Name: Rabies Vaccine
Rabies vaccine is a sterile, freeze-dried vaccine containing inactivated rabies virus antigen (≥2.5 international units/mL).208 234
Commercially available as human diploid-cell rabies vaccine (HDCV; Imovax) or purified chick embryo cell culture rabies vaccine (PCECV; RabAvert).208 234
HDCV (Imovax) contains antigen prepared from the Wistar Institute Pitman-Moore strain (PM-1503-3M) of rabies virus propagated in MRC-5 strain of human diploid-cell tissue culture.208 PCECV (RabAvert) contains antigens prepared from the fixed-virus strain Flury low egg passage (LEP) of rabies virus propagated in primary cultures of chicken fibroblasts.234
Stimulates active immunity to rabies by inducing production of antirabies neutralizing antibodies.208 213 234 236 Antirabies antibodies neutralize rabies virus and are believed to have a primary role in preventing rabies infection.236
HDCV (Imovax) and PCECV (RabAvert) are highly immunogenic in immunocompetent children, adolescents, and adults.208 234 236 When administered according to the recommended preexposure immunization schedule in clinical studies, 100% of vaccinees achieved protective levels of antirabies antibody.208 234
Following IM administration of rabies vaccine, antirabies antibody levels are detectable in serum within 7–10 days and persist for several years.236
Development of immunity and protection from rabies infection are evaluated by appearance of antirabies antibody in serum.236 Minimum titers of antirabies antibodies indicating protection against rabies have not been definitely established to date (varies among laboratories and by type of test performed).236 ACIP considers antirabies antibody titers ≥1:5 as determined by RFFIT to be indicative of an adequate response to rabies immunization.236 250 WHO states that an antirabies antibody titer of ≥0.5 international units/mL can be considered protective.249
Following rabies exposure and inoculation, the virus remains close to the wound for an indeterminate time and can be partially neutralized with RIG while at this site.213 In susceptible individuals, the virus is transported to the CNS via the peripheral nerves.249 Following entrance into the CNS, the virus is unlikely to be affected by antirabies antibodies and a fatal encephalomyelitis almost always develops.234 249
Incubation period for rabies infection in humans can range from days to years (usually 1–3 months).212 213 234 236 250 After severe bites to the face, neck, or arms, the incubation period may be as short as 10 days.246
Common prodromal symptoms of rabies infection include malaise, anorexia, fatigue, headache, and fever followed by pain or paresthesia at the site of exposure.234 249 Anxiety, agitation, and irritability may also occur during the prodromal stage followed by hyperactivity, disorientation, seizures, aerophobia, hydrophobia, hypersalivation, and eventually paralysis, coma, and death.212 213 234 249 Following appearance of clinical symptoms of rabies, use of rabies vaccine or RIG will not improve the prognosis and may be detrimental; there is no specific proven effective treatment for rabies once symptoms develop.212 213 236 249
There have been no cases of rabies in the US in previously unvaccinated individuals who received the recommended postexposure prophylaxis regimen (i.e., proper wound care followed by a single dose of RIG and a 4- or 5-dose regimen of HDCV [Imovax] or PCECV [RabAvert] rabies vaccine).236 246 250
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of meningitis like headache with fever, stiff neck, upset stomach, confusion, or if lights bother your eyes.
- Feeling very tired or weak.
- Not able to move face muscles as much.
- Muscle weakness.
- Not able to move.
- Very bad headache.
- Feeling confused.
- Change in eyesight.
- Swollen gland.
If OVERDOSE is suspected
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injectable, Intramuscular [preservative free]:
Imovax Rabies: 2.5 units/mL (1 ea) [contains albumin human, neomycin sulfate]
Suspension Reconstituted, Intramuscular:
RabAvert: 2.5 units (1 ea) [contains albumin human, chicken protein, edetate disodium, gelatin (bovine), neomycin]
Preexposure vaccination: IM: A total of 3 doses, 1 mL each, on days 0, 7, and 21 or 28.
Booster vaccination (for persons with continuous or frequent risk of infection): IM: 1 mL based on antibody titers
Note: Prolonging the interval between doses does not interfere with immunity achieved after the concluding dose of the basic series.
Postexposure vaccination: All postexposure treatment should begin with immediate cleansing of the wound with soap and water
Persons not previously immunized as above:
Immunocompetent: IM: 4 doses (1 mL each) on days 0, 3, 7, 14 (ACIP [Rupprecht 2010]).
Immunocompromised: IM: 5 doses (1 mL each) on days 0, 3, 7, 14, 28 (ACIP [Rupprecht 2010]).
Note: In addition, patients should receive rabies immune globulin with the first dose (day 0).
Persons who have previously received postexposure prophylaxis with rabies vaccine, received a recommended IM pre-exposure series of rabies vaccine or have a previously documented rabies antibody titer considered adequate: IM: Two doses (1 mL each) on days 0 and 3; do not administer rabies immune globulin
For IM administration only; do not administer intradermally or subcutaneously; in adults and children, administer IM injections in the deltoid muscle; for younger children, use the outer aspect of the thigh. Avoid administration into the gluteal area; may result in lower response. Postexposure prophylaxis should begin with immediate cleansing of wounds with soap and water; if available, a virucidal agent (eg, povidone-iodine solution) should be used to irrigate the wounds. Do not mix rabies vaccine and human rabies immune globulin in the same syringe, and do not administer in the same anatomical site. US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, and the administering person's name, title, and address be entered into the patient's permanent medical record.
For patients at risk of hemorrhage following intramuscular injection, the vaccine should be administered intramuscularly if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, intramuscular vaccination can be scheduled shortly after such therapy is administered. A fine needle (23 gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (NCIRD/ACIP 2011).