Phase 1
N=11
Immunization With HIV-1 Peptides in Adjuvant for Treatment of Patients With Chronic HIV-infection
HIV INFECTIONS
Bottom Line
View on ClinicalTrials.gov: NCT01009762 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Numbers of Treatment Related Side Effects (DLT = Reaction 3 or More) — 0; 0 side effects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- peptide vaccine (AFO-18) (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gitte Kronborg
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numbers of Treatment Related Side Effects (DLT = Reaction 3 or More) |
0; 0 | — |
| SECONDARY Number of Participants With New T Cell Response to the Vaccine Target Epitopes |
0; 10 | — |
| SECONDARY Numbers of Participants With Lowering of HIV RNA Viral-load |
0; 0 | — |
Summary
Treatment: Immunization with a peptide-mix of 17 Clusters of Differentiation number 8 (CD8) T cell minimal epitopes and 3 Clusters of Differentiation number 4 (CD4) T cell epitopes and a new adjuvant (CAF01). The vaccine should induce cellular immunity against human immuno-deficiency virus type-1 (HIV-1).
Target group: Untreated healthy individuals with chronic HIV-1 infection who are not in antiretroviral treatment.
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 new T cell immunity, lowering of HIV-1 ribonucleic acid (RNA) viral load in plasma, and improvement in the patient CD4 lymphocyte blood counts.
Design: The experiment is designed as a single-blinded, placebo-controlled phase 1 clinical trial in HIV-1 infected individuals in Denmark.
Numbers of individuals: 20 fully evaluable HIV-1-infected patients should enter the study (15 vaccine treated and 5 placebo(saline) treated controls).
The hypothesis is that a redirection of cytotoxic T lymphocyte (CTL) immunity to selected relatively immune silent (subdominant) but conserved CTL targets on multiple sites in HIV-1 could provide a better immune control of the virus replication. This could result in lowering of viral load thereby prolonging the time to antiretroviral therapy.
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 60 years, where females are not breastfeeding, are not pregnant and use contraception until at least 3 months after end of vaccinations
- 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 experimental vaccines within 3 months before the first vaccination
- Treated with immune modulating medicine within 3 month before the first immunization
- Other significant active chronic infectious diseases likely to influence the HIV-1 infection, like Hepatitis B Virus (HBV), Hepatitis C Virus (HCV)
- Significant medical disease as judged by the investigators, for example severe asthma/chronic obstructive lung disease (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 and/or brest feeding
Data sourced from ClinicalTrials.gov (NCT01009762). 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.