Hepatitis APhase 4NCT01865968
Comparison of Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines in Young Adults
A Phase 4 study testing Inactivated HAV vaccine and Live attenuated HAV vaccine in people with Hepatitis A, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
A phase IV, randomization, single center, controlled clinical trial to compare the safety, immunogenicity,three-year immune persistence of inactivated hepatitis A vaccine (HAV) with one- or two-dose regimen and live attenuated HAV with one-dose regimen in Chinese young adults, and to evaluate the immunogenicity of a… Read more about this study
- Who is it for?
- Ages 16 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis A
- What is being tested?
- Inactivated HAV vaccine and Live attenuated HAV vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 1 siteChina
- Study dates
- Oct 2008to Sep 2012
- 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 16 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy undergraduate students aged 16 to 25 years
- Sign the informed consent
- Provide ID
Who cannot join
- Axillary temperature > 37.0 centigrade at the time of dosing
- Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
- Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- Autoimmune disease or immunodeficiency
- Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders)
- Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
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- History or family history of convulsions, epilepsy, brain disease and psychiatric
- History of any blood products within 3 months
- Administration of any other investigational research agents within 30 days
- Administration of any live attenuated vaccine within 30 days
- Administration of subunit or inactivated vaccines within 14 days
- 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
- anti-HBsAg positive
- anti-HAV positive
- Pregnancy test result is positive
Trial locations and contacts
1 site in 1 country.
China1 site
Nanchang Center for Disease prevention and Control
Nanchang, Jiangxi, 330000
About this study
Official title: Phase IV Trial to Compare the Safety, Immunogenicity,Three-year Immune Persistence of Inactivated Hepatitis A Vaccine (HAV) With One- or Two-dose Regimen and Live Attenuated HAV With One-dose Regimen in Chinese Young Adults, and to Evaluate the Immunogenicity of a Booster Dose.
A phase IV, randomization, single center, controlled clinical trial to compare the safety, immunogenicity,three-year immune persistence of inactivated hepatitis A vaccine (HAV) with one- or two-dose regimen and live attenuated HAV with one-dose regimen in Chinese young adults, and to evaluate the immunogenicity of a booster dose.
Read the detailed description
Healthy undergraduate students aged 16 to 25 years with anti-HAV negative were randomly divided into three groups. Group A and B were administrated with one-dose inactivated and live attenuated hepatitis A vaccines respectively; Group C was immunized with two doses of an inactivated vaccine with 6 months apart. Blood samples were collected at month 1, and 12, 24 and 36 for anti-HAV titers determination. Safety observation in 30 minutes' duration after vaccinations and injection-site reactions and systemic reactions for three consecutive days were recorded to assess the safety of investigational vaccines. At Month 36, subjects who received one dose of inactivated or live attenuated HAV were administrated a booster dose and then were taken blood samples one month later for anti-HAV titers determination.
- Conditions
- Hepatitis A
- Being tested
- Inactivated HAV vaccine, Live attenuated HAV vaccine
- Keywords
- inactivated HAV vaccine; live attenuated HAV vaccine; immunogenicity; safety
- Medical subject headings
- Hepatitis A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated HAV vaccineBiological
Also called Inactivated hepatitis A vaccines
Hepatitis A vaccine (Healive), 500 u per dose per 0.5 millilitre. Vaccines will be administered with one-dose or two-dose regimen of the arm 6 months apart in the deltoid muscle.
Live attenuated HAV vaccineBiological
Also called Live attenuated hepatitis A vaccines
Live attenuated hepatitis A vaccine, 6.50 lgCCID50 per dose per 0.5 millilitre. Vaccines will be administered with one-dose regimen in the deltoid muscle.
| Study group | Role | What they receive |
|---|---|---|
| Inactivated HAV vaccine | Experimental | Healthy undergraduate students aged 16 to 25 years with anti-HAV negative received inactivated HAV vaccine containing 500u/vial with one-dose regimen. Receives: Biological: Inactivated HAV vaccine |
| Live attenuated HAV vaccine | Active comparator | Healthy undergraduate students aged 16 to 25 years with anti-HAV negative received live attenuated HAV vaccine containing 6.50 lgCCID50/vial with one-dose regimen. Receives: Biological: Live attenuated HAV vaccine |
| Two-dose inactivated HAV vaccine | Experimental | Healthy undergraduate students aged 16 to 25 years with anti-HAV negative received inactivated HAV vaccine containing 500u/vial with two-dose regimen. Receives: Biological: Inactivated HAV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of antibody to hepatitis A virus
Anti-HAV antibody geometric mean concentrations pre-vaccination, and at month 1, and 12, 24 and 36, and 1 months (month 37) after the booster vaccination.
Measured: 37 months
Secondary outcomes (1)
reported side effects and adverse events
After each dose, solicited injection-site and general adverse events (AEs) were recorded for 7 days and unsolicited AEs were recorded for 28 days.
Measured: 37 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startOct 2008
- Primary completionDec 2011
- Study completionSep 2012
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.
- More trials run by Sinovac Biotech Co., LtdThe sponsor's other registered studies.
- 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
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hui Zhuang, Ph.D, MD, Principal investigator, Medical school of Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865968
- Sponsor's protocol ID
- PRO-HA-4009
- Status last verified
- May 2013
- First submitted
- 28 May 2013
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Liu XE, Chen HY, Liao Z, Zhou Y, Wen H, Peng S, Liu Y, Li R, Li J, Zhuang H. Comparison of Immunogenicity Between Inactivated and Live Attenuated Hepatitis A Vaccines Among Young Adults: A 3-Year Follow-up Study. J Infect Dis. 2015 Oct 15;212(8):1232-6. doi: 10.1093/infdis/jiv213. Epub 2015 May 12.
PubMed 25969561
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Trial to Compare the Safety, Immunogenicity,Three-year Immune Persistence of Inactivated Hepatitis A Vaccine (HAV) With One- or Two-dose Regimen and Live Attenuated HAV With One-dose Regimen in Chinese Young Adults, and to Evaluate the Immunogenicity of a Booster Dose.
- ClinicalTrials.gov ID
- NCT01865968
- Acronym / sponsor ID
- PRO-HA-4009
- Conditions
- Hepatitis A
- Keywords
- inactivated HAV vaccine; live attenuated HAV vaccine; immunogenicity; safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 31 May 2013 (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.
A phase IV, randomization, single center, controlled clinical trial to compare the safety, immunogenicity,three-year immune persistence of inactivated hepatitis A vaccine (HAV) with one- or two-dose regimen and live attenuated HAV with one-dose regimen in Chinese young adults, and to evaluate the immunogenicity of a booster dose.
Detailed description
Healthy undergraduate students aged 16 to 25 years with anti-HAV negative were randomly divided into three groups. Group A and B were administrated with one-dose inactivated and live attenuated hepatitis A vaccines respectively; Group C was immunized with two doses of an inactivated vaccine with 6 months apart. Blood samples were collected at month 1, and 12, 24 and 36 for anti-HAV titers determination. Safety observation in 30 minutes' duration after vaccinations and injection-site reactions and systemic reactions for three consecutive days were recorded to assess the safety of investigational vaccines. At Month 36, subjects who received one dose of inactivated or live attenuated HAV were administrated a booster dose and then were taken blood samples one month later for anti-HAV titers determination.
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 |
|---|---|---|
| Inactivated HAV vaccine | Experimental | Biological: Inactivated HAV vaccineHealthy undergraduate students aged 16 to 25 years with anti-HAV negative received inactivated HAV vaccine containing 500u/vial with one-dose regimen. |
| Live attenuated HAV vaccine | Active comparator | Biological: Live attenuated HAV vaccineHealthy undergraduate students aged 16 to 25 years with anti-HAV negative received live attenuated HAV vaccine containing 6.50 lgCCID50/vial with one-dose regimen. |
| Two-dose inactivated HAV vaccine | Experimental | Biological: Inactivated HAV vaccineHealthy undergraduate students aged 16 to 25 years with anti-HAV negative received inactivated HAV vaccine containing 500u/vial with two-dose regimen. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Healthy undergraduate students aged 16 to 25 years
- Sign the informed consent
- Provide ID
Key exclusion criteria (15 listed)
- Axillary temperature > 37.0 centigrade at the time of dosing
- Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
- Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- Autoimmune disease or immunodeficiency
- Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders)
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 |
|---|---|---|
| Inactivated HAV vaccineAlso: Inactivated hepatitis A vaccinesHepatitis A vaccine (Healive), 500 u per dose per 0.5 millilitre. Vaccines will be administered with one-dose or two-dose regimen of the arm 6 months apart in the deltoid muscle. | Biological | Inactivated HAV vaccine, Two-dose inactivated HAV vaccine |
| Live attenuated HAV vaccineAlso: Live attenuated hepatitis A vaccinesLive attenuated hepatitis A vaccine, 6.50 lgCCID50 per dose per 0.5 millilitre. Vaccines will be administered with one-dose regimen in the deltoid muscle. | Biological | Live attenuated HAV vaccine |
Primary outcome
concentration of antibody to hepatitis A virus
Time frame: 37 months
Anti-HAV antibody geometric mean concentrations pre-vaccination, and at month 1, and 12, 24 and 36, and 1 months (month 37) after the booster vaccination.
1 secondary outcome
reported side effects and adverse events
Time frame: 37 months
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 14 May 2015.
- Derived from this study: PubMed 25969561Liu XE, Chen HY, Liao Z, Zhou Y, Wen H, Peng S, Liu Y, Li R, Li J, Zhuang H. Comparison of Immunogenicity Between Inactivated and Live Attenuated Hepatitis A Vaccines Among Young Adults: A 3-Year Follow-up Study. J Infect Dis. 2015 Oct 15;212(8):1232-6. doi: 10.1093/infdis/jiv213. Epub 2015 May 12.
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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.
Hui Zhuang, Ph.D, MD principal investigator
Medical school of Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inactivated HAV vaccine and Live attenuated HAV vaccine in people with Hepatitis A, run by Sinovac Biotech Co., Ltd 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 3 inclusion and 15 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 14 May 2015. 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 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?
concentration of antibody to hepatitis A virus (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 NCT01865968, 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 14 May 2015.