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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)

Group Offers Guidelines to Lessen Vaccination Pain
Source: Medscape Pediatrics Headlines [2015.08.28]
Clinicians can shuffle the order of vaccine injections, leverage the calming influence of parents and breast-feeding, and routinely apply topical anesthetic to ease vaccination pain for patients.
Medscape Medical News

One dose or 2? Cholera vaccination strategies
Source: Immune System / Vaccines News From Medical News Today [2015.08.26]
A new modeling study appearing this week in PLOS Medicine supports consideration of vaccination campaigns using a single dose of cholera vaccine versus campaigns using the recommended two doses given...

Study backs flu vaccinations for elderly
Source: Flu / Cold / SARS News From Medical News Today [2015.08.25]
A new study of the records of millions of nursing home residents affirms the value of influenza vaccination among the elderly.

Reducing pain during vaccination: New guideline to help manage pain in children and adults
Source: Immune System / Vaccines News From Medical News Today [2015.08.25]
A new Canadian guideline aims to ensure that pain during vaccination is minimized in both children and adults.

Project Boosts Vaccination Rates in At-Risk Pediatric Patients
Source: Medscape Infectious Diseases Headlines [2015.08.24]
A quality improvement project directed primarily at providers significantly improved PCV13 and PPSV23 vaccination rates in high-risk pediatric rheumatology patients.
Medscape Medical News

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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: 2015-08-28

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