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)

WHO To Launch Yellow Fever Vaccination Campaign In West Africa
Source: Health News from Medical News Today [2009.11.19]
The WHO on Tuesday announced it would lead a week-long, multi-country vaccination campaign in Africa next week to protect those "deemed at highest risk from yellow fever," Reuters reports. The vaccination drive will target nearly 12 million Africans living in Benin, Liberia and Sierra Leone - all countries at high risk of yellow fever outbreaks (Nebehay/MacInnis, 11/17).

Blogs Comment On Abortion Issues In Health Reform, HPV Vaccinations For Immigrants
Source: Abortion News From Medical News Today [2009.11.18]
The following summarizes selected women's health-related blog entries. ~ "DeGette: Stupak Agenda Is Much Wider Restrictions on Abortion," Brian Beutler, Talking Points Memo: Rep. Diana DeGette (D-Colo.) "takes issue" with Rep. Bart Stupak's (D-Mich.

Senators Blame HHS for Mishandling H1N1 Vaccination Effort
Source: MedPage Today Infectious Disease [2009.11.17]
WASHINGTON (MedPage Today) -- Senators on the Homeland Security Committee scolded Health and Human Services Secretary Kathleen Sebelius Tuesday for overly optimistic estimates of pandemic H1N1 flu vaccine supplies.

The Diagnostic Clinic Introduces A Vaccination Alternative To The Flu Jab
Source: Flu / Cold / SARS News From Medical News Today [2009.11.12]
The Diagnostic Clinic in London's New Cavendish Street, the UK's premier centre for Integrated Medicine, offers a vaccination alternative for private and corporate patients not wishing to have the Flu or Swine Flu jab. Many people have concerns regarding vaccinations. Whether this is as simple as needle phobia or concerns over the safety of vaccinations, an alternative can be considered.

Potential Downside Of Yearly Influenza Vaccination For Children
Source: Bird Flu / Avian Flu News From Medical News Today [2009.11.02]
An article published Online First and in the December edition of The Lancet Infectious Diseases discusses the benefits and disadvantages of vaccination for children against seasonal flu. It reports that infection with "seasonal" influenza A could in fact benefit children by giving them improved immunity against pandemic strains such as the current swine flu H1N1 strain.

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Published Studies Related to Recombivax HB (Hepatitis B Vaccine)

Recombinant interferon-alpha2b improves immune response to hepatitis B vaccination in haemodialysis patients: results of a randomised clinical trial. [2009.09.18]
The use of adjuvants capable of improving the deficient immune response to hepatitis B virus (HBV) vaccine in haemodialysis patients is highly needed. Among potential adjuvants, type I interferons deserve a special attention in view of their known effects promoting cellular and humoral immune responses...

Intradermal versus intramuscular hepatitis B vaccination in hemodialysis patients: a prospective open-label randomized controlled trial in nonresponders to primary vaccination. [2009.07]
BACKGROUND: Primary hepatitis B virus (HBV) vaccination through the intramuscular (IM) route is less efficacious in dialysis patients than in the general population. Previous studies suggest improved seroconversion with intradermal (ID) vaccination... CONCLUSIONS: Significantly greater seroconversion rates and peak antibody titers can be achieved with ID compared with IM vaccination in hemodialysis patients nonresponsive to primary vaccination. ID vaccination should become the standard of care in this setting.

Differences in the immune response to hepatitis B and Haemophilus influenzae type b vaccines in Guatemalan infants by ethnic group and nutritional status. [2009.06.02]
Ladino and native Indian Guatemalan infants developed high rates (96-100%) of protective antibodies after receiving conjugate Haemophilus influenzae type b and hepatitis B vaccines at 2, 4 and 6 months of age.

Safety and immunogenicity of a hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine at 2, 3, 4, and 12-14 months of age. [2009.04.28]
Combination vaccines improve parental and provider satisfaction and schedule compliance by decreasing the number of injections. In a Phase 2, randomized, double-blind, multicenter study, we compared four formulations of a liquid, hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B virus (DTaP-IPV-Hib-HBV) vaccine in 708 infants immunized at 2, 3, 4, and 12-14 months of age...

Hepatitis B vaccination in haemodialysis patients: a randomized clinical trial. [2009.04]
AIM: A short vaccination protocol against hepatitis B was compared to the standard approach in patients under haemodialysis who were primarily non-responsive to the vaccine... CONCLUSION: In haemodialysis patients, a short vaccination protocol against hepatitis B did not provide any benefit compared to the standard approach with respect to peak anti-HBs titres or a higher rate of seroprotection at the end of follow up. Other strategies to increase seroconversion rates should be explored, especially in the elderly and in patients with hepatitis C.

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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.

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