Clinical Trial of Recombinant Adenovirus Type 5 AIDS Vaccine

NCT02762045 | Unknown Phase 1

• 1 other identifier: CDCPChina
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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) .

Conditions

Acquired Immunodeficiency Syndrome

Keywords

Therapeutic Vaccine HIV Adenovirus type 5 vector

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 replication defective adenovirus expressing HIV-1 gag in HIV-1 infected subjects on highly active antiretroviral therapy.

  12 months

Secondary Outcomes (1)

• Immunogenicity of vaccine

  24 month

Study Arms (3)

Low dose Ad5-gag or Placebo

EXPERIMENTAL

1ml low dose Ad5-gag(2x10\^9VP) or Preservation solution at weeks 0 and weeks 4.

Biological: Ad5-gag; Biological: Placebo

Medium dose Ad5-gag or Placebo

EXPERIMENTAL

1ml medium dose Ad5-gag(2x10\^10VP) or Preservation solution at weeks 0 and weeks 4.

Biological: Ad5-gag; Biological: Placebo

High dose Ad5-gag or Placebo

EXPERIMENTAL

1ml high dose Ad5-gag(2x10\^11VP) or Preservation solution at weeks 0 and weeks 4.

Biological: Ad5-gag; Biological: Placebo

Interventions

Ad5-gag BIOLOGICAL

Ad5-gag is used as vaccine in all arms.

High dose Ad5-gag or Placebo; Low dose Ad5-gag or Placebo; Medium dose Ad5-gag or Placebo

Placebo BIOLOGICAL

Preservation Solution is used as control in all arms.

Also known as: Preservation Solution

High dose Ad5-gag or Placebo; Low dose Ad5-gag or Placebo; Medium dose Ad5-gag or Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.

Sponsors & Collaborators

• Centers for Disease Control and Prevention, China: lead
• Beijing Ditan Hospital: collaborator
• National Institutes for Food and Drug Control, China: collaborator

Study Sites (1)

Beijing Ditan Hospital of Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; 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; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Yi Zeng, M.D.

  National Institute for Viral Disease Control and Prevention, China CDC

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rongmeng Jiang, M.D.

CONTACT

0086-13911900791; 13911900791@163.com

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: Yi Zeng, Departement Director, Centers for Disease Control and Prevention, China

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 4, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: May 4, 2016

Record last verified: 2016-05

Locations

CN (1)