Hepatitis APhase 4NCT02601040
Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines
A Phase 4 study testing Attenuated Hepatitis A Vaccine, H2 Strain, Inactivated Hepatitis A Vaccine, Lu8 Strain and Group A Meningococcal Polysaccharide vaccine in people with Hepatitis A, run by Jiangsu Province Centers for Disease Control and Prevention at 2 sites in China.
Trial summary
The main purpose of this study was to evaluate the safety and immunogenicity of Immunogenicity of Inactivated and Live Attenuated Hepatitis A Vaccines for healthy Chinese people. Read more about this study
- Who is it for?
- Ages 18 months to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis A
- What is being tested?
- Attenuated Hepatitis A Vaccine, H2 Strain, Inactivated Hepatitis A Vaccine, Lu8 Strain and Group A Meningococcal Polysaccharide vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13,500 participants
- Where
- 2 sitesChina
- Study dates
- Nov 2011to Oct 2015
- Phase
- Phase 4
- 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 months to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Only subjects fulfilling all of the following criteria will be eligible for the study:
- People aged from 18 months to 65 years old.
- The subjects or subjects' guardians are able to understand and sign the informed consent
- The subjects or subjects' guardians allow to comply with the requirements of the protocol
- Subjects with temperature <=37.0°C on axillary setting
- The subjects have signed informed consent already
Who cannot join
- Subjects will not be eligible for the study if any of the following criteria is met:
- Subject who has a medical history of serious disease including Tumor, autoimmune disease, progressive atherosclerosis diseases or complications of diabetes, chronic obstructive pulmonary disease (copd), kidney disease, congestive heart failure etc.
- Have a history of neurological symptoms or signs
- Have medical history or family history relating to allergies, seizures, epilepsy, brain and spirit etc.
- Suffering from serious chronic diseases
- Suffering from known or suspected of diseases including respiratory diseases, acute infection , mothers have HIV infection, cardiovascular disease, severe hypertension, skin diseases, malignant tumor
Show all 17Show fewer
- Allergic to any ingredient in research, history of allergies to any vaccination (always), especially for people allergic to high protein food like eggs and milk
- Any prior known or suspected damage or abnormal immune function. As for patients who are treated with immune inhibitors or immune enhancer medicine, accept with immunoglobin, blood products and plasma extraction within 3 months
- Any prior diseases including human immunodeficiency virus infection or related
- Bleeding constitution or prolong bleeding time situation
- Accept hepatitis A vaccination within a month
- Received vaccines, other immune globulin, any research drug injections in the past 4 weeks
- People who had any acute illness, needed systemic antibiotics or antiviral treatment in the past 7 days
- Caught a fever with axillary temperature 38°C or higher in past 3 days
- Take part in another clinical researchers
- Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
- Pregnancy test result is positive
Trial locations and contacts
2 sites in 1 country.
China2 sites
Institute of Medical Biology -Chinese Academy of Medical Sciences
Kunming, Yunnan, 650118
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, 210009
About this study
Official title: Phase IV Clinical Trial to Assess the Safety, Immunogenicity,Three-year Immune Persistence of Inactivated Hepatitis A Vaccine (HAV) and Live Attenuated HAV Vaccine in Health Chinese Children and Adult
The main purpose of this study was to evaluate the safety and immunogenicity of Immunogenicity of Inactivated and Live Attenuated Hepatitis A Vaccines for healthy Chinese people.
- Conditions
- Hepatitis A
- Being tested
- Attenuated Hepatitis A Vaccine, H2 Strain, Inactivated Hepatitis A Vaccine, Lu8 Strain, Group A Meningococcal Polysaccharide vaccine
- Keywords
- Safety, Immunogenicity, Vaccine, Hepatitis A
- Medical subject headings
- Hepatitis A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attenuated Hepatitis A Vaccine, H2 StrainBiological
6.50 lgCCID50/ml in babies aged 18-35 months\6.50 lgCCID50/ml in children aged 3-16 years \6.50 lgCCID50/ml in adults aged 17 up to 65 years old
Inactivated Hepatitis A Vaccine, Lu8 StrainBiological
320EU/Vial in babies aged 18-35 months \320EU/Vial in children aged 3-16 years \640EU/Vial in adults aged 17 up to 65 years old\boost at month 6\two-dose
Group A Meningococcal Polysaccharide vaccineBiological
30µg Group A Meningococcal Polysaccharide vaccine in subjects aged 18 months-65 years old
| Study group | Role | What they receive |
|---|---|---|
| Attenuated Hepatitis A Vaccine, H2 Strain | Experimental | Health subjects received attenuated Hepatitis A vaccine intramuscularly in the deltoid region. Receives: Biological: Attenuated Hepatitis A Vaccine, H2 Strain |
| Inactivated Hepatitis A Vaccine, Lu8 Strain | Experimental | Health subjects received inactivated Hepatitis A vaccine intramuscularly in the deltoid region. Receives: Biological: Inactivated Hepatitis A Vaccine, Lu8 Strain |
| Group A Meningococcal Polysaccharide vaccine | Placebo comparator | Health subjects received Group A Meningococcal Polysaccharide vaccine intramuscularly in the deltoid region. Receives: Biological: Group A Meningococcal Polysaccharide vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of hepatitis A antibody concentration
Changes of anti Hepatitis A antibody geometric mean concentrations at pre-vaccination, month 1,12, 24, 36, and 1 months after the booster vaccination.
Measured: 37 months
Secondary outcomes (1)
Incidence of adverse events
Compare incidence of all the solicited events(AEs), unsolicited AEs and serious AEs within 28 days post-vaccination.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study startNov 2011
- Primary completionJun 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis AStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Collaborators
- Institute of Medical Biology, Chinese Academy of Medical Sciences
- Responsible party
- Sponsor
- Investigators
- Jingsi Yang, PhD, Study chair, Institude of Medical Biology, Chinese Academy of Medical SciencesFubao Ma, Study director, Jiangsu Province Centers for Disease Control and PreventionQiangming Sun, PhD, Principal investigator, Institude of Medical Biology, Chinese Academy of Medical SciencesGuodong Kang, Principal investigator, Jiangsu Province Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601040
- Sponsor's protocol ID
- JSEPI-004
- Status last verified
- Oct 2015
- First submitted
- 25 Oct 2015
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang X, Luo J, Ma F, Kang G, Ding Z, Pan Y, Zhao Y, Chen J, Feng K, Yan L, Zhang J, Li L, Lan Q, Li D, Yang X, Li G, Yang J, Sun Q. The Safety, Immunogenicity, and Immunopersistence of Hepatitis A Vaccine in HBs-Ag-Positive Participants: A Retrospective Study. Front Cell Infect Microbiol. 2021 Jun 17;11:672221. doi: 10.3389/fcimb.2021.672221. eCollection 2021.
PubMed 34222044
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Clinical Trial to Assess the Safety, Immunogenicity,Three-year Immune Persistence of Inactivated Hepatitis A Vaccine (HAV) and Live Attenuated HAV Vaccine in Health Chinese Children and Adult
- ClinicalTrials.gov ID
- NCT02601040
- Acronym / sponsor ID
- JSEPI-004
- Conditions
- Hepatitis A
- Keywords
- Safety, Immunogenicity, Vaccine, Hepatitis A
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13,500 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Collaborators
- Institute of Medical Biology, Chinese Academy of Medical Sciences
- Study start
- Nov 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 10 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.
The main purpose of this study was to evaluate the safety and immunogenicity of Immunogenicity of Inactivated and Live Attenuated Hepatitis A Vaccines for healthy Chinese people.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Attenuated Hepatitis A Vaccine, H2 Strain | Experimental | Biological: Attenuated Hepatitis A Vaccine, H2 StrainHealth subjects received attenuated Hepatitis A vaccine intramuscularly in the deltoid region. |
| Inactivated Hepatitis A Vaccine, Lu8 Strain | Experimental | Biological: Inactivated Hepatitis A Vaccine, Lu8 StrainHealth subjects received inactivated Hepatitis A vaccine intramuscularly in the deltoid region. |
| Group A Meningococcal Polysaccharide vaccine | Placebo comparator | Biological: Group A Meningococcal Polysaccharide vaccineHealth subjects received Group A Meningococcal Polysaccharide vaccine intramuscularly in the deltoid region. |
Who may qualify
- Ages
- 18 months to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Only subjects fulfilling all of the following criteria will be eligible for the study:
- People aged from 18 months to 65 years old.
- The subjects or subjects' guardians are able to understand and sign the informed consent
- The subjects or subjects' guardians allow to comply with the requirements of the protocol
- Subjects with temperature <=37.0°C on axillary setting
Key exclusion criteria (17 listed)
- Subjects will not be eligible for the study if any of the following criteria is met:
- Subject who has a medical history of serious disease including Tumor, autoimmune disease, progressive atherosclerosis diseases or complications of diabetes, chronic obstructive pulmonary disease (copd), kidney disease, congestive heart failure etc.
- Have a history of neurological symptoms or signs
- Have medical history or family history relating to allergies, seizures, epilepsy, brain and spirit etc.
- Suffering from serious chronic diseases
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 |
|---|---|---|
| Attenuated Hepatitis A Vaccine, H2 Strain6.50 lgCCID50/ml in babies aged 18-35 months\6.50 lgCCID50/ml in children aged 3-16 years \6.50 lgCCID50/ml in adults aged 17 up to 65 years old | Biological | Attenuated Hepatitis A Vaccine, H2 Strain |
| Inactivated Hepatitis A Vaccine, Lu8 Strain320EU/Vial in babies aged 18-35 months \320EU/Vial in children aged 3-16 years \640EU/Vial in adults aged 17 up to 65 years old\boost at month 6\two-dose | Biological | Inactivated Hepatitis A Vaccine, Lu8 Strain |
| Group A Meningococcal Polysaccharide vaccine30µg Group A Meningococcal Polysaccharide vaccine in subjects aged 18 months-65 years old | Biological | Group A Meningococcal Polysaccharide vaccine |
Primary outcome
Changes of hepatitis A antibody concentration
Time frame: 37 months
Changes of anti Hepatitis A antibody geometric mean concentrations at pre-vaccination, month 1,12, 24, 36, and 1 months after the booster vaccination.
1 secondary outcome
Incidence of adverse events
Time frame: 28 days
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 10 Nov 2015.
- Derived from this study: PubMed 34222044Wang X, Luo J, Ma F, Kang G, Ding Z, Pan Y, Zhao Y, Chen J, Feng K, Yan L, Zhang J, Li L, Lan Q, Li D, Yang X, Li G, Yang J, Sun Q. The Safety, Immunogenicity, and Immunopersistence of Hepatitis A Vaccine in HBs-Ag-Positive Participants: A Retrospective Study. Front Cell Infect Microbiol. 2021 Jun 17;11:672221. doi: 10.3389/fcimb.2021.672221. eCollection 2021.
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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.
Jingsi Yang, PhD study chair
Institude of Medical Biology, Chinese Academy of Medical Sciences
Fubao Ma study director
Jiangsu Province Centers for Disease Control and Prevention
Qiangming Sun, PhD principal investigator
Institude of Medical Biology, Chinese Academy of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Attenuated Hepatitis A Vaccine, H2 Strain, Inactivated Hepatitis A Vaccine, Lu8 Strain and Group A Meningococcal Polysaccharide vaccine in people with Hepatitis A, run by Jiangsu Province Centers for Disease Control and Prevention at 2 sites 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 6 inclusion and 17 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 10 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Changes of hepatitis A antibody concentration (time frame: 37 months). 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 NCT02601040, which also lists 1 linked publication.
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 10 Nov 2015.