Brucellosis is one of the infectious diseases characteristic of animals, but capable of infecting the human body. This pathological condition affects vital organ systems, in particular, the structural elements of the reproductive, cardiovascular, nervous system and musculoskeletal system.
The causative agent of brucellosis is a bacterium of the same name, which enters the human body through nutrition and contact from cattle, pigs, hares, deer, and the like. Today you can protect yourself from the disease through routine vaccination.
The modern vaccine against brucellosis is a reliable immune preparation that can protect a person from pathogenic microorganisms and prevent the development of symptoms of the disease, as well as its complications.
Composition and effect of brucellosis vaccine live dry
Live dry vaccine against brucellosis is a lyophilisate for preparing a suspension. The solution obtained during the preparation process is indicated for subcutaneous administration or scarification application to the epidermal integument.
The dry vaccine looks like a porous mass of white color with a yellowish tint. It is a lyophilized mixture of living microorganisms that are in a weakened state. To produce the drug, the vaccine strain Brucella abortus 19 BA is used.
Live brucellosis vaccine, dry
Each dose of the vaccine for subcutaneous use contains 0.5 ml of solution from 3.4 to 4.6 x 108 live pathogens. The suspension for scarification application is more concentrated. Every tenth of a milliliter contains from 4.0 x 109 to 1.6 x 1010 pathogenic microorganisms.
As a rule, one ampoule of the drug contains from four to ten doses of the vaccine for adult patients. After the vaccine is administered, the body develops reliable immune protection for up to a month, sufficient to prevent the pathological process.
Such anti-brucellosis immunity can persist in a person’s blood for up to 12 months, after which the patient is recommended to be revaccinated. The maximum amount of antibodies to brucellosis is determined in serum up to 5-6 months after the procedure.
Release form, packaging and composition of the drug Inactivated therapeutic brucellosis vaccine
Suspension for intradermal administration
homogeneous, grayish-white in color; during storage, a sediment forms that easily breaks up when shaken.
| 1 amp. | |
| Brucella melitensis strains No. 21 and 145 and Brucella abortus No. 544, heat inactivated, mixture in the ratio 1:1:1 | 2×109 microbial cells |
Excipients
: sodium chloride 0.018 g, phenol 5 mg.
2 ml - ampoules (10) complete with an ampoule knife - cardboard packs.
When is a person vaccinated against brucellosis?
Vaccination against brucellosis is recommended for those people who quite often come into contact with animals, that is, their type of work is related to this.
First of all, the following categories of the population should be immunized against brucellosis bacteria:
- workers of farms and agricultural enterprises raising large and small livestock, pigs, etc.;
- people working at enterprises for the procurement, processing and storage of animal products obtained from farms where episodic outbreaks of brucellosis in animals have been recorded;
- slaughterers of livestock with brucellosis infection;
- veterinarians;
- hunters and foresters;
- children living in rural areas and farms, where there is always a risk of contact with an infected animal;
- animal science.
Laboratory workers who produce vaccines against brucellosis are also subject to vaccination, as they are always at increased risk of contracting the disease.
Farm owners today monitor the health of their livestock, and therefore take a responsible approach to animal vaccination, which includes vaccination against brucellosis. Naturally, for people working at such enterprises, the risk of contracting an infection is minimal, but it is still present.
Preparation for vaccination against brucellosis in humans
Before the vaccination procedure, a person does not need special preparation.
Directly on the day of the injection, the doctor conducts a survey of the patient and his general examination with the obligatory measurement of body temperature. If thermal indicators during examination are elevated, then vaccination should be postponed until they normalize.
Before vaccination, patients are recommended to undergo a general blood test to determine signs of hidden inflammation in the body.
This will help ensure that the condition of the vaccinated person is satisfactory and prevent the occurrence of post-vaccination complications. Doctors often decide on the need to conduct serological tests to determine the presence of specific immunity against brucellosis. The vaccine is given only to patients with a negative reaction.
Vaccination should be carried out four weeks before taking on a job that poses an increased risk of infection. This time is enough for the human immune system to form protective antibodies against the pathogen.
Brucellosis vaccine
Once cutaneously and subcutaneously.
One dose for cutaneous administration is 2 drops (contains 10 billion microbial cells), for subcutaneous administration - 0.5 ml (contains 400 million microbial cells). Revaccination is carried out after 10-12 months cutaneously, using half the dose (5 billion microbial cells).
Cutaneously: the drug is diluted with a 0.9% NaCl solution, which is added to the ampoule with a sterile syringe with a needle at the rate of 0.1 ml (2 drops) per 1 vaccination dose. The ampoule is shaken until a uniform suspension is formed. The dissolution time of the vaccine should not exceed 1 minute. The dissolved drug should not contain sediment or flakes. The outer surface of the middle third of the shoulder is treated with ethanol or a mixture of ethanol and ether; the use of disinfectant solutions is not permitted. After the ethanol and ether have evaporated, without touching the skin, apply 2 drops of the vaccine at a distance of 30-40 mm from each other, stretch the skin and use a sterile scarifier to make 6 cuts (3 longitudinal and 3 transverse) through each applied drop of vaccine, each 10 mm long with a distance between notches 3 mm. The notches should not bleed, blood should only come out. Using the flat side of the scarifier, rub the vaccine into the incisions for 30 seconds and allow to dry for 5 minutes.
When revaccinating, use half the dose, i.e. 1 drop of vaccine, through which 6 cuts are made.
S/c: the vaccination dose of the drug is 25 times less than with cutaneous vaccination; The vaccine is diluted at the rate of 12.5 ml of 0.9% NaCl solution per dose of the vaccine for cutaneous use (s.c. dose - 0.5 ml x 25 = 12.5 ml). The drug contained in the ampoule is dissolved in the same way as for cutaneous vaccination, after which the resulting suspension is transferred into a sterile injector bottle into which the required volume of solvent is added (for example, if the ampoule contains 7 cutaneous doses of the vaccine, then the contents should be suspended in 12.5 ml x 7, i.e. in 87.5 ml).
Vaccination is carried out in the area of the outer surface of the shoulder at the border between the upper and middle third. The injection site is treated in the same way as with the cutaneous route of administration. The vaccine is administered in a volume of 0.5 ml with the injector operating mode designed for subcutaneous administration (according to the Instructions for use of the BI-ZM injector and the PPI-2 anti-infective protector).
Before vaccination, the presence of specific immunity must be determined using one of the serological or skin-allergic reactions. Persons with a negative reaction are subject to vaccination.
Vaccine administration method and dosage
In humans and animals, the same dry vaccine against brucellosis is used during immunization. The only difference is the dosage of the drug used in different groups of patients.
There are two main ways to introduce a vaccine into the body:
- subcutaneous injection;
- cutaneous scarification injection.
When administering the vaccine subcutaneously, the drug must first be diluted with a 0.9% sodium chloride solution, which is added to the ampoule using a sterile syringe. After this, the ampoule should be shaken well until a homogeneous suspension is obtained. The resulting liquid is transferred into a sterile injector bottle with the required volume of solvent. The vaccination is done using an injector, following all points of the instructions for use of the drug.
The ideal place to inject the solution is the lateral surface of the upper third of the shoulder. Before the procedure, the injection site is treated with a disinfectant. For subcutaneous administration, the suspension is prepared in the same way as for the subcutaneous vaccination option. The graft is done on the outer surface of the middle third of the shoulder.
The site where the vaccine is applied is treated with an alcohol solution. After the alcohol product has evaporated, two drops of the drug are applied to the skin of the shoulder at a distance of 3-4 cm from each other. After this, the skin should be stretched and a sterile scarifier should be pulled through each drop six times, making notches in the form of a mesh, that is, three longitudinal and three transverse lines.
The cuts made should not bleed. Blood should appear only in droplets. Use the flat side of the scarifier to rub the solution into the incisions for 30 seconds. Then you need to let the liquid dry.
For revaccination, one drop of the product is applied to the skin of the shoulder instead of two.
Inactivated therapeutic brucellosis vaccine
Once cutaneously and subcutaneously.
One dose for cutaneous administration is 2 drops (contains 10 billion microbial cells), for subcutaneous administration - 0.5 ml (contains 400 million microbial cells). Revaccination is carried out after 10-12 months cutaneously, using half the dose (5 billion microbial cells).
Cutaneously: the drug is diluted with a 0.9% NaCl solution, which is added to the ampoule with a sterile syringe with a needle at the rate of 0.1 ml (2 drops) per 1 vaccination dose. The ampoule is shaken until a uniform suspension is formed. The dissolution time of the vaccine should not exceed 1 minute. The dissolved drug should not contain sediment or flakes. The outer surface of the middle third of the shoulder is treated with ethanol or a mixture of ethanol and ether; the use of disinfectant solutions is not permitted. After the ethanol and ether have evaporated, without touching the skin, apply 2 drops of the vaccine at a distance of 30-40 mm from each other, stretch the skin and use a sterile scarifier to make 6 cuts (3 longitudinal and 3 transverse) through each applied drop of vaccine, each 10 mm long with a distance between notches 3 mm. The notches should not bleed, blood should only come out. Using the flat side of the scarifier, rub the vaccine into the incisions for 30 seconds and allow to dry for 5 minutes.
When revaccinating, use half the dose, i.e. 1 drop of vaccine, through which 6 cuts are made.
S/c: the vaccination dose of the drug is 25 times less than with cutaneous vaccination; The vaccine is diluted at the rate of 12.5 ml of 0.9% NaCl solution per dose of the vaccine for cutaneous use (s.c. dose - 0.5 ml x 25 = 12.5 ml). The drug contained in the ampoule is dissolved in the same way as for cutaneous vaccination, after which the resulting suspension is transferred into a sterile injector bottle into which the required volume of solvent is added (for example, if the ampoule contains 7 cutaneous doses of the vaccine, then the contents should be suspended in 12.5 ml x 7, i.e. in 87.5 ml).
Vaccination is carried out in the area of the outer surface of the shoulder at the border between the upper and middle third. The injection site is treated in the same way as with the cutaneous route of administration. The vaccine is administered in a volume of 0.5 ml with the injector operating mode designed for subcutaneous administration (according to the Instructions for use of the BI-ZM injector and the PPI-2 anti-infective protector).
Before vaccination, the presence of specific immunity must be determined using one of the serological or skin-allergic reactions. Persons with a negative reaction are subject to vaccination.
Contraindications
The brucellosis vaccine cannot be used in a number of cases, including:
- individual intolerance to vaccine components in humans;
- the patient has symptoms of an acute inflammatory disease or an exacerbation of a chronic form of the disease;
- increased body temperature and signs of catarrhal symptoms in humans;
- immunodeficiency states;
- tumor pathological formations and blood diseases that require radiation or chemotherapy;
- diseases of the skin with damage to the epidermis at the intended site of exposure;
- the patient has a history of allergic reactions to the previous administration of the vaccine;
- period of pregnancy and breastfeeding;
- tendency to bronchospasm and severe variants of bronchial asthma.
Ignoring contraindications to the use of a live vaccine against brucellosis is fraught with consequences and complications of immunization, which are sometimes accompanied by complex pathological conditions that are life-threatening for the patient.
Side effects and complications
According to statistical studies, vaccination against brucellosis can provoke the development of the following adverse reactions:
- swelling and inflammation at the injection site, which is sometimes accompanied by the formation of hard red nodules;
- infiltration of tissues around the site of injection of the vaccine solution with the appearance of unpleasant sensations and discomfort;
- development of headaches, sometimes slight dizziness;
- general weakness several days after vaccination;
- increase in body temperature after the procedure;
- allergic reactions in the form of skin rash and redness with itching;
- Quincke's edema and anaphylactic reaction.
Directions for use and doses
The vaccine is administered to patients intradermally in increasing doses in the area of the joints, shoulders or hips at points at a distance of 40-60 mm from each other; the minimum dose is 2x105 microbial cells, the maximum is 3x108 microbial cells.
Before use, each ampoule of vaccine is carefully inspected. The vaccine cannot be used if the packaging is damaged, the appearance changes (foreign particles), the label is missing or damaged, or after the expiration date.
The ampoule with the vaccine is thoroughly shaken until a homogeneous suspension is obtained, wiped with alcohol, the neck of the ampoule is filed, covered with a sterile swab, and the sawn end is broken off. The vaccine from an opened ampoule must be used immediately.
Vaccine dilution technique. The vaccine is diluted immediately before use with 0.9% sodium chloride solution for injection, which is poured into three sterile vials of 9 ml. Add 1 ml of vaccine to the first bottle using a syringe and mix well, then transfer 1 ml of vaccine from the first bottle to the second bottle, and transfer 1 ml of vaccine from the second bottle to the third bottle. In the first bottle, a dilution of the vaccine is obtained 1:10 with a content of 1 × 108 microbial cells in 1 ml, in the second bottle - 1:100 with a content of 1 × 107 microbial cells in 1 ml, in the third bottle - 1:1000 with a content of 1 × 106 microbial cells in 1 ml.
Using the data presented in the table, it is determined how much of the diluted vaccine contains the required number of microbial cells.
| Drug volume, ml | The number of microbial cells when diluting the vaccine | ||
| 1:10 | 1:100 | 1:1000 | |
| 0,1 | 1×107 | 1×106 | 1×105 |
| 0,2 | 2×107 | 2×106 | 2×105 |
| 0,3 | 3×107 | 3×106 | 3×105 |
| 0,4 | 4×107 | 4×106 | 4×105 |
| 0,5 | 5×107 | 5×106 | 5×105 |
| 0,6 | 6×107 | 6×106 | 6×105 |
| 0,7 | 7×107 | 7×106 | 7×105 |
| 0,8 | 8×107 | 8×106 | 8×105 |
| 0,9 | 9×107 | 9×106 | 9×105 |
| 1,0 | 1×108 | 1×107 | 1×106 |
| 1,5 | 1,5×108 | — | — |
| 2,0 | 2×108 | — | — |
| 2,5 | 2,5×108 | — | — |
Vaccine treatment method.
Treatment with intradermal vaccine can be administered in clinical and outpatient settings.
The dosage and duration of treatment is determined by the attending physician, depending on the form of the brucellosis disease and the individual sensitivity of the patient. I determine the allergic reaction of the body! according to the Burnet test indicators before the start of treatment and the body’s response to the first administration of the minimum dose of the vaccine.
The Burnet test is performed using liquid brucellosis allergen for intradermal use in accordance with the instructions for use of the drug.
Reactivity (allergic reaction) can be: 1) insufficient (areresponsiveness, hyporeactivity) - lack of reaction or the appearance of mild swelling (no more than 2 cm in diameter) at the site of allergen injection and without a response to the vaccine; 2) moderate intensity (normoreactivity) - a positive Burnet test (swelling ranging from 2 to 6 cm in diameter), the appearance of a general reaction of the body to the administration of the vaccine in the form of an increase in body temperature to 37.5 ° C, chilling; 3) strong (hyper-reactivity) - a sharply positive Burnet test (swelling over 6 cm, sometimes accompanied by lymphadenitis and a general reaction of the body), the appearance of a general reaction of the body to the introduction of the vaccine in the form of an increase in body temperature above 37.5 ° C, chills, increased pain in the affected areas.
When determining the dosage of the vaccine, the individual sensitivity of the patient should be taken into account each time.
The approximate treatment regimen for patients with brucellosis with normoreactivity with intracutaneous administration of the vaccine with an interval between injections of 2-3 days is as follows:
1 injection - 2x106 microbial cells in 0.2 ml of vaccine dilution 1:100 at 2 points;
2nd injection - 4x106 microbial cells in 0.4 ml of vaccine dilution 1:100 at 4 points;
3rd injection - 1x107 microbial cells in 1.0 ml of vaccine dilution 1:100 at 10 points;
4th injection - 2x107 microbial cells in 0.2 ml of vaccine dilution 1:10 at 4 points;
5th injection - 1x108 microbial cells in 1.0 ml of vaccine dilution 1:10 at 10 points;
6 injection - 2x108 microbial cells in 2.0 ml of vaccine dilution 1:10 at 10 points;
7th injection - 3x108 microbial cells in 0.3 ml of undiluted vaccine at 6 points.
In case of hyperreactivity, treatment begins with a dose of 2 × 105 microbial cells; in case of a pronounced local reaction, the dose of the vaccine should not be increased during subsequent injections.
In case of hyporeactivity, treatment begins with a dose of 1×107 microbial cells.
Repeated courses of vaccine therapy, if necessary, can be carried out no earlier than after 2-3 months.
Video on the topic
About methods of combating brucellosis in the video:
The vaccine against brucellosis is one of the immune drugs, the administration of which is rarely accompanied by pathological reactions and complications. Today it is offered to be done annually for patients from high-risk groups for infection.
Despite the positive qualities of the vaccine, scientists continue to work towards creating an inactivated drug against the brucellosis pathogen, which they first propose to use for revaccination.
