A phase 1 randomized open-label clinical study to evaluate the safety and tolerability of a novel recombinant hepatitis E vaccine |
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| Affiliation: | 1. College of Veterinary Medicine, Jilin University, 5333 Xian Road, Changchun 130062, Jilin, China;2. Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, Jiangsu, China;3. Changchun Institute of Biological Products Co. Ltd., 3456 Xian Road, Changchun 130062, Jilin, China;4. Department of Microbiology and Immunology, Southeast University School of Medicine, Nanjing 210009, Jiangsu, China;5. National Institutes for Food and Drug Control, 100050 Beijing, China;6. Key Laboratory for Zoonosis, Ministry of Education, and Institute for Zoonosis of Jilin University, Changchun 130062, Jilin, China;1. Université Paris Est, IMRB-GRC GEMINI, 94000 Créteil, France;2. Clinical Research Center (CRC), Centre Hospitalier Intercommunal de Créteil, Créteil, France;3. GPIP, Pediatric Infectious Disease Group, France;14. Department of General Pediatrics, Hôpital Intercommunal, Créteil, France;12. Department of Pediatric Emergency, AP-HP, Hôpital Le Kremlin-Bicêtre, Université Paris Sud, Bicêtre, France;8. Department of Pediatric Emergency, HFME Lyon, Lyon, France;9. Department of Pediatrics, CHU Nantes, Nantes, France;10. Department General Pediatrics, AP-HP, Hôpital Robert Debré, Université Paris Diderot, Sorbonne Paris Cité, Paris, France;7. Univ. Lille, CHU Lille, Pediatric Emergency Unit & Infectious Diseases, Lille, France;15. National Reference Center for Pneumococci, Laboratoire de Microbiologie, Assistance Publique-Hôpitaux de Paris, Hopital Européen Georges-Pompidou, Paris, France;4. ACTIV, Pediatric Clinical and Therapeutical Association of the Val de Marne, Saint-Maur des Fossés, France;1. Université Paris Est, IMRB-GRC GEMINI, 94000 Créteil, France;2. Clinical Research Center (CRC), Centre Hospitalier Intercommunal de Créteil, Créteil, France;3. GPIP, Pediatric Infectious Disease Group, France;4. ACTIV, Pediatric Clinical and Therapeutical Association of the Val de Marne, Saint-Maur des Fossés, France;5. Department of Pediatric Emergency, Hôpital Intercommunal, Créteil, France;6. Department General Pediatrics, Centre Hospitalier de Versailles, Le Chesnay, France;7. Univ. Lille, CHU Lille, Pediatric Emergency Unit & Infectious Diseases, Lille, France;8. Department of Pediatric Emergency, HFME Lyon, Lyon, France;9. Department of Pediatrics, CHU Nantes, Nantes, France;10. Department General Pediatrics, AP-HP, Hôpital Robert Debré, Université Paris Diderot, Sorbonne Paris Cité, Paris, France;11. Department of Pediatric Emergency, CHU Nord, Marseille, France;12. Department of Pediatric Emergency, AP-HP, Hôpital Le Kremlin-Bicêtre, Université Paris Sud, Bicêtre, France;13. Unité Court Séjour, Petits Nourrissons, Service de Néonatologie, Centre Hospitalier Intercommunal de Créteil, France;1. College of Veterinary Medicine, Jilin University, Changchun, Jilin 130062, China;2. Division of Swine Infectious Diseases, State Key Laboratory of Veterinary Biotechnology, Harbin Veterinary Research Institute, Chinese Academy of Agricultural Sciences, Harbin 150000, China;3. Key Laboratory for Zoonosis, Ministry of Education, Changchun 130062, China;1. Instituto Maimonides de Investigación Biomédica de Córdoba (IMIBIC), Avenida Menendez Pidal s/n, 14006, Cordoba, Spain;2. Animal Pathology Department, Veterinary Science College, Universidad de Córdoba, Cordoba, Spain;3. Animal Health Department, Veterinary Science College, Campus Universitario de Rabanales, 14014, Cordoba, Spain;4. Unidad de Enfermedades Infecciosas, Hospital Provincial, Complejo Hospitalario Reina Sofía de Córdoba, Avenida Menendez Pidal s/n, 14006, Cordoba, Spain;5. Consejería de Agricultura, Pesca y Desarrollo Rural, Junta de Andalucía, Calle Tabladilla, s/n, 41001, Sevilla, Spain;1. Unit of Infectious Diseases, Hospital Universitario Reina Sofía, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Universidad de Córdoba (UCO), Córdoba, Spain;2. CIBERINFEC, ISCIII - CIBER de Enfermedades Infecciosas, Instituto de Salud Carlos III, Madrid, Spain;3. Clinical Microbiology Unit, Hospital Universitario Reina Sofía, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, Spain;4. Unit of Infectious Diseases and Microbiology, Hospital Universitario de Valme, Seville, Spain;5. Microbiology Department, Clínica Universidad de Navarra, STUN, Institute of Tropical Health, Universidad de Navarra, diSNA, Navarra Institute for Health Research, Pamplona, Spain;6. Clinical Microbiology Unit, Hospital Universitario Clínico San Cecilio, Granada, Spain;7. Instituto de Investigación Biosanitaria Ibs.Granada, Granada, Spain;8. Clinical Microbiology Unit, University Hospital of Puerto Real, Cádiz, Spain;9. Infectious Diseases, Microbiology and Preventive Medicine Unit, Virgen Macarena Univ. Hospital, and Department of Medicine, University of Sevilla / Biomedicine Institute of Sevilla, Sevilla, Spain;10. Clinical Microbiology Unit, Hospital Universitario de Jerez, Cádiz, Spain |
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| Abstract: | BackgroundThis study aimed to evaluate the safety and tolerability for variable dosages of a novel hepatitis E vaccine p179.MethodsThe randomized open-label parallel control phase 1 clinical trial enrolled 120 eligible participants aged 16–65 years in Jiangsu Province, China. The experimental groups were randomized to receive different dosages of 20 μg, 30 μg, and 40 μg Hepatitis E Virus (HEV) p179 vaccines, with the 30 μg HEV vaccine p239 Hecolin as control, and vaccinated at 0, 1 and 6 month intervals. Participants were observed for solicited local and systemic adverse reactions (ARs) occurring within 7 days after each vaccination, and any serious adverse events (SAEs) occurring within 6 months post-vaccination. Blood samples were collected from participants 3 days before and after each injection, to determine the blood routine and serum biochemical indexes.ResultsThe solicited local ARs incidence in experimental groups were significantly lower than that of the control group (P = 0.027). The difference between solicited total and systemic ARs incidence of experimental groups and the control group were not significant (P > 0.05). Similar patterns were observed when the analyses were performed on the group having ARs of varying grades and symptoms. All changes in blood biochemical indexes and routine blood tests before and after different vaccinations were mild (grade 1) or moderate (grade 2), and the difference in experimental groups and the control group were not statistically significant. No vaccine related SAEs occurred in any of the subjects during the study.ConclusionThree different dosages of HEV p179 vaccine were deemed safe and well tolerated. No vaccine-associated SAEs were identified, and the 30 μg dosage formulation was selected for further investigation for efficacy.Clinical trials registration number: 2012L01657. |
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| Keywords: | Hepatitis E HEV Vaccine Safety Clinical trial |
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