Clinical Trial of Recombinant Adenovirus Type 5 AIDS Vaccine

Phase I Clinical Trial of Recombinant Adenovirus Type 5 Therapeutic AIDS Vaccine Expressing Gag

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) .

Study Overview

• Status: Unknown
• Conditions: Acquired Immunodeficiency Syndrome
• Intervention / Treatment: Biological: Ad5-gag; Biological: Placebo

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: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Ditan Hospital of Capital Medical University
    • Contact: Rongmeng Jiang, M.D.; Phone Number: 0086-13911900791; Email: 13911900791@163.com
    • Principal Investigator: Rongmeng Jiang, M.D
    • Principal Investigator: Xingwang Li, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: Preservation Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence, intensity and relationship to vaccination of local and systemic adverse events	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity of vaccine	To evaluate immune responses pre- and post-immunization and between the vaccine and placebo groups.	24 month

Collaborators and Investigators

• Sponsor: Centers for Disease Control and Prevention, China
• Collaborators: Beijing Ditan Hospital; National Institutes for Food and Drug Control, China
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: May 2, 2016
• First Submitted That Met QC Criteria: May 2, 2016
• First Posted (Estimate): May 4, 2016

Study Record Updates

• Last Update Posted (Estimate): May 4, 2016
• Last Update Submitted That Met QC Criteria: May 2, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Therapeutic Vaccine HIV Adenovirus type 5 vector
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; DNA Virus Infections; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes; Adenoviridae Infections
• Other Study ID Numbers: CDCPChina

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED