Table 5.
Go/no go criterion to support licensure study. Studies must simultaneously meet all four main variables
| Variable measured at month 6.5 | Rationale |
|---|---|
| Env Ab response rate (≥2 of 3)** | Adequate Ab take to vaccine Env |
| Env Ab magnitude (≥2 of 3)* | Non-inferior Ab magnitude vs. RV144 |
| Env CD4 response rate (1 of 1)* | Non-inferior CD4 T cell take vs. RV144 |
| Env V1V2 response rate (≥1 of 3)** | Adequate to predict achieving VE=50% for 2 years if V1V2 Ab is an immune correlate |
*
Based on variables 1–3 (Insert binding Abs); ** Require that the same two Env inserts pass on ‘take’.
Adapted from Tartaglia J. Substantiating and extending upon the results of RV144. An update on HIV vaccines: prospects for the future. Les Cent Gardes Conference. October 2014. Veyrier du Lac, France.