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Safety and Immunogenicity Study of a DNA Priming and MVA Boosting Strategy of HIV Vaccine

NCT01407497 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2013-12-04

No results posted yet for this study

Summary

While antiretroviral drugs have shown great promise in reducing HIV replication and thus in reducing HIV/AIDS associated morbi-mortality and HIV transmission, the cost is substantial and side effects are a potentially limiting factor. Development of an effective safe-affordable vaccine is likely to be the best way to stop further virus spread. The study aims to determine safety and immunogenicity of the DNA-vaccine at a dose of 600µg and 1200µg delivered id in combination with MVA-CMDR boost im.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

DNA HIVIS and MVA-CMDR

600 µg i.d. (separate plasmids pools) of DNA priming at weeks 0, 4 and 12; 108 pfu i.m. MVA boosting at weeks 24 and 36

BIOLOGICAL

DNA HIVIS and MVA-CMDR

1200 µg i.d. (separate plasmids pools) of DNA priming at weeks 0, 4 and 12 ; 108 pfu i.m. MVA boosting at weeks 24 and 36

BIOLOGICAL

Saline solution

2 x 0.1 ml of saline solution i.d at weeks 0, 4 and 12 ; saline solution i.m at weeks 24 and 36

BIOLOGICAL

Saline solution

2 x 0.2 ml of saline solution i.d at weeks 0, 4 and 12 ; saline solution i.m at weeks 24 and 36

Sponsors & Collaborators

  • Swedish Institute for Communicable Disease Control, Sweden

    collaborator UNKNOWN

  • European and Developing Countries Clinical Trials Partnership (EDCTP)

    collaborator OTHER_GOV

  • Instituto Nacional de Saúde, Mozambique

    lead OTHER_GOV

Principal Investigators

  • Ilesh Jani, PhD · Instituto Nacional de Saúde, Mozambique

  • Nafissa Osman, MD, PhD · Hospital Central de Maputo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
26 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-03-31
Completion
2013-08-31

Countries

  • Mozambique

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 NCT01407497 on ClinicalTrials.gov