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Warning:
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Current Trends Rabies Vaccine, Adsorbed: A New Rabies Vaccine for Use in Humans
MMWR 37(14);217-218,223
Publication date: 04/15/1988
Table of Contents
POINT OF CONTACT FOR THIS DOCUMENT:
Article
Rabies Vaccine, Adsorbed (RVA, Michigan Department of Public Health), a new cell culture-derived rabies vaccine for use in humans, was licensed on March 18, 1988, for both preexposure and postexposure prophylaxis. The Biologics Products Program, Michigan Department of Public Health, developed, produces, and distributes the vaccine. RVA is currently available only to residents of the state of Michigan, but plans are being developed for out-of-state distribution.The vaccine is prepared from the Kissling strain of rabies virus adapted to a diploid cell line of the fetal rhesus lung (1). The virus is inactivated with *gb-propiolactone and concentrated by adsorption to aluminum phosphate (AlPO4). AlPO4 may also serve as an adjuvant.
RVA differs from the rabies vaccine currently available in the United States, the human diploid cell rabies vaccine (HDCV) produced by Merieux Institute, Inc. A different virus strain, cell line, and concentration process are used in making RVA, and, because RVA is adsorbed to AlPO4, it is liquid rather than lyophilized.
After preexposure (2), simulated postexposure (3), and booster vaccination (4), acceptable levels of rabies-neutralizing antibody have been found in over 99% of 3,000 persons tested. The recommended timing of vaccinations with RVA is identical to that of vaccinations with HDCV. Preexposure vaccination consists of three 1-mL doses, one dose to be administered intramuscularly (IM) in the deltoid area on days 0, 7, and 28. Preexposure booster doses of RVA (one 1-mL IM dose) should be administered according to previous guidelines (5). In contrast to HDCV (6), the antibody response and side effects after intradermal administration of RVA have not been studied. RVA should not be used intradermally.
Postexposure vaccination of individuals who have not previously been immunized consists of five 1.0-mL doses of RVA, one dose to be administered IM in the deltoid (IM in the anterior lateral thigh for infants) on days 0, 3, 7, 14, and 28. At the same time that the first 1-mL dose of RVA is administered on day 0, rabies immune globulin (RIG) 20 IU/kg is administered as a separate injection. Up to half of the RIG is infiltrated around the site of the bite, if feasible; the rest is administered IM in the gluteal area (for infants, IM in the anterior lateral thigh). Rabies vaccine and RIG should never be administered into the same limb. If exposed to rabies, persons who were previously vaccinated with HDCV or RVA (preexposure or postexposure) and persons who were immunized with other rabies vaccines and who had a documented neutralizing antibody response after vaccination should receive only two 1-mL IM booster doses of RVA, one on day 0 and one on day 3. Testing to document primary seroconversion is recommended only for persons whose immune system is suppressed by a disease or medication.
Reactions after primary vaccination with RVA appear similar in nature and frequency to those observed with HDCV. They include local reactions (pain and redness or swelling at the injection site) in 85%-90% of volunteers receiving RVA and mild systemic reactions (fever, nausea, and arthralgia) in 10%. Physicians and other health-care providers are urged to report any other type of reactions to either RVA or HDCV to the manufacturer or the Food and Drug Administration on CDC form 55.19 9/82 (formerly CDC form 4.650), which is available from state and local health departments.
The use of preexposure booster doses of HDCV has been limited because approximately 6% of individuals who receive both primary and booster vaccinations with HDCV develop a serum sickness like an allergic reaction (7,8). These reactions are thought to be due to the presence of a small amount of human serum albumin that has been rendered allergenic by the *gb-propiolactone used in making HDCV (9,10). Human serum albumin is not a component of the medium used to grow the rabies virus for RVA and, therefore, is not present when *gb-propiolactone is added to inactivate the virus. However, systemic allergic reactions have also occurred in four persons after they received booster doses of RVA, for a rate of less than 1%. Reported by: Biologics Products Program, Michigan Dept of Public Health. Quinnan GV, MD, Fitzgerald EA, PhD, Center for Biologics Evaluation and Research, Food and Drug Administration. Viral and Rickettsial Zoonoses Br, Div of Viral Diseases, Center for Infectious Diseases, CDC.
References
- 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.
- Berlin BS, Mitchell JR, Burgoyne GH, et al. Rhesus diploid rabies vaccine (adsorbed), a new rabies vaccine: results of initial clinical studies of preexposure vaccination. JAMA 1982; 247:1726-8.
- Berlin BS, Mitchell JR, Burgoyne GH, Brown WE, Goswick C. Rhesus diploid rabies vaccine (adsorbed), a new rabies vaccine: II. Results of clinical studies simulating prophylactic therapy for rabies exposure. JAMA 1983;249:2663-5.
- Berlin BS, Goswick C. Rapidity of booster response to rabies vaccine produced in cell culture (Letter). J Infect Dis 1984;150:785.
- Immunization Practices Advisory Committee. Rabies prevention--United States, 1984. MMWR 1984;33:393-402,407-8.
- Immunization Practices Advisory Committee. Rabies prevention: supplementary statement on the preexposure use of human diploid cell rabies vaccine by the intradermal route. MMWR 1986;35:767-8.
- Centers for Disease Control. Systemic allergic reactions following immunization with human diploid cell rabies vaccine. MMWR 1984;33:185-7.
- Dreesen DW, Bernard KW, Parker RA, Deutsch AJ, Brown J. Immune complex-like disease in 23 persons following a booster dose of rabies human diploid cell vaccine. Vaccine 1986;4:45-9.
- Swanson MC, Rosanoff E, Gurwith M, Deitch M, Schnurrenberger P, Reed CE. IgE and IgG antibodies to *gb-propiolactone and human serum albumin associated with urticarial reactions to rabies vaccine. J Infect Dis 1987;155:909-13.
- Anderson MC, Baer H, Frazier DJ, Quinnan GV. The role of specific IgE and beta- propiolactone in reactions resulting from booster doses of human diploid cell rabies vaccine. J Allergy Clin Immunol 1987;80:861-8.
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