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Your search keyword '"Ghany, M. G."' showing total 4 results
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4 results on '"Ghany, M. G."'

1. Prevalence of hepatitis B antiviral drug resistance variants in North American patients with chronic hepatitis B not receiving antiviral treatment

Author

Lok, A. S., Ganova‐Raeva, L., Cloonan, Y., Punkova, L., Lin, H.‐H. S., Lee, W. M., Ghany, M. G., Lau, Daryl T‐Y, Chung, Raymond T., Roberts, Lewis R., Smith, Coleman I., Di Bisceglie, Adrian M., ‐Melman, Mauricio, Janssen, L. A., Wong, David K., Juan, Joshua, Feld, Jordan, Yim, Colina, Heathcote, Jenny, Perrillo, Robert, Do, Son, Han, Steven‐Huy B., Tran, Tram T., Terrault, Norah A., Khalili, Mandana, Cooper, Stewart L., Fontana, Robert J., Tsai, Naoky, Fried, Michael W., Patel, Keyur, Evon, Donna, Carithers, Robert C., Shuhart, Margaret, Kowdley, Kris V., Wang, Chia C., Sterling, Richard K., Jake Liang, T., Hoofnagle, Jay H., Doo, Edward, Chang, Kyong‐Mi, Park, Jang‐June, Belle, Steven H., Wahed, Abdus, and Kleiner, David

Published
2017
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4. Randomized Trial of a Vaccine Regimen to Prevent Chronic HCV Infection

Author

Kimberly E Rousseau, Elisa Scarselli, Matthew E. Winter, Kimberly Page, Karla Thornton, Ellen Stein, Andrea L. Cox, Michael R. Wierzbicki, Paula J. Lum, Soju Chang, Antonella Folgori, Alfredo Nicosia, Guido Massaccesi, Michael Forman, Katherine Wagner, Marc G. Ghany, Alice Asher, Linda C. Giudice, T. Jake Liang, Elaine Thomas, Stefania Capone, William O. Osburn, Rebecca T. Veenhuis, Lan Lin, Richard L. Gorman, Michael T. Melia, Ventzislav Vassilev, Page, K., Melia, M. T., Veenhuis, R. T., Winter, M., Rousseau, K. E., Massaccesi, G., Osburn, W. O., Forman, M., Thomas, E., Thornton, K., Wagner, K., Vassilev, V., Lin, L., Lum, P. J., Giudice, L. C., Stein, E., Asher, A., Chang, S., Gorman, R., Ghany, M. G., Liang, T. J., Wierzbicki, M. R., Scarselli, E., Nicosia, A., Folgori, A., Capone, S., and Cox, A. L.

Subjects
Male, Adenoviruses, and promotion of well-being, T-Lymphocytes, Disease, Substance Abuse, Intravenou, 030204 cardiovascular system & hematology, Medical and Health Sciences, law.invention, Hepatitis, 0302 clinical medicine, Immunogenicity, Vaccine, Randomized controlled trial, law, Medicine, 030212 general & internal medicine, Young adult, Chronic, Substance Abuse, Intravenous, Vaccines, Vaccines, Synthetic, Immunogenicity, Liver Disease, Incidence, Pan troglodyte, Substance Abuse, General Medicine, Hepatitis C, Middle Aged, Infectious Diseases, 3.4 Vaccines, 5.1 Pharmaceuticals, 6.1 Pharmaceuticals, HIV/AIDS, Female, Genetic Vector, Development of treatments and therapeutic interventions, Intravenous, Infection, Human, Biotechnology, Adult, Viral Hepatitis Vaccines, medicine.medical_specialty, Adolescent, Pan troglodytes, Clinical Trials and Supportive Activities, Chronic Liver Disease and Cirrhosis, Genetic Vectors, Virus, Article, Vaccine Related, 03 medical and health sciences, Young Adult, Hepatitis - C, Double-Blind Method, Clinical Research, Internal medicine, General & Internal Medicine, Animals, Humans, Animal, business.industry, Prevention, Synthetic, Evaluation of treatments and therapeutic interventions, Hepatitis C Antibodies, Hepatitis C, Chronic, medicine.disease, Prevention of disease and conditions, Clinical trial, Regimen, Emerging Infectious Diseases, Good Health and Well Being, T-Lymphocyte, Adenoviruses, Simian, Immunization, Hepatitis C Antibodie, business, Simian, Digestive Diseases, Vaccine, Viral Hepatitis Vaccine
Abstract

BACKGROUND: A safe and effective vaccine to prevent chronic hepatitis C virus (HCV) infection is a critical component of efforts to eliminate the disease. METHODS: In this phase 1–2 randomized, double-blind, placebo-controlled trial, we evaluated a recombinant chimpanzee adenovirus 3 vector priming vaccination followed by a recombinant modified vaccinia Ankara boost; both vaccines encode HCV nonstructural proteins. Adults who were considered to be at risk for HCV infection on the basis of a history of recent injection drug use were randomly assigned (in a 1:1 ratio) to receive vaccine or placebo on days 0 and 56. Vaccine-related serious adverse events, severe local or systemic adverse events, and laboratory adverse events were the primary safety end points. The primary efficacy end point was chronic HCV infection, defined as persistent viremia for 6 months. RESULTS: A total of 548 participants underwent randomization, with 274 assigned to each group. There was no significant difference in the incidence of chronic HCV infection between the groups. In the per-protocol population, chronic HCV infection developed in 14 participants in each group (hazard ratio [vaccine vs. placebo], 1.53; 95% confidence interval [CI], 0.66 to 3.55; vaccine efficacy, −53%; 95% CI, −255 to 34). In the modified intention-to-treat population, chronic HCV infection developed in 19 participants in the vaccine group and 17 in placebo group (hazard ratio, 1.66; 95% CI, 0.79 to 3.50; vaccine efficacy, −66%; 95% CI, −250 to 21). The geometric mean peak HCV RNA level after infection differed between the vaccine group and the placebo group (152.51×10(3) IU per milliliter and 1804.93×10(3) IU per milliliter, respectively). T-cell responses to HCV were detected in 78% of the participants in the vaccine group. The percentages of participants with serious adverse events were similar in the two groups. CONCLUSIONS: In this trial, the HCV vaccine regimen did not cause serious adverse events, produced HCV-specific T-cell responses, and lowered the peak HCV RNA level, but it did not prevent chronic HCV infection. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT01436357.)

Published
2021

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