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Recommendation of the Immunization Practices Advisory Committee Supplementary Statement on Pre-Exposure Rabies Prophylaxis by the Intradermal Route

These revised ACIP pre-exposure rabies prophylaxis recommendations represent an update of the previous recommendations (MMWR 1981;30:535-6) to include current information about vaccine use and optional dose regimens.

The Immunization Practices Advisory Committee (ACIP) has examined data on the use of intradermal (ID) vaccination for pre-exposure rabies prophylaxis with Merieux Institute's human diploid cell strain rabies vaccine (HDCV). Over 1,500 persons have received intradermal HDCV as pre-exposure vaccination; all those who received a 3-dose regimen developed adequate antibody. It appears that, with this vaccine, the 0.1-ml intradermal (ID) regimen is an acceptable alternative to the currently approved 1.0-ml intramuscular (IM) regimen for pre-exposure prophylaxis (1,2). Although the accepted pre-exposure vaccination regimen is 3 doses of vaccine, 1.0 ml IM each, given on days 0, 7, and 21 or 28, apparently the 0.1-ml ID regimen will be an acceptable alternative after Merieux Institute produces a product with appropriate packaging and labelling changes. Intradermal vaccination should be administered in the lateral aspect of the upper arm over the deltoid. Booster vaccination (either 1.0 ml IM or 0.1 ml ID) should still be given every 2 years to persons such as veterinarians, animal handlers, and laboratory diagnosticians who are at continuing risk. Laboratory workers in rabies biologics production or in rabies research laboratories who might be at high risk of high-dose inapparent exposure should still receive a booster dose every 6 months or be tested for rabies antibody and vaccinated when antibody level falls below 16 as measured with the rapid fluorescent focus inhibition (RFFI) test.

Except as noted above or in the case of persons suspected of being immunocompromised, the ACIP suggests that routine serologic testing to confirm a satisfactory antibody response is not necessary regardless of whether the recommended IM or ID regimens are used (3). Reaction rates following ID vaccination have been comparable with those following IM vaccination except that a slight increase in transient local reactions has been observed following ID vaccination, especially when the vaccine is given in the forearm rather than in the lateral aspect of the upper arm.

Data are not available to support the use of intradermal vaccination for post-exposure use, and the Committee emphasizes the need to continue to use only the 1.0-ml IM regimen for post-exposure treatment.

Editorial Note

Editorial Note: Although the Committee has determined that the 0.1-ml ID regimen is an acceptable alternative for pre-exposure prophylaxis, the manufacturer--Merieux Institute--has not yet formally requested approval from the Food and Drug Administration's Bureau of Biologics (BOB) for the vaccine to be administered according to this alternate regimen. The currently available 1.0-ml vaccine package is approved only for IM use and is not recommended for multi-dose use if the 0.1-ml ID regimen is used. Although BOB concurs with the interpretation of the clinical data, FDA approval for the use of Merieux's HDCV rabies vaccine by the ID route can be obtained after the manufacturer makes necessary packaging and labelling changes. It is emphasized that the ACIP has accepted the ID regimen only for pre-exposure vaccination.

References

  1. Bernard KW, Roberts MA, Sumner J, et al. Human diploid cell rabies vaccine: effectiveness of immunization with small intradermal or subcutaneous doses. JAMA 1982;247:1138-42.

  2. Nicholson KG, Turner GS, Aoki FY. Immunization with a human diploid cell strain of rabies virus vaccine: two-year results. J Infect Dis 1978;137:783-8.

  3. ACIP. Supplementary statement on rabies vaccine and serologic testing. MMWR 1981;30:535-6.



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