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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

Tracking Information
First Submitted Date  ICMJE May 2, 2016
First Posted Date  ICMJE May 4, 2016
Last Update Posted Date May 4, 2016
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2016)
Immunogenicity of vaccine [ Time Frame: 24 month ]
To evaluate immune responses pre- and post-immunization and between the vaccine and placebo groups.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Recombinant Adenovirus Type 5 AIDS Vaccine
Official Title  ICMJE Phase I Clinical Trial of Recombinant Adenovirus Type 5 Therapeutic AIDS Vaccine Expressing Gag
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) .
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acquired Immunodeficiency Syndrome
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Low dose Ad5-gag or Placebo
    1ml low dose Ad5-gag(2x10^9VP) or Preservation solution at weeks 0 and weeks 4.
    Interventions:
    • Biological: Ad5-gag
    • Biological: Placebo
  • Experimental: Medium dose Ad5-gag or Placebo
    1ml medium dose Ad5-gag(2x10^10VP) or Preservation solution at weeks 0 and weeks 4.
    Interventions:
    • Biological: Ad5-gag
    • Biological: Placebo
  • Experimental: High dose Ad5-gag or Placebo
    1ml high dose Ad5-gag(2x10^11VP) or Preservation solution at weeks 0 and weeks 4.
    Interventions:
    • Biological: Ad5-gag
    • Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 2, 2016)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02762045
Other Study ID Numbers  ICMJE CDCPChina
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Yi Zeng, Centers for Disease Control and Prevention, China
Study Sponsor  ICMJE Centers for Disease Control and Prevention, China
Collaborators  ICMJE
  • Beijing Ditan Hospital
  • National Institutes for Food and Drug Control, China
Investigators  ICMJE
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
PRS Account Centers for Disease Control and Prevention, China
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP