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Int J Tuberc Lung Dis. 2019 Jan 1;23(1):38-44. doi: 10.5588/ijtld.18.0137. Epub 2018 Dec 20.

Interaction between C-Tb and PPD given concomitantly in a split-body randomised controlled trial.

Author information

1
Department of Vaccine Development.
2
Department of Infectious Diseases Immunology, Statens Serum Institut, Copenhagen, Denmark.
3
Be Part Yoluntu Centre, Paarl.
4
Setshaba Research Centre, Pretoria.
5
Tiervlei Trial Centre, Cape Town.
6
Global Clinical Trials, Port Elizabeth.
7
TASK, Cape Town.
8
University of Cape Town, Cape Town, South Africa.

Abstract

SETTING:

Seven tuberculosis (TB) clinics in South Africa.

OBJECTIVE:

As both purified protein derivative (PPD) and a Mycobacterium tuberculosis-specific skin test (C-Tb) contain region of difference 1 (RD1) antigens, we conducted a study to evaluate whether there was any interaction between the two during concomitant and separate administration in patients with newly diagnosed culture-positive TB.

DESIGN:

Adult patients with active TB (n = 456, 20% human immunodeficiency virus infected) were randomised to receive only C-Tb, only PPD, or concomitant injection of both C-Tb and PPD using the Mantoux technique. Indurations were read after 48-72 h. QuantiFERON®-TB Gold In-Tube (QFT) was performed in tandem.

RESULTS:

Of the 456 study participants, 154 simultaneously received both C-Tb and PPD, 153 only C-Tb and 149 only PPD. There was no effect of concomitant injection of PPD on the mean C-Tb induration (19 mm, 95%CI 17-22 vs. 18 mm, 95%CI 16-21; P = 0.91). In patients with active TB, C-Tb sensitivity (78%) was similar to PPD (81%) and QFT (84%; excluding 82/429 [19%] indeterminate results). All tests showed reduced sensitivity in participants with CD4 <100 cells/μl.

CONCLUSION:

In patients with active TB, there was no interaction between C-Tb and PPD during concomitant injection of both agents. Sensitivities were similar for PPD and C-Tb.

PMID:
30572979
DOI:
10.5588/ijtld.18.0137

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