Tuberculosis Clinical Trial
Official title:
PPD Size and Mycobacteria Tuberculosis ELISPOT in Children Who Have Received BCG in Neonate Period
To investigate the size of PPD and TB specific ELISPOT among children between 3m/o and 15 y/o . Calculate the normal range of age specific PPD size in children who recieved BCG at new-born period.
Sampling
1. Age under 3 year-old: a targeted population contains 500 children will be used for
sampling of this group. This cohort were firstly enrolled for a trial of oral Rota
vaccine since 2004. They will be followed up in the cohort up to 2006. Sixty children
will be enrolled in the group younger than 1 year-old (1-2, 2-3 year-old, 20 children
will be enrolled in each age group).
2. Age of 3 to 5 year-old, cases will be enrolled from volunteered students from
kindergarden (3-4, 4-5, 5-6 year-old, 20 children will be enrolled in each age group)
3. Age of 6 to 15 year-old, cases will be enrolled from volunteered students from
elementary school and junior high school ( 30 children will be enrolled in each age
group). A total of 300 children will be enrolled from children between 6 year-old and
15 year-old.
3. A total of 460 children between the age of 3 month and 15 y/o will be enrolled.
Procedure of PPD test Children who fit the criteria will be given 0.1 ml of PPD (PPD RT23, 2
units) intradermally, in accordance with the guidelines recommended by WHO (17). The
tuberculin for the tests is obtained from Denmark and is used throughout the country. PPD
indurations will be read 48 to 72 h after administration at 90 degrees from the longest axis
of the arm and recorded to the nearest millimeter. Indurations <=5 mm in diameter are
classified as negative, those >5 but <=10 mm as doubtful and those >10 mm as positive
according to previous consensus (2). All size of indurations will be recorded for further
analysis other than arbiturary classification.
Procedure of ELISPOT assay to detect T cells specific for M. tuberculosis antigens 4 ml
whole blood is collected in a heparinized tube first and are processed and scored by two
scientists who had no access to personal identifiers or TST results within four hours after
collection. We amplified the esat-6 gene from genomic DNA isolated from M bovis strain AN5
by PCR, and cloned it into plasmid vector pET21d (Novagen, Madison, WI, USA). Escherichia
coli was transformed with this vector. Recombinant ESAT-6 was recovered from transformed E
coli and purified by nickel-affinity chromatography. We did ex-vivo interferon-gamma ELISPOT
assays, with 300 000 peripheral blood mononuclear cells per well (14,18). We used purified
recombinant ESAT-6 and PPD, in addition to negative controls (no added antigen) and positive
controls (phytohaemagglutinin). Positive ESAT-6 test wells were defined as containing at
least ten spot-forming cells more than, and at least twice as many as, negative control
wells—a detection threshold of one per 30 000 peripheral blood mononuclear cells. Assays
were done and independently scored by two scientists who were unaware of exposure category
and TST results of contacts. ELISPOT assay wells containing more than 300 spot-forming cells
cannot be counted accurately because the spots coalesce. 300 cells per well (equivalent to
1000 cells per million peripheral blood mononuclear cells) was therefore taken as the upper
limit for accuracy (15).
Exclusion and Follow-up steps Children who are found to have positive PPD test (>10 mm),
have a PPD size in the range of 1st 2.5 percentile or having a positive ELISPOT result at
the time of enrollment, will be closely followed up for clinical symptoms and signs of TB
and necessary diagnostic workup will be done. If LTBI is highly suspected, prophylaxis will
be initiated. Closed contact families and care-givers will be asked to take CXR for
excluding active pulmonary TB.
Information collection at the enrollment Cross-sectional study of 160 children will be
conducted. Children were examined and assessed for general health condition, BCG vaccination
record, and BCG scar over L’t arm (19). Possible TB exposure including elderly with chronic
cough or unexplained prolonged febrile illness in house-hold contact, any contact history
with documented open TB will be thoroughly evaluated. Children with suspicious
immuno-compromised status, active lung disease or exposure history of TB will be excluded
and follow-up will be done.
Biostatistic method Descriptive analysis will be used for size of PPD and result of ELISPOT.
P value is calculated with student t test or Chi-square or Fisher exact test for statistic
significance (Version 10.0, SPSS, SPSS Inc. Illinois) between different age group. 95%CI
will be calculated for the purpose of cut off value of PPD size (except those with
unexpected-found TB disease).
;
Primary Purpose: Screening, Time Perspective: Cross-Sectional
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