Notice to Readers
Availability of New Rabies Vaccine for Human Use
On October 20, 1997, the Food and Drug Administration licensed
a new rabies vaccine for both pre-exposure and postexposure
prophylactic use in humans. This purified chick embryo cell culture
(PCEC) vaccine (RabAvertTM) * is manufactured by Chiron Behring
GmbH
and Company. The addition of PCEC to the current products available
for pre-exposure and postexposure prophylactic use in humans allows
for greater flexibility in treatment choices for the vaccination
candidate who develops a sensitivity to one of the other available
vaccines. Although derived from chick embryo cells, antibodies to
chick cell proteins were not detected in recipients of the vaccine
(1).
Before introduction of the PCEC vaccine, two other products
were licensed for use as rabies vaccines in the United States:
human diploid cell vaccine (HDCV) and rabies vaccine adsorbed
(RVA). HDCV uses the Pitman Moore strain of fixed rabies virus
propagated in infected human diploid cells, and RVA uses a Kissling
strain of rabies virus adapted to a diploid cell line of fetal
rhesus lung (2,3).
The PCEC vaccine has been shown to be safe and immunogenic
when the current Advisory Committee on Immunization Practices
guidelines are employed (4,5). These guidelines are as follows:
pre-exposure vaccination for persons not previously vaccinated
consists of three 1.0-mL doses delivered intramuscularly in the
deltoid region for adults and in the anterolateral zone of the
thigh for young children on days 0, 7, and 21 or 28 (day 0
indicates the start of treatment); postexposure vaccination with
PCEC in persons not previously vaccinated consists of five 1.0-mL
doses delivered intramuscularly in the same regions as for
pre-exposure vaccination on days 0, 3, 7, 14, and 28, plus one dose
of human rabies immune globulin (HRIG) at 20 IU per kg of body
weight on day 0. As much as possible of the full dose of HRIG
should be thoroughly infiltrated into and around the wound(s). Any
remaining volume should be administered intramuscularly at a site
distant from the vaccine inoculation. Postexposure prophylaxis for
those persons who have been previously vaccinated should consist of
two 1.0-mL doses delivered intramuscularly, in the same regions as
previously stated for adults and children, on days 0 and 3. HRIG
should not be administered to previously vaccinated persons (4).
On the basis of information provided by the manufacturer (6)
RabAvertTM is a sterile freeze-dried vaccine obtained by growing
the fixed-virus strain Flury low egg passage (LEP) in primary
cultures of chicken fibroblasts. The tissue culture fluid is
harvested and filtered to remove cell debris. The virus is
inactivated with b-propiolactone, then further purified and
concentrated by zonal centrifugation. The vaccine is lyophilized
after addition of a stabilizer solution in 1.0-mL amounts, which
supplies at least 2.5 IU of rabies antigen. No preservative is
contained in the vaccine, and the vaccine should be used
immediately after reconstitution. The vaccine is designed for
intramuscular use only.
The manufacturer also reported the occurrence of a substantial
amnestic antibody response with no reports of IgE-mediated
hypersensitivity when PCEC was used as a booster, regardless of the
vaccine used for primary vaccination. As with the other available
products (HDCV and RVA), local reactions such as swelling,
induration, and reddening have been associated with administration
of PCEC. Because the product contains trace amounts of animal
by-products, antibiotics, and human serum albumin, systemic
allergic reactions are possible and have been reported.
Reported by: Viral and Rickettsial Zoonoses Br, Div of Viral and
Rickettsial Diseases, National Center for Infectious Diseases, CDC.
References
Dreesen DW. A global review of rabies vaccines for human use.
Vaccine 1997;suppl 15:S2-S6.
Wiktor TJ, Plotkin SA, Koprowski H. Development and clinical
trials of the new human rabies vaccine of tissue culture (human
diploid cell) origin. Dev Biol Stand 1978;40:3-9.
Burgoyne GH, Kajiya KD, Brown DW, Mitchell JR. Rhesus diploid
rabies vaccine (adsorbed): a new rabies vaccine using FRhL-2
cells.
J Infect Dis 1985;152:204-10.
CDC. Rabies prevention -- United States, 1991: recommendations
of
the Immunization Practices Advisory Committee (ACIP). MMWR
1991;40(no. RR-3).
Wasi C, Chaiprasithikul P, Thongcharoen P, Choomkasien P,
Sirikawin S. Progress and achievement of rabies control in
Thailand. Vaccine 1997;suppl 15:S7-S11.
Chiron Therapeutics. Rabies vaccine, RabAvertTM: rabies vaccine
for human use {Package insert}. Emeryville, California: Chiron
Therapeutics, 1998.
* Use of trade names and commercial sources is for identification
only and does not imply endorsement by CDC or the U.S. Department
of Health and Human Services.
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