Intranasal Modified Vacc-4x Gag Peptides With Endocine as Adjuvant
Immunotherapy of HIV-infected Patients: A Single-blinded, Randomized, Immunogenicity, Pilot Study of Intranasal Administration of Vacc-4x With Endocine as Adjuvant
1 other identifier
interventional
24
1 country
1
Brief Summary
HIV-specific cellular immunity is hampered in most HIV-infected individuals. Therapeutic immunization in HIV aims to strengthen the HIV-specific cellular immunity, usually in the absence of replicating HIV with antiretroviral drugs. The aims of this strategy can be to decrease the mass of latently infected CD4+ T cells, better tolerance of drug-free periods, and better select candidates for preventive HIV vaccines. Vacc-4x is one of the few peptide-based therapeutic vaccines tested, and consists of four, slightly modified HIV Gag p24 consensus peptides. Vacc-4x was first tested by intradermal injections using GM-CSF as adjuvant. A recent multinational placebo-controlled study found improvement of vaccine-specific T cell immunity and decrease in viral loads (presented at the AIDS vaccine 2011 conference, Bangkok). In this study the investigators hypothesize that the Vacc-4x peptides, deposited on the nasal mucosal surfaces in conjunction with Endocine, a newly developed and documented mucosal adjuvant, will induce T cell responses to HIV and improve HIV-specific immunity both systemically and at mucosal surfaces (oral, rectal, vaginal).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedFirst Posted
Study publicly available on registry
November 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedJune 20, 2012
June 1, 2012
4 months
November 1, 2011
June 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the safety of intranasal administration of Vacc-4x with Endocine as adjuvant at three different dose levels
Record adverse events including severe adverse events according to GCP
2 months after completion of last patient.
Secondary Outcomes (3)
Evaluate cellular immune response to Vacc-4x in vivo by Vacc-4x DTH skin test
Up to 2 months after completion of last patient
Evaluate cellular immune response to Vacc-4x in vitro
Up to 6 months after completion of last patient
Evaluate the effect on CD4+ T cell counts and viral load (HIV-1 RNA) in peripheral blood
Up to 2 months after completion of last patient
Study Arms (4)
Vacc-4x low dose
EXPERIMENTAL80 µg Vacc-4x (20 µg pr. peptide) in 300 µl Endocine divided into two administrations, one for each nose cavity
Vacc-4x medium dose
EXPERIMENTAL400 µg Vacc-4x (100 µg pr. peptide) in 300 µl Endocine divided into two administrations, one for each nose cavity
Vacc-4x high dose
EXPERIMENTAL1200 µg Vacc-4x (300 µg pr. peptide) in 300 µl Endocine divided into two administrations, one for each nose cavity
Zero dose
PLACEBO COMPARATORAdjuvant only, i.e. 300 µl Endocine divided into two administrations, one for each nose cavity
Interventions
80 µg Vacc-4x (20 µg pr. peptide) in 300 µl Endocine divided into two administrations, one for each nose cavity, administrated once weekly for four weeks
400 µg Vacc-4x (100 µg pr. peptide) in 300 µl Endocine divided into two administrations, one for each nose cavity, administrated once weekly for four weeks
1200 µg Vacc-4x (300 µg pr. peptide) in 300 µl Endocine divided into two administrations, one for each nose cavity, administrated once weekly for four weeks
300 µl Endocine divided into two administrations, one for each nose cavity, administrated once weekly for four weeks
Eligibility Criteria
You may qualify if:
- Age above 18 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.
- Documented stable CD4 cell count ≥ 400x106/L.
- Nadir (lowest ever) CD4 cell count ≥ 200x106/L.
- 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 chronic viral hepatitis B or C or active 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 patients 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oslo University Hospitallead
- Bionor Immuno AScollaborator
- Eurocine Vaccines ABcollaborator
Study Sites (1)
Department of Infectious Diseases, Oslo University Hospital
Oslo, NO-0450, Norway
Related Publications (1)
Brekke K, Lind A, Holm-Hansen C, Haugen IL, Sorensen B, Sommerfelt M, Kvale D. Intranasal administration of a therapeutic HIV vaccine (Vacc-4x) induces dose-dependent systemic and mucosal immune responses in a randomized controlled trial. PLoS One. 2014 Nov 14;9(11):e112556. doi: 10.1371/journal.pone.0112556. eCollection 2014.
PMID: 25398137DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dag Kvale, Professor/MD
Oslo University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2011
First Posted
November 17, 2011
Study Start
November 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
June 20, 2012
Record last verified: 2012-06