Pazienti con infezione verticale da HIV di eta' compresa tra 4 -16 anni di ambo i sessi. MedDRA version: 9.1 Level: LLT Classification code 10053500 Term: Human immunodeficiency virus transmission
Conditions
Interventions
Product Name: HIVIS-DNA vaccine
Pharmaceutical Form: Suspension for injection
Other descriptive name: 1.DNA plasmids with HIV env A, B, C and Rev B. + 2.DNA plasmids with HIV gag A,
Concentration uni
Sponsors
Swedish Institute for Infectious Disease Control
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 4 and 16 years 2. Females, who are willing not to father a child for the duration of the study. 3. Male participants will be cautioned of the unknown hazard to a foetus and advised to not have sexual relations for the duration of the study. 4. HIV infection detected by two serological and HIV plasma RNA tests 5. On HAART for at least 6 months with less than 50 copies/ml of plasma HIV-1 RNA at two determinations over 3 months 6. Stable CD4 value above 400 cells/mm3 or 25% in the last 12 months of follow-up 7. Viral isolate pre ART available is preferable but not mandatory 8. Able to give informed consent 9. Availability for follow-up for planned duration of the study Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with ongoing infection(s) other than HIV 2. Treatment with steroids, systemic or local at the immunizing sites, one month before or during the trial 3. Patients with signs of autoimmune diseases 4. Patients with creatinine > 2mg/dl, Hb < 12g/dl, leukocytes < 3,000ml, platelets <150,000/ml 5. Patients on any immune modulating or investigational drug 6. Anamnestic allergy to kanamycin or plasmid gene products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To document the feasibility and immunogenicity of topical HIV plasmid DNA immunization intramuscularly delivered to HIV vertically infected children.;Secondary Objective: 1. To investigate safety of DNA plasmids carrying HIV genes intramascular delivered in HIV vertically infected children on effective PI-sparing HAART. 2. To correlate the viral load and CD4+ counts after the DNA vaccination to immune responses 3. To characterize the new HIV specific immune responses by Elispot, T-cell proliferation and antibody reactivity. 4. To investigate the possible viral escape mutants in relation to the induced immune response. 5. To study the effect on CD4 counts in the two groups;Primary end point(s): 1.1. Any grade 3 or above toxicity possibly or probably related to the immunization. 2. Virological failure defined as 2 determinations over 1000 copies/ml consecutively. 3. Immunologic failure defined as progression in the CDC classification status. 4. Clinical failure defined as progression in the CDC classification status. | — |
Countries
Italy
Outcome results
None listed