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| Name | Class |
|---|---|
| Aaron Diamond AIDS Research Center | OTHER |
| University of Rochester | OTHER |
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The purpose of this study is to determine the safety and immune response to a investigational DNA Plasmid HIV vaccine, ADVAX e/g + ADVAX p/n-t (ADVAX), at three different dosage levels, in adults who are not infected with HIV.
This is a dose escalation trial. Study site staff and volunteers will be blinded, blinding will not apply to the assignment of dose levels (low, middle or high).
Volunteers will be screened up to 42 days before vaccination and will be followed for 18 months after the first vaccination.
15 volunteers will be randomized in a 4:1 ratio of active vaccine to placebo. Safety and tolerability of the ADVAX e/g + ADVAX p/n-t investigational product will be evaluated at least 14 days after the tenth volunteer in the lower dosage group receives the second injection before proceeding to the nextdosage group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV vaccine | Experimental | dosage escalation of ADVAX |
|
| Placebo | Placebo Comparator | Sodium phosphate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADVAX | Biological |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Safety of ADVAX | dose escalation study | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of ADVAX | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Ho, MD | Aaron Diamond AIDS Research Center | Principal Investigator |
| Michael Keefer, MD | University of Rochester | Principal Investigator |
| Soe Than, MD | International AIDS Vaccine Initiative | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rockefeller University Hospital | New York | New York | 10021 | United States | ||
| University of Rochester Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20111582 | Result | Vasan S, Schlesinger SJ, Huang Y, Hurley A, Lombardo A, Chen Z, Than S, Adesanya P, Bunce C, Boaz M, Boyle R, Sayeed E, Clark L, Dugin D, Schmidt C, Song Y, Seamons L, Dally L, Ho M, Smith C, Markowitz M, Cox J, Gill DK, Gilmour J, Keefer MC, Fast P, Ho DD. Phase 1 safety and immunogenicity evaluation of ADVAX, a multigenic, DNA-based clade C/B' HIV-1 candidate vaccine. PLoS One. 2010 Jan 25;5(1):e8617. doi: 10.1371/journal.pone.0008617. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C576871 | delta inulin |
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| Rochester |
| New York |
| 14642 |
| United States |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |