Clinical Trial of Recombinant Adenovirus Type 5 AIDS Vaccine
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acquired Immunodeficiency Syndrome | Biological: Ad5-gag Biological: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Phase I Clinical Trial of Recombinant Adenovirus Type 5 Therapeutic AIDS Vaccine Expressing Gag |
Study Start Date : | April 2016 |
Estimated Primary Completion Date : | December 2016 |
Estimated Study Completion Date : | December 2017 |

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 Name: 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 Name: 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 Name: Preservation Solution |
- 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.
- Immunogenicity of vaccine [ Time Frame: 24 month ]To evaluate immune responses pre- and post-immunization and between the vaccine and placebo groups.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02762045
Contact: Rongmeng Jiang, M.D. | 0086-13911900791 | 13911900791@163.com |
China | |
Beijing Ditan Hospital of Capital Medical University | Recruiting |
Beijing, China | |
Contact: Rongmeng Jiang, M.D. 0086-13911900791 13911900791@163.com | |
Principal Investigator: Rongmeng Jiang, M.D | |
Principal Investigator: Xingwang Li, M.D |
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 |
Responsible Party: | Yi Zeng, Yi Zeng, Departement Director, Centers for Disease Control and Prevention, China, Centers for Disease Control and Prevention, China |
ClinicalTrials.gov Identifier: | NCT02762045 |
Other Study ID Numbers: |
CDCPChina |
First Posted: | May 4, 2016 Key Record Dates |
Last Update Posted: | May 4, 2016 |
Last Verified: | May 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Therapeutic Vaccine HIV Adenovirus type 5 vector |
Acquired Immunodeficiency Syndrome HIV Infections Adenoviridae Infections Immunologic Deficiency Syndromes Immune System Diseases 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 DNA Virus Infections |