Comparing BCG Vaccination Methods in South African Infants
Author Information
Author(s): Hawkridge Anthony, Hatherill Mark, Little Francesca, Goetz Margaret Ann, Barker Lew, Mahomed Hassan, Sadoff Jerald, Hanekom Willem, Geiter Larry, Hussey Greg
Primary Institution: South African Tuberculosis Vaccine Initiative, University of Cape Town
Hypothesis
Is there a difference in the incidence of tuberculosis between infants vaccinated with intradermal BCG and those vaccinated with percutaneous BCG?
Conclusion
Both intradermal and percutaneous BCG vaccination methods were found to be equivalent in preventing tuberculosis in South African infants.
Supporting Evidence
- 11,680 infants were randomized and vaccinated in the trial.
- The cumulative incidence of tuberculosis was similar between both vaccination routes.
- Equivalence was shown if the 95.5% confidence intervals for the incidence rates in the percutaneous group fell within 25% of those for the intradermal group.
- Only 1.73% of infants in the intradermal group and 1.45% in the percutaneous group died during the study.
- Adverse events were low, with only a few cases of severe reactions reported.
Takeaway
The study tested two ways to give a vaccine to babies to see if one way worked better than the other. It found that both ways were just as good at preventing tuberculosis.
Methodology
A randomised trial comparing the incidence of tuberculosis in infants vaccinated with either intradermal or percutaneous BCG over two years.
Potential Biases
Potential bias due to lack of blinding in outcome assessment and possible contamination in laboratory results.
Limitations
The study may not be generalizable to all populations, as it only included infants eligible for routine BCG vaccination.
Participant Demographics
Newborn infants from South Africa, with a follow-up period of two years.
Statistical Information
Confidence Interval
95.5% CI -1.27% to 0.54%
Digital Object Identifier (DOI)
Want to read the original?
Access the complete publication on the publisher's website