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Recommendation of the Immunization Practices Advisory Committee Rabies Prevention: Supplementary Statement on the Preexposure Use of Human Diploid Cell Rabies Vaccine by the Intradermal Route

The human diploid cell rabies vaccine (HDCV) produced by the Merieux Institute has been used extensively for preexposure immunization in a regimen of three 0.1-ml doses, one each on days 0, 7, and 21 or 28. The intradermal (ID) dose/route has previously been recommended by the ACIP as an alternative to the 1.0-ml intramuscular (IM) dose/route for rabies preexposure prophylaxis (1), but the manufacturer had not met the packaging and labeling requirements necessary to obtain approval by the U.S. Food and Drug Administration (FDA).

Merieux Institute has now developed a syringe containing a single dose of lyophilized HDCV (Imovax Rabies ID) that is reconstituted in the syringe just before administration. The syringe is designed to reliably deliver 0.1 ml of HDCV and was approved by the FDA on May 30, 1986. Three 0.1-ml ID doses, given in the lateral aspect of the upper arm, on days 0, 7, and 21 or 28, are used for primary preexposure prophylaxis. One 0.1-ml ID dose is used for booster vaccination (based on previously outlined criteria (1)). Serologic testing is not necessary after preexposure prophylaxis with HDCV administered by either the ID or IM route. The ID dose/route should not be used for postexposure prophylaxis.

Chloroquine phosphate (administered for malaria chemoprophylaxis) and unidentified factors (that may include multiple concurrent vaccinations) may interfere with the antibody response to HDCV in persons traveling to developing countries (2,3). The IM dose/route of preexposure prophylaxis provides a sufficient margin of safety in this setting (3). HDCV should not be administered by the ID dose/route while a person is receiving chloroquine for malaria chemoprophylaxis. In persons receiving preexposure prophylaxis in preparation for travel to a rabies endemic area, the ID dose/route should be initiated early enough to allow the three-dose series to be completed 30 days or more before departure. If this is not possible, the IM dose/route should be used.

References

  1. ACIP. Rabies prevention--United States, 1984. MMWR 1984;33:393-402, 407-8.

  2. Bernard KW, Fishbein DB, Miller KD, et al. Pre-exposure rabies immunization with human diploid cell rabies vaccine: decreased antibody responses in persons immunized in developing countries. Am J Trop Med Hyg 1985;34:633-47.

  3. Pappaioanou M, Fishbein DB, Dreesen DW, et al. Antibody response to preexposure human-diploid cell rabies vaccine given concurrently with chloroquine. N Eng J Med 1986;314:280-4.

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