Table 1:
Summary of BCG revaccination and M72/AS01E vaccine trials
| BCG revaccination POSI trial | M72/AS01E POD trial | |
|---|---|---|
| Intervention | BCG vaccine, 1 intradermal injection of 5×105 CFU at Day 0 | M72/AS01E, 2 intra-muscular injections of 10μg M72 |
| Formulation | Live attenuated M. bovis (Danish strain 1331), reconstituted in Sauton diluent without adjuvant, ~4000 antigens | Subunit vaccine (M72: recombinant fusion protein of Mtb32A and Mtb39A) with adjuvant (Adjuvant System containing MPL, QS-21 and liposome (25 μg MPL and 25 μg QS-21) |
| Population | 659* HIV negative, IGRA negative adolescents, randomized 1:1 to BCG re-vaccination or placebo | 3575 HIV negative, IGRA positive adults, randomized 1:1 to M72/AS01E vaccination or placebo |
| Efficacy | 45.4 % (95% CI 6.4 to 68.1) | 49.7 (95% CI 2.1 to 74.2) |
| Case Definition | Sustained IGRA conversion (secondary endpoint) | Culture or PCR-confirmed pulmonary TB without HIV (primary endpoint) |
| Endpoints | 57 total 21/312 in BCG arm 36/310 in placebo arm |
39 total 13/1626 in M72/AS01E arm 26/1663 in placebo arm |
| Vaccine-reactive immune responses in placebo arm | detectable, high variability |
virtually undetectable, low variability |
| Samples for primary CoP analysis: PBMC Plasma Fixed cells from whole blood RNA from whole blood |
2 vials at Day 0, 70, Month 6 2 vials at Day 0, 70, Month 6 2 vials at Day 0, 3 (placebo) or 7 (BCG), Month 6 1 vial at Day 0, 3 (placebo) or 7 (BCG), Month 6 |
6 vials at Day 0, 37, Month 6 2 vials at Day 0, 37, Month 6 2 vials at Day 0, 37, Month 6 1 vial at Day 0, 37, Month 6 |
Abbreviations: CFU = colony forming unit; MPL = 3-O-desacyl-4-monophosphoryl lipid A; QS-21 = Quillaja saponaria Molina, fraction 21
*
H4:IC31 recipients not included in CoP analyses