Liver DiseasesSIMPLENCT05007665
Safety and Immune Response of COVID-19 Vaccination in Patients With Chronic Liver Diseases
An observational study of Liver Diseases and Covid19, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
On 11 February 2020, the International Committee for the Classification of Viruses named the disease caused by SAＲS-CoV-2 infection in humans as the new coronavirus pneumonia (coronavirus disease 2019, COVID-19). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases, Covid19, Adverse Reaction to Vaccine
- What is being tested?
- SARS-COV-2 VACCINE
- Type of treatment
- Vaccines
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with chronic liver disease vaccinated with SARS-Cov-2 vaccine.
Who may be able to join
- Healthy group were as follows: no history of hepatitis, no history of liver cirrhosis, no history of liver cancer and receiving the whole-course COVID-19 vaccination.
- Patients with chronic liver disease diagnosed clinically or pathologically and receiving the whole-course COVID-19 vaccination.
Who cannot join
- Patients previously diagnosed or with a history of contact with confirmed cases
- Patients with contraindications for vaccination.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
DACHUAN CAI, PH D, 18323409779, 597521685@qq.com
XIAOFENG SHI, PH D, 13983869655, sxf7776@163.com
About this study
Official title: Safety and Immune Response of COVID-19 Vaccination in Patients With Chronic Liver （CQMU）
On 11 February 2020, the International Committee for the Classification of Viruses named the disease caused by SAＲS-CoV-2 infection in humans as the new coronavirus pneumonia (coronavirus disease 2019, COVID-19). Due to the characteristics of liver microcirculation disturbance and immune function disorder in patients with chronic liver diseases (such as immune liver disease, chronic hepatitis C, liver cirrhosis, liver cancer, etc.), those patients has a higher risk of infection than the general population during the epidemic period. More attention should be paid to personal protection and disease prevention. Vaccination of COVID-19 vaccine can effectively prevent COVID-19 virus infection and delay or prevent patients from developing into critical illness and reduce mortality. To evaluate the safety and effectiveness of COVID-19 vaccine in those patients with chronic liver diseases, and to guide the COVID-19 vaccination more scientifically, reasonably and effectively, this study was carried out.
Read the detailed description
Due to the characteristics of liver microcirculation disturbance and immune function disorder in patients with chronic liver diseases (such as autoimmune liver disease, chronic hepatitis C, liver cirrhosis, liver cancer, etc.), those patients has a higher risk of infection than the general population during the epidemic period. More attention should be paid to personal protection and disease prevention. Vaccination of COVID-19 / influenza vaccine can effectively prevent COVID-19 / influenza virus infection and delay or prevent patients from developing into critical illness and reduce mortality. The safety and effectiveness of COVID-19 / influenza vaccine in this population were evaluated in order to play a scientific and theoretical supporting role in guiding COVID-19 vaccination more scientifically, reasonably and effectively. The samples of this study were collected and tested in the second affiliated Hospital of Chongqing Medical University. Patients with contraindications for vaccination will be excluded. The detected indexes included blood routine test, liver function, COVID-19 antibody titer, antibody duration and other indexes of healthy people (control group) and patients with chronic liver disease before and after vaccination ( 1, 3, 6, 12 months after vaccination). The adverse reactions related to the vaccine were recorded.
- Conditions
- Liver Diseases, Covid19, Adverse Reaction to Vaccine
- Being tested
- SARS-COV-2 VACCINE
- Medical subject headings
- Liver Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-COV-2 VACCINEBiological
the antibody titer and adverse reactions were observed.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Liver Diseases Patients/Healthy People | Chronic hepatitis (B OR C) , autoimmune hepatitis, liver cirrhosis, primary hepatocellular carcinoma Receives: Biological: SARS-COV-2 VACCINE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events after injection.
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
Measured: 4 weeks after vaccination
Number of participants with adverse events after injection.
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
Measured: 12 weeks after vaccination
Number of participants with adverse events after injection.
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
Measured: 24 weeks after vaccination
Number of participants with adverse events after injection.
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
Measured: 48 weeks after vaccination
Secondary outcomes (4)
Titer and duration of COVID-19 antibody production after vaccination
The titer and duration of COVID-19 antibody were produced at 4 weeks
Measured: 4 weeks after vaccination
Titer and duration of COVID-19 antibody production after vaccination
The titer and duration of COVID-19 antibody were produced at 12 weeks
Measured: 12 weeks after vaccination
Titer and duration of COVID-19 antibody production after vaccination
The titer and duration of COVID-19 antibody were produced at 24 weeks
Measured: 24 weeks after vaccination
Titer and duration of COVID-19 antibody production after vaccination
The titer and duration of COVID-19 antibody were produced at 48 weeks after vaccination, so as to clarify whether the level of immune response to COVID-19 vaccine was affected in people with chronic liver disease.
Measured: 48 weeks after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start1 Jul 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Ren, PH D, Principal investigator, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007665
- Sponsor's protocol ID
- 2021-48
- Acronym
- SIMPLE
- Status last verified
- Aug 2021
- First submitted
- 9 Aug 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PubMed 31986264Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
PubMed 31978945Zhang C, Shi L, Wang FS. Liver injury in COVID-19: management and challenges. Lancet Gastroenterol Hepatol. 2020 May;5(5):428-430. doi: 10.1016/S2468-1253(20)30057-1. Epub 2020 Mar 4. No abstract available.
PubMed 32145190Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
PubMed 32109013Grohskopf LA, Alyanak E, Broder KR, Walter EB, Fry AM, Jernigan DB. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2019-20 Influenza Season. MMWR Recomm Rep. 2019 Aug 23;68(3):1-21. doi: 10.15585/mmwr.rr6803a1.
PubMed 31441906Xu X, Sun J, Nie S, Li H, Kong Y, Liang M, Hou J, Huang X, Li D, Ma T, Peng J, Gao S, Shao Y, Zhu H, Lau JY, Wang G, Xie C, Jiang L, Huang A, Yang Z, Zhang K, Hou FF. Seroprevalence of immunoglobulin M and G antibodies against SARS-CoV-2 in China. Nat Med. 2020 Aug;26(8):1193-1195. doi: 10.1038/s41591-020-0949-6. Epub 2020 Jun 5.
PubMed 32504052Shi Q, Hu Y, Peng B, Tang XJ, Wang W, Su K, Luo C, Wu B, Zhang F, Zhang Y, Anderson B, Zhong XN, Qiu JF, Yang CY, Huang AL. Effective control of SARS-CoV-2 transmission in Wanzhou, China. Nat Med. 2021 Jan;27(1):86-93. doi: 10.1038/s41591-020-01178-5. Epub 2020 Nov 30.
PubMed 33257893Long QX, Tang XJ, Shi QL, Li Q, Deng HJ, Yuan J, Hu JL, Xu W, Zhang Y, Lv FJ, Su K, Zhang F, Gong J, Wu B, Liu XM, Li JJ, Qiu JF, Chen J, Huang AL. Clinical and immunological assessment of asymptomatic SARS-CoV-2 infections. Nat Med. 2020 Aug;26(8):1200-1204. doi: 10.1038/s41591-020-0965-6. Epub 2020 Jun 18.
PubMed 32555424Long QX, Liu BZ, Deng HJ, Wu GC, Deng K, Chen YK, Liao P, Qiu JF, Lin Y, Cai XF, Wang DQ, Hu Y, Ren JH, Tang N, Xu YY, Yu LH, Mo Z, Gong F, Zhang XL, Tian WG, Hu L, Zhang XX, Xiang JL, Du HX, Liu HW, Lang CH, Luo XH, Wu SB, Cui XP, Zhou Z, Zhu MM, Wang J, Xue CJ, Li XF, Wang L, Li ZJ, Wang K, Niu CC, Yang QJ, Tang XJ, Zhang Y, Liu XM, Li JJ, Zhang DC, Zhang F, Liu P, Yuan J, Li Q, Hu JL, Chen J, Huang AL. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med. 2020 Jun;26(6):845-848. doi: 10.1038/s41591-020-0897-1. Epub 2020 Apr 29.
PubMed 32350462Zhou Y, Chen Z, He Y, Peng X, Chang Y, Tan A, Li H, Cai D, Hu P, Chen M, Peng M, Xu H, Ren H. Humoral immune responses to inactivated COVID-19 vaccine up to 1 year in children with chronic hepatitis B infection. Front Cell Infect Microbiol. 2023 Jun 29;13:1201101. doi: 10.3389/fcimb.2023.1201101. eCollection 2023.
PubMed 37457966Chen Z, Huang T, He T, Zha G, Zhu Q, Zhang G, Xiang D, Chen M, Li H, Ling N, Lan Y, Shi X, Zhang D, Xu P, Pan Q, Song R, Cao J, Zhang Y, Xiang H, Feng Y, Yang Z, Zhang B, Shen W, Cai D, Peng M, Hu P, Ren H. Humoral responses after primary and booster SARS-CoV-2 inactivated vaccination in patients with chronic hepatitis B virus infection: A longitudinal observational study. J Med Virol. 2023 Apr;95(4):e28695. doi: 10.1002/jmv.28695.
PubMed 36946505He T, Ling N, Zhang G, Xiang D, Hu P, Peng M, Cai D, Zhang D, Chen M, Ren H. Decreased antibody response to influenza vaccine with an enhanced antibody response to subsequent SARS-CoV-2 vaccination in patients with chronic hepatitis B virus infection. Immun Inflamm Dis. 2023 Jan;11(1):e759. doi: 10.1002/iid3.759.
PubMed 36705404He T, Zhou Y, Xu P, Ling N, Chen M, Huang T, Zhang B, Yang Z, Ao L, Li H, Chen Z, Zhang D, Shi X, Lei Y, Wang Z, Zeng W, Hu P, Lan Y, Zhou Z, Kang J, Huang Y, Shi T, Pan Q, Zhu Q, Ran X, Zhang Y, Song R, Xiang D, Xiao S, Zhang G, Shen W, Peng M, Cai D, Ren H. Safety and antibody response to inactivated COVID-19 vaccine in patients with chronic hepatitis B virus infection. Liver Int. 2022 Jun;42(6):1287-1296. doi: 10.1111/liv.15173. Epub 2022 Feb 28.
PubMed 35107848
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immune Response of COVID-19 Vaccination in Patients With Chronic Liver （CQMU）
- ClinicalTrials.gov ID
- NCT05007665
- Acronym / sponsor ID
- SIMPLE / 2021-48
- Conditions
- Liver Diseases, Covid19, Adverse Reaction to Vaccine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
On 11 February 2020, the International Committee for the Classification of Viruses named the disease caused by SAＲS-CoV-2 infection in humans as the new coronavirus pneumonia (coronavirus disease 2019, COVID-19). Due to the characteristics of liver microcirculation disturbance and immune function disorder in patients with chronic liver diseases (such as immune liver disease, chronic hepatitis C, liver cirrhosis, liver cancer, etc.), those patients has a higher risk of infection than the general population during the epidemic period. More attention should be paid to personal protection and disease prevention. Vaccination of COVID-19 vaccine can effectively prevent COVID-19 virus infection and delay or prevent patients from developing into critical illness and reduce mortality. To evaluate the safety and effectiveness of COVID-19 vaccine in those patients with chronic liver diseases, and to guide the COVID-19 vaccination more scientifically, reasonably and effectively, this study was carried out.
Detailed description
Due to the characteristics of liver microcirculation disturbance and immune function disorder in patients with chronic liver diseases (such as autoimmune liver disease, chronic hepatitis C, liver cirrhosis, liver cancer, etc.), those patients has a higher risk of infection than the general population during the epidemic period. More attention should be paid to personal protection and disease prevention. Vaccination of COVID-19 / influenza vaccine can effectively prevent COVID-19 / influenza virus infection and delay or prevent patients from developing into critical illness and reduce mortality. The safety and effectiveness of COVID-19 / influenza vaccine in this population were evaluated in order to play a scientific and theoretical supporting role in guiding COVID-19 vaccination more scientifically, reasonably and effectively. The samples of this study were collected and tested in the second affiliated Hospital of Chongqing Medical University. Patients with contraindications for vaccination will be excluded. The detected indexes included blood routine test, liver function, COVID-19 antibody titer, antibody duration and other indexes of healthy people (control group) and patients with chronic liver disease before and after vaccination ( 1, 3, 6, 12 months after vaccination). The adverse reactions related to the vaccine were recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Liver Diseases Patients/Healthy People | – | Biological: SARS-COV-2 VACCINEChronic hepatitis (B OR C) , autoimmune hepatitis, liver cirrhosis, primary hepatocellular carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic liver disease vaccinated with SARS-Cov-2 vaccine.
Key inclusion criteria (2 listed)
- Healthy group were as follows: no history of hepatitis, no history of liver cirrhosis, no history of liver cancer and receiving the whole-course COVID-19 vaccination.
- Patients with chronic liver disease diagnosed clinically or pathologically and receiving the whole-course COVID-19 vaccination.
Key exclusion criteria (2 listed)
- Patients previously diagnosed or with a history of contact with confirmed cases
- Patients with contraindications for vaccination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-COV-2 VACCINEthe antibody titer and adverse reactions were observed. | Biological | Chronic Liver Diseases Patients/Healthy People |
Primary outcome
Number of participants with adverse events after injection.
Time frame: 4 weeks after vaccination
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
Number of participants with adverse events after injection.
Time frame: 12 weeks after vaccination
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
Number of participants with adverse events after injection.
Time frame: 24 weeks after vaccination
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
Number of participants with adverse events after injection.
Time frame: 48 weeks after vaccination
The vaccine-related adverse reactions (such as fever, dizziness, fatigue, myalgia, etc.) were recorded and its safety was evaluated.
4 secondary outcomes
Titer and duration of COVID-19 antibody production after vaccination
Time frame: 4 weeks after vaccination
Titer and duration of COVID-19 antibody production after vaccination
Time frame: 12 weeks after vaccination
Titer and duration of COVID-19 antibody production after vaccination
Time frame: 24 weeks after vaccination
Titer and duration of COVID-19 antibody production after vaccination
Time frame: 48 weeks after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Background: PubMed 31986264Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
- Background: PubMed 31978945Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
- Background: PubMed 32145190Zhang C, Shi L, Wang FS. Liver injury in COVID-19: management and challenges. Lancet Gastroenterol Hepatol. 2020 May;5(5):428-430. doi: 10.1016/S2468-1253(20)30057-1. Epub 2020 Mar 4. No abstract available.
- Background: PubMed 32109013Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
- Background: PubMed 31441906Grohskopf LA, Alyanak E, Broder KR, Walter EB, Fry AM, Jernigan DB. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2019-20 Influenza Season. MMWR Recomm Rep. 2019 Aug 23;68(3):1-21. doi: 10.15585/mmwr.rr6803a1.
- Results publication: PubMed 32504052Xu X, Sun J, Nie S, Li H, Kong Y, Liang M, Hou J, Huang X, Li D, Ma T, Peng J, Gao S, Shao Y, Zhu H, Lau JY, Wang G, Xie C, Jiang L, Huang A, Yang Z, Zhang K, Hou FF. Seroprevalence of immunoglobulin M and G antibodies against SARS-CoV-2 in China. Nat Med. 2020 Aug;26(8):1193-1195. doi: 10.1038/s41591-020-0949-6. Epub 2020 Jun 5.
- Results publication: PubMed 33257893Shi Q, Hu Y, Peng B, Tang XJ, Wang W, Su K, Luo C, Wu B, Zhang F, Zhang Y, Anderson B, Zhong XN, Qiu JF, Yang CY, Huang AL. Effective control of SARS-CoV-2 transmission in Wanzhou, China. Nat Med. 2021 Jan;27(1):86-93. doi: 10.1038/s41591-020-01178-5. Epub 2020 Nov 30.
- Results publication: PubMed 32555424Long QX, Tang XJ, Shi QL, Li Q, Deng HJ, Yuan J, Hu JL, Xu W, Zhang Y, Lv FJ, Su K, Zhang F, Gong J, Wu B, Liu XM, Li JJ, Qiu JF, Chen J, Huang AL. Clinical and immunological assessment of asymptomatic SARS-CoV-2 infections. Nat Med. 2020 Aug;26(8):1200-1204. doi: 10.1038/s41591-020-0965-6. Epub 2020 Jun 18.
- Results publication: PubMed 32350462Long QX, Liu BZ, Deng HJ, Wu GC, Deng K, Chen YK, Liao P, Qiu JF, Lin Y, Cai XF, Wang DQ, Hu Y, Ren JH, Tang N, Xu YY, Yu LH, Mo Z, Gong F, Zhang XL, Tian WG, Hu L, Zhang XX, Xiang JL, Du HX, Liu HW, Lang CH, Luo XH, Wu SB, Cui XP, Zhou Z, Zhu MM, Wang J, Xue CJ, Li XF, Wang L, Li ZJ, Wang K, Niu CC, Yang QJ, Tang XJ, Zhang Y, Liu XM, Li JJ, Zhang DC, Zhang F, Liu P, Yuan J, Li Q, Hu JL, Chen J, Huang AL. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med. 2020 Jun;26(6):845-848. doi: 10.1038/s41591-020-0897-1. Epub 2020 Apr 29.
- Derived from this study: PubMed 37457966Zhou Y, Chen Z, He Y, Peng X, Chang Y, Tan A, Li H, Cai D, Hu P, Chen M, Peng M, Xu H, Ren H. Humoral immune responses to inactivated COVID-19 vaccine up to 1 year in children with chronic hepatitis B infection. Front Cell Infect Microbiol. 2023 Jun 29;13:1201101. doi: 10.3389/fcimb.2023.1201101. eCollection 2023.
- Derived from this study: PubMed 36946505Chen Z, Huang T, He T, Zha G, Zhu Q, Zhang G, Xiang D, Chen M, Li H, Ling N, Lan Y, Shi X, Zhang D, Xu P, Pan Q, Song R, Cao J, Zhang Y, Xiang H, Feng Y, Yang Z, Zhang B, Shen W, Cai D, Peng M, Hu P, Ren H. Humoral responses after primary and booster SARS-CoV-2 inactivated vaccination in patients with chronic hepatitis B virus infection: A longitudinal observational study. J Med Virol. 2023 Apr;95(4):e28695. doi: 10.1002/jmv.28695.
- Derived from this study: PubMed 36705404He T, Ling N, Zhang G, Xiang D, Hu P, Peng M, Cai D, Zhang D, Chen M, Ren H. Decreased antibody response to influenza vaccine with an enhanced antibody response to subsequent SARS-CoV-2 vaccination in patients with chronic hepatitis B virus infection. Immun Inflamm Dis. 2023 Jan;11(1):e759. doi: 10.1002/iid3.759.
- World Health Organization (WHO) Influenza (Seasonal) 2018 Available fromLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Liver Diseases
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Ren, PH D principal investigator
The Second Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases and Covid19, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DACHUAN CAI, PH D (18323409779, 597521685@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events after injection. (time frame: 4 weeks after vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05007665, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.