Extended Data Fig. 2. Clinical parameters after BCG vaccination in NHPs.
To assess safety of BCG vaccinations, all macaques (cohorts 1–4 excluding unvaccinated) were monitored for changes in several clinical parameters at various time points after BCG. After vaccination, changes were observed predominantly in IV BCG macaques; however, all were transient. a, Weight and temperature: there was a 0.9 °C increase in body temperature in the IV BCG group at day 1, which resolved by day 2; the average pre-vaccination temperature across all NHPs was 38.4 °C. b, Liver function tests (alanine aminotransferase (ALT), aspartate aminotransferase (AST), albumin and globulin): there was a twofold increase in ALT and AST above pre-vaccination levels (20–30 IU l−1) in the IV BCG group, which resolved by day 28. c, C-reactive protein (CRP) in the IV BCG group increased up to a median of 400 μg ml−1 at day 2, which resolved by day 14; the average pre-vaccination CRP level in plasma across all NHPs ranged from 0 to 28 μg ml−1. d, Complete blood counts (CBC). Transient increases in numbers of circulating neutrophils (day 1) and lymphocytes, monocytes and basophils (day 7) were observed in the IV BCG group. All tests were performed longitudinally on whole blood at time of collection except CRP, which was batch-analysed from frozen plasma samples; the 6-h time point was measured for CRP only. Data points shown are individual NHPs (n = 11–13 per group, n = 63 total) with interquartile range (box) and median (line). For each parameter, pre-vaccination (P) measurements for all NHPs were combined and compared against distributions from every vaccine group at every time point using Dunnett’s test for multiple comparisons; *P < 0.05. No clinical signals, such as lethargy, appetite suppression or weight loss, were observed up to time of Mtb challenge, 24 weeks later.