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| ID | Type | Description | Link |
|---|---|---|---|
| VAC89220HTX1002 | Other Identifier | Janssen Vaccines & Prevention B.V. | |
| IPCAVD-013 | Other Identifier | National Institute of Allergy and Infectious Diseases |
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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
| Ragon Institute of MGH, MIT and Harvard | OTHER |
| US Military HIV Research Program | NETWORK |
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The primary purpose of this study is to assess safety/tolerability of 2 different prime/boost regimens containing adenovirus serotype 26 (Ad26).Mos4.HIV, Modified Vaccinia Ankara (MVA) -Mosaic or adjuvanted Mosaic and Clade C gp140 in Human immunodeficiency virus type 1 (HIV-1)-infected participants on suppressive antiretroviral treatment (ART).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Ad26.Mos4.HIV + MVA-Mosaic/Placebo | Experimental | Participants will receive adenovirus serotype 26-Mosaic 4 -Human Immunodeficiency Virus (Ad26.Mos4.HIV) 5*10^10 virus particles (vp) as intramuscular (IM) injection at Weeks 0 and 12 (1 injection) followed by modified Vaccinia Ankara-Mosaic (MVA-Mosaic) 10^8 Plaque-forming unit (pfu) and placebo as IM injection at Weeks 24 and 36 (2 injections). |
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| Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140 | Experimental | Participants will receive Ad26.Mos4.HIV, 5*10^10 vp as IM injection at Weeks 0 and 12 (1 injection) followed by both Ad26.Mos4.HIV 5*10^10 vp plus Clade C gp140 (125 microgram [mcg]) plus Mosaic gp140 (125 mcg) with aluminum phosphate adjuvant or an equivalent dose of a bivalent vaccine that includes both Clade C gp140 and Mosaic gp140, and aluminum phosphate adjuvant in a single vial, via IM injection at Weeks 24 and 36 (2 injections). |
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| Group 3: Placebo | Placebo Comparator | Participants will receive 0.9 percent (%) saline as IM injection at Weeks 0, 12 (one injection) and at Week 24, 36 (two injections). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ad26.Mos4.HIV | Biological | Participants will receive Ad26.Mos4.HIV 5*10^10 vp as 0.5 mL IM injection at Weeks 0, 12 in Group 1 and at Weeks 0, 12, 24, 36 in Group 2. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Solicited Local Adverse Events (AEs) as a Measure of Safety and Tolerability | Solicited local AEs: erythema, swelling/induration, and pain/tenderness will be assessed. | 7 days post-vaccination (approximately up to 37 weeks) |
| Percentage of Participants With Solicited Systemic AEs as a Measure of Safety and Tolerability | Solicited systemic AEs: fever (temperature measurement), fatigue, headache, nausea, myalgia, and chills will be assessed. | 7 days post-vaccination (approximately up to 37 weeks) |
| Percentage of Participants With AEs as a Measure of Safety and Tolerability | An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | Approximately up to 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total IgG and Subclass Specific Antibody Titer | Total immunoglobulin G (IgG) and subclass (IgG1-4) specific antibody titers (binding antibody) to envelope (Env) proteins representing Clades A, B, and C, as well as Mosaic antigens. | Up to post-vaccination follow-up period until Week 96 |
| Antibody Functionality Assessment by Antibody-dependent Cell-mediated Phagocytosis (ADCP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Vaccines & Prevention B.V. Clinical Trial | Janssen Vaccines & Prevention B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
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| MVA-Mosaic | Biological | Participants will receive MVA-Mosaic 10^8 pfu as IM injection at Weeks 24 and 36. |
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| Clade C gp140 + Mosaic gp140 | Biological | Participants will receive both Clade C gp140 125 mcg plus Mosaic gp140 125 mcg (250 mcg coformulated with Aluminum phosphate adjuvant) OR an equivalent dose of a bivalent vaccine that includes both Clade C gp140 and Mosaic gp140, and aluminum phosphate adjuvant in a single vial, via IM injection at Weeks 24 and 36. |
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| Placebo | Drug | Participants will receive matching placebo as IM injection at Weeks 24, 36 in Group 1 and at Weeks 0, 12, 24, 36 in Group 3. |
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Antibody functionality assessment will be assessed by antibody-dependent cell-mediated phagocytosis (ADCP) assay. |
| Up to post-vaccination follow-up period until Week 96 |
| Magnitude of T-cell Responses as Measured by Intracellular Cytokine Staining (ICS) Assay | Intracellular cytokine staining (ICS) assays with Env, group-specific antigen (Gag), and/or polymerase (Pol)-peptide pools will be used to determine the magnitude of T-cell responses elicited. | Up to post-vaccination follow-up period until Week 96 |
| Functionality of T-cell Responses as Measured by ICS Assay | ICS assays with Env, Gag, and/or Pol-peptide pools will be used to determine the functionality of T-cell responses elicited. | Up to post-vaccination follow-up period until Week 96 |
| Phenotype of T-cell Responses as Measured by ICS Assay | ICS assays with Env, Gag, and/or Pol-peptide pools will be used to determine the phenotype of T-cell responses elicited. | Up to post-vaccination follow-up period until Week 96 |
| Frequency of Epitope Recognition by Enzyme-Linked Immunospot (ELISPOT) | Assays of peptide pool sets covering the Gag, Env or Pol will be evaluated by standard enzyme linked immunospot assay (ELISPOT). | Up to post-vaccination follow-up period until Week 96 |
| 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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