NCT01140139: Vac09

Active Immunotherapy Against HIV During Highly Active Anti-retroviral Therapy Followed by Repeated Treatment Interruptions

Completed Phase 1 Last updated 8 June 2010

What this trial tests

Phase 1 trial testing HIV DNA Vaccine in HIV-1 in 12 participants. Completed in 1 December 2009.

Timeline

1 September 2006

Primary endpoint
1 October 2009

1 December 2009

Quick facts

Lead sponsor	Swedish Institute for Infectious Disease Control
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	12
Start date	1 September 2006
Primary completion	1 October 2009
Estimated completion	1 December 2009
Sites	1 location across Sweden

Drugs / interventions tested

• HIV DNA Vaccine — full drug profile →

Conditions studied

• HIV-1 — all drugs for HIV-1 →

Sponsor

Swedish Institute for Infectious Disease Control

Who can join

Adults 18 to 60, any sex, with HIV-1. 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.

• Safety and feasibility
  The safety and feasibility of dermal HIV-1 DNA vaccination will be evaluated by recording all medical events. They will be graded as to their seriousness, severity and relationship to the immunization. Plasma HIV-1 RNA levels and T-cell levels will be closely monitored. In addition to this the patient's individual experience and quality of life will be assessed.

Sponsor's own description

In this study, the investigators evaluated a therapeutic HIV-1 DNA vaccine administered with a novel topical application method to 12 chronically HIV-infected cART treated patients. The HIV DNA plasmids used in this study encode for envelope gp160 of HIV-1 subtypes A, B and C, rev B, Gag A and B and reverse transcriptase (RT) B. The patients were randomly assigned to three groups; group 1 (n=4) were immunized six times with 0.4 mg of HIV DNA plasmids topically, group 2 (n=4) were immunized six times with 0.4 mg of HIV DNA plasmids topically and treated with 500 mg of hydroxyurea daily until visit 10, group 3 (n=4) four patients received placebo. The immunization was performed during three cycles of 7 weeks of cART followed by four weeks of therapy interruption. After the last cycle of cART the patients were maintained on a definitive treatment interruption until CD4+ T cell counts dropped below 350/ mm3 at two time points. Cellular and humoral immune responses, viral load and CD4+ T a cell count was analysed throughout the study.

Publications & conference data

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

1. A review of the tortuous path of nonviral gene delivery and recent progress.
   Sharma D, Arora S, Singh J, Layek B. · · 2021 · cited 60× · PMID 34087309 · DOI 10.1016/j.ijbiomac.2021.05.192
2. Advanced biopolymeric materials and nanosystems for RNA/DNA vaccines: a review.
   Pereira LFT, Tredus JGR, Corá LO, Novacki LL, et al · · 2024 · cited 2× · PMID 39110059 · DOI 10.1080/17435889.2024.2382077