Phase I clinical trial in healthy adults of a nasal vaccine candidate containing recombinant hepatitis B surface and core antigens
| Autor: | N. Figueroa Baile, R. Sánchez Betancourt, E. Hardy Rando, L. Mila Cáceres, G. Véliz Ríos, M.E. Peña Martínez, Gema Nieto, A.I. Juvier Madrazo, A. Correa Fernández, R.E. Soto Mestre, D. Acosta Escobar, P.A. Días Reyes, Arístides Aguilar Betancourt, M.I. Alonso Martínez, N. Puble Alvarez, J.C. Aguilar Rubido, M.V. Pérez Pérez, A. Delahanty Fernández, S.R. Moreno Aureoles-Roselló, M. Alonso Guzmán, R. Alemán Zaldívar, M.J. Cerna Guanche, Y. Lobaina-Matos, M. Lago Baños, J. Cabrera Martínez, M. David Baldo, V.L. Muzio González, L. Olivera Ruano, Z. Cinza Estévez, C.A. González Delgado |
|---|---|
| Rok vydání: | 2007 |
| Předmět: |
Adult
Male Microbiology (medical) medicine.medical_specialty HBsAg Hepatitis B virus Nasal vaccine Adolescent medicine.medical_treatment medicine.disease_cause Gastroenterology Double-Blind Method Internal medicine medicine Humans Hepatitis B Vaccines Vaccines Combined Seroconversion Hepatitis B Antibodies Immunity Mucosal Administration Intranasal Hepatitis B core antigen Vaccines Synthetic rhinorrhea Hepatitis B Surface Antigens business.industry virus diseases General Medicine Vaccine therapy Hepatitis B Middle Aged medicine.disease Hepatitis B Core Antigens digestive system diseases Clinical trial HBcAg Infectious Diseases Hepatitis B surface antigen Nasal spray Immunology Nasal administration medicine.symptom business |
| Zdroj: | International Journal of Infectious Diseases. 11(5):394-401 |
| ISSN: | 1201-9712 |
| DOI: | 10.1016/j.ijid.2006.09.010 |
| Popis: | Summary Background The nasal vaccine candidate (NASVAC), comprising hepatitis B virus (HBV) surface (HBsAg) and core antigens (HBcAg), has been shown to be highly immunogenic in animal models. Methods A phase I double-blinded, placebo-controlled randomized clinical trial was carried out in 19 healthy male adults with no serologic markers of immunity/infection to HBV. This study was aimed at exploring the safety and immunogenic profile of nasal co-administration of both HBV recombinant antigens. The trial was performed according to Good Clinical Practice guidelines. Participants ranged in age from 18 to 45 years and were randomly allocated to receive a mixture of 50μg HBsAg and 50μg HBcAg or 0.9% physiologic saline solution, as a placebo, via nasal spray in a five-dose schedule at 0, 7, 15, 30, and 60 days. A total volume of 0.5ml was administered in two dosages of 125μl per nostril. Adverse events were actively recorded 1h, 6h, 12h, 24h, 48h, 72h, 7 days and 30 days after each dose. Anti-HBs and anti-HBc titers were evaluated using corresponding ELISA kits at days 30 and 90. Results The vaccine candidate was safe and well tolerated. Adverse reactions included sneezing (34.1%), rhinorrhea (12.2%), nasal stuffiness (9.8%), palate itching (9.8%), headache (9.8%), and general malaise (7.3%). These reactions were all self-limiting and mild in intensity. No severe or unexpected events were recorded during the trial. The vaccine elicited anti-HBc seroconversion in 100% of subjects as early as day 30 of the immunization schedule, while a seroprotective anti-HBs titer (≥10IU/l) was at a maximum at day 90 (75%). All subjects in the placebo group remained seronegative during the trial. Conclusion The HBsAg–HBcAg vaccine candidate was safe, well tolerated and immunogenic in this phase I study in healthy adults. To our knowledge, this is the first demonstration of safety and immunogenicity for a nasal vaccine candidate comprising HBV antigens. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|