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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004591-32 | EudraCT Number |
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The main purpose of the study is to evaluate the safety and to establish the recommended dose of iHIVARNA-01 as a new therapeutic vaccine against HIV
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100 μg TriMix mRNA (TriMix_100) | Other | Cohort 1 (control group) 3 patients will receive 100 μg of mRNA (i.e. 100 μg TriMix mRNA).If two or more of the three patients have a dose limiting toxicity (DLT), DSMB should be consulted and study will be terminated. If one or no patients have a dose limiting toxicity, three patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). |
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| 300 μg TriMix mRNA (TriMix_300) | Other | Cohort 2 (control group) 3 patients will receive 300 μg of mRNA (i.e. 100 μg TriMix mRNA).If two or more of the three patients have a DLT, DSMB should be consulted and study will be terminated. If one or no patients have a dose limiting toxicity, three patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). |
|
| 600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA) | Experimental | Cohort 3 (experimental group) 3 patients will receive 600 μg of mRNA (300 μg HIV mRNA + 300 μg TriMix mRNA). If two or more of the three patients have a DLT, DSMB should be consulted and study will be terminated. If one or no patients have a dose limiting toxicity, three patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). |
|
| 900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA) | Experimental | Cohort 4 (experimental group) 3 patients will receive 900 μg of mRNA (i.e. 600 μg HIV mRNA and 300 μg TriMix mRNA). If two or more of the three first patients have a DLT, then additional three patients will be enrolled at the previous level dose (dose will be reduced to 600 μg of mRNA per vaccination). If one or no patients have a DLT, additional three patients will be enrolled at 900 μg dose level. If two or more of the six patients receiving 900 μg of mRNA have a DLT, then additional 3 patients will be enrolled at the previous level dose (dose will be reduced to 600 μg of mRNA per vaccination). If one or no patients of the six patients have a DLT, six patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TriMix_100 | Biological | 100 μg of TriMix in |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity (DLT) | Safety as measured by dose limiting toxicity (DLT), defined as:
| week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoint: Immunogenicty - Changes in the Magnitude of Total HIV-1-specific Immune Response Against IN Peptide Pools as Measured by ELISPOT at Baseline and Weeks 4, 6, 8 and 24 Measured by ELISPOT at Baseline and Weeks 4, 6, 8 and 24. | Changes in the magnitude of total HIV-1-specific immune response against IN peptide pools as measured by ELISPOT at baseline and weeks 4, 6, 8 and 24 Results were considered positive if the number of SFC/106 cells in stimulated wells was two-fold higher than that in unstimulated control wells, and if there were at least 50 SFC/106 cells after background subtraction. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felipe García | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínic de Bacelona | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30289805 | Derived | Leal L, Guardo AC, Moron-Lopez S, Salgado M, Mothe B, Heirman C, Pannus P, Vanham G, van den Ham HJ, Gruters R, Andeweg A, Van Meirvenne S, Pich J, Arnaiz JA, Gatell JM, Brander C, Thielemans K, Martinez-Picado J, Plana M, Garcia F; iHIVARNA consortium. Phase I clinical trial of an intranodally administered mRNA-based therapeutic vaccine against HIV-1 infection. AIDS. 2018 Nov 13;32(17):2533-2545. doi: 10.1097/QAD.0000000000002026. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 100 μg TriMix mRNA (TriMix_100) | Cohort 1 (control group) 3 patients will receive 100 μg of mRNA (i.e. 100 μg TriMix mRNA).If two or more of the three patients have a dose limiting toxicity (DLT), DSMB should be consulted and study will be terminated. If one or no patients have a dose limiting toxicity, three patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). TriMix_100: 100 μg of TriMix in |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 1200μg mRNA(900 μg HIV mRNA+300 μg TriMix mRNA) | Experimental | Cohort 5 (experimental group) 6 patients will receive 1200 μg of mRNA (i.e. 900 μg HIV mRNA + 300 μg TriMix mRNA) in case one or no patients of the six patients at the previous dose level have a DLT. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). |
|
| TriMix_300 |
| Biological |
300 μg of TriMix in |
|
| 600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA) | Biological | 600 μg of mRNA (300 μg TriMix + 300 μg HIVACAT) |
|
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| 900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA) | Biological | 900 μg of mRNA (300 μg TriMix + 600 μg HIVACAT) |
|
|
| 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) | Biological | 1200 μg of mRNA (300 μg TriMix + 900 μg HIVACAT) |
|
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| weeks 4, 6, 8 and 24 |
| Secondary Endpoint: Immunogenicty - Changes in the Magnitude of Total HIV-1-specific Immune Response Against OUT Peptide Pools as Measured by ELISPOT at Abseline and Weeks 4, 6, 8 and 24 Measured by ELISPOT at Baseline and Weeks 4, 6, 8 and 24. | Changes in the magnitude of total HIV-1-specific immune response against OUT peptide pools as measured by ELISPOT at abseline and weeks 4, 6, 8 and 24. Results were considered positive if the number of SFC/106 cells in stimulated wells was two-fold higher than that in unstimulated control wells, and if there were at least 50 SFC/106 cells after background subtraction. | weeks 4, 6, 8 and 24 |
| Secondary End Point: Effect on Reservoir | Changes from baseline in the intracelullar viral RNA copy number per million cells during and after the immunzation at week 4, 6, 8 and 24 | weeks 4, 6, 8 and 24 |
| FG001 | 300 μg TriMix mRNA (TriMix_300) | Cohort 2 (control group) 3 patients will receive 300 μg of mRNA (i.e. 100 μg TriMix mRNA).If two or more of the three patients have a DLT, DSMB should be consulted and study will be terminated. If one or no patients have a dose limiting toxicity, three patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). TriMix_300: 300 μg of TriMix in |
| FG002 | 600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA) | Cohort 3 (experimental group) 3 patients will receive 600 μg of mRNA (300 μg HIV mRNA + 300 μg TriMix mRNA). If two or more of the three patients have a DLT, DSMB should be consulted and study will be terminated. If one or no patients have a dose limiting toxicity, three patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). 600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA): 600 μg of mRNA (300 μg TriMix + 300 μg HIVACAT) |
| FG003 | 900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA) | Cohort 4 (experimental group) 3 patients will receive 900 μg of mRNA (i.e. 600 μg HIV mRNA and 300 μg TriMix mRNA). If two or more of the three first patients have a DLT, then additional three patients will be enrolled at the previous level dose (dose will be reduced to 600 μg of mRNA per vaccination). If one or no patients have a DLT, additional three patients will be enrolled at 900 μg dose level. If two or more of the six patients receiving 900 μg of mRNA have a DLT, then additional 3 patients will be enrolled at the previous level dose (dose will be reduced to 600 μg of mRNA per vaccination). If one or no patients of the six patients have a DLT, six patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). 900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA): 900 μg of mRNA (300 μg TriMix + 600 μg HIVACAT) |
| FG004 | 1200μg mRNA(900 μg HIV mRNA+300 μg TriMix mRNA) | Cohort 5 (experimental group) 6 patients will receive 1200 μg of mRNA (i.e. 900 μg HIV mRNA + 300 μg TriMix mRNA) in case one or no patients of the six patients at the previous dose level have a DLT. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA): 1200 μg of mRNA (300 μg TriMix + 900 μg HIVACAT) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 100 μg TriMix mRNA (TriMix_100) | Cohort 1 (control group) 3 patients will receive 100 μg of mRNA (i.e. 100 μg TriMix mRNA).If two or more of the three patients have a dose limiting toxicity (DLT), DSMB should be consulted and study will be terminated. If one or no patients have a dose limiting toxicity, three patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). TriMix_100: 100 μg of TriMix in |
| BG001 | 300 μg TriMix mRNA (TriMix_300) | Cohort 2 (control group) 3 patients will receive 300 μg of mRNA (i.e. 100 μg TriMix mRNA).If two or more of the three patients have a DLT, DSMB should be consulted and study will be terminated. If one or no patients have a dose limiting toxicity, three patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). TriMix_300: 300 μg of TriMix in |
| BG002 | 600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA) | Cohort 3 (experimental group) 3 patients will receive 600 μg of mRNA (300 μg HIV mRNA + 300 μg TriMix mRNA). If two or more of the three patients have a DLT, DSMB should be consulted and study will be terminated. If one or no patients have a dose limiting toxicity, three patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). 600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA): 600 μg of mRNA (300 μg TriMix + 300 μg HIVACAT) |
| BG003 | 900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA) | Cohort 4 (experimental group) 3 patients will receive 900 μg of mRNA (i.e. 600 μg HIV mRNA and 300 μg TriMix mRNA). If two or more of the three first patients have a DLT, then additional three patients will be enrolled at the previous level dose (dose will be reduced to 600 μg of mRNA per vaccination). If one or no patients have a DLT, additional three patients will be enrolled at 900 μg dose level. If two or more of the six patients receiving 900 μg of mRNA have a DLT, then additional 3 patients will be enrolled at the previous level dose (dose will be reduced to 600 μg of mRNA per vaccination). If one or no patients of the six patients have a DLT, six patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). 900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA): 900 μg of mRNA (300 μg TriMix + 600 μg HIVACAT) |
| BG004 | 1200μg mRNA(900 μg HIV mRNA+300 μg TriMix mRNA) | Cohort 5 (experimental group) 6 patients will receive 1200 μg of mRNA (i.e. 900 μg HIV mRNA + 300 μg TriMix mRNA) in case one or no patients of the six patients at the previous dose level have a DLT. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA): 1200 μg of mRNA (300 μg TriMix + 900 μg HIVACAT) |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Dose Limiting Toxicity (DLT) | Safety as measured by dose limiting toxicity (DLT), defined as:
| Posted | Number | participants | week 24 |
|
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Secondary Endpoint: Immunogenicty - Changes in the Magnitude of Total HIV-1-specific Immune Response Against IN Peptide Pools as Measured by ELISPOT at Baseline and Weeks 4, 6, 8 and 24 Measured by ELISPOT at Baseline and Weeks 4, 6, 8 and 24. | Changes in the magnitude of total HIV-1-specific immune response against IN peptide pools as measured by ELISPOT at baseline and weeks 4, 6, 8 and 24 Results were considered positive if the number of SFC/106 cells in stimulated wells was two-fold higher than that in unstimulated control wells, and if there were at least 50 SFC/106 cells after background subtraction. | Posted | Median | Standard Error | Spot forming cells per million of cells | weeks 4, 6, 8 and 24 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Secondary Endpoint: Immunogenicty - Changes in the Magnitude of Total HIV-1-specific Immune Response Against OUT Peptide Pools as Measured by ELISPOT at Abseline and Weeks 4, 6, 8 and 24 Measured by ELISPOT at Baseline and Weeks 4, 6, 8 and 24. | Changes in the magnitude of total HIV-1-specific immune response against OUT peptide pools as measured by ELISPOT at abseline and weeks 4, 6, 8 and 24. Results were considered positive if the number of SFC/106 cells in stimulated wells was two-fold higher than that in unstimulated control wells, and if there were at least 50 SFC/106 cells after background subtraction. | Posted | Median | Standard Error | Spot forming cells per million of cells | weeks 4, 6, 8 and 24 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Secondary End Point: Effect on Reservoir | Changes from baseline in the intracelullar viral RNA copy number per million cells during and after the immunzation at week 4, 6, 8 and 24 | Baseline values were normalized to 1.0 for all groups. Subsequent measurements represent fold changes relative to baseline. | Posted | Mean | Standard Deviation | Ratio to baseline | weeks 4, 6, 8 and 24 |
|
24 weeks
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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 | 100 μg TriMix mRNA (TriMix_100) | Cohort 1 (control group) 3 patients will receive 100 μg of mRNA (i.e. 100 μg TriMix mRNA).If two or more of the three patients have a dose limiting toxicity (DLT), DSMB should be consulted and study will be terminated. If one or no patients have a dose limiting toxicity, three patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). TriMix_100: 100 μg of TriMix in | 0 | 3 | 0 | 3 | 3 | 3 |
| EG001 | 300 μg TriMix mRNA (TriMix_300) | Cohort 2 (control group) 3 patients will receive 300 μg of mRNA (i.e. 100 μg TriMix mRNA).If two or more of the three patients have a DLT, DSMB should be consulted and study will be terminated. If one or no patients have a dose limiting toxicity, three patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). TriMix_300: 300 μg of TriMix in | 0 | 3 | 0 | 3 | 3 | 3 |
| EG002 | 600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA) | Cohort 3 (experimental group) 3 patients will receive 600 μg of mRNA (300 μg HIV mRNA + 300 μg TriMix mRNA). If two or more of the three patients have a DLT, DSMB should be consulted and study will be terminated. If one or no patients have a dose limiting toxicity, three patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). 600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA): 600 μg of mRNA (300 μg TriMix + 300 μg HIVACAT) | 0 | 3 | 0 | 3 | 2 | 3 |
| EG003 | 900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA) | Cohort 4 (experimental group) 3 patients will receive 900 μg of mRNA (i.e. 600 μg HIV mRNA and 300 μg TriMix mRNA). If two or more of the three first patients have a DLT, then additional three patients will be enrolled at the previous level dose (dose will be reduced to 600 μg of mRNA per vaccination). If one or no patients have a DLT, additional three patients will be enrolled at 900 μg dose level. If two or more of the six patients receiving 900 μg of mRNA have a DLT, then additional 3 patients will be enrolled at the previous level dose (dose will be reduced to 600 μg of mRNA per vaccination). If one or no patients of the six patients have a DLT, six patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). 900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA): 900 μg of mRNA (300 μg TriMix + 600 μg HIVACAT) | 0 | 6 | 0 | 6 | 4 | 6 |
| EG004 | 1200μg mRNA(900 μg HIV mRNA+300 μg TriMix mRNA) | Cohort 5 (experimental group) 6 patients will receive 1200 μg of mRNA (i.e. 900 μg HIV mRNA + 300 μg TriMix mRNA) in case one or no patients of the six patients at the previous dose level have a DLT. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA): 1200 μg of mRNA (300 μg TriMix + 900 μg HIVACAT) | 0 | 6 | 0 | 6 | 3 | 6 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| haemotthoids | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| nightmare | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| insomnia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| anxiety | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| episcleritis | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| otitis extern | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| flu-like syndrome | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| rash | General disorders | MedDRA (Unspecified) | Systematic Assessment | After vaccination |
|
| dizziness | General disorders | MedDRA (Unspecified) | Systematic Assessment | Dizziness because painful after vaccination |
|
| fever | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| urethritis | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| urinary tract infrection | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| rosacea | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| ankle sprain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| cold sore | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| mumps | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
There was an error in the study product, see: https://insights.ovid.com/pubmed?pmid=31490219
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Felipe Garcia | Hospital Clinic-HIVACAT | 932275400 | 2844 | fgarcia@clinic.cat |
| 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 |
|---|---|
| D012333 | RNA, Messenger |
| ID | Term |
|---|---|
| D012313 | RNA |
| D009696 | Nucleic Acids |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| OG002 | 600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA) | Cohort 3 (experimental group) 3 patients will receive 600 μg of mRNA (300 μg HIV mRNA + 300 μg TriMix mRNA). If two or more of the three patients have a DLT, DSMB should be consulted and study will be terminated. If one or no patients have a dose limiting toxicity, three patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). 600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA): 600 μg of mRNA (300 μg TriMix + 300 μg HIVACAT) |
| OG003 | 900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA) | Cohort 4 (experimental group) 3 patients will receive 900 μg of mRNA (i.e. 600 μg HIV mRNA and 300 μg TriMix mRNA). If two or more of the three first patients have a DLT, then additional three patients will be enrolled at the previous level dose (dose will be reduced to 600 μg of mRNA per vaccination). If one or no patients have a DLT, additional three patients will be enrolled at 900 μg dose level. If two or more of the six patients receiving 900 μg of mRNA have a DLT, then additional 3 patients will be enrolled at the previous level dose (dose will be reduced to 600 μg of mRNA per vaccination). If one or no patients of the six patients have a DLT, six patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). 900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA): 900 μg of mRNA (300 μg TriMix + 600 μg HIVACAT) |
| OG004 | 1200μg mRNA(900 μg HIV mRNA+300 μg TriMix mRNA) | Cohort 5 (experimental group) 6 patients will receive 1200 μg of mRNA (i.e. 900 μg HIV mRNA + 300 μg TriMix mRNA) in case one or no patients of the six patients at the previous dose level have a DLT. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA): 1200 μg of mRNA (300 μg TriMix + 900 μg HIVACAT) |
|
|
| OG002 | 600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA) | Cohort 3 (experimental group) 3 patients will receive 600 μg of mRNA (300 μg HIV mRNA + 300 μg TriMix mRNA). If two or more of the three patients have a DLT, DSMB should be consulted and study will be terminated. If one or no patients have a dose limiting toxicity, three patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). 600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA): 600 μg of mRNA (300 μg TriMix + 300 μg HIVACAT) |
| OG003 | 900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA) | Cohort 4 (experimental group) 3 patients will receive 900 μg of mRNA (i.e. 600 μg HIV mRNA and 300 μg TriMix mRNA). If two or more of the three first patients have a DLT, then additional three patients will be enrolled at the previous level dose (dose will be reduced to 600 μg of mRNA per vaccination). If one or no patients have a DLT, additional three patients will be enrolled at 900 μg dose level. If two or more of the six patients receiving 900 μg of mRNA have a DLT, then additional 3 patients will be enrolled at the previous level dose (dose will be reduced to 600 μg of mRNA per vaccination). If one or no patients of the six patients have a DLT, six patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). 900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA): 900 μg of mRNA (300 μg TriMix + 600 μg HIVACAT) |
| OG004 | 1200μg mRNA(900 μg HIV mRNA+300 μg TriMix mRNA) | Cohort 5 (experimental group) 6 patients will receive 1200 μg of mRNA (i.e. 900 μg HIV mRNA + 300 μg TriMix mRNA) in case one or no patients of the six patients at the previous dose level have a DLT. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA): 1200 μg of mRNA (300 μg TriMix + 900 μg HIVACAT) |
|
|
| 600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA) |
Cohort 3 (experimental group) 3 patients will receive 600 μg of mRNA (300 μg HIV mRNA + 300 μg TriMix mRNA). If two or more of the three patients have a DLT, DSMB should be consulted and study will be terminated. If one or no patients have a dose limiting toxicity, three patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). 600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA): 600 μg of mRNA (300 μg TriMix + 300 μg HIVACAT) |
| OG003 | 900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA) | Cohort 4 (experimental group) 3 patients will receive 900 μg of mRNA (i.e. 600 μg HIV mRNA and 300 μg TriMix mRNA). If two or more of the three first patients have a DLT, then additional three patients will be enrolled at the previous level dose (dose will be reduced to 600 μg of mRNA per vaccination). If one or no patients have a DLT, additional three patients will be enrolled at 900 μg dose level. If two or more of the six patients receiving 900 μg of mRNA have a DLT, then additional 3 patients will be enrolled at the previous level dose (dose will be reduced to 600 μg of mRNA per vaccination). If one or no patients of the six patients have a DLT, six patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). 900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA): 900 μg of mRNA (300 μg TriMix + 600 μg HIVACAT) |
| OG004 | 1200μg mRNA(900 μg HIV mRNA+300 μg TriMix mRNA) | Cohort 5 (experimental group) 6 patients will receive 1200 μg of mRNA (i.e. 900 μg HIV mRNA + 300 μg TriMix mRNA) in case one or no patients of the six patients at the previous dose level have a DLT. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA): 1200 μg of mRNA (300 μg TriMix + 900 μg HIVACAT) |
|
|