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Investigation of the Safety of an HIV-1 Vaccine Given Intra-muscularly and Intra-nasally to Healthy Female Subjects

NCT01084343 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-07-13

No results posted yet for this study

Summary

This study is designed to investigate the safety and efficacy of a newly developed vaccine against HIV-1 in female healthy subjects. Safety will be assessed by local and systemic adverse reactions, investigations of blood and urine, and physical exam including vital sign measurements. Efficacy will be assessed in blood, and in vaginal and rectal mucosal samples.

Conditions

Interventions

BIOLOGICAL

MYM-V101

* Panel 1: 2 vaccinations in the muscles followed by 2 vaccinations in the nose, 10 microgram or placebo each, every 8 weeks. * Panel 2: 2 vaccinations in the muscles followed by 2 vaccinations in the nose, 50 microgram or placebo each, every 8 weeks.

Sponsors & Collaborators

  • Kinesis Pharma B.V.

    collaborator INDUSTRY

  • CEVAC

    collaborator UNKNOWN

  • M.A.R.C.O.

    collaborator UNKNOWN

  • Mouton's Safety Consultancy

    collaborator UNKNOWN

  • Pharmafour

    collaborator UNKNOWN

  • Pevion

    collaborator UNKNOWN

  • Chimera

    collaborator UNKNOWN

  • Institut Cochin

    collaborator OTHER

  • San Raffaele University Hospital, Italy

    collaborator OTHER

  • INSERM UMR 721

    collaborator UNKNOWN

  • Mymetics Corporation

    lead INDUSTRY

Principal Investigators

  • Geert Leroux-Roels, Prof. Dr. · CEVAC, University of Ghent, Belgium

  • Sylvain Fleury, PhD · Mymetics Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

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 NCT01084343 on ClinicalTrials.gov