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Immunotherapy With Vacc-C5 With Adjuvant GM-CSF or Alhydrogel in HIV-1-infected Subjects on ART

NCT01627678 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2014-01-14

No results posted yet for this study

Summary

Background:

Despite the introduction of highly effective antiretroviral therapy (ART) regimes, which control the HIV infection and results in increases in CD4 cell counts and an undetectable viral load, many patients suffer from increased morbidity. There is evidence that presence of antibodies against the C5 region of gp120 strongly correlates with slower disease progression, and that loss of antibody responses to this region are associated with progression.

Investigational product:

Vacc-C5 is a single heterodimeric peptide-based HIV therapeutic vaccine corresponding to the C5 region on gp120 and the external domain of gp41. The vaccine is intended to create a non-neutralizing antibody against C5 region.

Study objectives:

1. To evaluate safety of the vaccination regimens
2. To evaluate C5-specific humoral immune responses (antibodies), T cell responses, T cell activation markers and other immune markers.

Conditions

  • HIV-1 Infection

Interventions

DRUG

Vacc-C5/GM-CSF

Arm 1=Arm A: Vacc-C5 with GM-CSF as adjuvant administered intradermally.

DRUG

Vacc-C5/Alhydrogel

Arm 2=Arm B: Vacc-C5 with Alhydrogel as adjuvant administered intramuscularly.

Sponsors & Collaborators

  • Bionor Immuno AS

    lead INDUSTRY

Principal Investigators

  • Vidar Wendel-Hansen, MD PhD · Bionor Pharma AS

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01627678 on ClinicalTrials.gov