NCT01712256: Re-boost

Re-boosting of Subjects Previously Included in the CT BI-Vacc-4x 2007/1 Study. An Open, Multicenter, Immunogenicity, Follow-up Re-boosting Study With Vacc-4x in Subjects Infected With HIV-1 Who Have Maintained an Adequate Response to ART

Completed Phase 2 Results posted Last updated 11 January 2017

What this trial tests

Phase 2 trial testing Vacc-4x in HIV-1 Infection in 33 participants. Completed in 1 January 2014.

Timeline

1 December 2012

Primary endpoint
1 January 2014

1 January 2014

Quick facts

Lead sponsor	Bionor Immuno AS
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	33
Start date	1 December 2012
Primary completion	1 January 2014
Estimated completion	1 January 2014
Sites	10 locations across United States, Germany, Italy, Spain, United Kingdom

Drugs / interventions tested

• Vacc-4x — full drug profile →

Conditions studied

• HIV-1 Infection — all drugs for HIV-1 Infection →

Sponsor

Bionor Immuno AS — full company profile →

Who can join

Adults 18 to 63, any sex, with HIV-1 Infection. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Vacc-4x Effect on Viral Load Set-point
  Time frame: 37 weeks
  Viral load (VL) set point in the present re-boost study was compared with VL set point in the 2007/1 study.

Sponsor's own description

During the course of HIV infection the number of CD4 cells decreases, resulting in a reduced immunological response and eventually immune deficiency. Vacc-4x is a peptide-based HIV immunotherapy vaccine and is anticipated to strengthen the immune system's response to HIV.

All patients participating in this trial have previously received the vacc-4x vaccine in order to reduce the amount of HIV-1 virus in the blood and increase the immune response. The primary objective of this study is to evaluate if a re-boost with Vacc-4x could further reduce the amount of HIV-1 virus and increase the immune response.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Re-boost immunizations with the peptide-based therapeutic HIV vaccine, Vacc-4x, restores geometric mean viral load set-point during treatment interruption.
   Rockstroh JK, Asmuth D, Pantaleo G, Clotet B, et al · · 2019 · cited 10× · PMID 30699178 · DOI 10.1371/journal.pone.0210965
2. Conserved multiepitope vaccine constructs: A potent HIV-1 therapeutic vaccine in clinical trials.
   Akbari E, Seyedinkhorasani M, Bolhassani A. · · 2023 · cited 7× · PMID 37156468 · DOI 10.1016/j.bjid.2023.102774