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Recombivax HB (Hepatitis B Vaccine (Recombinant)) - Summary

 
 



RECOMBIVAX HB SUMMARY

RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) is a non-infectious subunit viral vaccine derived from Hepatitis B surface antigen (HBsAg) produced in yeast cells. A portion of the hepatitis B virus gene, coding for HBsAg, is cloned into yeast, and the vaccine for hepatitis B is produced from cultures of this recombinant yeast strain according to methods developed in the Merck Research Laboratories.

RECOMBIVAX HB is indicated for vaccination against infection caused by all known subtypes of hepatitis B virus. RECOMBIVAX HB Dialysis Formulation is indicated for vaccination of adult predialysis and dialysis patients against infection caused by all known subtypes of hepatitis B virus.


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NEWS HIGHLIGHTS

Media Articles Related to Recombivax HB (Hepatitis B Vaccine)

Pneumococcal Vaccination: Applying the ACIP Algorithms
Source: Medscape Pharmacists Headlines [2014.11.19]
CDC describes the 'one-two punch' pneumococcal vaccination of older adults.
CDC Expert Commentary

Wits study shows vaccination leads to critical decline in pneumococcal disease and antibiotic resistance in South Africa
Source: Respiratory / Asthma News From Medical News Today [2014.11.13]
Wits University and the National Institute for Communicable Diseases (NICD) released a new study, led by Wits academics, showing rates of invasive pneumococcal disease (IPD) - including cases...

Vaccination leads to decline in pneumococcal disease and antibiotic resistance
Source: Respiratory / Asthma News From Medical News Today [2014.11.13]
Reductions in disease among children and adults due to direct and indirect effects of vaccineWits University and the National Institute for Communicable Diseases (NICD) released a new study, led...

HPV Vaccination Rates Lowest in States With Highest Cervical Cancer Rates: Study
Source: MedicineNet Cancer Specialty [2014.11.12]
Title: HPV Vaccination Rates Lowest in States With Highest Cervical Cancer Rates: Study
Category: Health News
Created: 11/11/2014 12:00:00 AM
Last Editorial Review: 11/12/2014 12:00:00 AM

Automated tracking increases compliance of flu vaccination for health-care personnel
Source: Flu / Cold / SARS News From Medical News Today [2014.10.26]
New research found tracking influenza vaccination of healthcare personnel through an automated system increased vaccination compliance and reduced workload burden on human resources and...

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Published Studies Related to Recombivax HB (Hepatitis B Vaccine)

Safety and immunogenicity of a modified process hepatitis B vaccine in healthy infants. [2011.07]
BACKGROUND: A modified process hepatitis B vaccine (mpHBV) uses higher phosphate content in the manufacturing process relative to the current product, Recombivax-HB. The higher phosphate is thought to improve antigen presentation, and thereby, increase antibody production. The mpHBV was previously shown to be well tolerated and immunogenic in adults. The current study tested a 2-, 4-, 6-month vaccination schedule and a higher dose formulation (10 mug mpHBV) in healthy infants... CONCLUSIONS: All 4 hepatitis B vaccines elicited high anti-HBs SPRs. After dose 3, anti-HBs GMT were highest in the 10 mug mpHBV group, but did not meet the predefined criteria for superiority. All vaccines were well tolerated.

Immunogenicity and safety of an investigational hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-hepatitis B-Haemophilus influenzae B conjugate combined vaccine in healthy 2-, 4-, and 6-month-old Argentinean infants. [2011.06]
BACKGROUND AND AIMS: Assessment of a new, fully liquid, investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine (Hexaxim, Sanofi Pasteur), containing the same active ingredients as Pentaxim (DTaP-IPV//PRT-T) and 10 mug Hansenula polymorpha-derived recombinant hepatitis B (Hep B) surface antigen, Sanofi Pasteur, in Argentinean infants... CONCLUSIONS: The new, fully liquid, investigational DTaP-IPV-Hep B-PRP-T vaccine (Hexaxim) is highly immunogenic and safe when compared with licensed comparators, warranting further development.

Effect of high-flux hemodialysis on delayed hepatitis B virus vaccination response in hemodialysis patients. [2011.05]
OBJECTIVES: The aim of the study was to evaluate the effect of high-flux (HF) hemodialysis (HD) on delayed protective hepatitis B virus (HBV) antibody seroconversion in HD patients who had no response to the classic third dose of HBV vaccination... CONCLUSION: Hemodialysis patients who do not respond to the classic third dose of HBV vaccination could reobtain a delayed higher protective HBV antibody seroconversion rate by HF HD without other intervention.

Vaccination against hepatitis B among prisoners in Iran: accelerated vs. classic vaccination. [2011.05]
BACKGROUND: Prisoners and injecting drug users are at constant risk of hepatitis B virus (HBV) infection and the classic 6-months HBV vaccination might not provide immunization rapidly enough. In this randomized clinical trial we investigated the efficacy of an accelerated vaccination protocol vs. classic schedule among prisoners in Iran... CONCLUSION: Compared to classic HBV vaccination regimen, an accelerated 0, 1, 4 and 8 weeks vaccination schedule can achieve early seroprotection more rapidly, provides clinically sufficient seroprotection with higher compliance in prisoners and can be suggested in situations that rapid immunization against HBV infection is warranted. Copyright (c) 2011 Elsevier Ireland Ltd. All rights reserved.

Safety and immunogenicity of 4 intramuscular double doses and 4 intradermal low doses vs standard hepatitis B vaccine regimen in adults with HIV-1: a randomized controlled trial. [2011.04.13]
CONTEXT: Alternative schedules more immunogenic than the standard hepatitis B vaccine regimen are needed in patients with human immunodeficiency virus 1 (HIV-1) infection. OBJECTIVE: To compare the safety and immunogenicity of 4 intramuscular double-dose and 4 intradermal low-dose regimens vs the standard hepatitis B vaccine regimen... CONCLUSION: In adults with HIV-1, both the 4 intramuscular double-dose regimen and the 4 intradermal low-dose regimen improved serological response compared with the standard HBV vaccine regimen. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00480792.

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Clinical Trials Related to Recombivax HB (Hepatitis B Vaccine)

Effectiveness of Two Hepatitis B Vaccines in HIV-Negative Youths [Active, not recruiting]
This study will evaluate 2 licensed vaccine products (Recombivax and Twinrix) given in a two-dose schedule to youth at risk for hepatitis B and HIV infection to evaluate immunogenicity of the products in this population, barriers to vaccine delivery, and factors which predict a diminished immune response. Since these youths are also potential candidates for future HIV vaccine trials, this study will also include preliminary assessment of youths' understanding of informed consent forms, and willingness to participate in a vaccine trial and return for multiple visits (including blood draws for immunologic assessment).

Immunologic Memory (Supp. of ATN 024) [Completed]
This is an exploratory, laboratory-based evaluation of cellular immune response to immunization with hepatitis B surface antigen in HIV-infected and HIV-uninfected adolescents. This is a substudy of ATN 024 and ATN 025. This substudy will compare cellular immune response in responders and nonresponders to immunization and also evaluate the relationship of these factors to the persistence of known correlates of serologic protection for the hepatitis B virus.

Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062) [Not yet recruiting]
This is a study to evaluate immunogenicity, safety, and tolerability of 2XP HEPTAVAX-II compared with the 1XP HEPTAVAX-II in healthy Japanese young adults.

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Page last updated: 2014-11-19

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