RABIES VACCINE



Indications

– Prevention of rabies after category II and III exposures

Composition, forms, route of administration

– Inactivated virus vaccine, prepared from cell cultures (CCEEV): in embryonated egg or purified cells (chick embryo-cells, Vero-cells or human diploid-cells)
– Powder for injection in monodose vial, to be dissolved with the entire vial of the diluent (0.5 ml or 1 ml, supplied by the manufacturer)
– IM route: DO NOT ADMINISTER INTO THE GLUTEAL MUSCLE
• Child < 2 years: inject into the anterolateral part of the thigh
• Child ≥ 2 years and adult: inject into the deltoid muscle 
– ID route: 
Child and adult: inject into the deltoid muscle (or the anterolateral part of the thigh or the suprascapular region)

Dosage and vaccination schedule

– Child and adult: one IM dose = 0.5 or 1 ml, depending on the vaccine used; one ID dose = 0.1 ml, whichever vaccine used
– Vaccination schedules may vary from country to country, check national recommendations. The schedule depends on the patient’s vaccination status at the moment of exposure and the route of administration used (follow manufacturer’s instructions).
– The first dose of vaccine should be administered as soon as possible after exposure, even if the patient seeks medical attention long after exposure (rabies incubation period may last several months). The patient must receive all the recommended doses.
– If a vaccine dose is delayed or the route of administration is changed, continue vaccination according to the chosen route of administration and do not recommence the schedule.

The simplest vaccination schedules endorsed by the WHO are the following:


No rabies vaccination
or incomplete vaccination
or complete vaccination with an NTV
or unknown vaccination status


Complete
vaccination
with a CCEEV

IM route(a)

ID route

IM or ID route(d)

D0

2 doses(b)
(1 dose in each arm or thigh)

1 dose(b)

2 doses(b)
(1 dose in each arm)

1 dose

D3


1 dose

2 doses
(1 dose in each arm)

1 dose

D7

1 dose

1 dose

2 doses
(1 dose in each arm)


D14
1 dose(c)

D21

1 dose




(a) There are two possible schedules for the IM route: the Zagreb regimen (2-0-1-0-1) over 21 days or the 4-dose Essen regimen (1-1-1-1-0) over 14 to 28 days.
(b) As well as a single dose of rabies immunoglobulin into the wound in the event of category III exposure on D0.
(c) The last injection can be administered between D14 and D28. 
(d) Another possible ID schedule: 4 ID doses (1 dose in each arm and 1 dose in each thigh) on D0.

– Immunocompromised patient: 1 dose on D0, D7 and between D21 and D28 by IM or ID route (as well as a single dose of rabies immunoglobulin)

Contra-indications, adverse effects, precautions

– Do not administer corticoids concomitantly (vaccine efficacy diminished).
– May cause: benign local reactions at the injection site (pain, induration), fever, malaise, headache, fatigue, gastrointestinal disturbances; rarely: anaphylactic reaction.
– Ensure that the vaccine does not enter a blood vessel (risk of shock): aspirate prior to injection to confirm that the needle is not in a vein.
– ID vaccination: incorrect ID technique results in treatment failure. If correct ID technique cannot be assured, use IM route.
– If administered simultaneously with rabies immunoglobulin and other vaccines, use different syringes and injection sites.
– Pregnancy and breast-feedingno contra-indication

Remarks

– Rabies vaccine is also used for pre-exposure vaccination in persons at high risk of infection (prolonged stay in rabies endemic areas, professionals in contact with animals susceptible of carrying the virus). 
– Avoid the use of vaccines prepared from animal nerve tissue (NTVs): they are less immunogenic than CCEEV vaccines and more likely to cause severe adverse effects. 
– Storage
• Powder: between 2 °C and 8 °C. Do not freeze.
• 
Diluent: a cold chain is not required for storage. However, at least 12 hours before reconstitution of the vaccine, the diluent must be refrigerated between 2 °C and 8 °C so that the diluent and lyophilised powder are at the same temperature: a temperature difference during reconstitution may reduce vaccine efficacy. Do not freeze.
• 
Reconstituted vaccine: use immediately.