Hepatitis BPhase 3NCT01349283
Immunogenicity and Safety of the Hepatitis B Vaccine Hepavax-Gene TF and a Comparator Hepatitis B Vaccine in Newborns
A Phase 3 study testing HepavaxGene (thiomersal free) and Engerix B in people with Hepatitis B, run by Crucell Holland BV at 1 site in China.
Trial summary
The primary purpose of this study is to determine whether HepavaxGene TF is non-inferior to the comparator vaccine both at impeding hepatitis B transmission from mothers positive for chronic hepatitis B (Stratum 1) to their children and also in terms of seroconversion rate in children of mothers negative for chronic… Read more about this study
- Who is it for?
- Ages Up to 1 dayHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- HepavaxGene (thiomersal free) and Engerix B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,738 participants
- Where
- 1 siteChina
- Study dates
- May 2011to Nov 2013
- 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 Up to 1 day
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Full-term neonates with gestational age from 37 weeks to 42 weeks;
- Apgar scores are no less than 7 at birth;
- Neonates with standard body temperature (auxiliary temperature < 37.1°);
- Neonates weighing ≥ 2,500 grams at birth;
- Neonates with icteric index within the normal range (physiologic jaundice is permitted);
- Informed consent form signed by parent/guardian;
- The requirements of the clinical trial protocol can be observed on the basis of the opinion of the investigator.
Who cannot join
- Subject's parent has a history of family diseases such as convulsion and brain diseases;
- Mothers have low immunologic function or a history of organ transplantation or hemodialysis;
- Subject's parent is allergic to any composition of Hepatitis B vaccine;
- A family history of thrombocytopenia, or other disturbance of blood coagulation, which may result in a contraindication for intramuscular injection;
- Known immunologic function damage;
- Mothers had received gamma globulin or immunoglobulin injection during pregnancy;
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- Any congenital malformation
- Known or suspected to suffer from diseases such as active infection and cardiovascular disease;
- Any condition believed by the investigator to have possible impact on trial evaluation.
Trial locations and contacts
1 site in 1 country.
China1 site
Center for Disease Control and Prevention Jiangsu Province
Nanjing, Jiangsu
About this study
Official title: A Prospective, Randomized, Double-blind, Parallel-group, Controlled Study of the Immunogenicity and Safety of the Recombinant Hepatitis B Vaccine (Hepavax-Gene TF) and a Comparator Univalent Hepatitis B Vaccine in Neonates
The primary purpose of this study is to determine whether HepavaxGene TF is non-inferior to the comparator vaccine both at impeding hepatitis B transmission from mothers positive for chronic hepatitis B (Stratum 1) to their children and also in terms of seroconversion rate in children of mothers negative for chronic hepatitis B (Stratum 2) one month after completion of the immunization schedule.
- Conditions
- Hepatitis B
- Being tested
- HepavaxGene (thiomersal free), Engerix B
- Keywords
- Hepatitis B Vaccine, Hepatitis B Virus, Antigen, Antibody, Vaccination
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepavaxGene (thiomersal free)Biological
10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6
Engerix BBiological
10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6
| Study group | Role | What they receive |
|---|---|---|
| HepavaxGene Stratum 1a | Experimental | Subjects of mothers with chronic hepatitis B (positive for both HBsAg and hepatitis B envelope antigen - HBeAg) Receives: Biological: HepavaxGene (thiomersal free) |
| Comparator vaccine Stratum 1a | Active comparator | Subjects of mothers with chronic hepatitis B (positive for both HBsAg and HBeAg) Receives: Biological: Engerix B |
| HepavaxGene Stratum 1b | Experimental | Subjects of mothers with chronic hepatitis B (positive for HBsAg only) Receives: Biological: HepavaxGene (thiomersal free) |
| Comparator vaccine Stratum 1b | Active comparator | Subjects of mothers with chronic hepatitis B (positive for HBsAg only) Receives: Biological: Engerix B |
| HepavaxGene Stratum 2 | Experimental | Subjects of mothers without chronic hepatitis B (negative for both HBsAg and HBeAg) Receives: Biological: HepavaxGene (thiomersal free) |
| Comparator vaccine Stratum 2 | Active comparator | Subjects of mothers without chronic hepatitis B (negative for both HBsAg and HBeAg) Receives: Biological: Engerix B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate for subjects in Stratum 2
Hepatitis B surface antibody (HBsAb) concentrations are measured from blood samples by standard enzyme linked immuno sorbent assay (ELISA) for subjects whose mothers are negative for chronic hepatitis B. Seroconversion rate is defined as HBsAb ≥10 mIU/mL.
Measured: Month 7
Positivity for HBsAg for subjects in Stratum 1
The presence of hepatitis B surface antigen (HBsAg), as determined by ELISA, for subjects whose mothers are positive for chronic hepatitis B
Measured: Month 2, Month 7 and Month 12
Secondary outcomes (4)
Seroconversion rate for subjects in Stratum 1
Seroconversion rate is defined as HBsAb concentrations from ELISA ≥10 mIU/mL
Measured: Month 7
Solicited adverse events
Local adverse events: pain, erythema, swelling at the injection site Systemic adverse events: irritability, sleepiness, change in eating/breast feeding habits, crying, fever [body temperature ≥38°C]
Measured: Days 1 to 4
Seroconversion rate for subjects in Stratum 1
Seroconversion rate is defined as HBsAb concentrations from ELISA ≥10 mIU/mL
Measured: Month 12
Positivity for HBsAg for subjects in Stratum 2
Measured: Months 2, 7 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2012
- Study completionNov 2013
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 BStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,738 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crucell Holland BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhu Fencai, MD, Principal investigator, Jiangsu Provincial Center for Disease Prevention and Control, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349283
- Sponsor's protocol ID
- HVG-V-A002
- Status last verified
- Jan 2013
- First submitted
- 5 May 2011
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhu F, Deckx H, Roten R, Michiels B, Sarnecki M. Comparative Efficacy, Safety and Immunogenicity of Hepavax-Gene TF and Engerix-B Recombinant Hepatitis B Vaccines in Neonates in China. Pediatr Infect Dis J. 2017 Jan;36(1):94-101. doi: 10.1097/INF.0000000000001361.
PubMed 27753794
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind, Parallel-group, Controlled Study of the Immunogenicity and Safety of the Recombinant Hepatitis B Vaccine (Hepavax-Gene TF) and a Comparator Univalent Hepatitis B Vaccine in Neonates
- ClinicalTrials.gov ID
- NCT01349283
- Acronym / sponsor ID
- HVG-V-A002
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B Vaccine, Hepatitis B Virus, Antigen, Antibody, Vaccination
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,738 participants (actual)
- Lead sponsor
- Crucell Holland BVIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 6 May 2011 (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 HepavaxGene TF is non-inferior to the comparator vaccine both at impeding hepatitis B transmission from mothers positive for chronic hepatitis B (Stratum 1) to their children and also in terms of seroconversion rate in children of mothers negative for chronic hepatitis B (Stratum 2) one month after completion of the immunization schedule.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| HepavaxGene Stratum 1a | Experimental | Biological: HepavaxGene (thiomersal free)Subjects of mothers with chronic hepatitis B (positive for both HBsAg and hepatitis B envelope antigen - HBeAg) |
| Comparator vaccine Stratum 1a | Active comparator | Biological: Engerix BSubjects of mothers with chronic hepatitis B (positive for both HBsAg and HBeAg) |
| HepavaxGene Stratum 1b | Experimental | Biological: HepavaxGene (thiomersal free)Subjects of mothers with chronic hepatitis B (positive for HBsAg only) |
| Comparator vaccine Stratum 1b | Active comparator | Biological: Engerix BSubjects of mothers with chronic hepatitis B (positive for HBsAg only) |
| HepavaxGene Stratum 2 | Experimental | Biological: HepavaxGene (thiomersal free)Subjects of mothers without chronic hepatitis B (negative for both HBsAg and HBeAg) |
| Comparator vaccine Stratum 2 | Active comparator | Biological: Engerix BSubjects of mothers without chronic hepatitis B (negative for both HBsAg and HBeAg) |
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Full-term neonates with gestational age from 37 weeks to 42 weeks;
- Apgar scores are no less than 7 at birth;
- Neonates with standard body temperature (auxiliary temperature < 37.1°);
- Neonates weighing ≥ 2,500 grams at birth;
- Neonates with icteric index within the normal range (physiologic jaundice is permitted);
Key exclusion criteria (9 listed)
- Subject's parent has a history of family diseases such as convulsion and brain diseases;
- Mothers have low immunologic function or a history of organ transplantation or hemodialysis;
- Subject's parent is allergic to any composition of Hepatitis B vaccine;
- A family history of thrombocytopenia, or other disturbance of blood coagulation, which may result in a contraindication for intramuscular injection;
- Known immunologic function damage;
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 |
|---|---|---|
| HepavaxGene (thiomersal free)10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6 | Biological | HepavaxGene Stratum 1a, HepavaxGene Stratum 1b, HepavaxGene Stratum 2 |
| Engerix B10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6 | Biological | Comparator vaccine Stratum 1a, Comparator vaccine Stratum 1b, Comparator vaccine Stratum 2 |
Primary outcome
Seroconversion rate for subjects in Stratum 2
Time frame: Month 7
Hepatitis B surface antibody (HBsAb) concentrations are measured from blood samples by standard enzyme linked immuno sorbent assay (ELISA) for subjects whose mothers are negative for chronic hepatitis B. Seroconversion rate is defined as HBsAb ≥10 mIU/mL.
Positivity for HBsAg for subjects in Stratum 1
Time frame: Month 2, Month 7 and Month 12
The presence of hepatitis B surface antigen (HBsAg), as determined by ELISA, for subjects whose mothers are positive for chronic hepatitis B
4 secondary outcomes
Seroconversion rate for subjects in Stratum 1
Time frame: Month 7
Solicited adverse events
Time frame: Days 1 to 4
Seroconversion rate for subjects in Stratum 1
Time frame: Month 12
Positivity for HBsAg for subjects in Stratum 2
Time frame: Months 2, 7 and 12
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 4 Mar 2014.
- Derived from this study: PubMed 27753794Zhu F, Deckx H, Roten R, Michiels B, Sarnecki M. Comparative Efficacy, Safety and Immunogenicity of Hepavax-Gene TF and Engerix-B Recombinant Hepatitis B Vaccines in Neonates in China. Pediatr Infect Dis J. 2017 Jan;36(1):94-101. doi: 10.1097/INF.0000000000001361.
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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.
Zhu Fencai, MD principal investigator
Jiangsu Provincial Center for Disease Prevention and Control, 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 HepavaxGene (thiomersal free) and Engerix B in people with Hepatitis B, run by Crucell Holland BV 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 7 inclusion and 9 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 4 Mar 2014. 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 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?
Seroconversion rate for subjects in Stratum 2 (time frame: Month 7). 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?
On the ClinicalTrials.gov record for NCT01349283, 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 4 Mar 2014.