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Immunotherapy With Vacc-C5 With Adjuvant GM-CSF or Alhydrogel in HIV-1-infected Subjects on ART
This study has been completed.
Sponsor:
Bionor Immuno AS
Information provided by (Responsible Party):
Bionor Immuno AS
ClinicalTrials.gov Identifier:
NCT01627678
First received: June 21, 2012
Last updated: January 13, 2014
Last verified: January 2014
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Purpose
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:
- To evaluate safety of the vaccination regimens
- To evaluate C5-specific humoral immune responses (antibodies), T cell responses, T cell activation markers and other immune markers.
| Condition | Intervention | Phase |
|---|---|---|
| HIV-1 Infection | Drug: Vacc-C5/GM-CSF Drug: Vacc-C5/Alhydrogel | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: 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) |
Resource links provided by NLM:
Further study details as provided by Bionor Immuno AS:
Primary Outcome Measures:
- 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:
- 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).
| Enrollment: | 36 |
| Study Start Date: | September 2012 |
| Study Completion Date: | November 2013 |
| Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
|
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:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01627678
Please refer to this study by its ClinicalTrials.gov identifier: NCT01627678
Locations
| Norway | |
| Oslo University Hospital, Ullevål | |
| Oslo, Norway, 0450 | |
Sponsors and Collaborators
Bionor Immuno AS
Investigators
| Study Director: | Vidar Wendel-Hansen, MD PhD | Bionor Pharma AS |
More Information
| Responsible Party: | Bionor Immuno AS |
| ClinicalTrials.gov Identifier: | NCT01627678 History of Changes |
| Other Study ID Numbers: |
CTN-BI-Vacc-C5-2011/1 2012-000710-11 ( EudraCT Number ) |
| Study First Received: | June 21, 2012 |
| Last Updated: | January 13, 2014 |
Keywords provided by Bionor Immuno AS:
|
HIV-1, Vacc-C5 |
Additional relevant MeSH terms:
|
Aluminum Hydroxide Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |
Antacids Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents |
ClinicalTrials.gov processed this record on July 17, 2017