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