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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)

Childhood Vaccination Schedule
Source: MedicineNet Chickenpox (Varicella) Specialty [2016.03.21]
Title: Childhood Vaccination Schedule
Category: Procedures and Tests
Created: 2/21/2001 12:00:00 AM
Last Editorial Review: 3/21/2016 12:00:00 AM

State laws boost flu vaccination rates in health care workers
Source: Flu / Cold / SARS News From Medical News Today [2016.03.03]
State laws mandating influenza immunization for people who work in health care increase their vaccination rates, according to new research led by the University of Pittsburgh School of Medicine.

Hepatitis A and B Vaccinations
Source: MedicineNet Immunizations Specialty [2015.11.20]
Title: Hepatitis A and B Vaccinations
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 11/20/2015 12:00:00 AM

Pneumococcal Vaccination (Pneumonia Vaccine)
Source: MedicineNet Sickle Cell Specialty [2015.10.26]
Title: Pneumococcal Vaccination (Pneumonia Vaccine)
Category: Procedures and Tests
Created: 4/12/1999 12:00:00 AM
Last Editorial Review: 10/26/2015 12:00:00 AM

Vaccination FAQs
Source: MedicineNet Anthrax Specialty [2015.09.25]
Title: Vaccination FAQs
Category: Procedures and Tests
Created: 9/12/2008 12:00:00 AM
Last Editorial Review: 9/25/2015 12:00:00 AM

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Published Studies Related to Recombivax HB (Hepatitis B Vaccine)

Long-term efficacy of a hepatitis E vaccine. [2015]
long-term efficacy of a hepatitis E vaccine needs to be determined... CONCLUSIONS: Immunization with this hepatitis E vaccine induced antibodies

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.

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Clinical Trials Related to Recombivax HB (Hepatitis B Vaccine)

The Immunogenicity and Safety of 60mcg/30mcg Recombinant Hepatitis B Vaccines in People Who Failed to Respond to Routine Administration of Hepatitis B Vaccines [Completed]
This study is an expanded Phase 2/Phase 3 clinical trial base on the safety data obtained from the phase 1 clinical trial. The purpose of this study is to further evaluate the immunogenicity and safety of 60mcg/30mcg recombinant hepatitis B vaccines in people aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines and to explore the optimizing immunizing dose and immune procedure.

Study of Evaluating Safety and Immunogenicity of 10�g/0.5ml Hepatitis B Vaccine [Completed]
The main objective of this study was to evaluate the safety and immunogenicity of 10g/0. 5ml and 5g/0. 5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside yeast for infants and other age groups.

Hepatitis B Vaccine Predialysis/Dialysis Study (V232-060) [Completed]

Hepatitis B Vaccine Booster Study (V232-058) [Completed]
To assess the safety and immunogenicity of a booster dose of hepatitis B vaccine in children who have received a 3-dose primary series of either RECOMBIVAX HB or ENGERIX-B. The primary vaccination series (was given 4 to 8 years prior to study entry and consisted of a licensed hepatitis B vaccine product (either RECOMBIVAX HB or ENGERIX-B). The booster dose given in this study will be either an investigational Merck product (Modified Process Hepatitis B Vaccine) or licensed ENGERIX-B vaccine.

A Research Study to Test Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured With an Upgrade to the Production Process (V232-054) [Completed]
A study to evaluate the safety, tolerability, and immunogenicity of a recombinant hepatitis B vaccine manufactured using an upgrade to the production process. The primary hypotheses tested at 1 month after the third dose of vaccine are the following: 1) the 3 lots of the process upgrade vaccine induce similar seroprotection rates to hepatitis B surface antigen (HBsAg), 2) the combined lots of the process upgrade vaccine induce adequate seroprotection to HBsAg, and 3) the process upgrade vaccine will induce geometric mean antibody titers to HBsAg that are non-inferior or superior to those induced by the current process vaccine.

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Page last updated: 2016-03-21

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