RECOMBIVAX HB® HEPATITIS B VACCINE (RECOMBINANT)
DESCRIPTION
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.
The antigen is harvested and purified from fermentation cultures of a
recombinant strain of the yeast Saccharomyces cerevisiae containing the gene for
the adw subtype of HBsAg. The fermentation process involves growth of
Saccharomyces cerevisiae on a complex fermentation medium which consists of an
extract of yeast, soy peptone, dextrose, amino acids and mineral salts. The
HBsAg protein is released from the yeast cells by cell disruption and purified
by a series of physical and chemical methods. The purified protein is treated in
phosphate buffer with formaldehyde and then coprecipitated with alum (potassium
aluminum sulfate) to form bulk vaccine adjuvanted with amorphous aluminum
hydroxyphosphate sulfate. The vaccine contains no detectable yeast DNA but may
contain not more than 1% yeast protein. The vaccine produced by the Merck method
has been shown to be comparable to the plasma-derived vaccine in terms of animal
potency (mouse, monkey, and chimpanzee) and protective efficacy (chimpanzee and
human).
The vaccine against hepatitis B, prepared from recombinant yeast cultures, is
free of association with human blood or blood products.
Each lot of hepatitis B vaccine is tested for safety, in mice and guinea pigs,
and for sterility. RECOMBIVAX HB is a sterile suspension for intramuscular
injection. However, for persons at risk of hemorrhage following intramuscular
injection, the vaccine may be administered subcutaneously. (See DOSAGE AND
ADMINISTRATION.) RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) is supplied in
three formulations. (See HOW SUPPLIED.)
Pediatric/Adolescent Formulation (With and Without Preservative), 10 mcg/mL:
each 0.5 mL dose contains 5 mcg of hepatitis B surface antigen.
Adult Formulation (With and Without Preservative), 10 mcg/mL: each 1 mL dose
contains 10 mcg of hepatitis B surface antigen.
Dialysis Formulation (With and Without Preservative), 40 mcg/mL: each 1 mL dose
contains 40 mcg of hepatitis B surface antigen.
Formulations that contain a preservative include thimerosal, a mercury
derivative, at 1:20,000 or 50 mcg/mL. All formulations contain approximately 0.5
mg of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate,
previously referred to as aluminum hydroxide) per mL of vaccine. In each
formulation, hepatitis B surface antigen is adsorbed onto approximately 0.5 mg
of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate) per mL of
vaccine. The vaccine is of the adw subtype. RECOMBIVAX HB is indicated for
vaccination of persons at risk of infection from hepatitis B virus including all
known subtypes. 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.
BL Fisher Note:
In 1991, the Centers for Disease Control and the American Academy of
Pediatrics recommended that all 12 hour old newborns be injected with
hepatitis B vaccine before leaving the hospital nursery and be given another
dose of hepatitis B vaccine at 1 month and six months of age. At the time,
NVIC protested this recommendation for the following reasons:
- little is known about the neurological and immunological status of a 12
hour old infant;
- hepatitis B is an adult disease occurring primarily in high risk
populations such as IV drug users and persons with multiple sexual partners
and the only way a newborn infant can contract hepatitis B is from aninfected
mother or transfusion of infected blood;
- hepatitis B is not endemic in the US and less than 1/2 of one percent of
mothers who give birth to babies in the US have hepatitis B disease; - the
vaccine manufacturers admitted in their product manufacturer inserts that the
long term protection offered by hepatitis B vaccine is unknown but that there
are no detectable antibodies in the blood after 7 years
The result of the 1991 CDC and AAP hepatitis B vaccine recommendation was to
expose American babies born between 1991 and 2000 to mercury preservatives in
vaccines from the moment of birth. Mercury is a known neurotoxin and vaccine
mercury preservatives have been associated with the development of autism and
other neurodevelopmental disorders.
Now the study published in current issue of Pediatric Infectious Diseases
Journal has found that injecting newborns with hepatitis B vaccine offers
only five years of protection for most healthy infants.
Duration of Hepatitis B Immunity in Low Risk Children Receiving Hepatitis B
Vaccinations from Birth
Kenneth M. Petersen, MD; Lisa R. Bulkow, MS; Brian J. McMahon, MD; Carolyn
Zanis, BS; Marilyn Getty, RN; Helen Peters, RN; Alan J. Parkinson, PhD
Pediatr Infect Dis J 23(7):650-655, 2004.
Abstract
Background: The duration of protection after hepatitis B vaccination of
infants is unknown. Methods: We determined antibody to hepatitis B surface
antigen (anti-HBs) at 4-13 years of age in 363 low risk children who had been
vaccinated starting at birth with hepatitis B vaccine. Those with
nonprotective titers (<10 mIU/mL) received a booster dose. We similarly
followed 16 children of hepatitis B surface antigen (HBsAg)-positive mothers.
Results: Of low risk infants receiving a plasma-derived vaccine, 41% (42 of
102) of those whose primary response was unknown and 24% (4 of 17) who had
initially responded retained protective titers (>/=10 mIU/mL) of anti-HBs at
9 and 13 years, respectively. Of those who did not have protective antibody
titers, 61% (33 of 54) and 67% (8 of 12), respectively, responded to a
booster dose. In children of HBsAg-positive mothers, 31% retained protective
anti-HBs at 12 years, and 90% (9 of 10) with nonprotective titers responded
to a booster. In low risk children initially receiving a recombinant vaccine,
12.5% (26 of 208) and none (0 of 36) retained protective anti-HBs titers at 5
and 7 years of age, respectively. Of those who did not have protective
titers, 90% (120 of 134) and 91% (32 of 35), respectively, responded to a
booster.
Conclusions: Anti-HBs disappeared by 5 years of age in most children who were
vaccinated with hepatitis B vaccine from birth. Although most children showed
immunologic memory, one-third failed to demonstrate an anamnestic response to
a booster dose. Additional long term studies of low risk infants are needed
to determine duration of protection and the necessity for or timing of
booster doses.
Long-term immunogenicity and efficacy of hepatitis B
vaccine in homosexual men
SC Hadler, DP Francis, JE Maynard, SE Thompson, FN Judson, DF Echenberg, DG
Ostrow, PM O'Malley, KA Penley, NL Altman, and et al.
Abstract
To study the duration of antibody persistence and protection provided by the
hepatitis B vaccine, we followed 773 homosexual men for five years after
completion of vaccination. Among the 635 participants in whom antibody levels
above 9.9 sample ratio units (SRU) developed after vaccination, 15 percent
lost antibody altogether, and in another 27 percent, antibody levels declined
below 10 SRU within five years. The extent of the maximal antibody response
strongly predicted the persistence of protective antibody. Hepatitis B
infection occurred in 55 men; 8 of these infections were clinically important
(characterized by the presence of the hepatitis B surface antigen and
elevation of liver-enzyme levels), and two of the patients became hepatitis B
virus carriers. The long-term risk of hepatitis B infection was inversely
related to the maximal antibody response to vaccine. Most severe infections
occurred among those who responded poorly or had no response to the
vaccination. The risk of late infection with hepatitis B in those with an
initially adequate vaccine response increased markedly when antibody levels
decreased below 10 SRU, but only 1 of 34 late
infections resulted in viremia and liver inflammation. A second series of
vaccinations induced a moderate antibody response in 50 percent of the
subjects who initially had no response or a poor response; however, the
persistence of antibody was poor. Both antibody loss and the risk of severe
disease should be considered when booster-dose strategies for the hepatitis B
vaccine are being designed.
Duration of hepatitis B immunity in low risk children
receiving hepatitis B vaccinations from birth.
Petersen KM, Bulkow LR, McMahon BJ, Zanis C, Getty M, Peters H, Parkinson AJ.
Arctic Investigations Program, National Center for Infectious Diseases, Centers
for Disease Control and Prevention, Alaska Native Tribal Health Consortium,
Anchorage, AK 99508, USA.
BACKGROUND: The duration of protection after hepatitis B vaccination of infants
is unknown. METHODS: We determined antibody to hepatitis B surface
antigen (anti-HBs) at 4-13 years of age in 363 low risk children who had been
vaccinated starting at birth with hepatitis B vaccine. Those with nonprotective
titers (<10 mIU/mL) received a booster dose. We similarly followed 16 children
of hepatitis B surface antigen (HBsAg)-positive mothers. RESULTS: Of low risk
infants receiving a plasma-derived vaccine, 41% (42 of 102) of those whose
primary response was unknown and 24% (4 of 17) who had initially responded
retained protective titers (> or = 10 mIU/mL) of anti-HBs at 9 and 13 years,
respectively. Of those who did not have protective antibody titers, 61%
(33 of 54) and 67% (8 of 12), respectively, responded to a booster dose. In
children of HBsAg-positive mothers, 31% retained protective anti-HBs at 12
years, and 90% (9 of 10) with nonprotective titers responded to a booster. In
low risk children initially receiving a recombinant vaccine, 12.5% (26 of 208)
and
none (0 of 36) retained protective anti-HBs titers at 5 and 7 years of
age,respectively. Of those who did not have protective titers, 90% (120 of 134)
and 91% (32 of 35), respectively, responded to a booster.
CONCLUSIONS:
Anti-HBs disappeared by 5 years of age in most children who were vaccinated with
hepatitis B vaccine from birth. Although most children showed immunologic
memory, one-third failed to demonstrate an anamnestic response to a booster
dose. Additional long term studies of low risk infants are needed to determine
duration of protection and the necessity for or timing of booster doses.
PMID: 15247604 [PubMed - indexed for MEDLINE]
Hepatitis B triple series vaccine and developmental
disability in US children aged 1-9 years
http://www.informaworld.com/smpp/content~content=a905442343~db=all~jumptype=rss
Abstract
This study investigated the association between vaccination with the Hepatitis B
triple series vaccine prior to 2000 and developmental disability in children
aged 1-9 years (n = 1824), proxied by parental report that their child receives
early intervention or special education services (EIS). National Health and
Nutrition Examination Survey 1999-2000 data were analyzed and adjusted for
survey design by Taylor Linearization using SAS version 9.1 software, with SAS
callable SUDAAN version 9.0.1. The odds of receiving EIS were approximately nine
times as great for vaccinated boys (n = 46) as for unvaccinated boys (n = 7),
after adjustment for confounders. This study found statistically significant
evidence to suggest that boys in United States who were vaccinated with the
triple series Hepatitis B vaccine, during the time period in which vaccines were
manufactured with thimerosal, were more susceptible to developmental disability
than were unvaccinated boys.
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