Tuberculosis Study Guide - M.M. Savula 2002
Prevention
BCG Vaccination
Tuberculosis prevention includes: BCG vaccination, Chemoprophylaxis, sanitary and Social prevention.
BCG vaccination is aimed at developing specific antituberculosis Immunity in uninfected individuals. The BCG vaccine (Bacillus Calmette-Guérin vaccine) consists of freeze-dried live mycobacteria of the vaccine strain that have lost their virulence but retained their immunogenic properties. One ampoule contains 1 mg of the vaccine, which corresponds to 20 doses of 0.05 mg of the preparation each. The vaccine is intended for the immunization of healthy full-term newborns, as well as for the revaccination of children. In addition to the BCG vaccine, the BCG-M vaccine is produced, containing 0.5 mg in each ampoule, which corresponds to 20 doses of 0.025 mg each. It is intended for the vaccination of premature newborns and children who were not vaccinated at birth due to contraindications, as well as for the vaccination and revaccination of children living in radionuclide-contaminated territories (zones III-IV). The vaccine is supplied with a diluent - 2 ml of 0.9 % sodium chloride solution per ampoule.
The vaccine can be stored at temperatures up to +4 °C for up to 12 months. The same conditions must be maintained during vaccine transportation. The vaccine must not be used under the following conditions:
- a cracked ampoule;
- missing label;
- expired shelf life;
- flocculation in the reconstituted vaccine.
Primary vaccination is performed in the maternity hospital, or, in the case of home birth, in a children's outpatient clinic or at a FAP (feldsher-midwife station). The personnel performing the vaccination must undergo training at a tuberculosis dispensary and obtain an authorization certificate, which is renewed annually. Vaccination is administered to healthy infants on the 3rd day of life. Prior to this, the instructions should be reviewed in detail once again, the children examined, and their body Temperature measured. Only single-use 1-gram syringes with graduations up to 0.1 ml are used for vaccination.
Before vaccination, the vaccine ampoule is wiped with alcohol, filed, and the neck is carefully broken off after wrapping it in a sterile gauze wipe to prevent aerosolization of the vaccine. Using a sterile syringe with a long needle, 2 ml of diluent is transferred into the vaccine ampoule and mixed thoroughly to form a uniform suspension. A 1-gram syringe is filled with 0.2 ml of the vaccine, and air and excess vaccine are expelled to the 0.1 ml mark. The child's Skin is wiped with alcohol, and the vaccine is administered strictly intradermally at the border between the upper and middle thirds of the left shoulder (Fig. 33). For high-quality vaccination, one healthcare worker holds the child's arm, while another stretches the skin and administers the vaccine. After the injection, the skin is not disinfected, and no dressing is applied. A white papule 6-8 mm in diameter forms at the injection site and resolves within 15-20 min. Reconstituted vaccine is suitable for use within 2-3 hours, after which it must be destroyed by boiling or immersion in a disinfectant solution. When sending the referral exchange card (Form No. 113/o) to the children's outpatient clinic, the maternity hospital staff record the BCG vaccination details in it.
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Fig. 33. Technique of intradermal administration of the BCG vaccine.
Sequence of actions when performing BCG vaccination
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Required Materials |
Sequence of actions |
Notes |
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1. Ampoule of BCG vaccine 2. Ampoule of diluent (2 ml of 0.9 % NaCl solution) 3. Sterile 2 or 5 ml syringe and injection needles No. 0840 4. Sterile 1 ml syringes with graduations up to 0.1 ml (disposable) with needles No. 0415 5. Ethyl alcohol 70° 6. Sterile gauze wipes 7. Sterile cotton balls 8. Ampoule file 9. Black paper 10. Container with disinfectant solution |
1. Read the instructions enclosed in the box 2. Prepare hands for injection 3. Inspect the vaccine ampoule 4. Wipe the neck of the vaccine ampoule with 70° alcohol and file it 5. Wrap the ampoule in a sterile wipe and break off the neck 6. Draw into a 2 ml (or 5 ml) syringe with a needle No. 0840 2 ml of 0.9 NaCl solution and transfer it into the vaccine ampoule, mix until a uniform colorless suspension is formed 7. Wipe the child's skin at the border between the upper and middle thirds of the left shoulder with 70° alcohol 8. Draw 0.2 ml of reconstituted vaccine into a disposable 1 ml syringe 9. Change the needle to a fine needle No. 0415, expel air and a portion of the vaccine (into a sterile cotton ball) to the 0.1 ml mark 10. Administer the vaccine strictly intradermally 11. Cover the remaining vaccine with a black paper cylinder 12. Immerse the syringe, needle, and cotton balls in 5 % chloramine solution |
For step 3: if there is no label on the ampoule, the expiration date has passed, there are cracks on the ampoule, or the preparation is shriveled or has changed color - the vaccine is unusable! For step 4: if flocculation occurs during reconstitution - the vaccine is unusable! For step 8: with correct administration, a white papule ("orange peel" appearance) with a diameter of 68 mm is formed. Attention! Destroy any vaccine unused within 3 hours by boiling or immersion in 5 % chloramine solution |
Tuberculosis vaccination must not be combined with other parenteral Procedures on the same day.
Contraindications to BCG vaccination:
- prematurity with a body weight of less than 2000 g;
- intrauterine infections, purulent-septic diseases;
- hemolytic disease (moderate to severe);
- Birth injuries with neurological symptoms;
- generalized skin lesions;
- all acute illnesses;
- generalized BCG infection in other children in the same family;
- HIV-infected children.
Vaccination of a child born to an HIV-infected mother is performed after the Diagnosis of HIV infection in the child has been ruled out.
For children who were not vaccinated during the neonatal period, the BCG vaccination is administered in a children's outpatient clinic after contraindications are resolved, within a period of 1 to 6 months. For children older than 2 months, vaccination is performed only after a prior Mantoux test with 2 TU, provided the results are negative.
Premature infants, children from radionuclide-contaminated areas (zones III-IV), and those with contraindications are immunized with the BCG-M vaccine.
Immunity after BCG vaccination develops within 2 months and lasts for 7-12 years. Therefore, revaccination is performed at 7 and 14 years of age following prior tuberculin skin testing. Healthy, uninfected children who show a negative result to a Mantoux test with 2 TU are revaccinated.
The interval between the Mantoux test and vaccination must be at least 3 days and no more than 2 weeks.
Revaccination is not performed in individuals:
- who have had tuberculosis;
- who experienced post-vaccination complications;
- with Epilepsy or epileptic syndrome (seizures twice a month or more frequently);
- with malignant Blood diseases and neoplasms;
- with anemia at a Hemoglobin level below 80 g/L (vaccination is performed after the hemoglobin level increases);
- with immunodeficiency states;
- undergoing Treatment with immunosuppressants;
- who are HIV-infected;
- with acute illnesses or exacerbations of chronic diseases, vaccination is administered after recovery;
- BCG vaccination is not administered within 4 weeks after contracting measles or receiving a measles vaccine.
Children who have received immunosuppressive therapy with cytostatics or corticosteroids (more than 1 mg/kg/day of prednisolone equivalent) for longer than 14 days can only be vaccinated 1 month after discontinuing these drugs. In individuals with allergic diseases and immunodeficiency, the possibility of revaccination is determined by an appropriate specialist.
Other routine vaccinations can be administered at an interval of at least 2 months before or after BCG revaccination.
If There is a tuberculosis patient in the family, the child scheduled for BCG vaccination or revaccination must be isolated from the patient after the vaccination for the period of immunity development (for at least 2 months).
Revaccination is carried out by healthcare teams appointed by order of the chief physician of the district. The team is headed by a pediatrician. Within their service area, the team includes a paramedic and a nurse from the children's institution. Separate rooms are designated for revaccination in schools and vocational schools. The revaccination technique is the same as for primary immunization.
The requisition for the BCG vaccine to conduct revaccination in their service area is prepared by the paramedic and submitted to the regional SES. The amount of vaccine required is calculated based on the number of children in the age groups eligible for revaccination (7 and 14 years) who test negative to the Mantoux test with 2 TU. For every 10 children eligible for BCG revaccination, 1 ampoule of vaccine is required, complete with 1 ampoule of diluent (i.e., 2 doses per vaccination).
Data on BCG vaccination and revaccination (date of immunization, dose, batch, control number of the vaccine, its expiration date, and the name of the manufacturing institute) are recorded in the immunization log (form 064/0), the immunization card (form 063/0), the child's developmental history (form 112/0), and for children attending preschool institutions or school, in form 026/0.
Normal post-vaccination reactions. Within 4-6 weeks after vaccination and 2-4 weeks after revaccination, an infiltrate 5-12 mm in diameter develops at the injection site. Subsequently, a bluish nodule forms, which eventually undergoes necrosis, becomes crusted, and after 2-6 months, a white scar forms (Fig. 34 - see Appendix). Scar formation indicates high quality of the vaccination. Scars should develop in 90-95 % of vaccinated and revaccinated individuals. Simultaneously, post-vaccination allergy (a positive reaction to tuberculin) develops, which can be detected by a Mantoux test with 2 TU. If no post-vaccination scar has formed and the Mantoux test remains negative, the vaccination can be considered ineffective. Such children need to be revaccinated 2 years after the initial vaccination or revaccination.
The pediatrician or paramedic checks The Development of the local reaction to the vaccine administration 1, 3, and 12 months after vaccination and describes its nature in the medical records. After 12 months, special attention is paid to the presence of a post-vaccination scar.
In rare cases (0.02 0%), local complications may occur after BCG vaccinations:
- subcutaneous cold abscess;
- an ulcer with a diameter of 10 mm or more;
- peripheral lymphadenitis (most commonly axillary);
- keloid scar.
A subcutaneous cold abscess occurs when the vaccination technique is violated and the preparation is injected subcutaneously. Therefore, the vaccine must be administered strictly intradermally. A cold abscess develops no earlier than one month after vaccination, and sometimes later (up to 8 months). A painless, elastic, spherical Swelling of varying size appears at the injection site. Initially, the skin is unchanged. In some children, the abscesses resolve spontaneously within 2-3 months. In other cases, the tumor-like mass softens, fluctuation is detected on Palpation, and the skin becomes cyanotic. A fistula with odorless purulent discharge may form.
In the Cytology/cytology/16.html">Early stages of abscess formation, gauze soaked in a solution of the following composition is applied daily: rifampicin - 0.45 g, dimexide solution - 20 ml, distilled Water - up to 100 ml. It is covered with wax paper and bandaged. If the abscess does not resolve under treatment and fluctuation occurs, a puncture is performed to aspirate the contents and inject an isoniazid solution into the cavity. If local treatment is ineffective, surgical intervention is performed.
A superficial ulcer is considered a complication if its diameter is 10 mm or more. Its occurrence is due to the specific reactivity of the body; it is more common in overweight children who have also had reactions to other vaccinations. Isoniazid powder is used for treatment.
Regional lymphadenitis (of the axillary, cervical, or supraclavicular Lymph Nodes). They are also called "bcgitis". Their occurrence is attributed to the high reactogenicity of the vaccine. Lymphadenitis is more frequently observed in premature infants, children with chronic foci of infection, exudative diathesis, idiosyncrasy, etc. Recently, regional lymphadenitis has also been observed in revaccinated children. It begins asymptomatically, without signs of intoxication, and is painless. Gradually, softening and fluctuation occur, and a fistula may form. Children with this complication are prescribed 2-3 antituberculosis drugs. If there is no effect, the lymph nodes are surgically removed, followed by continued treatment with isoniazid.
A keloid scar is a Connective Tissue tumor-like formation at the site of a healed post-vaccination reaction. It sometimes forms a year or more after vaccination. Its formation is associated with a specific skin reaction to scarring. Similar keloids sometimes form at the site of postoperative scars or Burns. Keloid scars are treated by infiltration with lidase, hydrocortisone emulsion, and other Conservative Methods. Surgical removal of the scar is not indicated, as it is followed by recurrence with The formation of an even larger scar.
Sometimes, a necrotic reaction develops at the injection site, resulting in an ulcer and significant painful infiltration around it. This complication is called the Koch phenomenon. It develops if the BCG vaccination is administered to a child already infected with tuberculosis.
Very rarely, dissemination of BCG infection or osteitis occurs as a complication of BCG vaccination.
Complications associated with secondary infection at the vaccine injection site are also possible. They are caused by scratching or trauma, especially during the period of tissue necrosis at the site of the vaccine reaction. These complications can manifest as ulcers, Pyoderma, or regional lymphadenitis. Unlike specific lymphadenitis ("bcgitis"), they have an acute onset, are painful, and may be accompanied by a fever. Antibiotics are used for treatment, and surgical intervention is required in case of abscess formation.
After BCG vaccination, a local allergic reaction (swelling, skin itching, pronounced hyperemia) may occur within the first 1-2 days.
Children with complications from BCG vaccination must be referred to a phthisiologist for consultation. In the event of a complication following vaccine administration, the HEAD of the healthcare facility and the sanitary-epidemiological station must be notified.
BCG vaccination reduces the risk of contracting tuberculosis fivefold. Against the Background of its widespread use, the incidence of severe forms of respiratory tuberculosis has significantly decreased, and Tuberculous meningitis rarely occurs.
In case of refusal of vaccination, an entry is made in the preventive immunization card (Form 063/0) and the child's developmental history (Form 112/0), indicating that the healthcare worker explained the potential consequences of such refusal. The entry is signed by the healthcare worker and the refusing individual. A notification is sent to the local sanitary-epidemiological station (SES).
Questions
1. What is the BCG vaccine, and how should it be stored?
2. Which vaccine is considered unfit for use?
3. What is the technique for administering the BCG vaccine?
4. Who is authorized to administer the BCG vaccine?
5. What are the timeframes for vaccination and revaccination?
6. Name the contraindications for BCG vaccination.
7. How are children selected for BCG revaccination?
8. Name the contraindications for revaccination.
9. What normal reactions develop after BCG vaccination?
10. What complications are possible after BCG vaccination? What are the actions of a paramedic if these complications are suspected?
11. What is the efficacy of tuberculosis immunization?
Last update: 10/08/2026
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