Q-Vax

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Coxiella burnetii

Available from:

CSL Limited

Class:

Medicine Registered

Patient Information leaflet

Q-VAX(R) Q FEVER VACCINE
1
Q-VAX(R)
_Q FEVER VACCINE_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET? 
This leaflet answers some common
questions about Q-VAX(R). It does
not contain all the available
information.  It does not take the
place of talking to your doctor or
other health professional. 
KEEP THIS LEAFLET. 
You may want to read it again. 
All medicines, including vaccines,
have risks and benefits. Your doctor
considers the risks of you having
Q-VAX(R) and the benefits they
expect it will have for you. 
IF YOU HAVE ANY CONCERNS ABOUT THIS
VACCINE, ASK YOUR DOCTOR OR OTHER
HEALTH PROFESSIONAL. 
WHAT Q-VAX(R) IS USED
FOR
Q-VAX(R) Q Fever Vaccine is given
by injection under the skin, usually
in the upper arm. It is used to help
protect people against the infection
"Q fever." 
Q fever is caused by bacteria (called
Coxiella burnetii) which can be
caught by humans from animals that
carry the infection. These bacteria
can cause illness in humans,
sometimes mild, sometimes severe. 
Vaccination with Q-VAX(R) is
recommended for people working
with cattle, sheep or goats, or
products from these animals, for
example
*
abattoir workers, and visitors
*
veterinary personnel 
*
stockyard workers
*
farmers
*
shearers
*
animal transporters
*
laboratory workers handling
potentially infected veterinary
samples or visiting abattoirs 
*
people who cull and process
kangaroos. 
The risk of becoming infected with Q
fever is highest in the first few years
of exposure. Workers who are at risk
of contracting Q fever should be
immunised as soon as possible after
they commence work. 
_HOW Q-VAX(R) WORKS_
Q-VAX(R) works by causing your
body to produce its own protection
against the Coxiella burnetii bacteria
that cause Q fever. After you are
vaccinated with Q-VAX(R) your
immune system is able to destroy the
Q fever organism if you come into
contact with it. This prevents you
from getting Q fever. Howe

Summary of Product characteristics

Q-VAX
®
 Q Fever Vaccine and Q-VAX
®
 Skin Test (AUST R 100517 & 100518)
Page 1 of 6
Product Information –TGA Approved
December 2008
Version: 3
NAME OF THE MEDICINE
Q Fever Vaccine 
Q Fever Skin Test
DESCRIPTION
Q-VAX
®
 is a purified suspension of
formalin-inactivated, _Coxiella burnetii_ prepared from the Phase
1 Henzerling strain of the organism grown in the yolk sacs of
embryonated eggs. Excess egg
proteins are removed by fractionation and ultracentrifugation.
Q-VAX
®
 Vaccine contains 25 
µg of antigen in 0.5 mL of an aqueous solution. Thiomersal 0.01%
w/v is added as a preservative.
Q-VAX
®
 Skin Test contains 2.5
µg of antigen per 0.5mL of aqueous solution.  PRIOR TO
ADMINISTRATION
, Q-VAX
®
 Skin Test is diluted with Sodium Chloride injection to
ensure that 16.7ng
(nanograms) of antigen is delivered per 0.1mL intradermal dose.
(See DOSAGE AND
ADMINSTRATION). 
PHARMACOLOGY
Q fever is caused by _Coxiella burnetii_,
an obligate, intracellular, Gram-negative coccobacillus. The
_C. burnetii_
 is shed in the products of conception, and on the neonate
of the infected animal.  It may
also be present in the udder and milk of infected animals and is
passed on within their faeces. 
Infection is transmitted to humans by inhalation of infected airborne
particles or dust during the
handling or processing of these materials or by close proximity to
infected animals when giving
birth. 
Early antibody response to the vaccine is predominantly with the
IgM subclass; IgG antibodies
appear later. Although the seroconversion rate is low (50-80%)
and antibody levels are transient,
cell mediated immunity develops. Clinical trials have demonstrated
a high degree of efficacy (see
CLINICAL TRIALS). As Q fever is often asymptomatic or misdiagnosed due
to its non-specific
nature, many abattoir workers develop immunity to Q fever without an
obvious illness.
The duration of protective immunity following immunisation is
unknown, but is believed