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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)

Clinical trial evaluates heterologous prime/boost regimens in preventative HIV vaccination
Source: HIV / AIDS News From Medical News Today [2014.10.05]
Almost 40 million people worldwide live with HIV/AIDS, with an estimated 2.5 million new cases per year.

Researchers unlock vital new information to improve vaccinations against pneumococcus infection
Source: Respiratory / Asthma News From Medical News Today [2014.10.02]
Every ten seconds a human being dies from Streptococcus pneumoniae infection, also known as pneumococcus, making it a leading global killer.

Health officials urge flu vaccination for all, including healthy adults
Source: Flu / Cold / SARS News From Medical News Today [2014.09.23]
Influenza vaccination coverage estimates show an encouraging upward trend overall, but coverage among healthy 18 to 64 year-olds has yet to top 40 percent, according to new data announced at a news...

Moffitt Cancer Center study finds few physicians are recommending HPV vaccination for boys
Source: Sexual Health / STDs News From Medical News Today [2014.09.19]
Research from Moffitt Cancer Center shows family physicians and pediatricians are not always recommending vaccination against human papillomavirus (HPV) for young male patients.

Flu vaccination rates among health care workers climb with mandatory policy
Source: Flu / Cold / SARS News From Medical News Today [2014.09.09]
Hospitals can greatly improve their flu vaccination rate among health care workers by using a mandatory employee vaccination policy, according to a Henry Ford Health System study.

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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: 2014-10-05

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