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BCG Vaccination Scar Formation in Children Under Five Years :Factors Affecting Its Formation and Subsequent Adverse Effects . (bcgscars)

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ClinicalTrials.gov Identifier: NCT03548233
Recruitment Status : Not yet recruiting
First Posted : June 7, 2018
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Shimaa Abd elhamid Mahran, Assiut University

Tracking Information
First Submitted Date  ICMJE May 11, 2018
First Posted Date  ICMJE June 7, 2018
Last Update Posted Date August 26, 2019
Estimated Study Start Date  ICMJE December 1, 2019
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
number of children without bcg scar after bcg vaccination and factors that may lead to that nummber of children with adverse effects from bcg vaccine using clinical data about children included in the study [ Time Frame: one year ]
bcg vaccination reaction and adverse effects and factors affecting scar formation
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03548233 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BCG Vaccination Scar Formation in Children Under Five Years :Factors Affecting Its Formation and Subsequent Adverse Effects .
Official Title  ICMJE BCG Vaccination Scar Formation in Children Under Five Years :Factors Affecting Its Formation and Subsequent Adverse Effects .
Brief Summary Study of BCG Vaccination scars of under five years old children . Estimation of the frequency of children without BCG scar after BCG vaccine . Evaluation of factors which may affect scar formation . Tuberculin skin test response in children without BCG scar . Frequency of vaccine adverse effects as injection-site abscess, lymphadenitis, severe local reaction, and disseminated BCG infection.
Detailed Description

Tuberculosis (TB) is an ancient disease, with evidence of skeletal TB found in mummies in both the Old and New World. The causative agent is Mycobacterium tuberculosis, a fastidious, aerobic, acid-fast bacillus Tuberculosis (TB) remains a major global health problem. It ranks as the second leading cause of death from an infectious disease worldwide, after the human immunodeficiency virus (HIV). The latest estimates by the World Health Organization (WHO) reported that there were 9 million new cases in 2011 and 1.4 million TB deaths . Moreover, it is one of the top 10 causes of global mortality and affects low-income countries in particular. About half a million children (0-14 years old) are ill with TB, and 64,000 children died from the disease in 2011 . In Egypt, TB is considered the third most important public health problem after schistosomiasis and hepatitis C .

TB in children is often missed or overlooked due to non-specific symptoms and difficulties in diagnosis. This has made it difficult to assess the actual magnitude of the childhood TB epidemic, which may be higher than currently estimated.

There is an urgent need for public attention, prioritisation, commitment and funding for this disease that today should never take the life of a child.

Bacillus Calmette-Guérin (BCG) vaccine : a live attenuated vaccine that has been in use since 1921, is the most widely used vaccine worldwide . BCG is efficacious against the most severe forms of tuberculosis (TB) such as tuberculosis meningitis (73% protection) and miliary TB (77% protection) in children younger than 5 years .

It is one of the mandatory vaccines recommended by the ministry of health(MOH) of Egypt.

BCG vaccination became compulsory in all governorates of Egypt since 1974 . the recommended schedule of BCG is eight weeks postnatal. The usual response to administer BCG vaccine is the development of erythema or a papule at around 2 weeks, followed by an ulcer and healing with a scar at 6 weeks at the site of the injection.

Although the size of reaction after vaccination is not generally thought to influence the degree of protection offered by BCG, the presence of the BCG scar has been used as a criterion to assess the uptake of vaccination .

However, the sensitivity of BCG scar as an index of vaccination status is still the subject of controversy. Failure to form scar may be related to factors such as lack of maturation of the immune system, faulty technique or unipotent vaccine.

Adverse effects of Bcg vaccine: were classified, according to World Health Organization definitions , as injection-site abscess, lymphadenitis, severe local reaction, and disseminated BCG infection.

Tuberculin skin test response:

The reaction is read by measuring the diameter of induration (palpable raised, hardened area) across the forearm (perpendicular to the long axis) in millimeters. If there is no induration, the result should be recorded as "0 mm". Erythema (redness) should not be measured.

  • 5 mm or more is positive in
  • An HIV-positive person
  • Persons with recent contacts with a TB patient
  • Persons with nodular or fibrotic changes on chest X-ray consistent with old healed TB
  • Patients with organ transplants, and other immunosuppressed patients
  • 10 mm or more is positive in
  • Recent arrivals (less than five years) from high-prevalence countries
  • Injection drug users
  • Residents and employees of high-risk congregate settings (e.g., prisons, nursing homes, hospitals, homeless shelters, etc.)
  • Mycobacteriology lab personnel
  • Persons with clinical conditions that place them at high risk (e.g., diabetes, prolonged corticosteroid therapy, leukemia, end-stage renal disease, chronic malabsorption syndromes, low body weight, etc.)
  • Children less than four years of age, or children and adolescents exposed to adults in high-risk categories
  • 15 mm or more is positive in
  • Persons with no known risk factors for TB.

the study aims to• Estimate the frequency of children without BCG scar after bcg vaccination.

  • Evaluate factors which may affect scar formation.
  • Tuberculin skin test response in children without BCG scars if indicated.
  • Frequency of vaccine adverse effects

Exclusion criteria:

  • Infants with skin lesion on the left forearm.
  • Infant treated with steroids or intravenous immune globulins.
  • Infants with immunodeficiency.
  • Severe sepsis.
  • Infants with congenital anomalies.

All cases included in the study will be subjected to

  • Full clinical history including: Birth weight, nutritional status, gender, gestational age, weight at time of vaccination, mother awareness.
  • Detailed clinical examination: including site of bcg scar.
  • Tuberculin test in negative BCG scar children.
  • Revaccination of negative BCG scar children.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
bcg vaccine
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE BCG Vaccination Reaction
Intervention  ICMJE Biological: bcg vaccine
live attenuated vaccine
Study Arms  ICMJE bcg vaccinated
children under five year vaccinated by bcg vaccine
Intervention: Biological: bcg vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 5, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2020
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- Children between 6 and 60 months of age.

Exclusion Criteria:

  • • Infants with skin lesion on the left forearm.

    • Infant treated with steroids or intravenous immune globulins.
    • Infants with immunodeficiency and malnutrition.
    • Severe sepsis.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: shimaa mahran, master 01140574639 shimaamahran88@gmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03548233
Other Study ID Numbers  ICMJE bcgvaccinationscars
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shimaa Abd elhamid Mahran, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: mohamed ghazaly, professor assiut universitypediatric hospital
Principal Investigator: mustafa embaby, assistprof assiut universitypediatric hospital
PRS Account Assiut University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP