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Clinical Trial of Recombinant Adenovirus Type 5 AIDS Vaccine

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ClinicalTrials.gov Identifier: NCT02762045
Recruitment Status : Unknown
Verified May 2016 by Yi Zeng, Centers for Disease Control and Prevention, China.
Recruitment status was:  Recruiting
First Posted : May 4, 2016
Last Update Posted : May 4, 2016
Sponsor:
Collaborators:
Beijing Ditan Hospital
National Institutes for Food and Drug Control, China
Information provided by (Responsible Party):
Yi Zeng, Centers for Disease Control and Prevention, China

Study Description
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Brief Summary:
This is a randomized, double-blind placebo-controlled dose-escalation clinical trial to evaluate the safety and the immunogenicity of Adenoviral vector 5 HIV-1 vaccines in subjects receiving stable highly active antiretroviral therapy(HAART) .

Condition or disease Intervention/treatment Phase
Acquired Immunodeficiency Syndrome Biological: Ad5-gag Biological: Placebo Phase 1

Detailed Description:
Patients continue antiretroviral medications throughout the course of this study. Three groups of patients receive dose-escalation (2×10^9VP, 2×10^10VP or 2×10^11VP) injections of Adenovirus vector vaccine (Ad5-gag). Two weeks post immunization of lower dose, if the vaccine is safe and well tolerant, the next dose of immunization will begin. patients are monitored for safety 72 hours after each immunization. In addition, each patient records adverse events in a diary. Patients have regular physical exams, pregnancy tests, and blood drawn for virologic and immunologic assessments. The induction of HIV-specific responses will be measured.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase I Clinical Trial of Recombinant Adenovirus Type 5 Therapeutic AIDS Vaccine Expressing Gag
Study Start Date : April 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Low dose Ad5-gag or Placebo
1ml low dose Ad5-gag(2x10^9VP) or Preservation solution at weeks 0 and weeks 4.
 Biological: Ad5-gag
Ad5-gag is used as vaccine in all arms.

Biological: Placebo
Preservation Solution is used as control in all arms.
Other Name: Preservation Solution
Experimental: Medium dose Ad5-gag or Placebo
1ml medium dose Ad5-gag(2x10^10VP) or Preservation solution at weeks 0 and weeks 4.
 Biological: Ad5-gag
Ad5-gag is used as vaccine in all arms.

Biological: Placebo
Preservation Solution is used as control in all arms.
Other Name: Preservation Solution
Experimental: High dose Ad5-gag or Placebo
1ml high dose Ad5-gag(2x10^11VP) or Preservation solution at weeks 0 and weeks 4.
 Biological: Ad5-gag
Ad5-gag is used as vaccine in all arms.

Biological: Placebo
Preservation Solution is used as control in all arms.
Other Name: Preservation Solution


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence, intensity and relationship to vaccination of local and systemic adverse events [ Time Frame: 12 months ]
    To evaluate the safety and tolerance of a replication defective adenovirus expressing HIV-1 gag in HIV-1 infected subjects on highly active antiretroviral therapy.


Secondary Outcome Measures :
  1. Immunogenicity of vaccine [ Time Frame: 24 month ]
    To evaluate immune responses pre- and post-immunization and between the vaccine and placebo groups.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02762045


Contacts
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Contact: Rongmeng Jiang, M.D. 0086-13911900791 13911900791@163.com

Locations
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China
Beijing Ditan Hospital of Capital Medical University Recruiting
Beijing, China
Contact: Rongmeng Jiang, M.D.    0086-13911900791    13911900791@163.com   
Principal Investigator: Rongmeng Jiang, M.D         
Principal Investigator: Xingwang Li, M.D         
Sponsors and Collaborators
Centers for Disease Control and Prevention, China
Beijing Ditan Hospital
National Institutes for Food and Drug Control, China
Investigators
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Study Director: Yi Zeng, M.D. National Institute for Viral Disease Control and Prevention, China CDC
Principal Investigator: Xia Feng, M.D. 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
More Information
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Responsible Party: Yi Zeng, Yi Zeng, Departement Director, Centers for Disease Control and Prevention, China, Centers for Disease Control and Prevention, China
ClinicalTrials.gov Identifier: NCT02762045    
Other Study ID Numbers: CDCPChina
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: May 4, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Yi Zeng, Centers for Disease Control and Prevention, China:
Therapeutic Vaccine HIV Adenovirus type 5 vector
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Adenoviridae Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Blood-Borne Infections
Communicable Diseases
Infections
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
DNA Virus Infections