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
  Purpose

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).


Condition Intervention Phase
Aids, Cdc Group I
Biological: AFO-18
Drug: Saline
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Phase I Study: HIV-1 Peptide Immunisation of Individuals in West Africa to Prevent Disease

Resource links provided by NLM:


Further study details as provided by Statens Serum Institut:

Primary Outcome Measures:
  • 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".



Secondary Outcome Measures:
  • 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


Enrollment: 18
Study Start Date: August 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AFO-18
18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)
Biological: AFO-18
18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)
Other Names:
  • CAF01
  • HIV-1 peptides
Placebo Comparator: Saline
Saline
Drug: Saline
1.2 ml saline intramuscularly
Other Name: NaCl

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141205

Locations
Guinea-Bissau
Hospital Nacional Simao Mendes
Bissau, Guinea-Bissau
Sponsors and Collaborators
Statens Serum Institut
Ministry of the Interior and Health, Denmark
European and Developing Countries Clinical Trials Partnership (EDCTP)
Investigators
Study Director: Anders Fomsgaard, DMSc Statens Serum Institut
Principal Investigator: Zacarias Jose da Silva, PhD Bandim Health Project, Bissau, Guinea-Bissau
  More Information

Publications:
Responsible Party: Anders Fomsgaard, Chief Medical Doctor, Statens Serum Institut
ClinicalTrials.gov Identifier: NCT01141205     History of Changes
Other Study ID Numbers: HIV-BIS NCP03/2009, EDCTP_MSI.2009.10800.001
Study First Received: June 9, 2010
Results First Received: June 13, 2012
Last Updated: August 2, 2013
Health Authority: Guinea-Bissau: Ministry of Health

Keywords provided by Statens Serum Institut:
AIDS vaccines
HIV-1 vaccine
Therapeutic vaccine
Cellular immunity

ClinicalTrials.gov processed this record on September 30, 2014