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| ID | Type | Description | Link |
|---|---|---|---|
| R01AI066992-04 | U.S. NIH Grant/Contract | View source | |
| DAIDS-ES ID 10731 | Other Identifier | DAIDS |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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The purpose of the study is to find out whether an experimental autologous dendritic cell vaccine is safe, well tolerated, and whether it can strengthen the immune system's response to HIV.
This is a randomized trial to evaluate whether mRNA-transfected dendritic cell vaccination is safe and immunogenic in HIV-infected participants who are on antiretroviral therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-transfected dendritic cells | Active Comparator | Participants in this arm/group received mRNA-transfected autologous dendritic cells |
|
| Dendritic cells without mRNA | Placebo Comparator | Participants in this arm/group received autologous dendritic cells with no mRNA transfection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-transfected autologous dendritic cells | Biological | Injections will be administered intradermally at weeks 0, 2, 6 and 10. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the DC Vaccine (as Measured by Frequency of Adverse Events) | Number of participants with grade 3 or 4 adverse events related to vaccination | After vaccination |
| Change From Baseline to Week 14 in ELISPOT Response to Gag and Nef | Immunogenicity was measure by interferon gamma enzyme-linked immunospot (ELISPOT) assay. The number of spot forming cells per million PBMC was determined at each time point. The fold ratio represents week 14 value divided by value at baseline. | Baseline and 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| T Cell Proliferation | Baseline to week 14 | |
| IL2 and IFN Gamma Production | Baseline to week 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rajesh Gandhi, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infectious Disease Unit; Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26379068 | Background | Gandhi RT, Kwon DS, Macklin EA, Shopis JR, McLean AP, McBrine N, Flynn T, Peter L, Sbrolla A, Kaufmann DE, Porichis F, Walker BD, Bhardwaj N, Barouch DH, Kavanagh DG. Immunization of HIV-1-Infected Persons With Autologous Dendritic Cells Transfected With mRNA Encoding HIV-1 Gag and Nef: Results of a Randomized, Placebo-Controlled Clinical Trial. J Acquir Immune Defic Syndr. 2016 Mar 1;71(3):246-53. doi: 10.1097/QAI.0000000000000852. |
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| ID | Title | Description |
|---|---|---|
| FG000 | mRNA-transfected Autologous Dendritic Cell Vaccine. | mRNA-transfected autologous dendritic cells: Injections will be administered intradermally at weeks 0, 2, 6 and 10. |
| FG001 | Autologous Dendritic Cells Without Transfected mRNA. | Dendritic cell vaccine without transfected mRNA. Autologous dendritic cells not transfected with mRNA.: Injections will be administered intradermally at weeks 0, 2, 6 and 10. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | mRNA-transfected Autologous Dendritic Cell Vaccine. | mRNA-transfected autologous dendritic cells: Injections will be administered intradermally at weeks 0, 2, 6 and 10. |
| BG001 | Autologous Dendritic Cells Without Transfected mRNA. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety of the DC Vaccine (as Measured by Frequency of Adverse Events) | Number of participants with grade 3 or 4 adverse events related to vaccination | Posted | Number | participants | After vaccination |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | mRNA Transfected DCs |
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The trial size is small, precluding detection of small effect sizes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rajesh Gandhi | Mass General Hospital | 617-724-9690 | rgandhi@partners.org |
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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 |
|---|---|
| D012333 | RNA, Messenger |
| ID | Term |
|---|---|
| D012313 | RNA |
| D009696 | Nucleic Acids |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| autologous dendritic cells with no mRNA transfection | Biological | Injections will be administered intradermally at weeks 0, 2, 6 and 10. |
|
|
Dendritic cell vaccine without transfected mRNA.
Autologous dendritic cells not transfected with mRNA.: Injections will be administered intradermally at weeks 0, 2, 6 and 10.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| Secondary | T Cell Proliferation | Posted | Mean | 95% Confidence Interval | fold change | Baseline to week 14 |
|
|
|
| Primary | Change From Baseline to Week 14 in ELISPOT Response to Gag and Nef | Immunogenicity was measure by interferon gamma enzyme-linked immunospot (ELISPOT) assay. The number of spot forming cells per million PBMC was determined at each time point. The fold ratio represents week 14 value divided by value at baseline. | Posted | Median | Full Range | fold ratio | Baseline and 14 weeks |
|
|
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| Secondary | IL2 and IFN Gamma Production | Results from these assays were too variable to be interpretable. | Posted | Baseline to week 14 |
|
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| 0 |
| 15 |
| 0 |
| 15 |
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| 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 |