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

NCT01141205 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2013-08-08

Study results available
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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).

Conditions

  • Aids, Cdc Group I

Interventions

BIOLOGICAL

AFO-18

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

DRUG

Saline

1.2 ml saline intramuscularly

Sponsors & Collaborators

  • Ministry of the Interior and Health, Denmark

    collaborator OTHER_GOV

  • European and Developing Countries Clinical Trials Partnership (EDCTP)

    collaborator OTHER_GOV

  • Statens Serum Institut

    lead OTHER

Principal Investigators

  • Anders Fomsgaard, DMSc · Statens Serum Institut

  • Zacarias Jose da Silva, PhD · Bandim Health Project, Bissau, Guinea-Bissau

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Guinea-Bissau

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01141205 on ClinicalTrials.gov