Trials / Completed
CompletedNCT01571466
A Study to Evaluate the Safety of the HIV-1 Vaccine MVA-B in Chronic HIV-1 Infected Patients Successfully Treated With HAART
A Double-blind Phase I Study to Evaluate the Safety of the HIV-1 Vaccine MVA-B in Chronic HIV-1 Infected Patients Successfully Treated With HAART
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Hospital Clinic of Barcelona · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
30 treated chronic HIV-1 infected patients with CD4+ cell counts above 450 cells/ mm3 will be randomized 1:2 to receive placebo (n=10) or vaccine (n=20) at week 0, 4 and 16 and will be observed at the Investigation Unit of the study site for one hour following vaccination. At week 24 they will stop their HAART until the end of the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vaccination | * Modified Pox virus, strain MVA clade -B (expressing HIV-1 Bx08gp120 and IIIB gagpolnef) -\~ 1 x 10e8 pfu/ml * 3 immunisations at week 0, 4 and 16 |
| DRUG | Placebo | 3 immunisations at week 0, 4 and 16 |
Timeline
- Start date
- 2011-09-01
- Primary completion
- 2013-05-01
- Completion
- 2013-05-01
- First posted
- 2012-04-05
- Last updated
- 2015-04-01
Locations
3 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT01571466. Inclusion in this directory is not an endorsement.