Hepatitis BPhase 3CORE-HIVNCT02003703
Comparative Efficacy of an Intensified Re-vaccination Scheme for Hepatitis B Virus Infection Among Patients Infected With HIV .
A Phase 3 study testing Recombinant Hepatitis B Virus Vaccine in people with Hepatitis B and HIV, run by Universidad de Valparaiso at 1 site in Chile.
Trial summary
Hepatitis B virus infection is a common occurrence among patients with HIV. Effective vaccines are available, but there's some uncertainty regarding specific dosages, specially among those who have not responded to an initial vaccination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, HIV
- What is being tested?
- Recombinant Hepatitis B Virus Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteChile
- Study dates
- May 2015to Dec 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years of age.
- Patients infected with Human Immunodeficiency Virus (HIV)
- Failed previous vaccination with a standard dose scheme of recombinant hepatitis B vaccine (20mcg at 0, 1 and 6 months). Nonresponders will be considered as those patients presenting a hepatitis B surface antigen antibody titer lower than 10UI/mL 4 to 8 weeks after the last dose of the vaccine.
- Provision of informed consent.
Who cannot join
- Proven Hepatitis B virus infection (acute or chronic).
- Proven hypersensitivity to the vaccine or any of its components.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Efficacy of an Intensified Re-vaccination Scheme for Hepatitis B Virus Infection Among Patients Infected With HIV : A Randomised Trial
Hepatitis B virus infection is a common occurrence among patients with HIV. Effective vaccines are available, but there's some uncertainty regarding specific dosages, specially among those who have not responded to an initial vaccination. The purpose of this study is to determine the effectiveness of a simplified immunization schedule compared to a high-dose one.
- Conditions
- Hepatitis B, HIV
- Being tested
- Recombinant Hepatitis B Virus Vaccine
- Keywords
- Vaccine, Primary Prevention, Immunogenicity
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Hepatitis B Virus VaccineBiological
Also called Engerix B (GlaxoSmithKline)
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Hepatitis B Virus Vaccine (High Dose) | Experimental | Patients allocated to this arm will receive three doses of 40mcg each of recombinant hepatitis B vaccine (Engerix-B (R)). Doses will be administered at 0, 1 and 2 months. Receives: Biological: Recombinant Hepatitis B Virus Vaccine |
| Recombinant Hepatitis B Virus Vaccine (Standard Dose) | Active comparator | Patients allocated to this arm will receive three doses of 20mcg each of recombinant hepatitis B vaccine (Engerix-B (R)). Doses will be administered at 0, 1 and 2 months. Receives: Biological: Recombinant Hepatitis B Virus Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serologic Response
Number of participants with positive hepatitis B surface antigen (HBsAg) antibodies 4 to 8 weeks after completion of the vaccination schemes.
Measured: 4-8 weeks After Exposure
Secondary outcomes (2)
Local Reactions to Vaccine
Number of participants presenting dermatologic reactions to the vaccine up to one week after exposure.
Measured: One Week after Exposure
Systemic Reactions to the Vaccine
Number of participants presenting any systemic adverse reaction attributable to vaccination.
Measured: One Week after Exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startMay 2015
- Primary completionJun 2018
- Study completionDec 2018
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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Valparaiso
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG, GlaxoSmithKline, Aclin Laboratory
- Responsible party
- Principal investigator, Felipe Martinez, Universidad de Valparaiso
- Investigators
- Francisco Fuster, MD, Principal investigator, Hospital Gustavo Fricke, Viña del Mar, ChileJose I Vargas, MD, Principal investigator, Escuela de Medicina, Universidad de Valparaíso, ChileDaniela Jensen, MD, Principal investigator, Escuela de Medicina, Universidad de ValparaísoFelipe T Martinez, MD, Principal investigator, Centro de Investigaciones Biomédicas, Escuela de Medicina, Universidad de Valparaíso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003703
- Sponsor's protocol ID
- 45/2012
- Acronym
- CORE-HIV
- Status last verified
- Jan 2019
- First submitted
- 2 Dec 2013
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Vargas JI, Jensen D, Martinez F, Sarmiento V, Peirano F, Acuna P, Provoste F, Bustos V, Cornejo F, Fuster A, Acuna M, Fuster F, Soto S, Estay D, Jensen W, Ahumada R, Arab JP, Soza A, Fuster F. Comparative Efficacy of a High-Dose vs Standard-Dose Hepatitis B Revaccination Schedule Among Patients With HIV: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2120929. doi: 10.1001/jamanetworkopen.2021.20929.
PubMed 34424307
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of an Intensified Re-vaccination Scheme for Hepatitis B Virus Infection Among Patients Infected With HIV : A Randomised Trial
- ClinicalTrials.gov ID
- NCT02003703
- Acronym / sponsor ID
- CORE-HIV / 45/2012
- Conditions
- Hepatitis B, HIV
- Keywords
- Vaccine, Primary Prevention, Immunogenicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Universidad de ValparaisoUniversity, hospital or other
- Collaborators
- Roche Pharma AG, GlaxoSmithKline, Aclin Laboratory
- Study start
- May 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 6 Dec 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.
Hepatitis B virus infection is a common occurrence among patients with HIV. Effective vaccines are available, but there's some uncertainty regarding specific dosages, specially among those who have not responded to an initial vaccination. The purpose of this study is to determine the effectiveness of a simplified immunization schedule compared to a high-dose one.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant Hepatitis B Virus Vaccine (High Dose) | Experimental | Biological: Recombinant Hepatitis B Virus VaccinePatients allocated to this arm will receive three doses of 40mcg each of recombinant hepatitis B vaccine (Engerix-B (R)). Doses will be administered at 0, 1 and 2 months. |
| Recombinant Hepatitis B Virus Vaccine (Standard Dose) | Active comparator | Biological: Recombinant Hepatitis B Virus VaccinePatients allocated to this arm will receive three doses of 20mcg each of recombinant hepatitis B vaccine (Engerix-B (R)). Doses will be administered at 0, 1 and 2 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Older than 18 years of age.
- Patients infected with Human Immunodeficiency Virus (HIV)
- Failed previous vaccination with a standard dose scheme of recombinant hepatitis B vaccine (20mcg at 0, 1 and 6 months). Nonresponders will be considered as those patients presenting a hepatitis B surface antigen antibody titer lower than 10UI/mL 4 to 8 weeks after the last dose of the vaccine.
- Provision of informed consent.
Key exclusion criteria (2 listed)
- Proven Hepatitis B virus infection (acute or chronic).
- Proven hypersensitivity to the vaccine or any of its components.
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 |
|---|---|---|
| Recombinant Hepatitis B Virus VaccineAlso: Engerix B (GlaxoSmithKline) | Biological | Recombinant Hepatitis B Virus Vaccine (High Dose), Recombinant Hepatitis B Virus Vaccine (Standard Dose) |
Primary outcome
Serologic Response
Time frame: 4-8 weeks After Exposure
Number of participants with positive hepatitis B surface antigen (HBsAg) antibodies 4 to 8 weeks after completion of the vaccination schemes.
2 secondary outcomes
Local Reactions to Vaccine
Time frame: One Week after Exposure
Systemic Reactions to the Vaccine
Time frame: One Week after Exposure
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 31 Jan 2019.
- Derived from this study: PubMed 34424307Vargas JI, Jensen D, Martinez F, Sarmiento V, Peirano F, Acuna P, Provoste F, Bustos V, Cornejo F, Fuster A, Acuna M, Fuster F, Soto S, Estay D, Jensen W, Ahumada R, Arab JP, Soza A, Fuster F. Comparative Efficacy of a High-Dose vs Standard-Dose Hepatitis B Revaccination Schedule Among Patients With HIV: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2120929. doi: 10.1001/jamanetworkopen.2021.20929.
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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.
Francisco Fuster, MD principal investigator
Hospital Gustavo Fricke, Viña del Mar, Chile
Jose I Vargas, MD principal investigator
Escuela de Medicina, Universidad de Valparaíso, Chile
Daniela Jensen, MD principal investigator
Escuela de Medicina, Universidad de Valparaíso
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 Recombinant Hepatitis B Virus Vaccine in people with Hepatitis B and HIV, run by Universidad de Valparaiso at 1 site in Chile.
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 4 inclusion and 2 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 31 Jan 2019. 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 Chile. 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?
Serologic Response (time frame: 4-8 weeks After Exposure). 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 NCT02003703, 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 31 Jan 2019.