Hepatitis EPhase 1NCT02603055
A Clinical Trial to Evaluate a Recombinant Hepatitis E Vaccine in Healthy Adults
A Phase 1 study testing 30μg/0.5ml Hepatitis E vaccine and 30μg/0.5ml Recombinant Hepatitis E vaccine in people with Hepatitis E, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial summary
Hepatitis E is characteristic by sporadic and local epidemic around the world, and mainly infects adults aged 15 to 40 years old, resulting in the infection rate ranged from 1% to 15%. The investigational hepatitis E vaccine is a recombinant aluminium-adjuvant hepatitis E 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?
- 30μg/0.5ml Hepatitis E vaccine and 30μg/0.5ml Recombinant Hepatitis E vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Aug 2016
- Phase
- Phase 1
- 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
- Aged between 16 and 65 years with normal intelligence.
- Negative in antibody against hepatitis E test.
- No plan to go out for a long time within 9 months.
- Able to understand the content of informed consent and willing to sign the informed consent
- General good health as established by medical history and physical examination.
- Able and willing to complete all the secluded study process during the whole study follow-up period.
- No history of hepatitis B, hepatitis C and hepatitis E(Patients diagnosed as hepatitis B, hepatitis C and hepatitis E by town or above)
- Axillary temperature ≤37.0°C on the day of enrollment
Who cannot join
- Woman who is pregnant, breast-feeding or planning to be pregnant during the study period
- Allergic history of any vaccination or drugs, or allergic to any ingredient of the Hepatitis E vaccine
- History of serious adverse reactions after vaccination, such as allergies, urticaria, breathing difficulties, angioneurotic oedema or abdominal pain
- Autoimmune disease or immunodeficiency
- Asthma that was unstable and need emergency treatment, hospitalization, oral or intravenous corticosteroid within two years
- Type I or II diabetes, not including gestational diabetes
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- History of thyroidectomy, or need treatment for thyroid disease in the past 12 months
- History of serious angioneurotic edema in the past 3 years, or need treatment for it in the past 2 years
- Severe hypertension, with the blood pressure still more than 150/100 mmHg after drug maintenance treatment
- Abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or coagulation disorders diagnosed by the doctor.
- Patients who are active or not have a definite cure of malignant tumors, or who may recur in the study period.
- Epilepsy, not including alcohol epilepsy in the first 3 years abstinence or simple epilepsy without the need of treatment in the past 3 years
- Asplenia or functional asplenia, or asplenia and splenectomy under any circumstances
- Guillain Barre Syndrome
- Prior administration of immunodepressant, cytotoxic or corticosteroids (not including corticosteroid therapy for allergic rhinitis and acute non concurrent dermatitis )treatment in last 6 months
- Prior administration of immune globulin in last 3 months
- Prior administration of other research medicines in last 1 month
- Prior administration of attenuated vaccine in last 1 month
- Prior administration of subunit or inactivated vaccine in last 14 days, such as pneumococcal Vaccine
- Current anti-tuberculosis prophylaxis or therapy
- Fever (axillary temperature 38.0℃) in 3 days before vaccination or any acute disease, systemic application of antibiotics or antiviral therapy in the past five days
- Unable to comply with the study requirements due to the psychological situation, a past or present history of mental disease, two-stage affective psychosis which were not well controlled in the past two years; mental disease need medical treatment, and have suicidal tendency over the past five years
- Any condition that in the opinion of the investigators may interfere with the evaluation of study objectives
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, 210009
About this study
Official title: A Phase Ib Single Center, Randomized, Blinding, Parallel-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Hepatitis E Vaccine in Healthy Adults Aged 16 to 65 Years Old in China
Hepatitis E is characteristic by sporadic and local epidemic around the world, and mainly infects adults aged 15 to 40 years old, resulting in the infection rate ranged from 1% to 15%. The investigational hepatitis E vaccine is a recombinant aluminium-adjuvant hepatitis E vaccine.
This is a single center, randomized, blinding, parallel-controlled phase Ib clinical trial. This study will determine the safety and immunogenicity of the investigational recombinant hepatitis E vaccine in healthy adults between 16 and 65 years.
- Conditions
- Hepatitis E
- Being tested
- 30μg/0.5ml Hepatitis E vaccine, 30μg/0.5ml Recombinant Hepatitis E vaccine
- Keywords
- Safety, immunogenicity, Hepatitis E
- Medical subject headings
- Hepatitis E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30μg/0.5ml Hepatitis E vaccineBiological
three doses, 30μg/0.5ml per dose
30μg/0.5ml Recombinant Hepatitis E vaccineBiological
30μg/0.5ml Hepatitis E vaccine developed by Xiamen innovax biotech Co.,Ltd.,three doses, 30μg/0.5ml per dose
| Study group | Role | What they receive |
|---|---|---|
| 30μg/0.5ml Hepatitis E vaccine | Experimental | three doses, 30μg/0.5ml per dose Receives: Biological: 30μg/0.5ml Hepatitis E vaccine |
| 30μg/0.5ml Recombinant Hepatitis E vaccine | Active comparator | 30μg/0.5ml Hepatitis E vaccine developed by Xiamen innovax biotech Co., Ltd. three doses, 30μg/0.5ml per dose Receives: Biological: 30μg/0.5ml Recombinant Hepatitis E vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse reactions after vaccination
Occurrence of adverse reactions within 7 days after each vaccination with the Recombinant Hepatitis E vaccine.
Measured: within 7 days after each vaccination
The geometric mean concentration of antibody against Hepatitis E responses to the Hepatitis E vaccine
Antibody against Hepatitis E responses to the Hepatitis E vaccine at 7 months after the first vaccination
Measured: 7 months after the first vaccination
Secondary outcomes (3)
Occurrence of adverse events after each vaccination
Occurrence of adverse events within 28 days after each vaccination with the Hepatitis E vaccine.
Measured: within 28 days after each vaccination
Occurrence of serious adverse events after the vaccination.
Occurrence of serious adverse events within 12 months after the first vaccination with the Hepatitis E vaccine.
Measured: within 12 months after the first vaccination
The positive rates of antibody against Hepatitis E responses to the Hepatitis E vaccine.
The positive rates of antibody against Hepatitis E responses to the Hepatitis E vaccine at 7 months after the first vaccination.
Measured: 7 months after the first vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startJul 2015
- Primary completionApr 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Collaborators
- Changchun Institute of Biological Products Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603055
- Sponsor's protocol ID
- JSVCT025
- Status last verified
- Aug 2016
- First submitted
- 10 Nov 2015
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Single Center, Randomized, Blinding, Parallel-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Hepatitis E Vaccine in Healthy Adults Aged 16 to 65 Years Old in China
- ClinicalTrials.gov ID
- NCT02603055
- Acronym / sponsor ID
- JSVCT025
- Conditions
- Hepatitis E
- Keywords
- Safety, immunogenicity, Hepatitis E
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Collaborators
- Changchun Institute of Biological Products Co., Ltd.
- Study start
- Jul 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 11 Nov 2015 (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.
Hepatitis E is characteristic by sporadic and local epidemic around the world, and mainly infects adults aged 15 to 40 years old, resulting in the infection rate ranged from 1% to 15%. The investigational hepatitis E vaccine is a recombinant aluminium-adjuvant hepatitis E vaccine.
This is a single center, randomized, blinding, parallel-controlled phase Ib clinical trial. This study will determine the safety and immunogenicity of the investigational recombinant hepatitis E vaccine in healthy adults between 16 and 65 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30μg/0.5ml Hepatitis E vaccine | Experimental | Biological: 30μg/0.5ml Hepatitis E vaccinethree doses, 30μg/0.5ml per dose |
| 30μg/0.5ml Recombinant Hepatitis E vaccine | Active comparator | Biological: 30μg/0.5ml Recombinant Hepatitis E vaccine30μg/0.5ml Hepatitis E vaccine developed by Xiamen innovax biotech Co., Ltd. three doses, 30μg/0.5ml per dose |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Aged between 16 and 65 years with normal intelligence.
- Negative in antibody against hepatitis E test.
- No plan to go out for a long time within 9 months.
- Able to understand the content of informed consent and willing to sign the informed consent
- General good health as established by medical history and physical examination.
Key exclusion criteria (23 listed)
- Woman who is pregnant, breast-feeding or planning to be pregnant during the study period
- Allergic history of any vaccination or drugs, or allergic to any ingredient of the Hepatitis E vaccine
- History of serious adverse reactions after vaccination, such as allergies, urticaria, breathing difficulties, angioneurotic oedema or abdominal pain
- Autoimmune disease or immunodeficiency
- Asthma that was unstable and need emergency treatment, hospitalization, oral or intravenous corticosteroid within two years
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 |
|---|---|---|
| 30μg/0.5ml Hepatitis E vaccinethree doses, 30μg/0.5ml per dose | Biological | 30μg/0.5ml Hepatitis E vaccine |
| 30μg/0.5ml Recombinant Hepatitis E vaccine30μg/0.5ml Hepatitis E vaccine developed by Xiamen innovax biotech Co.,Ltd.,three doses, 30μg/0.5ml per dose | Biological | 30μg/0.5ml Recombinant Hepatitis E vaccine |
Primary outcome
Occurrence of adverse reactions after vaccination
Time frame: within 7 days after each vaccination
Occurrence of adverse reactions within 7 days after each vaccination with the Recombinant Hepatitis E vaccine.
The geometric mean concentration of antibody against Hepatitis E responses to the Hepatitis E vaccine
Time frame: 7 months after the first vaccination
Antibody against Hepatitis E responses to the Hepatitis E vaccine at 7 months after the first vaccination
3 secondary outcomes
Occurrence of adverse events after each vaccination
Time frame: within 28 days after each vaccination
Occurrence of serious adverse events after the vaccination.
Time frame: within 12 months after the first vaccination
The positive rates of antibody against Hepatitis E responses to the Hepatitis E vaccine.
Time frame: 7 months after the first vaccination
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 1 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 30μg/0.5ml Hepatitis E vaccine and 30μg/0.5ml Recombinant Hepatitis E vaccine in people with Hepatitis E, run by Jiangsu Province Centers for Disease Control and Prevention 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 8 inclusion and 23 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 1 Sep 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Occurrence of adverse reactions after vaccination (time frame: within 7 days after each vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2016.