Table 1

Characteristics of BCG vaccination trials

SettingAge profileRecruitment start, recruitment end, follow-up end*Long-est follow-up (years)Epidemiological backgroundLatitudeTST no, doseTST cut-off (mm)Follow-up screen-ingDiagnostic confirmationTB endpoint (authors’ terminology)Number recruited vaccinated, controlsTB cases in vaccinated, controlsIncidence rate ratio point estimate (confidence intervals)
Saskatchewan native infants, CanadaNeonates1933, 1945, 194714Rapidly declining following period of very high burden55 50.8 nNoneN/AX-rayX-ray and clinicalTB306, 3036, 290.19
(0.08 to 0.46)
Native infants, USANeonates1938, 1940, 19468Rapidly declining following period of very high burden33 48.8 n and 43.2 nNoneN/AX-ray, TSTRoutine diagnosis after active follow-up ceasedPrimary TB123, 1394, 110.41
(0.13 to 1.29)
New York infants, USANeonates1933, 1944, 194411Rapidly declining following period of very high burden56 40.7 nNone (for majority vaccinated before 1 month of age)N/AX-ray, TSTMicrobiological or autopsyNone566, 528Not reported (TB-related deaths: 8, 8)N/A
(TB mortality: 0.93 (0.35 to 2.49))
Chicago hospital-delivered infants, USANeonates1937, 1956,
1956
19Very high burden, then rapidly declining23 57 41.9 nNoneN/AClinical, TST, X-rayClinical, TST, X-ray, autopsy (X-ray sufficient for diagnosis)TB5426, 412818, 630.22
(0.13 to 0.37)
Chicago household contact infants, USANeonates1940, 1955,
1955
15Very high burden, then rapidly declining23 57 41.9 nNone (if mother not the index)N/AClinical, TST, X-rayClinical, TST, X-ray, autopsy (X-ray sufficient for diagnosis)TB231, 2203, 110.30
(0.08 to 1.07)
Mumbai infants, IndiaNeonates1972, 1972,
1975
2.5Very high burden25 19.0 nNoneN/AClinical, TSTTST sufficient for diagnosis, although most TB diagnoses had X-ray changesPrimary TB396, 30022, 270.63
(0.36 to 1.11)
Agra preschool children, India0–5 years1979, 1979,
1984
5Very high burden27 27.2 nOne-stage,
1 TU PPD-RT23
<10X-ray, sputum examinationNot statedRadiologically active or probably active TB1259, 125910, 250.40
(0.19 to 0.83)
Chicago housing project, USA0–12 years1942, 1955,
1955
13High burden23 57 41.8 nTwo-stage,
Vollmer then 100 TU OT TST
Not statedX-ray, TSTUnclear, presumed X-ray and clinicalActive pulmonary TB947, 9440, 30.17
(0.01 to 3.32)
Jeremie population-wide, HaitiAll ages, see figure 2 1965, 1966, 19693Very high burden58 18.6 nOne-stage, 5 TU PPD-S<6X-ray, TSTMicrobiologicalTB635, 3381, 50.11
(0.01 to 0.91)
Native Americans in four states, USA0–19 years, see figure 1 1935, 1938, 199863Low and declining following a period of very high burden59 32.2 n to 58.8 nTwo-stage,
1 then 250 TU PPD
Not statedX-ray, TSTX-ray during first 12 years, then microbiological, clinical and other testsRadiological evidence first 11 years, then by case definitions1551, 145784, 2800.27
(0.21 to 0.34)
Georgia schools, USA6–17 years1947, 1947, 196720Low and declining following a period of high burden32 32.5 nTwo-stage, 5 and 100 TU PPD-RT19-20-21<5TSTClinical, microbiological, X-ray, TSTTB2498, 23415, 31.56
(0.37 to 6.54)
English cities, UK14–15½ years1950, 1952, 197220Low and declining following a period of high burden54 51.5 n to 53.5 nTwo-stage, 3 and 100 TU OT<5Clinical, TST, X-rayClinical, microbiological, pathologicalTB13598, 12 86762, 2480.23
(0.18 to 0.31)
Puerto Rico children, USA1–18 years, see figure 2 1949, 1951, 196919.8Declining but substantial following a period of very high burden31 18.4 nPredominantly (~76%) two-stage†, 1 then 10 TU PPD-RT19-20-21<6No active follow-upExisting surveillance systemsTB50634, 27 338186, 1410.71
(0.57 to 0.89)
Chicago mental health patients, USAAdults up to 66 years1943, 1947, 19474High burden28 41.9 nTwo-stage, 100 TU OTNot statedNot statedNot statedPulmonary TB20, 150, 1 (unconfirmed case)Not estimated
Chicago nursing students, USAPresumed young adult1940, 1953, 19563High rates of exposure, higher in vaccinated38 41.9 nTwo-stage, 2 and 10 TU OT<6TSTClinical, X-ray, other tests (X-ray sufficient for diagnosis)TB231, 2632, 50.45
(0.09 to 2.34)
Chicago medical students, USA20–37 years1939, 1952, 19644High rates of exposure38 41.9 nTwo-stage, 2 and either 10 or 100 TU OT<6TSTClinical, X-ray, microbiologicalTB324, 2980, 30.15
(0.01 to 3.00)
Rand Mines, South Africa30.3±10.3 years‡1965, 1968, 19683.6Very high burden60 26.2 sNone for most of trial, then one-stage for last 8 monthsNot statedX-rayX-rayTB8317, 799729, 450.62
(0.39 to 0.99)
Muscogee and Russell Counties population-wide, USASee figure 2 1950, 1950, 197020Low and declining burden32.5 nOne-stage, 5 TU PPD-RT-19-20-21<5NoneExisting surveillance systemsTB16913, 17 85432, 360.94
(0.58 to 1.51)
Madanapalle population-wide, IndiaSee figure 2 1950, 1955, 197121Very high burden, rapidly declining due to active case finding9 13.6 nPredominantly one-stage (~95%), 5 TU PPD-RT-19-20-21†<5X-rayClinical, X-ray, microbiological, other testsBacteriologically-confirmed TB5069, 580833, 470.81
(0.52 to 1.27)
Lincoln State School, USANot stated‡1947, 1947, 196012Declining but substantial following a period of very high burden40 40.2 nTwo-stage, 10 and 100 TU OTNot statedTST, X-rayClinical, microbiological, other testsTB531, 49412, 81.38
(0.56 to 3.38)
Chengalpattu population-wide, IndiaSee figure 2 1968, 1971, 198715Very high burden61 12.7 nOne-stage, 3 TU PPD-S<8X-ray, sputum examinationCulture-positive on ≥1 sputumCulture-confirmed TB78693, 39 025380, 1801.05
(0.88 to 1.25)
  • *Italicised years indicate inferred/assumed dates/follow-up periods.

  • †Our assessment differs importantly from that of Mangtani et al 4.

  • ‡TB cases were aged 15–44, such that 'school' does not imply children.

  • OT, old tuberculin; PPD, purified protein derivative; TB, tuberculosis; TST, tuberculin skin test; TU, tuberculin units.