Hepatitis BPhase 2NCT03415672
Hepatitis B Vaccine for Non-responders
A Phase 2 study testing HBVaxPro and HBAI20 in people with Hepatitis B, run by Maastricht University Medical Center at 3 sites in 2 countries.
Trial summary
In the current study, the investigators study the efficacy of the HBAI20 vaccine to induce seroprotection in registered non-responders (adults who were previously vaccinated with the HBVaxPro-10μg but did not achieve seroprotection). Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- HBVaxPro and HBAI20
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 11 Oct 2017to 9 Jan 2019
- Phase
- Phase 2
- 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 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In good health as determined by the outcome of medical history, physical examination screening/baseline labs and clinical judgment of the clinical investigator
- Age 18 to 59 years, inclusive at the time of enrollment
- Willing and able to adhere to the study regimen
- Willing to adhere to a highly effective birth control method during the duration of the study
- Having a signed informed consent form
- Documented non-responders: Subjects with documented one or more cycles of Hepatitis B vaccination (total of 3 or more vaccinations) and titer analysis 1 to 3 months after the last vaccination that show that they have not developed the Hepatitis B antibody titer recommended after standard vaccination: HBsAg antibody titer superior to 10mIU/ml. In case the subjects do not have a titer analysis performed 1 to 3 months after their last recorded vaccination, the potential subject can be included after permission from the project leader after analysis of the case file.
Who cannot join
- Any infectious disease at the time of screening and/or enrollment
- Positive HIV, Hepatitis B virus or Hepatitis C virus serology
- Known or suspected immune deficiency
- Known or suspected disease that influences the immune system including chronic allergies that require frequent anti-allergy medication - excluding anti-histaminics -, cancer and transplantation recipients
- Known or suspected allergy to any of the vaccine components
- Dialysis patient
Show all 21Show fewer
- History of unusual or severe reactions to any previous vaccination
- History of any neurologic disorder, including epilepsy and autism
- Use of medication that influences the immune system (immune suppressive treatment or daily use of corticosteroids, including chronic use of local corticosteroids)
- Any vaccination within 3 months before screening excluding flu vaccination
- Blood donation within 1 month before screening
- Administration of plasma (incl. immunoglobulins) or blood products within 12 months before screening
- Participation in another clinical trial within 3 months before screening
- Abnormal pre-treatment laboratory parameters which are clinically relevant according to the investigator
- Bleeding disorders. Participants on coumadins anticoagulants and participants receiving 2 platelet aggregation inhibitors can not be included in the study. People on the direct oral anticoagulant dabigatran, apixaban, edoxaban, and rivaroxaban and participants using only one platelet aggregation inhibitor can be included.
- Female subjects planning to become pregnant or breastfeeding babies until visit 4
- Females: positive pregnancy test at screening date
- Excessive alcohol or controlled drug use - More than 2 alcohol measures per day (one alcohol measure is a beer (250ml) or one glass of wine (125ml) or one strong measure (35ml) or one port/sherry (75ml)). Regular use of controlled drugs
- Any Hepatitis B vaccination in the last 3 months Temporary exclusion criterion for vaccination
- Temperature > 38.4°C will lead to postponement of participation and vaccination.
- Screening may continue when the temperature has normalized.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Belgium2 sites
Vaxinfectio - Antwerp University
Antwerp
Ziekenhuis Oost-Limburg
Genk
About this study
Official title: Immunogenicity and Safety of HBAI20 Hepatitis B Vaccine in Non-responders
In the current study, the investigators study the efficacy of the HBAI20 vaccine to induce seroprotection in registered non-responders (adults who were previously vaccinated with the HBVaxPro-10μg but did not achieve seroprotection). The study will further assess the safety of the HBAI20 vaccine in comparison with HBVaxPro-10μg.
Read the detailed description
Rationale:
Worldwide, people are suffering from the consequences of Hepatitis B (HB) virus infection. Currently available vaccines are protective in most of the vaccinees, however, a small part of the population does not respond to these vaccines (non-responders). A new adjuvant (AI20) has been developed by CyTuVax to improve the standard Hepatitis B vaccine for the protection of non-responders. The AI20 adjuvant consists of depot-attached rhuIL-2 (aggregated Interleukin-2 (IL-2) molecules attached to alum), facilitating the slow release of highly concentrated IL-2 nano aggregates. In preclinical experiments, vaccination of mice, rats, and rabbits with the new HBAI20 vaccine results in higher and earlier immune responses to HBsAg compared to vaccination with one of the standard Hepatitis B vaccines. The phase 1 clinical trial showed that the HBAI20 vaccine was well tolerated and it induced protective anti Hepatitis B antibody titers in 9 out of 10 non-responders (subjects vaccinated at least 6 times with the Hepatitis B vaccine). The phase 2 clinical trial will be conducted in order to assess the immunogenicity and safety of the AI20 adjuvant and further test if the AI20 adjuvanted Hepatitis B vaccine induces protective antibody titers in the vaccinated non-responders.
Objective: In the current study, the investigators study the efficacy of the HBAI20 vaccine to induce seroprotection. Furthermore, the investigators will compare the safety of the HBAI20 vaccine with the HBVaxPro-10μg.
Study design:
Multicenter double blinded randomized controlled intervention phase II study.
Study population:
Registered non-responders after at least 3 HBV vaccinations (n=132- 140) 18-59 years of age, males and females.
Intervention:
The study will include 2 groups. HB vaccine registered non-responder subjects after at least 3 vaccinations are randomized into group 1 (n= 33 to 35) or 2 (n= 99 to 105) at a 1 to 3 ratio. No less than 40% of the subjects of each group should have received only 1 series of Hepatitis B vaccination. "Group 1" subjects receive the standard HB vaccine (HBVaxPro-10μg) and "Group 2" subjects receive the HBAI20 vaccine. All study subjects will receive 3 vaccinations separated by one month (0, 1, and 2 months) in accordance with the recommended vaccination schedule for non-responders in the Netherlands.
Main study parameters/endpoints:
The primary study parameter is the immunogenicity of the adjuvanted vaccine. The immunogenicity of the adjuvanted vaccine is measured as the percentage of subjects that attain seroprotection after the first vaccination at 1, 2, and 3,5 months (HBsAg antibodies ≥10 mIU/ml measure by the COBAS system). The secondary study parameter is the safety of the vaccination. The safety of the vaccination is the number and severity of the local and systemic adverse reactions.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Study subjects will be vaccinated 3 times at 0, 1, and 2 months from the beginning of the study and invited to the hospital or vaccination centre for 4 or 5 visits. The risks associated with participation in this study are considered to be low and comparable with standard vaccines. Physical discomfort after vaccine administration can occur at the injection site (redness, swelling, etc.) and systemically (fever, fatigue, headache). Effects are expected to occur for a short period of time (within the first 4 days after the first and second injection). In addition subjects may experience adverse reactions to the cytokine component of the adjuvant. Because of the very low dose of the cytokine component of the adjuvant, which will be gradually released, the risks are expected to be low. The potential risks of venepuncture for blood sampling are mild pain and haematoma, and are considered low. Subjects may benefit from this study by becoming immunized (seroprotected) against Hepatitis B. Becoming seroprotected is important for the non-responder subjects because most of the registered non-responders are healthcare workers who can be exposed to the Hepatitis B virus.
- Conditions
- Hepatitis B
- Being tested
- HBVaxPro, HBAI20
- Keywords
- Interleukin-2, Hepatitis B Vaccines, Non-responders, Liver Diseases, Digestive system, Vaccines
- Medical subject headings
- Hepatitis B, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBVaxProBiological
Three doses of HBVaxPro-10μg at 0, 1, and 2 months. The HBVaxPro-10μg vaccines are administered strictly intramuscularly in the deltoid muscle and must not be injected intravascularly.
HBAI20Biological
Three doses of HBAI20 at 0, 1, and 2 months. The HBAI20 vaccines are administered strictly intramuscularly in the deltoid muscle and must not be injected intravascularly.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Subjects included in Group 1 are adults who are non-responders (did not achieve seroprotection after 3 or more vaccinations with a Hepatitis B vaccine. They will receive three doses of HBVaxPro-10μg at 0, 1, and 2 months. The HBVaxPro-10μg vaccines are administered strictly intramuscularly in the deltoid muscle and must not be injected intravascularly. Receives: Biological: HBVaxPro |
| Group 2 | Experimental | Subjects included in Group 2 are adults who are non-responders (did not achieve seroprotection after 3 or more vaccinations with a Hepatitis B vaccine). They will receive three doses of HBAI20 at 0, 1, and 2 months.
The HBAI20 vaccines are administered strictly intramuscularly in the deltoid muscle and must not be injected intravascularly. Receives: Biological: HBAI20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity of the HBAI20
Anti Hepatitis B surface antigen antibody titer.
Measured: Six weeks after the third vaccination.
Secondary outcomes (1)
Safety of the HBAI20 Hepatitis B vaccine: Percentage of subjects reporting adverse events after being vaccinated.
Percentage of subjects reporting adverse events after being vaccinated.
Measured: The whole duration of the study protocol (102 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start11 Oct 2017
- Primary completion9 Jan 2019
- Study completion9 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- CyTuVax
- Responsible party
- Sponsor
- Investigators
- Pierre van Damme, MD, PhD, Principal investigator, Vaxinfectio - Antwerp UniversityGeert Robaeys, MD, PhD, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415672
- Sponsor's protocol ID
- HBnr02
- Other IDs
- 2016-002720-91, 2016
- Status last verified
- Jan 2019
- First submitted
- 5 Jan 2018
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Coates T, Wilson R, Patrick G, Andre F, Watson V. Hepatitis B vaccines: assessment of the seroprotective efficacy of two recombinant DNA vaccines. Clin Ther. 2001 Mar;23(3):392-403. doi: 10.1016/s0149-2918(01)80044-8.
PubMed 11318074Jack AD, Hall AJ, Maine N, Mendy M, Whittle HC. What level of hepatitis B antibody is protective? J Infect Dis. 1999 Feb;179(2):489-92. doi: 10.1086/314578.
PubMed 9878036Yu AS, Cheung RC, Keeffe EB. Hepatitis B vaccines. Infect Dis Clin North Am. 2006 Mar;20(1):27-45. doi: 10.1016/j.idc.2006.01.004.
PubMed 16527647Cardell K, Akerlind B, Sallberg M, Fryden A. Excellent response rate to a double dose of the combined hepatitis A and B vaccine in previous nonresponders to hepatitis B vaccine. J Infect Dis. 2008 Aug 1;198(3):299-304. doi: 10.1086/589722.
PubMed 18544037Halperin SA, Dobson S, McNeil S, Langley JM, Smith B, McCall-Sani R, Levitt D, Nest GV, Gennevois D, Eiden JJ. Comparison of the safety and immunogenicity of hepatitis B virus surface antigen co-administered with an immunostimulatory phosphorothioate oligonucleotide and a licensed hepatitis B vaccine in healthy young adults. Vaccine. 2006 Jan 9;24(1):20-6. doi: 10.1016/j.vaccine.2005.08.095. Epub 2005 Sep 12.
PubMed 16198027Halperin SA, Ward BJ, Dionne M, Langley JM, McNeil SA, Smith B, Mackinnon-Cameron D, Heyward WL, Martin JT. Immunogenicity of an investigational hepatitis B vaccine (hepatitis B surface antigen co-administered with an immunostimulatory phosphorothioate oligodeoxyribonucleotide) in nonresponders to licensed hepatitis B vaccine. Hum Vaccin Immunother. 2013 Jul;9(7):1438-44. doi: 10.4161/hv.24256. Epub 2013 Apr 9.
PubMed 23571179Ambrosch F, Wiedermann G, Kundi M, Leroux-Roels G, Desombere I, Garcon N, Thiriart C, Slaoui M, Thoelen S. A hepatitis B vaccine formulated with a novel adjuvant system. Vaccine. 2000 Apr 14;18(20):2095-101. doi: 10.1016/s0264-410x(99)00566-6.
PubMed 10715523Levie K, Gjorup I, Skinhoj P, Stoffel M. A 2-dose regimen of a recombinant hepatitis B vaccine with the immune stimulant AS04 compared with the standard 3-dose regimen of Engerix-B in healthy young adults. Scand J Infect Dis. 2002;34(8):610-4. doi: 10.1080/00365540110080881.
PubMed 12238579Desombere I, Van der Wielen M, Van Damme P, Stoffel M, De Clercq N, Goilav C, Leroux-Roels G. Immune response of HLA DQ2 positive subjects, vaccinated with HBsAg/AS04, a hepatitis B vaccine with a novel adjuvant. Vaccine. 2002 Jun 7;20(19-20):2597-602. doi: 10.1016/s0264-410x(02)00150-0.
PubMed 12057618Jacques P, Moens G, Desombere I, Dewijngaert J, Leroux-Roels G, Wettendorff M, Thoelen S. The immunogenicity and reactogenicity profile of a candidate hepatitis B vaccine in an adult vaccine non-responder population. Vaccine. 2002 Nov 1;20(31-32):3644-9. doi: 10.1016/s0264-410x(02)00397-3.
PubMed 12399191Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 1975 Mar;31(1):103-15.
PubMed 1100130Siegel JP, Puri RK. Interleukin-2 toxicity. J Clin Oncol. 1991 Apr;9(4):694-704. doi: 10.1200/JCO.1991.9.4.694.
PubMed 2066765Vial T, Descotes J. Clinical toxicity of interleukin-2. Drug Saf. 1992 Nov-Dec;7(6):417-33. doi: 10.2165/00002018-199207060-00004.
PubMed 1418698
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
- Immunogenicity and Safety of HBAI20 Hepatitis B Vaccine in Non-responders
- ClinicalTrials.gov ID
- NCT03415672
- Acronym / sponsor ID
- HBnr02
- Conditions
- Hepatitis B
- Keywords
- Interleukin-2, Hepatitis B Vaccines, Non-responders, Liver Diseases, Digestive system, Vaccines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- CyTuVax
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 9 Jan 2019 (actual)
- Study completion
- 9 Jan 2019 (actual)
- First posted
- 30 Jan 2018 (actual)
- 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.
In the current study, the investigators study the efficacy of the HBAI20 vaccine to induce seroprotection in registered non-responders (adults who were previously vaccinated with the HBVaxPro-10μg but did not achieve seroprotection). The study will further assess the safety of the HBAI20 vaccine in comparison with HBVaxPro-10μg.
Detailed description
Rationale:
Worldwide, people are suffering from the consequences of Hepatitis B (HB) virus infection. Currently available vaccines are protective in most of the vaccinees, however, a small part of the population does not respond to these vaccines (non-responders). A new adjuvant (AI20) has been developed by CyTuVax to improve the standard Hepatitis B vaccine for the protection of non-responders. The AI20 adjuvant consists of depot-attached rhuIL-2 (aggregated Interleukin-2 (IL-2) molecules attached to alum), facilitating the slow release of highly concentrated IL-2 nano aggregates. In preclinical experiments, vaccination of mice, rats, and rabbits with the new HBAI20 vaccine results in higher and earlier immune responses to HBsAg compared to vaccination with one of the standard Hepatitis B vaccines. The phase 1 clinical trial showed that the HBAI20 vaccine was well tolerated and it induced protective anti Hepatitis B antibody titers in 9 out of 10 non-responders (subjects vaccinated at least 6 times with the Hepatitis B vaccine). The phase 2 clinical trial will be conducted in order to assess the immunogenicity and safety of the AI20 adjuvant and further test if the AI20 adjuvanted Hepatitis B vaccine induces protective antibody titers in the vaccinated non-responders.
Objective: In the current study, the investigators study the efficacy of the HBAI20 vaccine to induce seroprotection. Furthermore, the investigators will compare the safety of the HBAI20 vaccine with the HBVaxPro-10μg.
Study design:
Multicenter double blinded randomized controlled intervention phase II study.
Study population:
Registered non-responders after at least 3 HBV vaccinations (n=132- 140) 18-59 years of age, males and females.
Intervention:
The study will include 2 groups. HB vaccine registered non-responder subjects after at least 3 vaccinations are randomized into group 1 (n= 33 to 35) or 2 (n= 99 to 105) at a 1 to 3 ratio. No less than 40% of the subjects of each group should have received only 1 series of Hepatitis B vaccination. "Group 1" subjects receive the standard HB vaccine (HBVaxPro-10μg) and "Group 2" subjects receive the HBAI20 vaccine. All study subjects will receive 3 vaccinations separated by one month (0, 1, and 2 months) in accordance with the recommended vaccination schedule for non-responders in the Netherlands.
Main study parameters/endpoints:
The primary study parameter is the immunogenicity of the adjuvanted vaccine. The immunogenicity of the adjuvanted vaccine is measured as the percentage of subjects that attain seroprotection after the first vaccination at 1, 2, and 3,5 months (HBsAg antibodies ≥10 mIU/ml measure by the COBAS system). The secondary study parameter is the safety of the vaccination. The safety of the vaccination is the number and severity of the local and systemic adverse reactions.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Study subjects will be vaccinated 3 times at 0, 1, and 2 months from the beginning of the study and invited to the hospital or vaccination centre for 4 or 5 visits. The risks associated with participation in this study are considered to be low and comparable with standard vaccines. Physical discomfort after vaccine administration can occur at the injection site (redness, swelling, etc.) and systemically (fever, fatigue, headache). Effects are expected to occur for a short period of time (within the first 4 days after the first and second injection). In addition subjects may experience adverse reactions to the cytokine component of the adjuvant. Because of the very low dose of the cytokine component of the adjuvant, which will be gradually released, the risks are expected to be low. The potential risks of venepuncture for blood sampling are mild pain and haematoma, and are considered low. Subjects may benefit from this study by becoming immunized (seroprotected) against Hepatitis B. Becoming seroprotected is important for the non-responder subjects because most of the registered non-responders are healthcare workers who can be exposed to the Hepatitis B virus.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Biological: HBVaxProSubjects included in Group 1 are adults who are non-responders (did not achieve seroprotection after 3 or more vaccinations with a Hepatitis B vaccine. They will receive three doses of HBVaxPro-10μg at 0, 1, and 2 months. The HBVaxPro-10μg vaccines are administered strictly intramuscularly in the deltoid muscle and must not be injected intravascularly. |
| Group 2 | Experimental | Biological: HBAI20Subjects included in Group 2 are adults who are non-responders (did not achieve seroprotection after 3 or more vaccinations with a Hepatitis B vaccine). They will receive three doses of HBAI20 at 0, 1, and 2 months. The HBAI20 vaccines are administered strictly intramuscularly in the deltoid muscle and must not be injected intravascularly. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- In good health as determined by the outcome of medical history, physical examination screening/baseline labs and clinical judgment of the clinical investigator
- Age 18 to 59 years, inclusive at the time of enrollment
- Willing and able to adhere to the study regimen
- Willing to adhere to a highly effective birth control method during the duration of the study
- Having a signed informed consent form
Key exclusion criteria (21 listed)
- Any infectious disease at the time of screening and/or enrollment
- Positive HIV, Hepatitis B virus or Hepatitis C virus serology
- Known or suspected immune deficiency
- Known or suspected disease that influences the immune system including chronic allergies that require frequent anti-allergy medication - excluding anti-histaminics -, cancer and transplantation recipients
- Known or suspected allergy to any of the vaccine 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 |
|---|---|---|
| HBVaxProThree doses of HBVaxPro-10μg at 0, 1, and 2 months. The HBVaxPro-10μg vaccines are administered strictly intramuscularly in the deltoid muscle and must not be injected intravascularly. | Biological | Group 1 |
| HBAI20Three doses of HBAI20 at 0, 1, and 2 months. The HBAI20 vaccines are administered strictly intramuscularly in the deltoid muscle and must not be injected intravascularly. | Biological | Group 2 |
Primary outcome
Immunogenicity of the HBAI20
Time frame: Six weeks after the third vaccination.
Anti Hepatitis B surface antigen antibody titer.
1 secondary outcome
Safety of the HBAI20 Hepatitis B vaccine: Percentage of subjects reporting adverse events after being vaccinated.
Time frame: The whole duration of the study protocol (102 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 31 Jan 2019.
- Background: PubMed 11318074Coates T, Wilson R, Patrick G, Andre F, Watson V. Hepatitis B vaccines: assessment of the seroprotective efficacy of two recombinant DNA vaccines. Clin Ther. 2001 Mar;23(3):392-403. doi: 10.1016/s0149-2918(01)80044-8.
- Background: PubMed 9878036Jack AD, Hall AJ, Maine N, Mendy M, Whittle HC. What level of hepatitis B antibody is protective? J Infect Dis. 1999 Feb;179(2):489-92. doi: 10.1086/314578.
- Background: PubMed 16527647Yu AS, Cheung RC, Keeffe EB. Hepatitis B vaccines. Infect Dis Clin North Am. 2006 Mar;20(1):27-45. doi: 10.1016/j.idc.2006.01.004.
- Background: PubMed 18544037Cardell K, Akerlind B, Sallberg M, Fryden A. Excellent response rate to a double dose of the combined hepatitis A and B vaccine in previous nonresponders to hepatitis B vaccine. J Infect Dis. 2008 Aug 1;198(3):299-304. doi: 10.1086/589722.
- Background: PubMed 16198027Halperin SA, Dobson S, McNeil S, Langley JM, Smith B, McCall-Sani R, Levitt D, Nest GV, Gennevois D, Eiden JJ. Comparison of the safety and immunogenicity of hepatitis B virus surface antigen co-administered with an immunostimulatory phosphorothioate oligonucleotide and a licensed hepatitis B vaccine in healthy young adults. Vaccine. 2006 Jan 9;24(1):20-6. doi: 10.1016/j.vaccine.2005.08.095. Epub 2005 Sep 12.
- Background: PubMed 23571179Halperin SA, Ward BJ, Dionne M, Langley JM, McNeil SA, Smith B, Mackinnon-Cameron D, Heyward WL, Martin JT. Immunogenicity of an investigational hepatitis B vaccine (hepatitis B surface antigen co-administered with an immunostimulatory phosphorothioate oligodeoxyribonucleotide) in nonresponders to licensed hepatitis B vaccine. Hum Vaccin Immunother. 2013 Jul;9(7):1438-44. doi: 10.4161/hv.24256. Epub 2013 Apr 9.
- Background: PubMed 10715523Ambrosch F, Wiedermann G, Kundi M, Leroux-Roels G, Desombere I, Garcon N, Thiriart C, Slaoui M, Thoelen S. A hepatitis B vaccine formulated with a novel adjuvant system. Vaccine. 2000 Apr 14;18(20):2095-101. doi: 10.1016/s0264-410x(99)00566-6.
- Background: PubMed 12238579Levie K, Gjorup I, Skinhoj P, Stoffel M. A 2-dose regimen of a recombinant hepatitis B vaccine with the immune stimulant AS04 compared with the standard 3-dose regimen of Engerix-B in healthy young adults. Scand J Infect Dis. 2002;34(8):610-4. doi: 10.1080/00365540110080881.
- Background: PubMed 12057618Desombere I, Van der Wielen M, Van Damme P, Stoffel M, De Clercq N, Goilav C, Leroux-Roels G. Immune response of HLA DQ2 positive subjects, vaccinated with HBsAg/AS04, a hepatitis B vaccine with a novel adjuvant. Vaccine. 2002 Jun 7;20(19-20):2597-602. doi: 10.1016/s0264-410x(02)00150-0.
- Background: PubMed 12399191Jacques P, Moens G, Desombere I, Dewijngaert J, Leroux-Roels G, Wettendorff M, Thoelen S. The immunogenicity and reactogenicity profile of a candidate hepatitis B vaccine in an adult vaccine non-responder population. Vaccine. 2002 Nov 1;20(31-32):3644-9. doi: 10.1016/s0264-410x(02)00397-3.
- Background: PubMed 1100130Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 1975 Mar;31(1):103-15.
- Background: PubMed 2066765Siegel JP, Puri RK. Interleukin-2 toxicity. J Clin Oncol. 1991 Apr;9(4):694-704. doi: 10.1200/JCO.1991.9.4.694.
- Individual participant dataSharing planned: Undecided
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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.
Pierre van Damme, MD, PhD principal investigator
Vaxinfectio - Antwerp University
Geert Robaeys, MD, PhD principal investigator
Ziekenhuis Oost-Limburg
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HBVaxPro and HBAI20 in people with Hepatitis B, run by Maastricht University Medical Center at 3 sites in 2 countries.
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 21 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 3 sites in Belgium, Netherlands. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Immunogenicity of the HBAI20 (time frame: Six weeks after the third vaccination.). 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 NCT03415672, which also lists 13 linked publications.
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.