Table 1C.

Summary of the outcome measures of efficacy assessed in therapeutic HIV vaccine clinical trials with analytical treatment interruptions: DNA vaccines

Vaccine	Study design	Primary outcome measure(s)	Other relevant efficacy outcome measures	Main findings	References
DNA vaccine encoding the HIV-1 Nef, Rev and Tat proteins	RCT	Changes in immune responses of previously immunized HIV-positive participants following ART initiation.	CD4 T cell count CD8 T cell count pVL	In a substudy in which participants had undergone ATI, there was no significant change in HIV-specific responses during or after ATI.	[144]
VRC-HIV DNA 009-00-VP (a four-plasmid mixture encoding modified envelope constructs from HIV-1 subtypes A, B and C and a subtype B Gag-Pol-Nef fusion protein)	RCT; participants initiated ART during early HIV infection	Safety Immunogenicity	CD4 T cell count Viral load set point following ATI	The vaccine was safe but not immunogenic and had no effect on the viral set point during ATI.	[104]
DNA vaccine consisting of seven plasmids encoding HIV-1 Gag (subtypes A and B), Env (subtypes A, B or C), RT or Rev	RCT	HIV-specific epitope reactivity Immunogenicity Time to ART resumption	CD4 T cell count Viral load rebound following ATI Viral load set point following ATI	Although immunogenic, the vaccine did not affect the viral set point during ATI or the time to resume ART.	[145]