NCT01881581

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

June 20, 2013

Status Verified

June 1, 2013

Enrollment Period

9 months

First QC Date

June 16, 2013

Last Update Submit

June 19, 2013

Conditions

Acquired Immunodeficiency Syndrome

Keywords

TherapeuticVaccineHIVMVADNA

Outcome Measures

Primary Outcomes (1)

  • Occurrence, intensity and relationship to vaccination of local and systemic adverse events

    To evaluate the safety and tolerance of a DNA and a replication-defective MVA vaccine expressing HIV-1 gag-pol and env in HIV-1 infected subjects on highly active antiretroviral therapy. Frequency and severity of adverse events, laboratory abnormalities, and local and systemic reactogenicity signs and symptoms following vaccinations

    8 months

Secondary Outcomes (1)

  • Immunogenicity of vaccine

    14 months

Study Arms (8)

Lower dose DNA or Placebo

EXPERIMENTAL

2.0 mL lower dose D-GPEi (0.5mg) or Saline solution at weeks 0

Biological: Saline SolutionBiological: D-GPEi

Medium dose DNA or Placebo

EXPERIMENTAL

2.0 mL medium dose D-GPEi (2mg) or Saline solution at weeks 0

Biological: Saline SolutionBiological: D-GPEi

High dose DNA or Placebo

EXPERIMENTAL

2.0 mL high dose D-GPEi (4mg) or Saline solution at weeks 0

Biological: Saline SolutionBiological: D-GPEi

Lower dose MVA or Placebo

EXPERIMENTAL

100μL lower dose M-GPE (3×10\^7pfu) or Saline solution at weeks 0

Biological: Saline SolutionBiological: M-GPE

Medium dose MVA or Placebo

EXPERIMENTAL

100μL medium dose M-GPE (1×10\^8pfu) or Saline solution at weeks 0

Biological: Saline SolutionBiological: M-GPE

High dose MVA or Placebo

EXPERIMENTAL

300μL high dose M-GPE (3×10\^8pfu) or Saline solution at weeks 0

Biological: Saline SolutionBiological: M-GPE

Low dose DNA+MVA or Placebo control

EXPERIMENTAL

The dose below the maximum tolerated dose of D-GPEi or 2.0 mL Saline solution at week 0,1; The dose below the maximum tolerated dose of M-GPE or 100/300μL Saline solution at week 2,3

Biological: Saline SolutionBiological: D-GPEiBiological: M-GPE

High dose DNA+MVA or Placebo control

EXPERIMENTAL

The maximum tolerated dose of D-GPEi or 2.0 mL Saline solution at week 0,1;The maximum tolerated dose of M-GPE or 100/300μL Saline solution at week 2,3

Biological: Saline SolutionBiological: D-GPEiBiological: M-GPE

Interventions

Saline SolutionBIOLOGICAL

Saline Solution is used as control in all arms.

High dose DNA or PlaceboHigh dose DNA+MVA or Placebo controlHigh dose MVA or PlaceboLow dose DNA+MVA or Placebo controlLower dose DNA or PlaceboLower dose MVA or PlaceboMedium dose DNA or PlaceboMedium dose MVA or Placebo
D-GPEiBIOLOGICAL

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

High dose DNA or PlaceboHigh dose DNA+MVA or Placebo controlLow dose DNA+MVA or Placebo controlLower dose DNA or PlaceboMedium dose DNA or Placebo
M-GPEBIOLOGICAL

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

High dose DNA+MVA or Placebo controlHigh dose MVA or PlaceboLow dose DNA+MVA or Placebo controlLower dose MVA or PlaceboMedium dose MVA or Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Are willing to participate this study and available for follow-up for the duration of the study.
  • Men and women aged 18-50 years.
  • Are HIV-positive.
  • Have been taking stable anti-HIV drugs for at least 6 months.
  • CD4 count ≥ 350 cells/mm3
  • Plasma viral load \< 50 copies/ml.
  • Willing to use acceptable forms of contraception at least 21 days prior to first vaccination until 56 days after the last vaccination.

You may not qualify if:

  • Pregnancy or breast-feeding.
  • History of previous vaccination with an HIV-1 vaccine.
  • Use of immunoinhibitory agents, such as corticosteroids or cytotoxic drugs by oral administration, injection route or inhalation route within 6 months of study entry (But corticosteroids used for allergic rhinitis and skin topical application of corticosteroids were not included); Use of immunomodulatory agents including but not limited to interleukin-2(IL-2） and granulocyte-macrophage colony-stimulating factor (GM-CSF) within 30 days of study entry.
  • Use of blood products within 3 months of study entry.
  • Use of other experimental drugs within 3 months of study entry.
  • Any immunization within 3 months of study entry.
  • Comply with any of the following items： Active pulmonary tuberculosis； History of serious adverse reaction to other vaccines； Serious asthma； Have untreated thyroid disease; Syphilis
  • Laboratory values（Comply with any of the following items）:
  • Hemoglobin \< 100 g/L (male subjects)，\<90 g/L (female subjects)； Absolute neutrophil count ≤ 1000 cells/mm3； Serum creatinine ≥15 mg/L，endogenous creatinine clearance rate \<50 ml/min； alanine aminotransferase（ALT）, aspartate aminotransferase(AST) ≥3× upper limit of normal range； Total bilirubin ≥2× upper limit of normal range
  • Clinically significant electrocardiogram changes.
  • Hypertension ( If it is well controlled by medication and is less than 150/100mmHg , should not be excluded) and other cardiac disease；
  • Any medical, psychiatric, social condition, occupational reason judged by the investigator that would limit the evaluation of a subject.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Ditan Hospital of Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Xingwang Li, M.D.

    Beijng Ditan Hospital of Capital Medical University

    PRINCIPAL INVESTIGATOR

  • Rongmeng Jiang, M.D.

    Beijng Ditan Hospital of Capital Medical University

    PRINCIPAL INVESTIGATOR

  • Yi Zeng

    National Institute for Viral Disease Control and Prevention, China CDC

    PRINCIPAL INVESTIGATOR

  • Xia Feng, Ph.D

    National Institute for Viral Disease Control and Prevention, China CDC

    PRINCIPAL INVESTIGATOR

  • Ke Xu, Ph.D

    National Institute for Viral Disease Control and Prevention, China CDC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Departement Director

Study Record Dates

First Submitted

June 16, 2013

First Posted

June 19, 2013

Study Start

June 1, 2013

Primary Completion

March 1, 2014

Study Completion

August 1, 2014

Last Updated

June 20, 2013

Record last verified: 2013-06

Locations

CN(1)