NCT03204617 - Safety and Immunogenicity Study of DNA.HTI, MVA.HTI and ChAdOx1.HTI in HIV-1-positive Patients (AELIX-002) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 7, 2017

Primary Completion Date

July 1, 2020

Study Completion Date

March 10, 2021

Conditions

HIV

Interventions

BIOLOGICAL

DNA.HTI 0.5mL at weeks 0, 4 and 8 + MVA.HTI 0.5mL at weeks 12 and 20 (DDDMM)

Vaccine DNA.HTI 0.5mL at weeks 0, 4 and 8 + Vaccine MVA.HTI 0.5mL at weeks 12 and 20 (DDDMM).

BIOLOGICAL

At least 24 weeks since DDDMM, ChAdOx1.HTI 0.5mL at weeks 0 and 12 + MVA.HTI 0.5mL at week 24 (CCM)

At least 24 weeks since second MVA.HTI administration (week 20), administration of ChAdOx1.HTI 0.5mL at weeks 0 and 12 + MVA.HTI 0.5mL at week 24.

DRUG

Placebo

0.9% sterile normal saline solution at weeks 0, 4, 8, 12 and 20. At least 24 weeks since the fifth Placebo administration, 0.9% sterile normal saline solution at weeks 0, 12 and 24

Trial Locations (1)

08916

IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Badalona