Clinical Trial of Recombinant Adenovirus Type 5 AIDS Vaccine

NCT ID: NCT02762045

Last Updated: 2016-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-12-31

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.

Conditions

Acquired Immunodeficiency Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Low dose Ad5-gag or Placebo

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

Group Type: EXPERIMENTAL

Ad5-gag

Intervention Type: BIOLOGICAL

Ad5-gag is used as vaccine in all arms.

Placebo

Intervention Type: BIOLOGICAL

Preservation Solution is used as control in all arms.

Medium dose Ad5-gag or Placebo

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

Group Type: EXPERIMENTAL

Ad5-gag

Intervention Type: BIOLOGICAL

Ad5-gag is used as vaccine in all arms.

Placebo

Intervention Type: BIOLOGICAL

Preservation Solution is used as control in all arms.

High dose Ad5-gag or Placebo

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

Group Type: EXPERIMENTAL

Ad5-gag

Intervention Type: BIOLOGICAL

Ad5-gag is used as vaccine in all arms.

Placebo

Intervention Type: BIOLOGICAL

Preservation Solution is used as control in all arms.

Interventions

Ad5-gag

Ad5-gag is used as vaccine in all arms.

Intervention Type: BIOLOGICAL

Placebo

Preservation Solution is used as control in all arms.

Intervention Type: BIOLOGICAL

Other Intervention Names

Preservation Solution

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Ditan Hospital

OTHER

Sponsor Role: collaborator

National Institutes for Food and Drug Control, China

OTHER

Sponsor Role: collaborator

Centers for Disease Control and Prevention, China

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yi Zeng

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yi Zeng, M.D.

Role: STUDY_DIRECTOR

National Institute for Viral Disease Control and Prevention, China CDC

Xia Feng, M.D. Ph.D

Role: PRINCIPAL_INVESTIGATOR

National Institute for Viral Disease Control and Prevention, China CDC

Ke Xu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

National Institute for Viral Disease Control and Prevention, China CDC

Locations

Beijing Ditan Hospital of Capital Medical University

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Rongmeng Jiang, M.D.

Role: CONTACT

13911900791@163.com

0086-13911900791

Facility Contacts

Rongmeng Jiang, M.D.

Role: primary

13911900791@163.com

0086-13911900791

Other Identifiers

CDCPChina

Identifier Type: -

Identifier Source: org_study_id