MedTrace Logo

A Phase II Trial to Assess the Safety and Immunogenicity of DNA Priming Administered by the ID Zetajet® With or Without ID Derma Vax™ Electroporation Followed by IM MVA Boosting in Healthy Volunteers in Tanzania and Mozambique

NCT01697007 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2015-06-29

No results posted yet for this study

Summary

Electroporation will increase the efficiency of DNA priming in terms of immune responses and will lead to a dose sparing DNA vaccine regimen. Furthermore increased DNA vaccine concentration will reduce the number of shots necessary to deliver the full dose and induce comparable immune responses as with lower DNA vaccine concentrations.

Conditions

  • Vaccines
  • HIV
  • Safety
  • Immunogenicity

Interventions

BIOLOGICAL

HIVIS DNA vaccine

DEVICE

Zetajet

DEVICE

Derma Vax Electroporation

BIOLOGICAL

Modified Vaccinia Ankara (MVA-CDMR)

Sponsors & Collaborators

  • Swedish Institute for Infectious Disease Control

    collaborator OTHER

  • Karolinska Institutet

    collaborator OTHER

  • US Military HIV Research Program

    collaborator NETWORK

  • Medical Research Council

    collaborator OTHER_GOV

  • National Institute for Medical Research, Tanzania

    collaborator OTHER_GOV

  • Ludwig-Maximilians - University of Munich

    collaborator OTHER

  • Imperial College London

    collaborator OTHER

  • Mbeya medical research program

    collaborator UNKNOWN

  • Instituto Nacional de Saúde, Mozambique

    collaborator OTHER_GOV

  • Muhimbili University of Health and Allied Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-12-31
Completion
2015-06-30

Countries

  • Mozambique
  • Tanzania

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT01697007 on ClinicalTrials.gov