HIV-1 Peptide Immunisation of Individuals in West Africa to Prevent Disease (HIV-BIS)

This study has been completed.
Sponsor:
Collaborators:
Ministry of the Interior and Health, Denmark
European and Developing Countries Clinical Trials Partnership (EDCTP)
Information provided by (Responsible Party):
Anders Fomsgaard, Statens Serum Institut
ClinicalTrials.gov Identifier:
NCT01141205
First received: June 9, 2010
Last updated: August 2, 2013
Last verified: August 2013

June 9, 2010
August 2, 2013
August 2009
June 2012   (final data collection date for primary outcome measure)
Tolerability and Safety of the Treatment. [ Time Frame: up to 6 months after end of treatment ] [ Designated as safety issue: Yes ]

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".

To evaluate tolerability and safety of the treatment. [ Time Frame: up to 6 months after end of treatment ] [ Designated as safety issue: Yes ]
Fewer than or 3 patients of the 15 vaccine treated show treatment related (reaction 3) side-effects of degree 3 or 4.
Complete list of historical versions of study NCT01141205 on ClinicalTrials.gov Archive Site
  • Induction of New T-cell Immune Response by the Vaccine [ Time Frame: up to 6 months after last immunisation ] [ Designated as safety issue: No ]
    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).
  • Lowering of HIV-1 RNA Viral-load in HIV-1 Immune Responders More Than 1 Log [ Time Frame: up to 6 months post immunization ] [ Designated as safety issue: No ]
    changes (lowering) in Plasma HIV-1 RNA viral-load (measured by Quantitative RT-PCR kit, ROCHE) of more than 1 log
  • Increase in Blood CD4 T-cell Counts [ Time Frame: up to 6 months post vaccination ] [ Designated as safety issue: No ]
    Analyzed: Participants (minus drop-outs and withdrawn) with measured blood CD4 T-cell counts (cells/microliter).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
to evaluate the clinical effect measured as induction of new T-cell immune response, lowering of viral-load, and increase in the CD4 cell count. [ Time Frame: up to 6 months after last immunisation ] [ Designated as safety issue: No ]

induction of new TCD8 cell immunity against one or more of the vaccine epitopes using either of the assays mentioned in at least half of the patients treated.

Significant lowering of RNA viral load in at least half immunological responders Fewer or equal to 5 of the 15 vaccinated individuals drop out of the study before end of study.

Not Provided
Not Provided
 
HIV-1 Peptide Immunisation of Individuals in West Africa to Prevent Disease
Phase I Study: HIV-1 Peptide Immunisation of Individuals in West Africa to Prevent Disease

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).

The HIV infection does not leave lifelong immunity, but leads to break down of the immune system, opportunistic infections and death. The immunity obtained by the infection itself can only partially contain the HIV infection. The purpose with a targeted therapeutic vaccination is therefore in addition to the existing immunity to induce a broader, more powerful and more rationally or better directed immunity than the one induced by the "natural" HIV-1 infection. This would potentially lower the viral load in the blood making it more difficult to spread the virus to others and prolong the time to AIDS disease and medical treatment. There is a need for new rational vaccination possibilities, able to prevent (HIV) disease, postpone the need for antiretroviral medical treatment, prolong the life, and limit spread of HIV-1 in the population. The present protocol seak to introduce such a new immune treatment principle for HIV-1 infected individuals. In this study, individuals with chronic HIV-1 infection will be vaccinated with selected synthetic HIV immune-peptides representing new discovered conserved target´s on the virus. The vaccine should induce new immunity against several epitope targets on their HIV, whereby the HIV infection may be controlled for a longer time by the immune system. The purpose of the study is primarily to evaluate the safety and tolerability of the vaccine and secondary to evaluate the immunological and antiviral response in the vaccinated individuals.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Aids, Cdc Group I
  • Biological: AFO-18
    18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)
    Other Names:
    • CAF01
    • HIV-1 peptides
  • Drug: Saline
    1.2 ml saline intramuscularly
    Other Name: NaCl
  • Experimental: AFO-18
    18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)
    Intervention: Biological: AFO-18
  • Placebo Comparator: Saline
    Saline
    Intervention: Drug: Saline
Román VR, Jensen KJ, Jensen SS, Leo-Hansen C, Jespersen S, Té DD, 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 Jun 21. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Guinea-Bissau
 
NCT01141205
HIV-BIS NCP03/2009, EDCTP_MSI.2009.10800.001
No
Anders Fomsgaard, Statens Serum Institut
Statens Serum Institut
  • Ministry of the Interior and Health, Denmark
  • European and Developing Countries Clinical Trials Partnership (EDCTP)
Study Director: Anders Fomsgaard, DMSc Statens Serum Institut
Principal Investigator: Zacarias Jose da Silva, PhD Bandim Health Project, Bissau, Guinea-Bissau
Statens Serum Institut
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP