Ann: ISLA-101 Phase 2a clinical trial update, page-15

this is my understanding, based on a very quick appraisal:

According to clinical trials.gov, in 2015, a first-in-human trial of DENV-1-LVHC as a valid “model” for dengue fever commenced. they planned to recruit 27 subjects. the updated trial details said that recruitment finished in 2019.

In 2021, an academic paper was published, reporting on 12 subjects, 6 received high dose and 6, low dose. of these 12 subjects, 11 showed dengue-like symptoms.
The authors concluded that DENV-1-LVHC showed promise for dengue fever challenge studies(?) I think that was the essence of their conclusions.

Have any follow up studies been done using much larger subject groups, or is this small group of 11 human subjects all there is?


My question is: how can ILA run a study to show that their drug candidate can help prevent dengue fever, using a challenge test that has only been tested on 11 human subjects?

would this bother the FDA when they are asked to approve ILA's IND application?

Please, if anyone can correct my information here, please do so.