Phase 1
N=23
HIV-1 Peptide Immunisation of Individuals in West Africa to Prevent Disease
Aids, Cdc Group I
Bottom Line
View on ClinicalTrials.gov: NCT01141205 ↗Enrolled (actual)
23
Serious AEs
8.7%
Results posted
Oct 2012
Primary outcome: Primary: Tolerability and Safety of the Treatment. — 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- AFO-18 (Biological); Saline (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Statens Serum Institut
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tolerability and Safety of the Treatment. |
0; 0 | — |
| SECONDARY Induction of New T-cell Immune Response by the Vaccine |
6; 0 | — |
| SECONDARY Lowering of HIV-1 RNA Viral-load in HIV-1 Immune Responders More Than 1 Log |
0; 0 | — |
| SECONDARY Increase in Blood CD4 T-cell Counts |
0; 0 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- HIV-1 seropositive with measurable viral load >10e3 copies/ml and CD4+ T-cell count >400 CD4+ cells/µl.
- Not in Antiretroviral Therapy (>1 year).
- Male or female with age between 18 and 50 years.
- 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
- Expected to follow the instructions.
- Written informed consent after oral and written information.
Exclusion Criteria
- Vaccinated with other vaccines within 3 months before the first vaccination.
- Treated with immune modulating medicine within 3 month before the first immunization.
- Other important active chronic infectious diseases likely to influence the HIV-1 infection, like HIV-2, HBV, HCV and TB
- Significant medical disease as judged by the investigators, for example severe asthma/COLD, badly regulated heart disease, insulin-dependent diabetes mellitus.
- Severe allergy or earlier anaphylactic reactions.
- Active autoimmune diseases.
- Simultaneous treatment with other experimental drugs.
- Laboratory parameters outside the 'normal' range for the area and which are considered clinically significant.
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT01141205). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.