NCT00270205

A Phase I/II, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of LC002, a DermaVir Vaccine, in HIV-1-Infected Subjects Currently Under Treatment With Highly Active Antiretroviral Therapy (HAART)

Completed Phase 1/Phase 2 Results posted Last updated 2 November 2021

What this trial tests

Phase 1/Phase 2 trial testing LC002 standard vaccination in HIV Infections in 28 participants. Completed in 1 September 2010.

Timeline

1 January 2006

Primary endpoint
1 September 2010

1 September 2010

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	28
Start date	1 January 2006
Primary completion	1 September 2010
Estimated completion	1 September 2010
Sites	5 locations across United States

Drugs / interventions tested

• LC002 standard vaccination — full drug profile →
• LC002 high-dose vaccination — full drug profile →
• LC002 placebo vaccination — full drug profile →

Conditions studied

• HIV Infections — all drugs for HIV Infections →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 50, any sex, with HIV Infections. 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.

• Percent of Participants With Primary Safety Endpoint
  Time frame: From start of study vaccination to 28 days after the last study vaccination
  Primary safety endpoint is defined as occurrence of at least one grade 3 or higher adverse event, including signs/symptoms, lab toxicities, and/or clinical events that is possibly or definitely related to study treatment. Event's relationship to the study treatment was determined by the protocol core team, including site clinicians on the team, blinded to the treatment arm. Adverse events solely a

Sponsor's own description

LC002 is an experimental therapeutic vaccine designed to boost the immune response of people infected with HIV. The purpose of this study was to determine the safety and tolerability of and immune response to LC002 in HIV-1-infected adults who are currently receiving anti-HIV treatment.

Publications & conference data

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

1. The role of nanotechnology in the treatment of viral infections.
   Singh L, Kruger HG, Maguire GEM, Govender T, et al · · 2017 · cited 170× · PMID 28748089 · DOI 10.1177/2049936117713593
2. Polymeric nanoparticle vaccines to combat emerging and pandemic threats.
   Wibowo D, Jorritsma SHT, Gonzaga ZJ, Evert B, et al · · 2021 · cited 111× · PMID 33360074 · DOI 10.1016/j.biomaterials.2020.120597
3. Nanomaterials Designed for Antiviral Drug Delivery Transport across Biological Barriers.
   Cojocaru FD, Botezat D, Gardikiotis I, Uritu CM, et al · · 2020 · cited 109× · PMID 32085535 · DOI 10.3390/pharmaceutics12020171
4. Safety, tolerability, and immunogenicity of repeated doses of dermavir, a candidate therapeutic HIV vaccine, in HIV-infected patients receiving combination antiretroviral therapy: results of the ACTG 5176 trial.
   Rodriguez B, Asmuth DM, Matining RM, Spritzler J, et al · · 2013 · cited 40× · PMID 24169120 · DOI 10.1097/qai.0b013e3182a99590
5. Perspectives for immunotherapy: which applications might achieve an HIV functional cure?
   Vieillard V, Gharakhanian S, Lucar O, Katlama C, et al · · 2016 · cited 10× · PMID 26950274 · DOI 10.18632/oncotarget.7793