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The purpose of this Phase 1/2 study is to generate sufficient safety and immunogenicity data of mRNA-1018 pandemic influenza candidate vaccines in healthy adults ≥18 years of age to enable the initiation of a large Phase 3 trial with one selected vaccine candidate. The study will be conducted in 2 Parts (Part A and Part B) that will enroll and run concurrently. Part A of the study will evaluate 4 vaccine candidates (H5N8, H7N9, H5 only, and H7 only). Part B of the study will evaluate a single vaccine candidate (H5 only-CG).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 1 | Experimental | Participants will receive mRNA-1018 for H5N8 at dose level 1 by intramuscular (IM) injection on Day 1 and Day 22. |
|
| Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 2 | Experimental | Participants will receive mRNA-1018 for H5N8 at dose level 2 by IM injection on Day 1 and Day 22. |
|
| Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 3 | Experimental | Participants will receive mRNA-1018 for H5N8 at dose level 3 by IM injection on Day 1 and Day 22. |
|
| Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 1 | Experimental | Participants will receive mRNA-1018 for H5 only at dose level 1 by IM injection on Day 1 and Day 22. |
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| Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 2 | Experimental | Participants will receive mRNA-1018 for H5 only at dose level 2 by IM injection on Day 1 and Day 22. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1018 for H5N8 | Biological | Sterile liquid for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) | Up to Day 29 (7 days after each injection) | |
| Number of Participants with Unsolicited Adverse Events (AEs) | Up to Day 43 (21 days after each injection) | |
| Number of Participants with AEs Leading to Discontinuation From Study | Day 1 to Day 205 (end of study [EoS]) | |
| Number of Participants with Medically-Attended AEs (MAAEs) | Day 1 to Day 205 (EoS) | |
| Number of Participants with Serious Adverse Events (SAEs) | Day 1 to Day 205 (EoS) | |
| Number of Participants with Adverse Events of Special Interest (AESIs) | Day 1 to Day 205 (EoS) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Days 22, 29, and 43, as Measured by Hemagglutination Inhibition (HAI) Assay | Days 22, 29, and 43 | |
| Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies From Baseline to Days 22, 29, and 43, as Measured by HAI Assay |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Other inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CenExel RCA | Hollywood | Florida | 33024 | United States | ||
| Velocity Clinical Research |
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| Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 3 | Experimental | Participants will receive mRNA-1018 for H5 only at dose level 3 by IM injection on Day 1 and Day 22. |
|
| Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 1 | Experimental | Participants will receive mRNA-1018 for H7N9 at dose level 1 by IM injection on Day 1 and Day 22. |
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| Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 2 | Experimental | Participants will receive mRNA-1018 for H7N9 at dose level 2 by IM injection on Day 1 and Day 22. |
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| Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 3 | Experimental | Participants will receive mRNA-1018 for H7N9 at dose level 3 by IM injection on Day 1 and Day 22. |
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| Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 1 | Experimental | Participants will receive mRNA-1018 for H7 only at dose level 1 by IM injection on Day 1 and Day 22. |
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| Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 2 | Experimental | Participants will receive mRNA-1018 for H7 only at dose level 2 by IM injection on Day 1 and Day 22. |
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| Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 3 | Experimental | Participants will receive mRNA-1018 for H7 only at dose level 3 by IM injection on Day 1 and Day 22. |
|
| Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 1 | Experimental | Participants will receive mRNA-1018 for H5 Only-CG at dose level 1 by IM injection on Day 1 and Day 22. |
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| Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 2 | Experimental | Participants will receive mRNA-1018 for H5 Only-CG at dose level 2 by IM injection on Day 1 and Day 22. |
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| Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 3 | Experimental | Participants will receive mRNA-1018 for H5 Only-CG at dose level 3 by IM injection on Day 1 and Day 22. |
|
| mRNA-1018 for H7N9 | Biological | Sterile liquid for injection |
|
| mRNA-1018 for H5 Only | Biological | Sterile liquid for injection |
|
| mRNA-1018 for H7 Only | Biological | Sterile liquid for injection |
|
| mRNA-1018 for H5 Only-CG | Biological | Sterile liquid for injection |
|
| Baseline (Day 1), Days 22, 29, and 43 |
| Number of Participants With Seroconversion at Days 22, 29, and 43, as Measured by HAI Assay | Seroconversion is defined as a Day 22, 29, or 43 titer ≥1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay. | Baseline (Day 1) to Days 22, 29, and 43 |
| Number of Participants With HAI Titer ≥ 1:40 at Days 22, 29, and 43 | Days 22, 29, and 43 |
| GMT of Anti-Neuraminidase (NA) Antibodies at Days 22, 29, and 43, as Measured by Neuraminidase Inhibition (NAI) Assay | Days 22, 29, and 43 |
| GMFR of Anti-NA Antibodies From Baseline to Days 22, 29, and 43, as Measured by NAI Assay | Baseline (Day 1), Days 22, 29, and 43 |
| Number of Participants with a Change in the Days 22, 29, and 43 NAI Titer of at Least 2-/3-/4-Fold Rise | Number of participants with a change in the Days 22, 29, or 43 NAI titer of at least 2-/3-/4-fold rise, defined as ≥2-/3-/4-fold of the lower level of quantitation (LLOQ) if the Day 1 titer is \ | Baseline (Day 1) to Days 22, 29, and 43 |
| Savannah |
| Georgia |
| 31406 |
| United States |
| Johnson County Clin-Trials | Lenexa | Kansas | 66219 | United States |
| DM Clinical Research | Southfield | Michigan | 48076 | United States |
| Velocity Clinical Research | Lincoln | Nebraska | 68510 | United States |
| Velocity Clinical Research Providence | East Greenwich | Rhode Island | 02818 | United States |
| DM Clinical Research | Sugar Land | Texas | 77478 | United States |
| DM Clinical Research | Tomball | Texas | 77375 | United States |
| J. Lewis Research, Inc/Jordan River Family Medicine | South Jordan | Utah | 84095 | United States |
| Royal Victoria Infirmary | Newcastle upon Tyne | England | NE1 4LP | United Kingdom |
| Southampton General Hospital | Southampton | England | SO16 6YD | United Kingdom |
| University Hospitals Birmingham | Birmingham | London | B15 2TH | United Kingdom |
| Bradford Teaching Hospitals NHS Foundation Trust | Bradford | London | BD9 6RL | United Kingdom |
| University Hospitals | Bristol | London | Bs2 8DX | United Kingdom |
| Cardiff and Vale University | Cardiff | London | CF14 4XW | United Kingdom |
| Northern Care Alliance | Salford | London | M6 8HD | United Kingdom |
| Royal Cornwall Hospital | Truro | London | TR1 3LJ | United Kingdom |
| North Wales Clinical Research Centre | Wrexham | London | LL13 7YP | United Kingdom |
| Quadram Institute NNUH CRF | Norwich | Norfolk | NR4 7UQ | United Kingdom |
| Lakeside Healthcare Research Unit | Corby | Northamptonshire | NN17 2UR | United Kingdom |
| Western Hospital Edinburgh | Edinburgh | EH4 CXU | United Kingdom |
| Royal Free Hospital | London | NW3 2QG | United Kingdom |
| Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital | London | SE1 7EH | United Kingdom |
| Chelsea and Westminster Hospital | London | SW10 9NH | United Kingdom |
| St Georges Vaccine Institute Cranmer Terrace | London | SW17 ORE | United Kingdom |
| University College London Hospitals NHS Foundation Trust | London | W1T 7HA | United Kingdom |
| Velocity Clinical Research | North Finchley | N12 8BU | United Kingdom |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D012140 | Respiratory Tract Diseases |
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