine Clinical Trials Department; Center for Genetic Engineering and Biotechnology; Habana, Cuba
N.S. Expósito
Vaccine Division; Vaccine Clinical Trials Dept.; Center for Genetic Engineering and Biotechnology; Habana, Cuba
G.E. Guillén Nieto
Vaccine Division; Vaccine Clinical Trials Department; Center for Genetic Engineering and Biotechnology; Habana, Cuba
Verena L. Muzio González
Vaccine Division; Vaccine Clinical Trials Department; Center for Genetic Engineering and Biotechnology; Habana, Cuba