Intranasal Modified Vacc-4x Gag Peptides With Endocine as Adjuvant
HIV Infection
About this trial
This is an interventional treatment trial for HIV Infection focused on measuring HIV, vaccination, T cells, mucosal immunity, safety, nasal administration, DTH skin test
Eligibility Criteria
Inclusion Criteria:
- 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.
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 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.
Sites / Locations
- Department of Infectious Diseases, Oslo University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
Vacc-4x low dose
Vacc-4x medium dose
Vacc-4x high dose
Zero dose
80 µg Vacc-4x (20 µg pr. peptide) in 300 µl Endocine divided into two administrations, one for each nose cavity
400 µg Vacc-4x (100 µg pr. peptide) in 300 µl Endocine divided into two administrations, one for each nose cavity
1200 µg Vacc-4x (300 µg pr. peptide) in 300 µl Endocine divided into two administrations, one for each nose cavity
Adjuvant only, i.e. 300 µl Endocine divided into two administrations, one for each nose cavity