Hepatitis EPhase 3NCT01014845
Clinical Trial of Recombinant Hepatitis E Vaccine
A Phase 3 study testing hepatitis E vaccine and Hepatitis B vaccine in people with Hepatitis E, run by Xiamen University at 1 site in China.
Trial summary
The primary purpose of this study is to determine whether the preventive hepatitis E are effective in the prevention of hepatitis E occurring at least 30 days after the administration of the third dose of vaccine. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis E
- What is being tested?
- hepatitis E vaccine and Hepatitis B vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112,604 participants
- Where
- 1 siteChina
- Study dates
- Aug 2007to Oct 2017
- Phase
- Phase 3
- 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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy people aged from 16 years to 65 years old at the time of the first vaccination, normal intelligence and agree to sign the informed consent form.
- Subjects will reside in the study region in the next 19 months.
- Free of history of hepatitis B or hepatitis E.
- Can comply with the request of study.
- Axillary temperature is below 37 degree centigrade.
Who cannot join
- For dose 1:
- Having other vaccine or immunoglobulin within two weeks;
- Having allergic history to vaccine and medicine
- Eclampsia, epilepsy, encephalopathy and history of mental disease or family;
- Thrombocytopenia or other disturbance of blood coagulation which would lead to muscle injection taboo;
- Fixed or suspected deficiency of immunologic function, containing immunosuppressant treatment(radiation therapy, chemical treatment, steroid hormone, antimetabolites, cytotoxic drugs), genetic defect(e.g. fabism), HIV or other factors;
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- congenital malformation, eccyliosis or severe chronic disease(e.g. Down Syndrome, diabetes, sickle cell anemia or mental disease);
- fixed or suspected other disease including fever, active infection, liver and kidney disease, angiocardiopathy, malignancy, acute and chronic disease;
- joining other clinical study undergoing;
- women pregnant or in lactation.
- For dose 2 or 3:
- Severe allergy for dose 1 or 2;
- Severe adverse reaction associated with last vaccination;
- New occurrence of symptoms meet dose 1 exclusion criteria after the first dose.
Trial locations and contacts
1 site in 1 country.
China1 site
Dongtai Center for Disease Control and Prevention
Dongtai, Jiangsu, 224200
About this study
Official title: A Phase 3, Randomized, Double-blind, Placebo (Hepatitis B Vaccine) Controlled Clinical Trial of Recombinant (E. Coli) Hepatitis E Vaccine
The primary purpose of this study is to determine whether the preventive hepatitis E are effective in the prevention of hepatitis E occurring at least 30 days after the administration of the third dose of vaccine.
The secondary purpose of this study is to to evaluate the safety and immunogenicity and immunopersistence of the study vaccine.
The initial study is planed to be ended on month 19 and the results were analysed and used for registration purpose. The extended study will be continued to assess the long-term efficacy, immunogenicity and safety.
Read the detailed description
Participants were randomly allocated into two groups, one received Hepatitis E vaccine and the other received hepatitis B vaccine. The study was carried out with two stages. In the first stage (phase 3a), 2 645 subjects was enrolled and actively monitored for solicited adverse events for 1 month after each injection. Serum samples from all the subjects were collected on day 0, 7m, 13m, 19m and timely after then to evaluate the immunogenicity and immuno-persistency. In the second stage (phase 3b), another 109 959 subjects was enrolled and monitored for solicited adverse events for 1 month after each injection. Serum samples from 9764 subjects among the phase 3b participants were collected on day 0, 7m, 19m and timely after then to evaluate the immunogenicity and immuno-persistency. Serious adverse events during the trial were followed up.
Suspected hepatitis cases were identified through an established active hepatitis surveillance system. The sentinels of the system comprised all the healthcare facilities in the field. Suspected hepatitis was defined as when patients presented with systemic symptoms such as fatigue and/or loss of appetite for more than 3 days with alanine aminotransferase (ALT) exceeding 2.5 fold upper limit of normal range (ULN). Paired sera were obtained from these patients at the time of presentation and 2-6 weeks later. Sera were tested for the HEV antibodies and HEV-RNA.
- Conditions
- Hepatitis E
- Being tested
- hepatitis E vaccine, Hepatitis B vaccine
- Keywords
- hepatitis E, vaccine, efficacy
- Medical subject headings
- Hepatitis E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatitis E vaccineBiological
Also called Hecolin
Intramuscularly given at 0, 1, 6m for three doses.
Hepatitis B vaccineBiological
Intramuscularly given at 0, 1, 6m for three doses.
| Study group | Role | What they receive |
|---|---|---|
| Hepatitis E vaccine | Experimental | Hepatitis E vaccine, containing 30mcg of HEV239 recombinant antigen adsorbed to alum adjuvant suspended in 0.5ml phosphate buffer, was given at 0, 1, 6m for three doses. Receives: Biological: hepatitis E vaccine |
| HBV vaccine | Placebo comparator | Hepatitis B vaccine, containing 5mcg of HBsAg recombinant antigen adsorbed to alum adjuvant suspended in 0.5ml phosphate buffer, was given at 0, 1, 6m for three doses. Receives: Biological: Hepatitis B vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of confirmed hepatitis E cases
Measured: One year since one month post the third injection
Secondary outcomes (2)
IgG anti-HEV seroconversion rate
Measured: On one month post the third injection
Persistency of IgG anti-HEV
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study startAug 2007
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Hepatitis EStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112,604 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiamen University
- Sponsor type
- University, hospital or other
- Collaborators
- Xiamen Innovax Biotech Co., Ltd, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd., National Institute of Diagnostics and Vaccine Development in infectious disease, Jiangsu Province Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Jun Zhang, Xiamen University
- Investigators
- Jun Zhang, M.D., Study director, National Institute of Diagnostics and Vaccine Development in infectious disease, Xiamen UniversityFeng-Cai Zhu, M.D., Principal investigator, Jiangsu Provincial Center for Disease Control and Prevention, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014845
- Sponsor's protocol ID
- Pro-HE-003
- Other IDs
- 2006AA02A209
- Status last verified
- Jul 2020
- First submitted
- 13 Nov 2009
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang J, Liu CB, Li RC, Li YM, Zheng YJ, Li YP, Luo D, Pan BB, Nong Y, Ge SX, Xiong JH, Shih JW, Ng MH, Xia NS. Randomized-controlled phase II clinical trial of a bacterially expressed recombinant hepatitis E vaccine. Vaccine. 2009 Mar 13;27(12):1869-74. doi: 10.1016/j.vaccine.2008.12.061. Epub 2009 Jan 23.
PubMed 19168109Li S, Tang X, Seetharaman J, Yang C, Gu Y, Zhang J, Du H, Shih JW, Hew CL, Sivaraman J, Xia N. Dimerization of hepatitis E virus capsid protein E2s domain is essential for virus-host interaction. PLoS Pathog. 2009 Aug;5(8):e1000537. doi: 10.1371/journal.ppat.1000537. Epub 2009 Aug 7.
PubMed 19662165He S, Miao J, Zheng Z, Wu T, Xie M, Tang M, Zhang J, Ng MH, Xia N. Putative receptor-binding sites of hepatitis E virus. J Gen Virol. 2008 Jan;89(Pt 1):245-249. doi: 10.1099/vir.0.83308-0.
PubMed 18089748Li SW, Zhang J, Li YM, Ou SH, Huang GY, He ZQ, Ge SX, Xian YL, Pang SQ, Ng MH, Xia NS. A bacterially expressed particulate hepatitis E vaccine: antigenicity, immunogenicity and protectivity on primates. Vaccine. 2005 Apr 22;23(22):2893-901. doi: 10.1016/j.vaccine.2004.11.064.
PubMed 15780738Zhang J, Gu Y, Ge SX, Li SW, He ZQ, Huang GY, Zhuang H, Ng MH, Xia NS. Analysis of hepatitis E virus neutralization sites using monoclonal antibodies directed against a virus capsid protein. Vaccine. 2005 Apr 22;23(22):2881-92. doi: 10.1016/j.vaccine.2004.11.065.
PubMed 15780737Li SW, Zhang J, He ZQ, Gu Y, Liu RS, Lin J, Chen YX, Ng MH, Xia NS. Mutational analysis of essential interactions involved in the assembly of hepatitis E virus capsid. J Biol Chem. 2005 Feb 4;280(5):3400-6. doi: 10.1074/jbc.M410361200. Epub 2004 Nov 22.
PubMed 15557331Zhu FC, Zhang J, Zhang XF, Zhou C, Wang ZZ, Huang SJ, Wang H, Yang CL, Jiang HM, Cai JP, Wang YJ, Ai X, Hu YM, Tang Q, Yao X, Yan Q, Xian YL, Wu T, Li YM, Miao J, Ng MH, Shih JW, Xia NS. Efficacy and safety of a recombinant hepatitis E vaccine in healthy adults: a large-scale, randomised, double-blind placebo-controlled, phase 3 trial. Lancet. 2010 Sep 11;376(9744):895-902. doi: 10.1016/S0140-6736(10)61030-6. Epub 2010 Aug 20.
PubMed 20728932Wu T, Huang SJ, Zhu FC, Zhang XF, Ai X, Yan Q, Wang ZZ, Yang CL, Jiang HM, Liu XH, Guo M, Du HL, Ng MH, Zhang J, Xia NS. Immunogenicity and safety of hepatitis E vaccine in healthy hepatitis B surface antigen positive adults. Hum Vaccin Immunother. 2013 Nov;9(11):2474-9. doi: 10.4161/hv.25814. Epub 2013 Jul 25.
PubMed 23887167Wu T, Zhu FC, Huang SJ, Zhang XF, Wang ZZ, Zhang J, Xia NS. Safety of the hepatitis E vaccine for pregnant women: a preliminary analysis. Hepatology. 2012 Jun;55(6):2038. doi: 10.1002/hep.25522. No abstract available.
PubMed 22161542Zhu FC, Huang SJ, Wu T, Zhang XF, Wang ZZ, Ai X, Yan Q, Yang CL, Cai JP, Jiang HM, Wang YJ, Ng MH, Zhang J, Xia NS. Epidemiology of zoonotic hepatitis E: a community-based surveillance study in a rural population in China. PLoS One. 2014 Jan 31;9(1):e87154. doi: 10.1371/journal.pone.0087154. eCollection 2014.
PubMed 24498033Zhang J, Zhang XF, Zhou C, Wang ZZ, Huang SJ, Yao X, Liang ZL, Wu T, Li JX, Yan Q, Yang CL, Jiang HM, Huang HJ, Xian YL, Shih JW, Ng MH, Li YM, Wang JZ, Zhu FC, Xia NS. Protection against hepatitis E virus infection by naturally acquired and vaccine-induced immunity. Clin Microbiol Infect. 2014 Jun;20(6):O397-405. doi: 10.1111/1469-0691.12419. Epub 2013 Nov 18.
PubMed 24118636Huang S, Zhang X, Su Y, Zhuang C, Tang Z, Huang X, Chen Q, Zhu K, Hu X, Ying D, Liu X, Jiang H, Zang X, Wang Z, Yang C, Liu D, Wang Y, Tang Q, Shen W, Cao H, Pan H, Ge S, Huang Y, Wu T, Zheng Z, Zhu F, Zhang J, Xia N. Long-term efficacy of a recombinant hepatitis E vaccine in adults: 10-year results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024 Mar 2;403(10429):813-823. doi: 10.1016/S0140-6736(23)02234-1. Epub 2024 Feb 19.
PubMed 38387470Kmush BL, Yu H, Huang S, Zhang X, Wu T, Nelson KE, Labrique AB. Long-term Antibody Persistence After Hepatitis E Virus Infection and Vaccination in Dongtai, China. Open Forum Infect Dis. 2019 Mar 28;6(4):ofz144. doi: 10.1093/ofid/ofz144. eCollection 2019 Apr.
PubMed 31024978Chen S, Zhou Z, Wei FX, Huang SJ, Tan Z, Fang Y, Zhu FC, Wu T, Zhang J, Xia NS. Modeling the long-term antibody response of a hepatitis E vaccine. Vaccine. 2015 Aug 7;33(33):4124-9. doi: 10.1016/j.vaccine.2015.06.050. Epub 2015 Jun 28.
PubMed 26126668Zhang J, Zhang XF, Huang SJ, Wu T, Hu YM, Wang ZZ, Wang H, Jiang HM, Wang YJ, Yan Q, Guo M, Liu XH, Li JX, Yang CL, Tang Q, Jiang RJ, Pan HR, Li YM, Shih JW, Ng MH, Zhu FC, Xia NS. Long-term efficacy of a hepatitis E vaccine. N Engl J Med. 2015 Mar 5;372(10):914-22. doi: 10.1056/NEJMoa1406011.
PubMed 25738667
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Placebo (Hepatitis B Vaccine) Controlled Clinical Trial of Recombinant (E. Coli) Hepatitis E Vaccine
- ClinicalTrials.gov ID
- NCT01014845
- Acronym / sponsor ID
- Pro-HE-003
- Conditions
- Hepatitis E
- Keywords
- hepatitis E, vaccine, efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112,604 participants (actual)
- Lead sponsor
- Xiamen UniversityUniversity, hospital or other
- Collaborators
- Xiamen Innovax Biotech Co., Ltd, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd., National Institute of Diagnostics and Vaccine Development in infectious disease, Jiangsu Province Centers for Disease Control and Prevention
- Study start
- Aug 2007
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 17 Nov 2009 (estimated)
- 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.
The primary purpose of this study is to determine whether the preventive hepatitis E are effective in the prevention of hepatitis E occurring at least 30 days after the administration of the third dose of vaccine.
The secondary purpose of this study is to to evaluate the safety and immunogenicity and immunopersistence of the study vaccine.
The initial study is planed to be ended on month 19 and the results were analysed and used for registration purpose. The extended study will be continued to assess the long-term efficacy, immunogenicity and safety.
Detailed description
Participants were randomly allocated into two groups, one received Hepatitis E vaccine and the other received hepatitis B vaccine. The study was carried out with two stages. In the first stage (phase 3a), 2 645 subjects was enrolled and actively monitored for solicited adverse events for 1 month after each injection. Serum samples from all the subjects were collected on day 0, 7m, 13m, 19m and timely after then to evaluate the immunogenicity and immuno-persistency. In the second stage (phase 3b), another 109 959 subjects was enrolled and monitored for solicited adverse events for 1 month after each injection. Serum samples from 9764 subjects among the phase 3b participants were collected on day 0, 7m, 19m and timely after then to evaluate the immunogenicity and immuno-persistency. Serious adverse events during the trial were followed up.
Suspected hepatitis cases were identified through an established active hepatitis surveillance system. The sentinels of the system comprised all the healthcare facilities in the field. Suspected hepatitis was defined as when patients presented with systemic symptoms such as fatigue and/or loss of appetite for more than 3 days with alanine aminotransferase (ALT) exceeding 2.5 fold upper limit of normal range (ULN). Paired sera were obtained from these patients at the time of presentation and 2-6 weeks later. Sera were tested for the HEV antibodies and HEV-RNA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hepatitis E vaccine | Experimental | Biological: hepatitis E vaccineHepatitis E vaccine, containing 30mcg of HEV239 recombinant antigen adsorbed to alum adjuvant suspended in 0.5ml phosphate buffer, was given at 0, 1, 6m for three doses. |
| HBV vaccine | Placebo comparator | Biological: Hepatitis B vaccineHepatitis B vaccine, containing 5mcg of HBsAg recombinant antigen adsorbed to alum adjuvant suspended in 0.5ml phosphate buffer, was given at 0, 1, 6m for three doses. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy people aged from 16 years to 65 years old at the time of the first vaccination, normal intelligence and agree to sign the informed consent form.
- Subjects will reside in the study region in the next 19 months.
- Free of history of hepatitis B or hepatitis E.
- Can comply with the request of study.
- Axillary temperature is below 37 degree centigrade.
Key exclusion criteria (14 listed)
- Having other vaccine or immunoglobulin within two weeks;
- Having allergic history to vaccine and medicine
- Eclampsia, epilepsy, encephalopathy and history of mental disease or family;
- Thrombocytopenia or other disturbance of blood coagulation which would lead to muscle injection taboo;
- Fixed or suspected deficiency of immunologic function, containing immunosuppressant treatment(radiation therapy, chemical treatment, steroid hormone, antimetabolites, cytotoxic drugs), genetic defect(e.g. fabism), HIV or other factors;
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 |
|---|---|---|
| hepatitis E vaccineAlso: HecolinIntramuscularly given at 0, 1, 6m for three doses. | Biological | Hepatitis E vaccine |
| Hepatitis B vaccineIntramuscularly given at 0, 1, 6m for three doses. | Biological | HBV vaccine |
Primary outcome
Rate of confirmed hepatitis E cases
Time frame: One year since one month post the third injection
2 secondary outcomes
IgG anti-HEV seroconversion rate
Time frame: On one month post the third injection
Persistency of IgG anti-HEV
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Background: PubMed 19168109Zhang J, Liu CB, Li RC, Li YM, Zheng YJ, Li YP, Luo D, Pan BB, Nong Y, Ge SX, Xiong JH, Shih JW, Ng MH, Xia NS. Randomized-controlled phase II clinical trial of a bacterially expressed recombinant hepatitis E vaccine. Vaccine. 2009 Mar 13;27(12):1869-74. doi: 10.1016/j.vaccine.2008.12.061. Epub 2009 Jan 23.
- Background: PubMed 19662165Li S, Tang X, Seetharaman J, Yang C, Gu Y, Zhang J, Du H, Shih JW, Hew CL, Sivaraman J, Xia N. Dimerization of hepatitis E virus capsid protein E2s domain is essential for virus-host interaction. PLoS Pathog. 2009 Aug;5(8):e1000537. doi: 10.1371/journal.ppat.1000537. Epub 2009 Aug 7.
- Background: PubMed 18089748He S, Miao J, Zheng Z, Wu T, Xie M, Tang M, Zhang J, Ng MH, Xia N. Putative receptor-binding sites of hepatitis E virus. J Gen Virol. 2008 Jan;89(Pt 1):245-249. doi: 10.1099/vir.0.83308-0.
- Background: PubMed 15780738Li SW, Zhang J, Li YM, Ou SH, Huang GY, He ZQ, Ge SX, Xian YL, Pang SQ, Ng MH, Xia NS. A bacterially expressed particulate hepatitis E vaccine: antigenicity, immunogenicity and protectivity on primates. Vaccine. 2005 Apr 22;23(22):2893-901. doi: 10.1016/j.vaccine.2004.11.064.
- Background: PubMed 15780737Zhang J, Gu Y, Ge SX, Li SW, He ZQ, Huang GY, Zhuang H, Ng MH, Xia NS. Analysis of hepatitis E virus neutralization sites using monoclonal antibodies directed against a virus capsid protein. Vaccine. 2005 Apr 22;23(22):2881-92. doi: 10.1016/j.vaccine.2004.11.065.
- Background: PubMed 15557331Li SW, Zhang J, He ZQ, Gu Y, Liu RS, Lin J, Chen YX, Ng MH, Xia NS. Mutational analysis of essential interactions involved in the assembly of hepatitis E virus capsid. J Biol Chem. 2005 Feb 4;280(5):3400-6. doi: 10.1074/jbc.M410361200. Epub 2004 Nov 22.
- Results publication: PubMed 20728932Zhu FC, Zhang J, Zhang XF, Zhou C, Wang ZZ, Huang SJ, Wang H, Yang CL, Jiang HM, Cai JP, Wang YJ, Ai X, Hu YM, Tang Q, Yao X, Yan Q, Xian YL, Wu T, Li YM, Miao J, Ng MH, Shih JW, Xia NS. Efficacy and safety of a recombinant hepatitis E vaccine in healthy adults: a large-scale, randomised, double-blind placebo-controlled, phase 3 trial. Lancet. 2010 Sep 11;376(9744):895-902. doi: 10.1016/S0140-6736(10)61030-6. Epub 2010 Aug 20.
- Results publication: PubMed 23887167Wu T, Huang SJ, Zhu FC, Zhang XF, Ai X, Yan Q, Wang ZZ, Yang CL, Jiang HM, Liu XH, Guo M, Du HL, Ng MH, Zhang J, Xia NS. Immunogenicity and safety of hepatitis E vaccine in healthy hepatitis B surface antigen positive adults. Hum Vaccin Immunother. 2013 Nov;9(11):2474-9. doi: 10.4161/hv.25814. Epub 2013 Jul 25.
- Results publication: PubMed 22161542Wu T, Zhu FC, Huang SJ, Zhang XF, Wang ZZ, Zhang J, Xia NS. Safety of the hepatitis E vaccine for pregnant women: a preliminary analysis. Hepatology. 2012 Jun;55(6):2038. doi: 10.1002/hep.25522. No abstract available.
- Results publication: PubMed 24498033Zhu FC, Huang SJ, Wu T, Zhang XF, Wang ZZ, Ai X, Yan Q, Yang CL, Cai JP, Jiang HM, Wang YJ, Ng MH, Zhang J, Xia NS. Epidemiology of zoonotic hepatitis E: a community-based surveillance study in a rural population in China. PLoS One. 2014 Jan 31;9(1):e87154. doi: 10.1371/journal.pone.0087154. eCollection 2014.
- Results publication: PubMed 24118636Zhang J, Zhang XF, Zhou C, Wang ZZ, Huang SJ, Yao X, Liang ZL, Wu T, Li JX, Yan Q, Yang CL, Jiang HM, Huang HJ, Xian YL, Shih JW, Ng MH, Li YM, Wang JZ, Zhu FC, Xia NS. Protection against hepatitis E virus infection by naturally acquired and vaccine-induced immunity. Clin Microbiol Infect. 2014 Jun;20(6):O397-405. doi: 10.1111/1469-0691.12419. Epub 2013 Nov 18.
- Derived from this study: PubMed 38387470Huang S, Zhang X, Su Y, Zhuang C, Tang Z, Huang X, Chen Q, Zhu K, Hu X, Ying D, Liu X, Jiang H, Zang X, Wang Z, Yang C, Liu D, Wang Y, Tang Q, Shen W, Cao H, Pan H, Ge S, Huang Y, Wu T, Zheng Z, Zhu F, Zhang J, Xia N. Long-term efficacy of a recombinant hepatitis E vaccine in adults: 10-year results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024 Mar 2;403(10429):813-823. doi: 10.1016/S0140-6736(23)02234-1. Epub 2024 Feb 19.
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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.
Jun Zhang, M.D. study director
National Institute of Diagnostics and Vaccine Development in infectious disease, Xiamen University
Feng-Cai Zhu, M.D. principal investigator
Jiangsu Provincial Center for Disease Control and Prevention, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing hepatitis E vaccine and Hepatitis B vaccine in people with Hepatitis E, run by Xiamen 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 5 inclusion and 14 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: finished, as of the sponsor's last update on 13 Jul 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of confirmed hepatitis E cases (time frame: One year since one month post the third injection). 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 NCT01014845, which also lists 15 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 13 Jul 2020.