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Clinical Trial of Recombinant Adenovirus Type 5 AIDS Vaccine

Primary Purpose

Acquired Immunodeficiency Syndrome

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Ad5-gag

Placebo

About this trial

This is an interventional treatment trial for Acquired Immunodeficiency Syndrome focused on measuring Therapeutic Vaccine HIV Adenovirus type 5 vector

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Beijing Ditan Hospital of Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Low dose Ad5-gag or Placebo

Medium dose Ad5-gag or Placebo

High dose Ad5-gag or Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Immunogenicity of vaccine

To evaluate immune responses pre- and post-immunization and between the vaccine and placebo groups.

Full Information

NCT ID

NCT02762045

First Posted

May 2, 2016

Last Updated

May 2, 2016

Sponsor

Centers for Disease Control and Prevention, China

Collaborators

Beijing Ditan Hospital, National Institutes for Food and Drug Control, China

1. Study Identification

Unique Protocol Identification Number

NCT02762045

Brief Title

Clinical Trial of Recombinant Adenovirus Type 5 AIDS Vaccine

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Unknown status

Study Start Date

April 2016 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centers for Disease Control and Prevention, China

Collaborators

Beijing Ditan Hospital, National Institutes for Food and Drug Control, China

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acquired Immunodeficiency Syndrome

Keywords

Therapeutic Vaccine HIV Adenovirus type 5 vector

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Low dose Ad5-gag or Placebo

Arm Type

Experimental

Arm Description

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

Arm Title

Medium dose Ad5-gag or Placebo

Arm Type

Experimental

Arm Description

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

Arm Title

High dose Ad5-gag or Placebo

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Ad5-gag

Intervention Description

Ad5-gag is used as vaccine in all arms.

Intervention Type

Biological

Intervention Name(s)

Placebo

Other Intervention Name(s)

Preservation Solution

Intervention Description

Preservation Solution is used as control in all arms.

Primary Outcome Measure Information:

Title

Occurrence, intensity and relationship to vaccination of local and systemic adverse events

Description

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.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Immunogenicity of vaccine

Description

To evaluate immune responses pre- and post-immunization and between the vaccine and placebo groups.

Time Frame

24 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rongmeng Jiang, M.D.

Phone

0086-13911900791

13911900791@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yi Zeng, M.D.

Organizational Affiliation

National Institute for Viral Disease Control and Prevention, China CDC

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Xia Feng, M.D. Ph.D

Organizational Affiliation

National Institute for Viral Disease Control and Prevention, China CDC

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ke Xu, Ph.D

Organizational Affiliation

National Institute for Viral Disease Control and Prevention, China CDC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Ditan Hospital of Capital Medical University

City

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rongmeng Jiang, M.D.

Phone

0086-13911900791

13911900791@163.com

First Name & Middle Initial & Last Name & Degree

Rongmeng Jiang, M.D

First Name & Middle Initial & Last Name & Degree

Xingwang Li, M.D

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Clinical Trial of Recombinant Adenovirus Type 5 AIDS Vaccine

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