Q-Fever (Coxiella Burnetti) Protocol - Mcgill University

Q-fever protocol

Rev. October 3, 2018; Page 1 of 8

Prepared by Dr. Mark Miller

Q-fever (Coxiella burnetii) protocol - McGillUniversity

Contents of this protocol

1. PreamblePage

- description of disease 1

- general preventive measures 2

- specific preventive measures 2

2. Q-fever vaccination protocol 3

3. Consent form to undergo a skin test for

determining immunity to Coxiella burnetii (Q-fever) 5

4. Consent form to undergo vaccination

against Coxiella burnetii (Q-fever) 6

5. Q-fever vaccination information form 7

Preamble

Description of disease

Q fever is an infection caused by Coxiella burnetii, one of the rickettsial organisms. This organism is found in cattle, sheep, goats, farm-raised cats, and some other wild animals. Infection usually follows contact with aerosolized infected animal fluids - usually placental tissues, birth fluids, stool/urine, or unpasteurized milk. The incubation period (i.e. time from contact to illness) is believed to be 2 to 3 weeks.

The infection may be asymptomatic, or may lead to an acute illness consisting of any or all of the following: fever, chills, headache, weakness, and sweats. These may be accompanied by pneumonia, hepatitis (i.e. liver infection), or RARELY by pericarditis (i.e. infection of the outer lining of the heart), or endocarditis (i.e. infection of the heart valves). The disease usually passes on its own, with or without treatment. Less than 1 in 100 untreated patients will die as a result of this infection and treated patients usually respond quite favourably. The treatment usually consists of a tetracycline.

General Preventive measures

1. Strict adherence to the institutional biosafety protocol, including:

- Universal Precautions when handling biological tissues/liquids

- separation of animal, research, and eating facilities

- appropriate use of barriers (i.e. gloves, masks, gowns, face shields, etc.)

- avoidance of aerosolization of biological liquids

- avoidance of manipulation of sharps; safe disposal of sharps without recapping

- adherence to applicable local, municipal, provincial, and federal biosafety

regulations

2. Adequate disinfection and disposal of animal products, including products of conception, urine, stool, and other biological tissues/liquids. Adequate disinfection and disposal of contaminated objects, as well as disinfection of contaminated barn, housing, or lab surfaces.

3. Safe management of sheep, with separate housing facilities and dedicated negative-pressure ventilation, disposal of contaminated objects inside the facility or sterilization prior to general disposal (see separate “Sheep facilities protocol”)

Specific Preventive Measures

Research workers who are in contact with sheep and/or their excreta/body fluids should be offered vaccination, using the inactivated C. burnetii (Phase I)-infected yolk sac (i.e. made in hen’s eggs) preparation (see “Q fever vaccination protocol” below).

Q-fever vaccination protocol

For each employee who will be in contact with sheep,

other C. burnetii-infected animals, or their excreta/body fluids:

1. Complete review of occupational health form/questionnaire and prior vaccinations, illness, and exposures. Employee to fill out Q-fever risk factor assessment sheet.

2. Ensure routine immunization (including 2-step TB skin test, if applicable) has been carried out.

3. Ask employee to read “Q-fever vaccination information sheet” and to sign acceptance or refusal of Q-fever skin testing/blood testing and vaccination. Separate consents are required for skin testing/serology and vaccination. Follow rest of protocol (steps 4 and on) if employee accepts.

4. Obtain “pre-vaccine” serum from employee (1 red-topped tube of blood) for determination of Q fever antibodies.

5. Obtain urine from all female employees to perform urine pregnancy test. Pregnant women should not undergo Q-fever skin testing or vaccination. These should be delayed until the end of pregnancy and lactation.

6. Determination of immune status: this can only be determined by means of a skin test AND serology. The skin test is done using a standardized dose of diluted vaccine* as antigen (i.e. each 0.1 ml skin test “dose” contains 16.6 nanograms of C. burnetii), and the serology is done using a ???? method.

i) make up “skin test antigen” by reconstituting Q-fever vaccine*, and then diluting as per directions for skin testing. This diluted solution remains stable for up to 6 hours only at 4o C.

ii) Clean injection site on volar aspect of arm with methylated spirits (not alcohol). Allow the are to dry. Inoculate the injection site intradermally with 0.1 ml of “antigen” (create a bleb).

iii) Examine injection site on day 7 after injection. A positive skin test is indicated by any degree of induration present.

7. Vaccination of employees with Q-fever vaccine*: this can only be done for employees with BOTH a NEGATIVE Q-fever skin test AND a NEGATIVE Q-fever serology result. As well, women must not be pregnant or lactating. Vaccination of skin-test-positive or serology-positive individuals may lead to severe local and/or systemic reactions. Safety of the vaccine in pregnancy and/or lactation has not been established. Ensure no other contraindications to vaccination exist:

-previous Q-fever vaccination

-previous Q-fever disease (proven or strongly suspected)

-immunocompromise

-allergy to hen’s eggs

8. A dose of 0.5 ml of the Q-fever vaccine will be administered subcutaneously to each consenting eligible employee. The following information will be recorded on the employee health record: results of Q-fever skin test and serology test, vaccine dose, route, site, lot number, lot date, and reaction(s), if any. In addition, the vaccination dose and date will be recorded on the employee’s personal vaccine record, if applicable.

9. Each employee will be requested to report any severe or unusual local or systemic reactions IMMEDIATELY to the vaccinating physician.

10. An employee is considered “protected” from Q-fever by the 21st (twenty-first) day following vaccination with the Q-fever vaccine, or if a POSITIVE skin test or POSITIVE serology test has been demonstrated.

*vaccine, and “vaccine for skin test” may both be obtained by calling CSL Limited, Parkville, Victoria, Australia.

Consent to undergo a skin test and blood test for determining

immunity to Coxiella burnetii (Q-fever)

1. I have been given a copy of the vaccination information sheet.

2. I understand the benefits of undergoing the skin test and blood test, which include knowing my immune status against Coxiella burnetii (the cause of Q-fever), and being eligible for the Q-fever vaccine if the skin test AND blood test are both negative.

3. I understand the real and potential risks of undergoing this skin test, including (but not limited to) allergic reactions, local reactions (soreness, swelling, blistering, itching, and/or lumps at the injection site), and possibly systemic reactions (fever, headache, fatigue, and/or muscle aches). I understand the risks of undergoing the blood test, including (but not limited to) bruising at the blood-taking site and fainting during the blood-taking.

4. I understand that, if I am a woman, I must not be pregnant or breast-feeding when I undergo this skin test & that I will submit a urine sample for a pregnancy test prior to being skin-tested. If I think that I may be pregnant, I must inform Dr. Miller so that a more sensitive pregnancy test can be done and/or a delay in the Q-fever testing occurs.

5. I know that I can ask Dr. Mark Miller questions about this skin test, the blood test, and the Q-fever protocol now and any time in the future.

6. I understand that if I do not undergo the skin test AND the serology blood test, then my susceptibility to Q-fever will not be known and I am not eligible for the vaccine. Therefore, without undergoing the skin test AND blood test, I cannot enter or work in the sheep facility without wearing special respiratory protective equipment.

7. I understand that I may refuse the Q-fever skin test and blood test. I understand that Dr. Miller is working as an independent consultant who has been hired to protect sheep workers in my facility against Q fever. He has no other relationship to my employer. Therefore, he is not able to state how my acceptance or refusal of Q fever vaccination may alter my employment status or my rights with my employer and/or McGillUniversity. I must discuss this with my employer and/or McGillUniversity.

8. I acknowledge that the Q-fever protocol has been explained to my satisfaction, and I understand that skin testing and subsequent vaccination (if necessary) is only one aspect of protection against Q-fever.

I have read this consent form and I consent to undergo the Q-fever skin test AND the

blood test. I assume all liability for this decision.

I have read this consent form. I refuse to undergo the Q-fever skin test AND the

blood test at this time. I assume all liability for this decision.

Date: ______

dd / mm / yy

Name (PRINT): ______

Signature: ______

Consent to undergo vaccination against Coxiella burnetii (Q-fever)

1. I have ben given a copy of the vaccination information sheet.

2. I understand the benefit of receiving the vaccine, which includes probable lifelong protection from Q-fever. However, I understand that such protection cannot be guaranteed, and the duration of such protection cannot be predicted on an individual basis.

3. I understand the real and potential risks of receiving this vaccination, including (but not limited to) allergic reactions, local reactions (soreness, swelling, and/or lumps at the injection site), and possibly systemic reactions (fever, headache, fatigue, and/or muscle aches).

4. I understand that, if I am a woman, I must not be pregnant or breast-feeding when I receive this vaccine and that I will submit a urine sample for a pregnancy test prior to being vaccinated. If I think that I may be pregnant, I must inform Dr. Miller so that a more sensitive pregnancy test can be done and/or a delay in the Q-fever vaccination occurs.

5. I know that I can ask Dr. Mark Miller questions about this vaccination and the Q-fever protocol now and any time in the future.

6. I understand that if I do not receive the vaccine, I cannot enter or work in the sheep facility without wearing special respiratory protective equipment, unless I am known to be immune to Q fever by skin testing and/or serology testing.

7. I understand that I may refuse Q-fever vaccination. I understand that Dr. Miller is working as an independent medical consultant who has been hired to protect sheep workers in my facility against Q fever. He has no other relationship to my employer. Therefore, he is not able to state how my acceptance or refusal of Q fever vaccination may alter my employment status or my rights with my employer and/or McGillUniversity. I must discuss this with my employer and/or McGillUniversity.

8. I acknowledge that the Q-fever protocol has been explained to my satisfaction, and that I understand that vaccination is only one aspect of protection against Q-fever.

I have read this consent form and I consent to receive the Q-fever vaccination. I assume all

liability for this decision.

I have read this consent form and I refuse to receive the Q-fever vaccination at this time. I assume

all liability for this decision.

Date: ______

dd / mm / yy

Name (PRINT): ______

Signature: ______

Q-fever vaccination information form

What is Q-fever?

Q fever is an infection caused by Coxiella burnetii, one of the rickettsial organisms. This organism is found in cattle, sheep, goats, farm-raised cats, and some other wild animals. Infection usually follows contact with aerosolized infected animal fluids - usually placental tissues, birth fluids, stool/urine, or unpasteurized milk. The incubation period (i.e. time from contact to illness) is believed to be 2 to 3 weeks.

The infection may be asymptomatic, or may lead to an acute illness consisting of any or all of the following: fever, chills, headache, weakness, and sweats. These may be accompanied by pneumonia, hepatitis (i.e. liver infection), or RARELY by pericarditis (i.e. infection of the outer lining of the heart), or endocarditis (i.e. infection of the heart valves). The disease usually passes on its own, with or without treatment. Less than 1 in 100 untreated patients will die as a result of this infection and treated patients usually respond quite favourably. The treatment usually consists of a tetracycline.

How can you be protected from Q-fever?

Protection from Q-fever is achieved through a combination of avoiding contact with Coxiella burnetii and immunologic protection against infection (i.e. vaccination). Avoiding contact with C. burnetii can be achieved through proper handling of possibly-infected animals, proper disposal of animals’ biological liquids, tissues, and excreta (stool and urine), and disinfection of all contaminated surfaces. Vaccination confers additional protection by artificially inducing resistance in your immune system, so that you can fight off any infection with this organism.

Why are you being offered vaccination against Q-fever?

Vaccination against Coxiella burnetii is being offered to you because you are at risk of exposure to Coxiella burnetii through your employment and your contact with possibly infected animals and/or their body fluids or excreta.

What is in the vaccine?

The vaccine you are being offered was developed by CSL Limited of Victoria, Australia. It is the only Q-fever vaccine currently available in the world. It is made from inactivated (i.e. dead)

C. burnetii organisms which have been grown in hen’s eggs and then killed, purified, and freeze-dried for storage. This material is reconstituted with sterile salt water immediately prior to use.

What is the actual procedure?

The first step in the immunization process consists of a skin test AND a blood test to determine if you have already been infected with C. burnetii and if you are already immune (i.e. protected). For the blood test, a small amount (i.e. 5 teaspoons) of blood will be drawn in the standard way. For the skin test, a small amount (0.1 ml) of highly-diluted vaccine will be injected under the skin of your

arm. If no reaction (i.e. swelling) is seen at the injection site after 7 days AND if your blood test is negative, then you are considered “susceptible” to Q-fever and will be offered the vaccine. If either the skin test OR the blood test is positive, then you are considered already infected by Q-fever and immune, and you do not require the vaccine and are NOT eligible for it. If you are “susceptible” and accept vaccination, a 0.5 ml dose of the vaccine will be administered under the skin of your upper arm. You will remain under observation for 20 minutes following the vaccine, and will be asked to report any severe reactions to the physician administering the vaccine at any time. You are considered “immune” (i.e. protected) 21 days after the vaccination.

Separate consent forms need to be signed prior to the skin test/blood test AND prior to the vaccination. You may withdraw from the process at any time for any reason.

If you are female, you will need to undergo a urine pregnancy test prior to both the skin test and the vaccination. If you think that you may be pregnant, you must inform Dr. Miller so that a more sensitive pregnancy test can be done and/or a delay in the Q-fever testing and/or vaccination occurs.

Benefits and risks

If you undergo the skin test and blood test, then you will know if you are susceptible or immune to Q-fever and if you are eligible for the vaccine. If you take the vaccine you will have a very reduced likelihood of ever contracting Q-fever. However, even after receiving the vaccine, no one can guarantee protection from Q-fever and the duration of protection cannot be predicted on an individual basis.

Theoretically, risks of vaccination include allergic reactions of all kinds, local and/or systemic reactions, and Guillain-Barre syndrome (a neurologic illness which has been associated with many other vaccines and/or many types of viral infections).

Thousands of individuals have been given this type or a similar Q-fever vaccine for over 15 years, both in the USA and in Australia. Reactions after skin testing and/or vaccination most often reported are local, self-limited pain and swelling and redness at the injection site. A distinct lump may occur at this site, but will usually resolve over a period of weeks to months. More serious local reactions, including sterile (i.e. non-infected) abscesses, may rarely occur at the site of injection. In addition, a small proportion of individuals will get systemic reactions to the vaccine, such as headache, fever, and/or muscle aches. More serious reactions are possible, but extremely rare.

The benefits of the vaccine must be weighed

against the risks of contracting Q-fever.

Only you can decide if the risk of disease justifies undergoing the vaccination process and its associated risks.