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

NCT01627678 | Completed Phase 1

• 2 other identifiers: CTN-BI-Vacc-C5-2011/12012-000710-11
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

HIV-1 Infection

Keywords

HIV-1, Vacc-C5

Outcome Measures

Primary Outcomes (1)

• Safety measured as change of AE records, clinical chemistry (incl. CD4, CD8, HIV-1 RNA)and hematology laboratory elevations

  * 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).

  From screening and week 1 to weeks 2, 4, 6, 12, 13, 15, 21, 22 and 26

Secondary Outcomes (1)

• Change in Humoral and T cell responses

  From screening and week 1 to weeks 4, 6, 12, 13, 15, 21, 22 and 26

Study Arms (2)

Arm 1= Arm A: Vacc-C5 /GM-CSF.

EXPERIMENTAL

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

Drug: Vacc-C5/GM-CSF

Arm 2=Arm B: Vacc-C5/Alhydrogel

EXPERIMENTAL

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

Drug: Vacc-C5/Alhydrogel

Interventions

Vacc-C5/GM-CSF DRUG

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

Also known as: Vacc-C5 = C5-peptide, GM-CSF = Leukine

Arm 1= Arm A: Vacc-C5 /GM-CSF.

Vacc-C5/Alhydrogel DRUG

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

Also known as: Vacc-C5 = C5-pepide, Alhydrogel = Aluminum-containing adjuvant

Arm 2=Arm B: Vacc-C5/Alhydrogel

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bionor Immuno AS: lead

Study Sites (1)

Oslo University Hospital, Ullevål

Oslo, 0450, Norway

Location

Related Publications (1)

• Brekke K, Sommerfelt M, Okvist M, Dyrhol-Riise AM, Kvale D. The therapeutic HIV Env C5/gp41 vaccine candidate Vacc-C5 induces specific T cell regulation in a phase I/II clinical study. BMC Infect Dis. 2017 Mar 24;17(1):228. doi: 10.1186/s12879-017-2316-x.

  PMID: 28340570 DERIVED

MeSH Terms

Interventions

sargramostim

Study Officials

• Vidar Wendel-Hansen, MD PhD

  Bionor Pharma AS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2012
• First Posted: June 26, 2012
• Study Start: September 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 14, 2014

Record last verified: 2014-01

Locations

NO (1)