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Trials |  |
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- | Fendrix (hepatitis B (rDNA) vaccine adjuvanted, adsorbed) / GSK, HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
Journal: Efficacy of Hepatitis B Virus Vaccines HBVaxpro40© and Fendrix© in Patients with Chronic Liver Disease in Clinical Practice. (Pubmed Central) - Aug 27, 2022
In the univariate analysis, active alcohol intake, alcohol etiology, liver cirrhosis and ultrasound signs of portal hypertension were associated with a lower response to vaccination, whereas in the multivariate analysis, liver cirrhosis was the only factor that significantly increased the likelihood of nonresponse (OR 10.5). HBVAXPRO and FENDRIX are good options for HBV vaccination in patients with chronic liver disease.
- | Fendrix (hepatitis B (rDNA) vaccine adjuvanted, adsorbed) / GSK, HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: Efficacy of HBVaxpro40 (clinicaltrials.gov) - Jul 11, 2022
P=N/A, N=125, Completed, Sponsor: Corporacion Parc Tauli
HBVAXPRO and FENDRIX are good options for HBV vaccination in patients with chronic liver disease. Unknown status --> Completed | N=200 --> 125 | Trial completion date: Apr 2020 --> Aug 2021 | Trial primary completion date: Apr 2019 --> Aug 2021
- || HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
Clinical, Journal: Cholecalciferol supplementation to improve the hepatitis B vaccination response in hemodialysis patients: A first randomized open label pilot study (DeVitaHep). (Pubmed Central) - Jan 27, 2022
P3
In this small pilot study, high-dose oral cholecalciferol supplementation did not improve the hepatitis B vaccination response in haemodialysis patients with vitamin D insufficiency. This clinical trial was registered within EudraCT (EudraCT number 2011-004621-26).
- || hepatitis B adjuvanted vaccine (HBAI20) / CyTuVax
Clinical, P2 data, Journal: Immunogenicity and safety of HBAI20 Hepatitis B vaccine in non-responders: double-blinded, randomised, controlled phase 2 trial. (Pubmed Central) - Nov 4, 2021
This clinical trial was registered within EudraCT (EudraCT number 2011-004621-26). In this group of hepatitis B vaccine non-responders, the HBAI20 vaccine demonstrated a higher seroprotection rate when adjusting for stratification factors and a similar safety profile compared to the licensed recombinant HBVaxPro®-10µg.
- || HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
Clinical, Journal: Efficacy of an accelerated double dose Hepatitis B vaccine regimen in patients with cirrhosis. (Pubmed Central) - Oct 3, 2021
All patients with cirrhosis admitted to the hepatology ward without exclusion criteria were offered the HBV HBVAXPRO 40mcg vaccine at months 0, 1 and 2...Only one patient had a mild adverse event.Most patients with cirrhosis admitted in the Hepatology ward are unprotected against HBV. Although a second HBV vaccination cycle increases the response rate, the poor overall response reinforces the implementation of HBV vaccination before the development of cirrhosis.
- HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
EFFECTIVENESS OF THE HBVAXPRO® AND FENDRIX® HEPATITIS B VACCINES IN CHRONIC LIVER DISEASE IN CLINICAL PRACTICE () - Jul 31, 2021 - Abstract #AEEH2021AEEH_229;
- HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
[VIRTUAL] Efficacy of hepatitis B virus vaccines HBVaxpro40 and Fendrix in patients with chronic liver disease in clinical practice (Poster area) - Apr 9, 2021 - Abstract #EASLILC2021EASL_ILC_1104;
The aetiology of chronic liver disease was 33% alcohol, 27.2% metabolic, 23.3% virus c hepatitis and 16.5% autoimmune/primary biliary cholangitis. 73 patients were vaccinated with HBVaxpro40 and 30 with Fendrix.
- ||||||| Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
Trial completion: A Hepatitis B Vaccine Challenge Study After Previous Vaxelis (clinicaltrials.gov) - Jan 6, 2021
P3, N=207, Completed, Sponsor: Merck Sharp & Dohme Corp.
73 patients were vaccinated with HBVaxpro40 and 30 with Fendrix. Active, not recruiting --> Completed
- | Vaxneuvance (15-valent pneumococcal conjugate vaccine) / Merck (MSD)
Trial completion: A Study to Evaluate the Interchangeability of V114 and Prevnar 13 (clinicaltrials.gov) - Dec 22, 2020
P3, N=900, Completed, Sponsor: Merck Sharp & Dohme Corp.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- | Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
Enrollment closed: A Hepatitis B Vaccine Challenge Study After Previous Vaxelis (clinicaltrials.gov) - Dec 7, 2020
P3, N=200, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- | Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
Enrollment open: A Hepatitis B Vaccine Challenge Study After Previous Vaxelis (clinicaltrials.gov) - Sep 14, 2020
P3, N=200, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- | Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
New P3 trial: A Hepatitis B Vaccine Challenge Study After Previous Vaxelis (clinicaltrials.gov) - Aug 6, 2020
P3, N=200, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
- HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
[VIRTUAL] Response to a double dose (40 mcg) and an accelerated schedule (0-1-2 months) of hepatitis B vaccine in patients with advance cirrhosis. A prospective study (Poster Area) - May 30, 2020 - Abstract #EASLILCI2020EASL-ILC-I-1301;
More than 80% of patients with advanced cirrhosis admitted to a referral hepatology unit were unprotected against HBV. The response to a double dose and accelerated cycle of HBV vaccine was low (22%), but it improved significantly (61%) after a second cycle.
- | Vaxneuvance (15-valent pneumococcal conjugate vaccine) / Merck (MSD)
Enrollment closed, Trial completion date, Trial primary completion date: A Study to Evaluate the Interchangeability of V114 and Prevnar 13 (clinicaltrials.gov) - Aug 4, 2019
P3, N=900, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
The response to a double dose and accelerated cycle of HBV vaccine was low (22%), but it improved significantly (61%) after a second cycle. Recruiting --> Active, not recruiting | Trial completion date: Aug 2020 --> Mar 2021 | Trial primary completion date: Aug 2020 --> Mar 2021
- | Fendrix (hepatitis B (rDNA) vaccine adjuvanted, adsorbed) / GSK, HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
Enrollment open: Efficacy of HBVaxpro40 (clinicaltrials.gov) - Feb 8, 2019
P=N/A, N=200, Recruiting, Sponsor: Corporacion Parc Tauli
Recruiting --> Active, not recruiting | Trial completion date: Aug 2020 --> Mar 2021 | Trial primary completion date: Aug 2020 --> Mar 2021 Not yet recruiting --> Recruiting
- | hepatitis B adjuvanted vaccine (HBAI20) / CyTuVax
Trial completion: Hepatitis B Vaccine for Non-responders (clinicaltrials.gov) - Jan 31, 2019
P2, N=133, Completed, Sponsor: Maastricht University Medical Center
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- | hepatitis B adjuvanted vaccine (HBAI20) / CyTuVax
Enrollment closed: Hepatitis B Vaccine for Non-responders (clinicaltrials.gov) - Dec 5, 2018
P2, N=133, Active, not recruiting, Sponsor: Maastricht University Medical Center
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- | Vaxneuvance (15-valent pneumococcal conjugate vaccine) / Merck (MSD)
Enrollment open: A Study to Evaluate the Interchangeability of V114 and Prevnar 13 (clinicaltrials.gov) - Oct 31, 2018
P3, N=900, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- | Fendrix (hepatitis B (rDNA) vaccine adjuvanted, adsorbed) / GSK, HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
New P4 trial: Phase IV, open, low-level intervention, clinical trial to compare the immunogenicity inimmunosuppressed patients of an adjuvanted anti-hepatitis B vaccine with an anti-hepatitis Bvaccine with increased antigenic load Ensayo cl (EUDRACT) - Aug 9, 2018
P4, N=740, Ongoing, Sponsor: FUNDACI
- | Vaxneuvance (15-valent pneumococcal conjugate vaccine) / Merck (MSD)
New P3 trial: A Study to Evaluate the Interchangeability of V114 and Prevnar 13 (clinicaltrials.gov) - Aug 8, 2018
P3, N=900, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.
- | Fendrix (hepatitis B (rDNA) vaccine adjuvanted, adsorbed) / GSK, HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
New trial: Efficacy of HBVaxpro40 (clinicaltrials.gov) - Mar 9, 2018
P=N/A, N=200, Not yet recruiting, Sponsor: Corporacion Parc Tauli
- | hepatitis B adjuvanted vaccine (HBAI20) / CyTuVax
New P2 trial: Hepatitis B Vaccine for Non-responders (clinicaltrials.gov) - Jan 30, 2018
P2, N=140, Recruiting, Sponsor: Maastricht University Medical Center
- HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
Trial primary completion date: Proof Of Concept : Immunogenicity and Safety of hepB Injection in the Dermis Using VAX-ID (clinicaltrials.gov) - Mar 27, 2017
P1, N=48, Completed, Sponsor: Novosanis NV
Not yet recruiting --> Recruiting Trial primary completion date: Jul 2016 --> Dec 2016
- | HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
Trial completion: Proof Of Concept : Immunogenicity and Safety of hepB Injection in the Dermis Using VAX-ID (clinicaltrials.gov) - Sep 21, 2016
P1, N=48, Completed, Sponsor: Novosanis NV
Trial primary completion date: Jul 2016 --> Dec 2016 Recruiting --> Completed
- hepatitis B adjuvanted vaccine (HBAI20) / CyTuVax
Trial completion: Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders (clinicaltrials.gov) - Sep 14, 2016
P1, N=34, Completed, Sponsor: Maastricht University Medical Center
Recruiting --> Completed Active, not recruiting --> Completed
- HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
Trial primary completion date: Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis (clinicaltrials.gov) - Aug 25, 2016
P3, N=89, Recruiting, Sponsor: Fundaci
Active, not recruiting --> Completed Trial primary completion date: Dec 2016 --> Oct 2017
- HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
Trial completion, Enrollment change, Trial primary completion date: New Methods to Measure the Immune Response to Hepatitis B Vaccine (clinicaltrials.gov) - Jun 24, 2016
P4, N=21, Completed, Sponsor: University of Oxford
Trial primary completion date: Dec 2016 --> Oct 2017 Recruiting --> Completed | N=16 --> 21 | Trial primary completion date: Nov 2013 --> Apr 2014
- HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
Enrollment open, Enrollment change, Trial initiation date, Trial primary completion date: Proof Of Concept : Immunogenicity and Safety of hepB Injection in the Dermis Using VAX-ID (clinicaltrials.gov) - Mar 31, 2016
P1, N=44, Recruiting, Sponsor: Novosanis NV
Recruiting --> Completed | N=16 --> 21 | Trial primary completion date: Nov 2013 --> Apr 2014 Not yet recruiting --> Recruiting | N=33 --> 44 | Initiation date: Jul 2015 --> Mar 2016 | Trial primary completion date: Sep 2015 --> Jun 2016
- | HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
Enrollment change, Trial primary completion date: Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis (clinicaltrials.gov) - Feb 3, 2016
P3, N=89, Recruiting, Sponsor: Fundaci
Not yet recruiting --> Recruiting | N=33 --> 44 | Initiation date: Jul 2015 --> Mar 2016 | Trial primary completion date: Sep 2015 --> Jun 2016 N=69 --> 89 | Trial primary completion date: Dec 2015 --> Dec 2016
- hepatitis B adjuvanted vaccine (HBAI20) / CyTuVax
Enrollment closed: Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders (clinicaltrials.gov) - Dec 15, 2015
P1, N=34, Active, not recruiting, Sponsor: Maastricht University Medical Center
N=69 --> 89 | Trial primary completion date: Dec 2015 --> Dec 2016 Recruiting --> Active, not recruiting
- hepatitis B adjuvanted vaccine (HBAI20) / CyTuVax
Enrollment open: Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders (clinicaltrials.gov) - Oct 3, 2015
P1, N=36, Recruiting, Sponsor: Maastricht University Medical Center
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- hepatitis B adjuvanted vaccine (HBAI20) / CyTuVax
New P1 trial: Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders (clinicaltrials.gov) - Sep 4, 2015
P1, N=36, Not yet recruiting, Sponsor: Maastricht University Medical Center
- ||||||| HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
Trial completion: Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO in Healthy Children Vaccinated 10 Years Ago With 3 Doses of HEXAVAC or INFANRIX HEXA (clinicaltrials.gov) - Jun 1, 2015
P3, N=751, Completed, Sponsor: Sanofi Pasteur MSD
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- | HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
Enrollment change: Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis (clinicaltrials.gov) - Apr 14, 2015
P3, N=69, Recruiting, Sponsor: Fundaci
Active, not recruiting --> Completed N=44 --> 69
- HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
Trial initiation date, Trial primary completion date: Proof Of Concept : Immunogenicity and Safety of hepB Injection in the Dermis Using VAX-ID (clinicaltrials.gov) - Feb 19, 2015
P1, N=33, Not yet recruiting, Sponsor: Novosanis NV
N=44 --> 69 Initiation date: Jan 2015 --> Jul 2015 | Trial primary completion date: Mar 2015 --> Sep 2015
- ||||| HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
Enrollment closed: Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO in Healthy Children Vaccinated 10 Years Ago With 3 Doses of HEXAVAC or INFANRIX HEXA (clinicaltrials.gov) - Dec 13, 2014
P3, N=750, Active, not recruiting, Sponsor: Sanofi Pasteur MSD
Initiation date: Jan 2015 --> Jul 2015 | Trial primary completion date: Mar 2015 --> Sep 2015 Recruiting --> Active, not recruiting
- HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
Trial initiation date, Trial primary completion date: Proof Of Concept : Immunogenicity and Safety of hepB Injection in the Dermis Using VAX-ID (clinicaltrials.gov) - Aug 15, 2014
P1, N=33, Not yet recruiting, Sponsor: Novosanis NV
Recruiting --> Active, not recruiting Initiation date: Jul 2014 --> Jan 2015 | Trial primary completion date: Sep 2014 --> Mar 2015
- HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
New P1 trial: Proof Of Concept : Immunogenicity and Safety of hepB Injection in the Dermis Using VAX-ID (clinicaltrials.gov) - Jul 12, 2014
P1, N=33, Not yet recruiting, Sponsor: Novosanis NV
- HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
Enrollment change: Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis (clinicaltrials.gov) - Feb 12, 2014
P3, N=44, Recruiting, Sponsor: Fundaci
Initiation date: Jul 2014 --> Jan 2015 | Trial primary completion date: Sep 2014 --> Mar 2015 N=118 --> 44
- |||||| HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
Enrollment open: Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO in Healthy Children Vaccinated 10 Years Ago With 3 Doses of HEXAVAC or INFANRIX HEXA (clinicaltrials.gov) - Jan 22, 2014
P3, N=750, Recruiting, Sponsor: Sanofi Pasteur MSD
N=118 --> 44 Not yet recruiting --> Recruiting
- |||||||||| HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
New P3 trial: Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO in Healthy Children Vaccinated 10 Years Ago With 3 Doses of HEXAVAC or INFANRIX HEXA (clinicaltrials.gov) - Dec 15, 2013
P3, N=750, Recruiting, Sponsor: Sanofi Pasteur MSD
- ||| Entyvio (vedolizumab) / Takeda
Trial completion: Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedolizumab (clinicaltrials.gov) - Nov 4, 2013
P1, N=127, Completed, Sponsor: Millennium Pharmaceuticals, Inc.
Not yet recruiting --> Recruiting Not yet recruiting --> Completed
- ||| Entyvio (vedolizumab) / Takeda
New P1 trial: Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedolizumab (clinicaltrials.gov) - Oct 29, 2013
P1, N=127, Completed, Sponsor: Millennium Pharmaceuticals, Inc.
- HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
New P3 trial: Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis (clinicaltrials.gov) - Jun 20, 2013
P3, N=44, Recruiting, Sponsor: Fundaci
- HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
New P4 trial: New Methods to Measure the Immune Response to Hepatitis B Vaccine (clinicaltrials.gov) - Mar 28, 2013
P4, N=16, Recruiting, Sponsor: University of Oxford
- ||||||| HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi, Recombivax HB (hepatitis B vaccine recombinant) / Merck (MSD)
Trial completion: Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062) (clinicaltrials.gov) - Nov 26, 2012
P3, N=722, Completed, Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting --> Completed Active, not recruiting --> Completed
- | New P4 trial: Comparison of 4 different Hepatitis B vaccines in healthy persons in whom a standard hepatitis B vaccination schedule of three vaccinations did not induces a protective immune response, so-called non-responders. Vergelijking van 4 verschillende hepatitis B vaccins in gezonde personen die na een standaard serie hepatitis B vaccinaties (3 vaccinaties) geen beschermende afweerreactie hebben opgebouwd, de non-responders. (EUDRACT) - Jul 18, 2012
P4, N=480, Ongoing, Sponsor: null
- ||| Twinrix (inactivated hepatitis A and recombinant hepatitis B) / GSK
Enrollment change, Head-to-Head: Study to Show That the Combined Hepatitis A and B Vaccine is Non-inferior to Monovalent Vaccines in Adults (clinicaltrials.gov) - Dec 1, 2011
P4, N=213, Completed, Sponsor: GlaxoSmithKline
Active, not recruiting --> Completed N=495 --> 213
- |||||||||| HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi, Recombivax HB (hepatitis B vaccine recombinant) / Merck (MSD)
New P3 trial: Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062) (clinicaltrials.gov) - Oct 31, 2011
P3, N=722, Completed, Sponsor: Merck Sharp & Dohme Corp.
- ||||||| HBVaxPro (hepatitis-B vaccine (rDNA)) / Merck (MSD), Sanofi
Trial completion: Hepatitis B Challenge Dose in Adults (V232-059-10) (clinicaltrials.gov) - Oct 10, 2011
P3, N=204, Completed, Sponsor: Sanofi Pasteur MSD
N=495 --> 213 Active, not recruiting --> Completed