PreHevbrio (recombinant hepatitis B vaccine) / VBI Vaccines 
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  • ||||||||||  Heplisav-B (hepatitis B vaccine (recombinant), adjuvanted) / Dynavax
    Journal:  The role of new hepatitis B vaccines in South Africa. (Pubmed Central) -  Mar 29, 2024   
    These two novel vaccines have not yet been investigated in children and licensed in SA. Should HEPLISAV-B become available in SA, it may be particularly valuable to target high-risk groups in the country, such as people living with HIV, who show a poor response to the currently licensed vaccine.
  • ||||||||||  PreHevbrio (recombinant hepatitis B vaccine) / VBI Vaccines
    Enrollment open:  PREHEVBRIO Pregnancy Outcomes Registry (clinicaltrials.gov) -  Dec 8, 2023   
    P=N/A,  N=120, Recruiting, 
    Should HEPLISAV-B become available in SA, it may be particularly valuable to target high-risk groups in the country, such as people living with HIV, who show a poor response to the currently licensed vaccine. Not yet recruiting --> Recruiting
  • ||||||||||  PreHevbrio (recombinant hepatitis B vaccine) / VBI Vaccines
    Review, Journal:  PreHevbrio: the first approved 3-antigen hepatitis B vaccine. (Pubmed Central) -  Nov 7, 2023   
    3A-HBV provides higher seroprotection rates after each vaccination compared to conventional 1A-HBV vaccines, allowing for more rapid protection. The higher overall immunogenicity is also reflected in more durable seroprotection years after vaccination, as supported by a follow-up study to one of the phase 3 studies.
  • ||||||||||  PreHevbrio (recombinant hepatitis B vaccine) / VBI Vaccines
    New trial:  PREHEVBRIO Pregnancy Outcomes Registry (clinicaltrials.gov) -  Oct 23, 2023   
    P=N/A,  N=120, Not yet recruiting, 
  • ||||||||||  Journal:  Adult immunization. (Pubmed Central) -  Oct 14, 2022   
    Figure: YI bursary request: No Plagia Similarity: Status: Comments: Source: Average Grade: 10.2 Reviewing Comments: Average score value: Comment: Suggested type: Rejection Suggested: Reason for rejection: Comment for rejection: : No abstract available
  • ||||||||||  PreHevbrio (recombinant hepatitis B vaccine) / VBI Vaccines
    Journal:  PreHevbrio: A New 3-Antigen Hepatitis B Vaccine for Adults. (Pubmed Central) -  Jul 31, 2022   
    The 3A-HepB represents another vaccine to prevent hepatitis B in adults. It is safe and immunogenic but is associated with more adverse reactions than 1A-HepB.
  • ||||||||||  Heplisav-B (hepatitis B vaccine (recombinant), adjuvanted) / Dynavax, PreHevbrio (recombinant hepatitis B vaccine) / VBI Vaccines
    Journal:  A three-antigen hepatitis B vaccine (PreHevbrio). (Pubmed Central) -  May 18, 2022   
    It is safe and immunogenic but is associated with more adverse reactions than 1A-HepB. No abstract available
  • ||||||||||  Heplisav-B (hepatitis B vaccine (recombinant), adjuvanted) / Dynavax
    Clinical, Journal:  CpG-Adjuvanted Hepatitis B Vaccine (HEPLISAV-B®) Update. (Pubmed Central) -  Apr 2, 2022   
    The safety profiles among 9,871 subjects were similar between HEPLISAV-B and Engerix-B .Expert opinion: HEPLISAV-B, a CpG adjuvant mixed with HBsAg, is more efficacious and produced earlier seroprotection compared to existing vaccines, with a favourable safety profile. The shorter, two-dose regimen, earlier seroprotection, higher adherence and a higher seroprotection rate, especially in populations with traditionally poor vaccine response, makes this an important therapeutic option in hepatitis B vaccination.
  • ||||||||||  PreHevbrio (recombinant hepatitis B vaccine) / VBI Vaccines
    Trial completion:  Lot-to-lot Consistency of Sci-B-Vac (clinicaltrials.gov) -  Nov 15, 2019   
    P3,  N=2837, Completed, 
    In this second pivotal Phase 3 study, TV continued to demonstrate its ability to safely and quickly elicit robust immune responses in adults. Active, not recruiting --> Completed
  • ||||||||||  PreHevbrio (recombinant hepatitis B vaccine) / VBI Vaccines
    Trial completion:  PROTECT: Immunogenicity and Safety of Sci-B-Vac (clinicaltrials.gov) -  May 20, 2019   
    P3,  N=1609, Completed, 
    Active, not recruiting --> Completed Active, not recruiting --> Completed
  • ||||||||||  PreHevbrio (recombinant hepatitis B vaccine) / VBI Vaccines
    Enrollment closed, Trial completion date, Trial primary completion date:  Lot-to-lot Consistency of Sci-B-Vac (clinicaltrials.gov) -  Nov 21, 2018   
    P3,  N=2837, Active, not recruiting, 
    Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial completion date: Apr 2019 --> Oct 2019 | Trial primary completion date: Nov 2018 --> Oct 2019
  • ||||||||||  PreHevbrio (recombinant hepatitis B vaccine) / VBI Vaccines
    Trial primary completion date:  PROTECT: Immunogenicity and Safety of Sci-B-Vac (clinicaltrials.gov) -  Nov 21, 2018   
    P3,  N=1609, Active, not recruiting, 
    Recruiting --> Active, not recruiting | Trial completion date: Apr 2019 --> Oct 2019 | Trial primary completion date: Nov 2018 --> Oct 2019 Trial primary completion date: Oct 2018 --> Apr 2019
  • ||||||||||  PreHevbrio (recombinant hepatitis B vaccine) / VBI Vaccines
    Enrollment closed:  PROTECT: Immunogenicity and Safety of Sci-B-Vac (clinicaltrials.gov) -  Oct 15, 2018   
    P3,  N=1609, Active, not recruiting, 
    Trial primary completion date: Oct 2018 --> Apr 2019 Recruiting --> Active, not recruiting
  • ||||||||||  PreHevbrio (recombinant hepatitis B vaccine) / VBI Vaccines
    New P3 trial:  Lot-to-lot Consistency of Sci-B-Vac (clinicaltrials.gov) -  Jan 24, 2018   
    P3,  N=3200, Recruiting, 
  • ||||||||||  PreHevbrio (recombinant hepatitis B vaccine) / VBI Vaccines, Engerix-B (hepatitis B vaccine recombinant) / GSK
    Enrollment open:  HBV VIP: Hepatitis B Vaccine in Patients With Inflammatory Bowel Disease (clinicaltrials.gov) -  Jun 5, 2012   
    P=N/A,  N=75, Recruiting, 
    Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting