Simulating rabies post-exposure prophylaxis among patients with human immunodeficiency virus infection using a six-dose Essen regimen administrated with human diploid cell vaccine: A single-arm pilot study in Chinese population

To explore the immunogencity and safety of HDCV using a six-dose Essen regimen in human immunodeficiency virus (HIV) infected patients. We conducted a single-arm pilot study by simulating post-exposure prophylaxis (PEP) in HIV-infected patients. All patients were administrated with HDCV using a 6-do...

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Main Authors: Huanyu Wu, Wei Ye, Xiaoming Deng, Lili Guo, Chao Chen, Hao Jiang
Format: Article
Language:English
Published: Taylor & Francis Group 2025-12-01
Series:Human Vaccines & Immunotherapeutics
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Online Access:https://www.tandfonline.com/doi/10.1080/21645515.2025.2500263
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author Huanyu Wu
Wei Ye
Xiaoming Deng
Lili Guo
Chao Chen
Hao Jiang
author_facet Huanyu Wu
Wei Ye
Xiaoming Deng
Lili Guo
Chao Chen
Hao Jiang
author_sort Huanyu Wu
collection DOAJ
description To explore the immunogencity and safety of HDCV using a six-dose Essen regimen in human immunodeficiency virus (HIV) infected patients. We conducted a single-arm pilot study by simulating post-exposure prophylaxis (PEP) in HIV-infected patients. All patients were administrated with HDCV using a 6-dose Essen regimen (consisting of 2 doses on day 0, and 4 doses each on day 3, 7, 14, and 28). Rabies virus-neutralizing antibody (RVNA) titers were detected on day 0, 7, 14, and 45, separately. The adverse reactions were also observed. In addition, we divided the patients with the baseline CD4+ T-cell counts of 500 cells/μL to examine the correlation between primary CD4+ T-cell counts and RVNA titers among HIV patients. Thirty patients included in the study were mostly male (96.7%), with a median age of 30.5 years and stable antiretroviral therapy (ART) treatment. Patients had RVNA titers of 0.84 IU/mL on day 7, 9.94 IU/mL on day 14, and 4.02 IU/mL on day 45 after vaccination, with significant differences between day 7 and day 14. The seroconversion rate reached 100% on day 14. Only three patients developed transient adverse reactions(including fever and redness, swelling, pain, and induration at the injection site). There was no significant difference in antibody titers and safety profile between patients with CD4+T-cell counts below and above 500 cells/μL. A favorable immune response was achieved in HIV patients using the six-dose Essen regimen with HDCV. The safety profile of HDCV is satisfactory, with no major adverse events.
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spelling doaj-art-4bd80425855f4ae787538be8055fbc972025-08-20T02:11:28ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2025-12-0121110.1080/21645515.2025.2500263Simulating rabies post-exposure prophylaxis among patients with human immunodeficiency virus infection using a six-dose Essen regimen administrated with human diploid cell vaccine: A single-arm pilot study in Chinese populationHuanyu Wu0Wei Ye1Xiaoming Deng2Lili Guo3Chao Chen4Hao Jiang5Department of Infectious Disease and Liver Disease, The Second Hospital of Nanjing, Affiliated to Nanjing University of Chinese Medicine, Nanjing, ChinaDepartment of Infectious Disease and Liver Disease, The Second Hospital of Nanjing, Affiliated to Nanjing University of Chinese Medicine, Nanjing, ChinaChengdu Kanghua Biological Products Co., Ltd., Chengdu, ChinaDepartment of Infection Management, The Second Hospital of Nanjing, Affiliated to Nanjing University of Chinese Medicine, Nanjing, ChinaDepartment of Emergency Medicine, The Second Hospital of Nanjing, Affiliated to Nanjing University of Chinese Medicine, Nanjing, ChinaDepartment of Emergency Medicine, The Second Hospital of Nanjing, Affiliated to Nanjing University of Chinese Medicine, Nanjing, ChinaTo explore the immunogencity and safety of HDCV using a six-dose Essen regimen in human immunodeficiency virus (HIV) infected patients. We conducted a single-arm pilot study by simulating post-exposure prophylaxis (PEP) in HIV-infected patients. All patients were administrated with HDCV using a 6-dose Essen regimen (consisting of 2 doses on day 0, and 4 doses each on day 3, 7, 14, and 28). Rabies virus-neutralizing antibody (RVNA) titers were detected on day 0, 7, 14, and 45, separately. The adverse reactions were also observed. In addition, we divided the patients with the baseline CD4+ T-cell counts of 500 cells/μL to examine the correlation between primary CD4+ T-cell counts and RVNA titers among HIV patients. Thirty patients included in the study were mostly male (96.7%), with a median age of 30.5 years and stable antiretroviral therapy (ART) treatment. Patients had RVNA titers of 0.84 IU/mL on day 7, 9.94 IU/mL on day 14, and 4.02 IU/mL on day 45 after vaccination, with significant differences between day 7 and day 14. The seroconversion rate reached 100% on day 14. Only three patients developed transient adverse reactions(including fever and redness, swelling, pain, and induration at the injection site). There was no significant difference in antibody titers and safety profile between patients with CD4+T-cell counts below and above 500 cells/μL. A favorable immune response was achieved in HIV patients using the six-dose Essen regimen with HDCV. The safety profile of HDCV is satisfactory, with no major adverse events.https://www.tandfonline.com/doi/10.1080/21645515.2025.2500263HDCVHIVsafetyCD4+T cell
spellingShingle Huanyu Wu
Wei Ye
Xiaoming Deng
Lili Guo
Chao Chen
Hao Jiang
Simulating rabies post-exposure prophylaxis among patients with human immunodeficiency virus infection using a six-dose Essen regimen administrated with human diploid cell vaccine: A single-arm pilot study in Chinese population
Human Vaccines & Immunotherapeutics
HDCV
HIV
safety
CD4+T cell
title Simulating rabies post-exposure prophylaxis among patients with human immunodeficiency virus infection using a six-dose Essen regimen administrated with human diploid cell vaccine: A single-arm pilot study in Chinese population
title_full Simulating rabies post-exposure prophylaxis among patients with human immunodeficiency virus infection using a six-dose Essen regimen administrated with human diploid cell vaccine: A single-arm pilot study in Chinese population
title_fullStr Simulating rabies post-exposure prophylaxis among patients with human immunodeficiency virus infection using a six-dose Essen regimen administrated with human diploid cell vaccine: A single-arm pilot study in Chinese population
title_full_unstemmed Simulating rabies post-exposure prophylaxis among patients with human immunodeficiency virus infection using a six-dose Essen regimen administrated with human diploid cell vaccine: A single-arm pilot study in Chinese population
title_short Simulating rabies post-exposure prophylaxis among patients with human immunodeficiency virus infection using a six-dose Essen regimen administrated with human diploid cell vaccine: A single-arm pilot study in Chinese population
title_sort simulating rabies post exposure prophylaxis among patients with human immunodeficiency virus infection using a six dose essen regimen administrated with human diploid cell vaccine a single arm pilot study in chinese population
topic HDCV
HIV
safety
CD4+T cell
url https://www.tandfonline.com/doi/10.1080/21645515.2025.2500263
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