Table 2.
Overview of CHMI studies.
| Study | Year | Challenge | Treatment drug | Subjects with parasitaemia (n) | Mean peak parasiteamia (Pf/ μL) | Subjects with LFT#a (n(%)) | Severity |
Treatment criterion | LFT timepoints | Registered | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| mild | moderate | severe | ||||||||||
| EHMI-3 | 2001 | 3D7- mosquito bite | chloroquine | 5 | 21.6 | 4 (80) | 2 | 2 | 0 | 48 h after positive TSb | multiple timepointse | – |
| EHMI-8A | 2007 | NF54- mosquito bite | artemether-lumefantrine | 5 | 15.1 | LFTs not measured during infectiond | positive TSb | – | NCT00442377 | |||
| LSA-3 | 2008 | NF54- mosquito bite | artemether-lumefantrine | 18 | 26.7 | 18 (100) | 10 | 4 | 4 | positive TSb | multiple timepointse | NCT00509158 |
| EHMI-8B | 2009 | NF54- mosquito bite | atovaquone-proguanil | 7 | 3.7 | 4 (57) | 4 | 0 | 0 | positive TSb | Standardc | NCT00757887 |
| TIP1 | 2010 | NF54-NF135 mosquito bite | atovaquone-proguanil | 10 | 17.6 | LFTs not measured during infectiond | positive TSb | – | NCT01002833 | |||
| TIP2 | 2010/2011 | NF54- PfSPZ I.M.⁎ | atovaquone-proguanil | 15 | 43.6 | 5 (33) | 4 | 0 | 1 | positive TSb | Standardc | NCT01086917 |
| ZonMw1 | 2011 | NF54- mosquito bite | atovaquone-proguanil | 12 | 28.5 | LFTs not measured during infectiond | positive TSb | – | NCT01218893 | |||
| EHMI-9 | 2011 | 3D7- mosquito bite or BS challenge⁎⁎ | atovaquone-proguanil | 19 | 9.5 | 11 (58) | 9 | 1 | 1 | positive TSb | standardc | NCT01236612 |
| ZonMw2 | 2012 | NF54- mosquito bite | atovaquone-proguanil | 9 | 27.8 | 6 (67) | 6 | 0 | 0 | positive TSb | standardc | NCT01422954 |
| TIP4 | 2012 | NF135- mosquito bite | atovaquone-proguanil | 19 | 81.1 | 8 (42) | 6 | 2 | 0 | positive TSb | standardc | NCT01660854 |
| TIP3 | 2012 | NF54-NF135-NF166 mosquito bite | atovaquone-proguanil | 15 | 37.4 | LFTs not measured during infectiond | positive TSb | – | NCT01627951 | |||
| TIP5 | 2012/2013 | NF54- mosquito bite | atovaquone-proguanil | 21 | 15.5 | 11 (52) | 4 | 6 | 1 | positive TSb | standardc | NCT01728701 |
| BMGF2a | 2014 | NF54-NF135-NF166 mosquito bite | atovaquone-proguanil | 20 | 20.1 | LFTs not measured during infectiond | 2 pos. qPCR (≥500Pf/mL) | – | NCT02149550 | |||
| BMGF1 | 2014 | NF54- mosquito bite | atovaquone-proguanil | 8 | 0.1 | 0 (0) | 0 | 0 | 0 | pos. qPCR (>100Pf/mL) | standardc | NCT02080026 |
| BMGF2b | 2015 | NF54-NF135-NF166 mosquito bite | atovaquone-proguanil | 31 | 1.5 | 7 (23) | 6 | 0 | 1 | pos. qPCR (>100Pf/mL) | standardc | NCT02098590 |
| BCG-EHMI | 2016 | NF54- mosquito bite | atovaquone-proguanil | 19 | 1.0 | 7 (37) | 6 | 1 | 0 | pos. qPCR (>100Pf/mL) | standardc | NCT02692963 |
| CHMI-trans1 | 2016 | 3D7- mosquito bite | sulfadoxine-pyrimethamine/ piperaquine | 16 | 20.0 | 16 (100) | 5 | 3 | 8 | positive TSb | multiple timepointse | NCT02836002 |
| Total subjects with LFTs measured | 187 | 97 (52) | 62 (33) | 19 (10) | 16 (9) | |||||||
| Total subjects with LFTs measured (thick smear studies) | 129 | 83 (64) | 50 (39) | 18 (14) | 15 (12) | |||||||
| Total subjects with LFTs measured (qPCR studies) | 58 | 14 (24) | 12 (21) | 1 (2) | 1 (2) | |||||||
a
liver function test abnormalities.
b
TS = thick smear.
c
standard LFT measurements at 3 time-points: baseline, 2 days after treatment, and at the end of study.
d
LFTs are only measured on baseline and at the end of study.
e
>3 LFT measurement time-points (range of 4–13).
⁎
intra-muscular injection.
⁎⁎
blood stage challenge.