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Safety and Immunogenicity of Recombinant HIV Vaccines for HIV/AIDS

NCT01881581 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2013-06-20

No results posted yet for this study

Summary

This is a randomized, double-blind placebo-controlled dose-escalation clinical trial to evaluate the safety and the immunogenicity of DNA and modified vaccinia virus Ankara (MVA) HIV-1 vaccines in subjects receiving stable highly active antiretroviral therapy (HAART) who have an HIV-1 RNA \< 50 copies/mm3 and CD4+ T cells count ≥ 350 cells/mm3.

Conditions

  • Acquired Immunodeficiency Syndrome

Interventions

BIOLOGICAL

Saline Solution

Saline Solution is used as control in all arms.

BIOLOGICAL

D-GPEi

D-GPEi is used in Arm A,B,C,G and H.

BIOLOGICAL

M-GPE

M-GPE is used in Arm D,E,F,G and H

Sponsors & Collaborators

  • Beijing Ditan Hospital

    collaborator OTHER

  • National Institutes for Food and Drug Control, China

    collaborator OTHER

  • Centers for Disease Control and Prevention, China

    lead OTHER_GOV

Principal Investigators

  • Xingwang Li, M.D. · Beijng Ditan Hospital of Capital Medical University

  • Rongmeng Jiang, M.D. · Beijng Ditan Hospital of Capital Medical University

  • Yi Zeng · National Institute for Viral Disease Control and Prevention, China CDC

  • Xia Feng, Ph.D · National Institute for Viral Disease Control and Prevention, China CDC

  • Ke Xu, Ph.D · National Institute for Viral Disease Control and Prevention, China CDC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-03-31
Completion
2014-08-31

Countries

  • China

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 NCT01881581 on ClinicalTrials.gov