HIV HIV-1 infection
Conditions
Interventions
Participants will be vaccinated twice via I.M. injection with 10E7.4 pfu of the
HIV-1 subtype-B specific vaccine NYVAC-B at week 0 and week 4.
Sponsors
EuroVacc Foundation
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patient is >= 18 years of age; 2. Voluntarily signed informed consent; 3. Patient is male, or female with negative pregnancy test prior to enrolment; 4. Patient has a proven HIV-1 infection (with positive antibodies against HIV-1 and a detectable plasma HIV-1 RNA, measured for the first time at least 6 months prior to inclusion); 5. Patient must be on stable treatment with HAART for at least 6 months (HAART is defined as an antiretroviral regimen consisting of at least three registered antiretroviral agents*; changes within the same class of drugs only for toxicity or simplification reasons are allowed, at least 3 months for inclusion); 6. Mean of all measured CD4+ T cell counts during the 6 months prior to the start of HAART is above or equal to 200 cells/ mm3; 7. Plasma HIV-1 RNA must be below 50 copies/ mL at screening and during at least 3 months prior to inclusion, during at least two measurements (occasional so called *blips* up to 200 copies/mL are permitted, but not at screening), 8. HIV-1 subtype is proven to be clade B; if subtype is unknown, subtype should determined in stored samples with detectable plasma HIV-1 OR in HIV-1 DNA isolated from PBMCs at screening; 9. Patient is one of the following: - the patient is a heterosexually active female, agreeing to use condoms with her partner from 14 days prior to the first vaccination until 4 months after the last, even though using another method of contraception, and willing to undergo pregnancy tests at screening and prior to each vaccination, OR - the patient is male and agreeing to use condoms with his partner from the day of the first vaccination until 4 months after the last vaccination, OR - none of these apply.
Exclusion criteria
Exclusion criteria: 1. History of a CDC class C event (see Appendix I, page 46); 2. Infection with a non-B HIV-1 subtype; 3. Interruption of HAART during the course of the study which is expected at the time of inclusion; 4. History of exposure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint (outcome measure) is the difference in plasma HIV-1 RNA between the study arms during the 28 weeks after the first vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| The difference in the percentage of patients with un undetectable plasma HIV-1 RNA (using an ultrasensitive assay with a lower limit of detection of 5 copies/mL) between patients who received two vaccinations with either the HIV-1 specific recombinant vaccinia vaccine NYVAC-B or a placebo vaccine; the changes in the plasma HIV-1 RNA (using an ultrasensitive assay with a lower limit of dectection of 5 copies/mL) in patients who received two vaccinations with the NYVAC-B vaccine compared to the patients who received a placebo vaccine, in HIV-1 infected patients during concomitant successful antiretroviral therapy; the changes of the cell-associated HIV-1 DNA in PBMC (using an ultrasensitive assay) in patients who received two vaccinations with the NYVAC-B vaccine compared to the patients who received a placebo vaccine, in HIV-1 infected patients during concomitant successful antiretroviral therapy; the changes from baseline in the numbers of HIV-specific PBMC producing IFN-g measured using an ELISpot assay in patients who received two vaccinations with the NYVAC-B vaccine compared to the patients who received a placebo vaccine, in HIV-1 infected patients during concomitant successful antiretroviral therapy; the characteristics of the HIV-1 specific T cell responses generated by the vaccine (multifunctional and differentiation characteristics, breadth of HIV-1 specific CD4+ and CD8+ T cells); safety parameters (measured as standard safety parameters ([targeted] physical examination, clinical symptoms, laboratory hematology and biochemistry, specific clinical signs and symptoms of vaccination [e.g. injection site reactions]) up to 12 and 28 weeks after the first vaccination. | — |
Countries
Netherlands
Outcome results
None listed