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This trial studies the safety and immunogenicity of a HIV clade B'/C DNA vaccine followed by recombinant vaccinia virus rTV boost in HIV-uninfected healthy volunteers at low or high risk of HIV infection. In addition, the effect of different intervals of the prime-boost will be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Experimental | DNA vaccine prime at week 0,4,8 and rTV boost at week 16 |
|
| group B | Experimental | DNA vaccine prime at week 0,4,8 and rTV boost at week 24 |
|
| group C | Experimental | DNA vaccine prime at week 0,4,8 and rTV boost at week 32 |
|
| group D | Experimental | DNA vaccine prime with the addition of electroporation at week 0, 4, 8 and rTV boost at week 24 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNA vaccine | Biological | 4mg/dose, three doses at week 0,4,8 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence, intensity and relationship to vaccination of local and general adverse events | 14-day follow-up after DNA vaccine vaccination | |
| Occurrence and relationship to vaccination of any serious AEs (SAEs) | During the study period (Month 0-20) | |
| Occurrence, intensity and relationship to vaccination of clinically significant abnormal haematology and biochemistry values (grade 4) | During the study period (Month 0-20) | |
| test HIV specific T cell response by ELISPOT | 2wk, 4wk, 14wk, 24wk after rTV vaccination | |
| test HIV specific antibody by ELISA | 2wk, 4wk, 14wk, 24wk, 48wk after rTV vaccination | |
| Occurrence, intensity and relationship to vaccination of local and general adverse events | 28-day follow-up after rTV vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| test HIV specific T cell response by ICS | 4wk, 8wk, 14wk, 48wk after rTV vaccination | |
| HIV neutralizing antibody test | 4wk, 14wk, 48wk after rTV vaccination | |
| vaccinia virus antibody test |
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Inclusion Criteria:
Exclusion Criteria:
Have close contact with people who are pregnant or lactating in the one month after vaccination of rTV vaccine;
Have listed diseases or medical history:
The following circumstances are:
The following laboratory test abnormalities, except for the results that are assessed by researchers as being no clinical significance:
Not complying with study protocol or not obtaining informed consent because of medical, spiritual, social, occupational, and/or other reasons.
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| Name | Affiliation | Role |
|---|---|---|
| Hao Wu, M.D. | Beijing YouAn Hospital | Principal Investigator |
| Tong Zhang, M.D. | Beijing YouAn Hospital | Principal Investigator |
| Yiming Shao, Ph.D. | NCAIDS, China CDC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Youan Hospital,Capital Medical University | Beijing | Beijing Municipality | China |
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| DNA vaccine prime with the addition of electroporation | Biological | 4mg/dose, three doses at week 0,4,8 |
|
| rTV boost | Biological | at week 16 |
|
| rTV boost | Biological | at week 24 |
|
| rTV boost | Biological | at week 32 |
|
| 2wk, 4wk, 24wk after rTV vaccination |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
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| ID | Term |
|---|---|
| D019444 | Vaccines, DNA |
| ID | Term |
|---|---|
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000941 | Antigens |
| D001685 | Biological Factors |
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