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| Name | Class |
|---|---|
| Beijing Ditan Hospital | OTHER |
| National Institutes for Food and Drug Control, China | OTHER |
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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) .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose Ad5-gag or Placebo | Experimental | 1ml low dose Ad5-gag(2x10^9VP) or Preservation solution at weeks 0 and weeks 4. |
|
| Medium dose Ad5-gag or Placebo | Experimental | 1ml medium dose Ad5-gag(2x10^10VP) or Preservation solution at weeks 0 and weeks 4. |
|
| High dose Ad5-gag or Placebo | Experimental | 1ml high dose Ad5-gag(2x10^11VP) or Preservation solution at weeks 0 and weeks 4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ad5-gag | Biological | Ad5-gag is used as vaccine in all arms. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of vaccine | To evaluate immune responses pre- and post-immunization and between the vaccine and placebo groups. | 24 month |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rongmeng Jiang, M.D. | Contact | 0086-13911900791 | 13911900791@163.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital of Capital Medical University | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Placebo | Biological | Preservation Solution is used as control in all arms. |
|
|
| Ke Xu, Ph.D | National Institute for Viral Disease Control and Prevention, China CDC | Principal Investigator |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |