Immunization of newborns Against Hepatitis B virus

choi

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(1) Taiwan was the the first in the world to start universal vaccination against hepatitis b virus (HBV), in 1984.

The vaccine then was produced by Merck from human serum. In 1986 California-based Chiron Corporation succeeded in making the first recombinant vaccine, the
hepatitis B vaccine
http://en.wikipedia.org/wiki/Hepatitis_B_vaccine
(section 1 The invention, whose reference 4 is Lawrence M Fisher, Biotechnology Spotlight Now Shines on Chiron. New York Times, Oct 13, 1986.
http://www.nytimes.com/1986/10/13/business/biotechnology-spotlight-now-shines-on-chiron.html
)
, and transferred the technology to Merck, whose product is Recombivax HB (see next).

(2) Recombivax HB. Merck, undated.
http://www.merck.com/product/usa/pi_circulars/r/recombivax_hb/recombivax_pi.pdf

Quote:

"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 * * * [after purification] The vaccine contains no detectable yeast DNA but may contain not more than
1% yeast protein.

"RECOMBIVAX HB was shown to be highly immunogenic in clinical studies involving infants * * * Three 5 mcg doses of vaccine induced a protective level of antibody in 100% of 92
infants[10] * * * The protective efficacy of three 5 mcg doses of RECOMBIVAX HB has been demonstrated in neonates born of mothers positive for both HBsAg and HBeAg (a core-associated antigenic complex which correlates with high infectivity). In a clinical study of infants who received one dose of HBIG at birth followed by the recommended three-dose regimen of RECOMBIVAX HB, chronic infection had not occurred in 96% of 130 infants after nine months of follow-up.[16]

Ref 10: Data on file at Merck Research Laboratories.
Ref 16: Stevens, C.E.; Taylor, P.E.; Tong, M.J., et al.: Prevention of Perinatal Hepatitis B Virus Infection with Hepatitis B Immune Globulin and Hepatitis B Vaccine, in Zuckerman, A.J. (ed.), “Viral Hepatitis and Liver Diseases”, Alan R. Liss, 982-983, 1988.

(2) Another recombinant HBV vaccine is
Engerix B. GlaxoSmithKline, undated.
http://www.medicines.org.uk/EMC/medicine/9283/SPC/Engerix+B+20+micrograms+1+ml+Suspension+for+injection%2c+Hepatitis+B+recombinant+vaccine%2c+adsorbed/

Quote:

"In field studies, a protective efficacy between 95% and 100% was demonstrated in neonates, children and adults at risk.

"A 95% protective efficacy was demonstrated in neonates of HBeAg positive mothers, immunised according to the 0, 1, 2 and 12 or 0, 1 and 6 schedules without the concomitant administration of HBIg at birth. However, simultaneous administration of HBIg and vaccine at birth increased the protective efficacy to 98%.

(c) However, US government is not so optimistic, whose conclusion is similar to Taiwan's.

"Clinical trials of the hepatitis B vaccines licensed in the United States have shown that they are 80%-95% effective in preventing HBV infection and clinical hepatitis among susceptible children and adults."
Katz SL et al, Hepatitis B Virus: A Comprehensive Strategy for Eliminating Transmission in the United States Through Universal Childhood Vaccination: Recommendations of the Immunization Practices Advisory Committee (ACIP). Morbidity and Mortality Weekly Report (MMWR) 40(RR-13); 1-19 (Nov 22, 1991).
http://www.cdc.gov/mmwr/preview/mmwrhtml/00033405.htm

(d) Those who are interested in HBV--particularly its surface antigen (HBs)--may read on.

HBV is made up of a protein coat with double-stranded DNA at the core. The DNA is made up of  four genes (S, C, P and X), encoding basically four proteins.
(i) The surface protein (or HBs antigen) has three lengths : L (large, 400 amino acids), M (medium, 281 amino acids), and S (small, 226 amino acids).
(ii) The C gene encodes two proteins: the longer HBc antigen and the shorter HBe antigen.

There are a few graphics in
Henryk Dancygier, Clinical Hepatology; Principle and practice of hepatobiliary Diseases, volume 2. Springer 2010, pages 675-678.
http://books.google.com/books?id=lrPX8C4p90QC&pg=PR6&dq=Henryk+Dancygier,+Clinical+Hepatology;+Principle+and+practice+of+hepatobiliary+Diseases,+volume+2&hl=en&ei=3717TZvrDITmrAHb4rzwBQ&sa=X&oi=book_result&ct=result&resnum=1&ved=0CC0Q6AEwAA#v=onepage&q&f=false

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choi

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(3) "Hepatitis B virus is transmitted between people by contact with the blood or other body fluids (i.e. semen and vaginal fluid) of an infected person. Modes of transmission are the same for the human immunodeficiency virus (HIV), but HBV is 50 to 100 times more infectious Unlike HIV, HBV can survive outside the body for at least 7 days. During that time, the virus can still cause infection if it enters the body of a person who is not infected."
Hepatitis B: Fact sheet N°204. World Health Organization (WHO), August 2008.
http://www.who.int/mediacentre/factsheets/fs204/en/

(3) "What are ways Hepatitis B is not spread?
Hepatitis B virus is not spread by sharing eating utensils, breastfeeding, hugging, kissing, holding hands, coughing, or sneezing."
Hepatitis B FAQs for the Public. US Center for Disease Control and Prevention, undated.
http://www.cdc.gov/hepatitis/B/bFAQ.htm

(4) China
(a) GAVI and China team up to vaccinate millions of children. United Nations Children's Fund (UNICEF), May 31, 2002.
http://www.unicef.org/media/media_19184.html

Note: GAVI was the acronym of The Global Alliance for Vaccines and Immunisation. It is "a global health partnership between the private and public sectors."
(i) GAVI Alliance
http://en.wikipedia.org/wiki/GAVI_Alliance
(ii) Innovative partnership. GAVI, undated.
http://www.gavialliance.org/about/in_partnership/index.php
(Bill and MelindaGates Foundation is one of them)

(b) Hepatitis B in China
http://en.wikipedia.org/wiki/Hepatitis_B_in_China
(section 2.2 Vaccination: "Even though the GAVI alliance (whose partners include UNICEF and the WHO), and Chinese government were providing the vaccine and one-use needles free of charge, health-care workers charged fees that parents were unwilling or unable to pay.")

【 在 choi 的大作中提到: 】
: (1) Taiwan was the the first in the world to start universal vaccination against hepatitis b virus (HBV), in 1984.
: The vaccine then was produced by Merck from human serum. In 1986 California-based Chiron Corporation succeeded in making the first recombinant vaccine, the
: (以下引言省略...)

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