Aids, Cdc Group I Clinical Trial
— HIV-BISOfficial title:
Phase I Study: HIV-1 Peptide Immunisation of Individuals in West Africa to Prevent Disease
| Verified date | August 2013 |
| Source | Statens Serum Institut |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Guinea-Bissau: Ministry of Health |
| Study type | Interventional |
Treatment: Immunization with peptide-mix and adjuvant. The vaccine should induce cellular
immunity against HIV-1.
Target group: Untreated healthy individuals with chronic HIV-1 infection.
Purpose: The primary purpose is to evaluate tolerability and safety of the vaccine.
The secondary purpose is to evaluate the clinical effect of the vaccination treatment as
measured by induction of immunity, lowering of viral load, induction of escape mutations in
the virus and improvement in the patient CD4 lymphocyte blood counts.
The third purpose is to evaluate the feasibility of conducting a therapeutic HIV
immunization study in a poorly-resourced African setting.
Design: The experiment is designed as a blinded, placebo-controlled phase 1 clinical trial
in HIV-1 infected individuals in West Africa.
Numbers of individuals: Phase I: 20 fully evaluable HIV-1-infected patients should enter the
study (15 vaccine treated and 5 placebo(saline) treated controls).
| Status | Completed |
| Enrollment | 18 |
| Est. completion date | June 2012 |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 50 Years |
| Eligibility |
Inclusion Criteria: 1. HIV-1 seropositive with measurable viral load >10e3 copies/ml and CD4+ T-cell count >400 CD4+ cells/µl. 2. Not in Antiretroviral Therapy (>1 year). 3. Male or female with age between 18 and 50 years. 4. Normal values for the area of liver and kidney enzymes, blood cell count with differential counts (e.g. white blood cells, lymphocytes, platelets/thrombocytes) and Hemoglobin 5. Expected to follow the instructions. 6. Written informed consent after oral and written information. Exclusion Criteria: 1. Vaccinated with other vaccines within 3 months before the first vaccination. 2. Treated with immune modulating medicine within 3 month before the first immunization. 3. Other important active chronic infectious diseases likely to influence the HIV-1 infection, like HIV-2, HBV, HCV and TB 4. Significant medical disease as judged by the investigators, for example severe asthma/COLD, badly regulated heart disease, insulin-dependent diabetes mellitus. 5. Severe allergy or earlier anaphylactic reactions. 6. Active autoimmune diseases. 7. Simultaneous treatment with other experimental drugs. 8. Laboratory parameters outside the 'normal' range for the area and which are considered clinically significant. 9. Pregnancy |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Guinea-Bissau | Hospital Nacional Simao Mendes | Bissau |
| Lead Sponsor | Collaborator |
|---|---|
| Statens Serum Institut | European and Developing Countries Clinical Trials Partnership (EDCTP), Ministry of the Interior and Health, Denmark |
Guinea-Bissau,
Román VR, Jensen KJ, Jensen SS, Leo-Hansen C, Jespersen S, da Silva Té D, Rodrigues CM, Janitzek CM, Vinner L, Katzenstein TL, Andersen P, Kromann I, Andreasen LV, Karlsson I, Fomsgaard A. Therapeutic vaccination using cationic liposome-adjuvanted HIV typ — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Tolerability and Safety of the Treatment. | We report here the numbers of participants with vaccine related adverse events degree 3 or 4. Our goal for safety and tolerability was: "Fewer than or 3 patients of the 15 vaccine treated show treatment related (reaction 3) side-effects of degree 3 or 4". |
up to 6 months after end of treatment | Yes |
| Secondary | Induction of New T-cell Immune Response by the Vaccine | induction of new T-cell immune response against one or more of the vaccine epitopes using Interferon gamma Enzyme Linked Immuno spot assay (IFNg-ELISPOT assay)measuring Spot forming Unis per 1 million periferal blood mononuclear cells (SFU/1 mio PBMCs) above treshold (> 50 sfu/mio PBMC). | up to 6 months after last immunisation | No |
| Secondary | Lowering of HIV-1 RNA Viral-load in HIV-1 Immune Responders More Than 1 Log | changes (lowering) in Plasma HIV-1 RNA viral-load (measured by Quantitative RT-PCR kit, ROCHE) of more than 1 log | up to 6 months post immunization | No |
| Secondary | Increase in Blood CD4 T-cell Counts | Analyzed: Participants (minus drop-outs and withdrawn) with measured blood CD4 T-cell counts (cells/microliter). Reported: Numbers of participants obtaining an increase in measured blood CD4 T-cell counts post vaccination of >100 CD4 Tcell per microliter | up to 6 months post vaccination | No |