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

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ClinicalTrials.gov Identifier: NCT01627678
Recruitment Status : Completed
First Posted : June 26, 2012
Last Update Posted : January 14, 2014
Information provided by (Responsible Party):
Bionor Immuno AS

Brief Summary:


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.

Condition or disease Intervention/treatment Phase
HIV-1 Infection Drug: Vacc-C5/GM-CSF Drug: Vacc-C5/Alhydrogel Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immunotherapy of HIV-infected Patients An Open, Dose-escalating Assessment of Vacc-C5 With Either GM-CSF or Alhydrogel as Adjuvant in HIV-1-infected Subjects on Antiretroviral Therapy (ART)
Study Start Date : September 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Algeldrate

Arm Intervention/treatment
Experimental: Arm 1= Arm A: Vacc-C5 /GM-CSF.
Arm 1=Arm A: Vacc-C5 with GM-CSF as adjuvant administered intradermally.
Drug: Vacc-C5/GM-CSF
Arm 1=Arm A: Vacc-C5 with GM-CSF as adjuvant administered intradermally.
Other Names:
  • Vacc-C5 = C5-peptide
  • GM-CSF = Leukine

Experimental: Arm 2=Arm B: Vacc-C5/Alhydrogel
Arm 2=Arm B: Vacc-C5 with Alhydrogel as adjuvant administered intramuscularly.
Drug: Vacc-C5/Alhydrogel
Arm 2=Arm B: Vacc-C5 with Alhydrogel as adjuvant administered intramuscularly.
Other Names:
  • Vacc-C5 = C5-pepide
  • Alhydrogel = Aluminum-containing adjuvant

Primary Outcome Measures :
  1. Safety measured as change of AE records, clinical chemistry (incl. CD4, CD8, HIV-1 RNA)and hematology laboratory elevations [ Time Frame: From screening and week 1 to weeks 2, 4, 6, 12, 13, 15, 21, 22 and 26 ]
    • AEs recorded at each scheduled and unscheduled visit.
    • Concomitant medications recorded at each scheduled visit.
    • Vital signs (heart rate, blood pressure) at screening, weeks 1, 4, 6, 12, 13, 15, 21, 22 and 26 (End of study).
    • Weight at screening and weight at weeks 1, 12 and 26 (End of study).
    • Clinical laboratory evaluations (clinical chemistry, hematology) at screening, weeks 1, 4, 6, 12, 15, 21 and 26 (End of study).
    • Viral load (HIV-1 RNA) at screening, weeks 1, 6, 15 and 26 (End of study).
    • Urine stix at weeks 1, 4, 6, 12, 15, 21 and 26 (End of study).

Secondary Outcome Measures :
  1. Change in Humoral and T cell responses [ Time Frame: From screening and week 1 to weeks 4, 6, 12, 13, 15, 21, 22 and 26 ]
    • Humoral immune response - C5 antibody level at screening, weeks 1, 4, 6, 12, 13, 15, 21, 22 and 26 (End of study).
    • B cell antibody level at weeks 1, 6, 13 and 22.
    • T cell response and activation markers (e.g. CD38, HLA-DR) and other immune markers at weeks 1, 6, 15and 26 (End of study).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age between18 years and 55 years, both genders.
  • HIV positive at least one year.
  • Clinically stable on ART for the last 6 months (changes in therapy is allowed as long as the viral load is stable).
  • Documented viral load (HIV-1 RNA) less than 50 copies/mL for the last six months. Single blips (up to 500 copies/mL) are allowed.
  • Documented pre-study CD4 cell count ≥ 400x106/L for at least six months (if below at screening, a re-analysis is allowed).
  • Nadir (lowest ever) CD4 cell count ≥ 200x106/L (nadir below 200x106/L requires two consecutive analyses).
  • Signed informed consent.

Exclusion Criteria:

  • Reported pre-study AIDS-defining illness within the previous year
  • Malignant disease.
  • On chronic treatment with immunosuppressive therapy.
  • Unacceptable values of the hematologic and clinical chemistry parameters, as judged by the Principle Investigator (or designee), including creatinine values >1.5x upper limit of normal (ULN), and AST (SGOT), ALT (SGPT) and alkaline phosphatase values >2.5x ULN.
  • Concurrent chronic active infection such as viral hepatitis B or C or tuberculosis.
  • Pregnant or breastfeeding women.
  • Women of childbearing potential not using reliable and adequate contraceptive methods (defined as: use of oral, implanted, injectable, mechanical or barrier products for the prevention of pregnancy; practicing abstinence; sterile) during the study, or sexually active male subjects with partners of childbearing potential unwilling to practice effective contraception during the study.
  • Current participation in other clinical therapeutic studies.
  • Incapability of compliance to the treatment protocol, in the opinion of the Investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01627678

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Oslo University Hospital, Ullevål
Oslo, Norway, 0450
Sponsors and Collaborators
Bionor Immuno AS
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Study Director: Vidar Wendel-Hansen, MD PhD Bionor Pharma AS
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bionor Immuno AS
ClinicalTrials.gov Identifier: NCT01627678    
Other Study ID Numbers: CTN-BI-Vacc-C5-2011/1
2012-000710-11 ( EudraCT Number )
First Posted: June 26, 2012    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014
Keywords provided by Bionor Immuno AS:
HIV-1, Vacc-C5
Additional relevant MeSH terms:
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Aluminum Hydroxide
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents