HIV-1 Peptide Immunisation of Individuals in West Africa to Prevent Disease
HIV-BIS
Phase I Study: HIV-1 Peptide Immunisation of Individuals in West Africa to Prevent Disease
2 other identifiers
interventional
18
1 country
2
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2009
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 9, 2010
CompletedFirst Posted
Study publicly available on registry
June 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
October 15, 2012
CompletedAugust 8, 2013
August 1, 2013
2.8 years
June 9, 2010
June 13, 2012
August 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Induction of New T-cell Immune Response by the Vaccine
up to 6 months after last immunisation
Lowering of HIV-1 RNA Viral-load in HIV-1 Immune Responders More Than 1 Log
up to 6 months post immunization
Increase in Blood CD4 T-cell Counts
up to 6 months post vaccination
Study Arms (2)
AFO-18
EXPERIMENTAL18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)
Saline
PLACEBO COMPARATORSaline
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hospital Nacional Simao Mendes
Bissau, Guinea-Bissau, Guinea-Bissau
Hospital Nacional Simao Mendes
Bissau, Guinea-Bissau
Related Publications (1)
Roman VR, Jensen KJ, Jensen SS, Leo-Hansen C, Jespersen S, da Silva Te 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 type 1 peptides representing HLA-supertype-restricted subdominant T cell epitopes: safety, immunogenicity, and feasibility in Guinea-Bissau. AIDS Res Hum Retroviruses. 2013 Nov;29(11):1504-12. doi: 10.1089/AID.2013.0076. Epub 2013 Jun 21.
PMID: 23634822RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Anders Fomsgaard
- Organization
- Statens Serum Institut
Study Officials
- STUDY DIRECTOR
Anders Fomsgaard, DMSc
Statens Serum Institut
- PRINCIPAL INVESTIGATOR
Zacarias Jose da Silva, PhD
Bandim Health Project, Bissau, Guinea-Bissau
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Medical Doctor
Study Record Dates
First Submitted
June 9, 2010
First Posted
June 10, 2010
Study Start
August 1, 2009
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
August 8, 2013
Results First Posted
October 15, 2012
Record last verified: 2013-08