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

NCT ID: NCT01141205

Last Updated: 2013-08-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2012-06-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Aids, Cdc Group I

Keywords

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AIDS vaccines HIV-1 vaccine Therapeutic vaccine Cellular immunity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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AFO-18

18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)

Group Type EXPERIMENTAL

AFO-18

Intervention Type BIOLOGICAL

18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)

Saline

Saline

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

1.2 ml saline intramuscularly

Interventions

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AFO-18

18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)

Intervention Type BIOLOGICAL

Saline

1.2 ml saline intramuscularly

Intervention Type DRUG

Other Intervention Names

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CAF01 HIV-1 peptides NaCl

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of the Interior and Health, Denmark

OTHER_GOV

Sponsor Role collaborator

European and Developing Countries Clinical Trials Partnership (EDCTP)

OTHER_GOV

Sponsor Role collaborator

Statens Serum Institut

OTHER

Sponsor Role lead

Responsible Party

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Anders Fomsgaard

Chief Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anders Fomsgaard, DMSc

Role: STUDY_DIRECTOR

Statens Serum Institut

Zacarias Jose da Silva, PhD

Role: PRINCIPAL_INVESTIGATOR

Bandim Health Project, Bissau, Guinea-Bissau

Locations

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Hospital Nacional Simao Mendes

Bissau, Guinea-Bissau, Guinea-Bissau

Site Status

Hospital Nacional Simao Mendes

Bissau, , Guinea-Bissau

Site Status

Countries

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Guinea-Bissau

References

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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.

Reference Type RESULT
PMID: 23634822 (View on PubMed)

Other Identifiers

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EDCTP_MSI.2009.10800.001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HIV-BIS NCP03/2009

Identifier Type: -

Identifier Source: org_study_id