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| ID | Type | Description | Link |
|---|---|---|---|
| HHSO100201600029C | Other Grant/Funding Number | Biomedical Advanced Research & Development Authority (BARDA) |
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| Name | Class |
|---|---|
| Biomedical Advanced Research and Development Authority | FED |
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The clinical study will assess the safety, tolerability, and immunogenicity of mRNA-1325 in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-1325 | Experimental |
| |
| Placebo | Placebo Comparator | 0.9% sodium chloride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1325 | Biological | Escalating dose levels |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Number of Participants With Solicited Adverse Events- Vaccination 1 | Solicited adverse reactions (ARs) (local and systemic) were collected in the electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the first study vaccination only. A summary of all serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section. | Up to 7 days post-vaccination 1 (up to 8 days) |
| Part A: Number of Participants With Solicited Adverse Events: Vaccination 2 | Solicited adverse reactions (ARs) (local and systemic) were collected in the electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the second study vaccination only. A summary of all serious AEs (SAEs) and all nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section. | Up to 7 days post-vaccination 2 (Day 29 to Day 36) |
| Part A: Number of Participants With Unsolicited Adverse Events | An unsolicited AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The treatment-emergent AEs are defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure. A summary of all SAEs and all nonserious AEs ("Other") reported up to the end of the study, regardless of causality, is located in the Reported "Adverse Events" section. | Up to Day 392 (all AEs considered an SAE were collected till end of study [Day 392]; the Other AEs [non-SAE] were collected up to Day 57) |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Geometric Mean Titer of Neutralizing Serum Antibody (PRNT50) to Zika Virus | GMT 95% CI is calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation. | Baseline, 28 days post each vaccination (Days 29 and 57) |
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Inclusion
Exclusion
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego | California | 92108 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36682364 | Derived | Essink B, Chu L, Seger W, Barranco E, Le Cam N, Bennett H, Faughnan V, Pajon R, Paila YD, Bollman B, Wang S, Dooley J, Kalidindi S, Leav B. The safety and immunogenicity of two Zika virus mRNA vaccine candidates in healthy flavivirus baseline seropositive and seronegative adults: the results of two randomised, placebo-controlled, dose-ranging, phase 1 clinical trials. Lancet Infect Dis. 2023 May;23(5):621-633. doi: 10.1016/S1473-3099(22)00764-2. Epub 2023 Jan 19. |
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This was a 2-part study. Part A was conducted for 28 days following the second vaccination. Once the participants completed the final visit in Part A, they were entered into Part B. Part B was conducted for 12 months following the second vaccination in Part A.
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| ID | Title | Description |
|---|---|---|
| FG000 | mRNA-1325 10 mcg | Participants received mRNA-1325 10 micrograms (mcg) intramuscular (IM) injection on Days 1 and 29. |
| FG001 | mRNA-1325 25 mcg | Participants received mRNA-1325 25 mcg as an IM injection on Days 1 and 29. |
| FG002 | mRNA-1325 100 mcg | Participants received mRNA-1325 100 mcg as an IM injection on Days 1 and 29. |
| FG003 | Placebo | Participants received placebo matched to mRNA-1325 as an IM injection on Days 1 and 29. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | mRNA-1325 10 mcg | Participants received mRNA-1325 10 mcg IM injection on Days 1 and 29. |
| BG001 | mRNA-1325 25 mcg | Participants received mRNA-1325 25 mcg as an IM injection on Days 1 and 29. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Part A: Number of Participants With Solicited Adverse Events- Vaccination 1 | Solicited adverse reactions (ARs) (local and systemic) were collected in the electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the first study vaccination only. A summary of all serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section. | The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo) and provided vaccination 1 safety data. | Posted | Count of Participants | Participants | Up to 7 days post-vaccination 1 (up to 8 days) |
|
Baseline up to Day 392
The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). Adverse Events reported in the Adverse Events section below include unsolicited AEs and solicited ARs. All AEs considered an SAE were collected till end of study (Day 392). The Other AEs (non-SAE) were collected up to Day 57. All cause mortality includes the deaths that were due to "AEs leading to death".
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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-1325 10 mcg | Participants received mRNA-1325 10 mcg IM injection on Days 1 and 29. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pharyngitis streptococcal | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Moderna Clinical Trials Support Center | ModernaTX, Inc | 1-877-777-7187 | clinicaltrials@modernatx.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 13, 2018 | Dec 22, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 15, 2017 | Dec 22, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 13, 2017 | Dec 22, 2023 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D000071243 | Zika Virus Infection |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
Not provided
Not provided
Not provided
Not provided
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| Other |
|
| Part A: Number of Participants With Medically-Attended Adverse Events (MAAEs) | An MAAE is an AE that leads to an unscheduled visit to an healthcare practitioner. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | Up to 1 year post-vaccination (Day 392) |
| Part B: Number of Participants With Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs) | An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions was a congenital anomaly/birth defect, or was an important medical event. AESIs included potentially immune-mediated medical conditions (autoimmune or autoinflammatory diseases) that may have the theoretical potential for association with novel vaccines. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | Up to 1 year post-vaccination (Day 392) |
| Melbourne |
| Florida |
| 32934 |
| United States |
| Peoria | Illinois | 61614 | United States |
| Lost to Follow-up |
|
| Adverse Event |
|
| BG002 | mRNA-1325 100 mcg | Participants received mRNA-1325 100 mcg as an IM injection on Days 1 and 29. |
| BG003 | Placebo | Participants received placebo matched to mRNA-1325 as an IM injection on Days 1 and 29. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| mRNA-1325 10 mcg |
Participants received mRNA-1325 10 mcg IM injection on Days 1 and 29. |
| OG001 | mRNA-1325 25 mcg | Participants received mRNA-1325 25 mcg as an IM injection on Days 1 and 29. |
| OG002 | mRNA-1325 100 mcg | Participants received mRNA-1325 100 mcg as an IM injection on Days 1 and 29. |
| OG003 | Placebo | Participants received placebo matched to mRNA-1325 as an IM injection on Days 1 and 29. |
|
|
| Primary | Part A: Number of Participants With Solicited Adverse Events: Vaccination 2 | Solicited adverse reactions (ARs) (local and systemic) were collected in the electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the second study vaccination only. A summary of all serious AEs (SAEs) and all nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section. | The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo) and provided post vaccination 2 safety data. | Posted | Count of Participants | Participants | Up to 7 days post-vaccination 2 (Day 29 to Day 36) |
|
|
|
| Primary | Part A: Number of Participants With Unsolicited Adverse Events | An unsolicited AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The treatment-emergent AEs are defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure. A summary of all SAEs and all nonserious AEs ("Other") reported up to the end of the study, regardless of causality, is located in the Reported "Adverse Events" section. | The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). | Posted | Count of Participants | Participants | Up to Day 392 (all AEs considered an SAE were collected till end of study [Day 392]; the Other AEs [non-SAE] were collected up to Day 57) |
|
|
|
| Primary | Part A: Number of Participants With Medically-Attended Adverse Events (MAAEs) | An MAAE is an AE that leads to an unscheduled visit to an healthcare practitioner. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). | Posted | Count of Participants | Participants | Up to 1 year post-vaccination (Day 392) |
|
|
|
| Primary | Part B: Number of Participants With Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs) | An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions was a congenital anomaly/birth defect, or was an important medical event. AESIs included potentially immune-mediated medical conditions (autoimmune or autoinflammatory diseases) that may have the theoretical potential for association with novel vaccines. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section. | The Safety set included all participants in Randomized Set who received at least 1 dose of study drug (mRNA-1325 or placebo). | Posted | Count of Participants | Participants | Up to 1 year post-vaccination (Day 392) |
|
|
|
| Secondary | Part A: Geometric Mean Titer of Neutralizing Serum Antibody (PRNT50) to Zika Virus | GMT 95% CI is calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation. | The per-protocol set included all participants in the randomized set who did not have a major protocol violation, received the full dose of the assigned investigational product within the acceptable vaccination window, had blood collection within accepted visit windows, and had a pre-vaccination and at least 1 serum sample from the post-vaccination immunogenicity testing period available for testing. Here, number analyzed signifies those participants who were evaluable at specified time points. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Baseline, 28 days post each vaccination (Days 29 and 57) |
|
|
|
| 1 |
| 25 |
| 1 |
| 25 |
| 24 |
| 25 |
| EG001 | mRNA-1325 25 mcg | Participants received placebo matched to mRNA-1325 as an IM injection on Days 1 and 29. | 0 | 24 | 0 | 24 | 23 | 24 |
| EG002 | mRNA-1325 100 mcg | Participants received mRNA-1325 25 mcg as an IM injection on Days 1 and 29. | 0 | 25 | 0 | 25 | 25 | 25 |
| EG003 | Placebo | Participants received mRNA-1325 100 mcg as an IM injection on Days 1 and 29. | 0 | 16 | 0 | 16 | 12 | 16 |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA v19.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v19.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v19.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA v19.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA v19.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v19.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA v19.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA v19.0 | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA v19.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA v19.0 | Systematic Assessment |
|
| Injection site lymphadenopathy | General disorders | MedDRA v19.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA v19.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA v19.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v19.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA v19.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA v19.0 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA v19.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA v19.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA v19.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA v19.0 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA v19.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA v19.0 | Systematic Assessment |
|
| Red blood cells urine positive | Investigations | MedDRA v19.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
|
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA v19.0 | Systematic Assessment |
|
Not provided
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| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| Local Event- Tenderness |
|
| Local Event- Swelling |
|
| Local Event- Redness |
|
| Systemic Event- Fever |
|
| Systemic Event- Vomiting |
|
| Systemic Event- Diarrhea |
|
| Systemic Event- Headache |
|
| Systemic Event- Fatigue |
|
| Systemic Event- Generalized Myalgia |
|
| Systemic Event- Generalized Arthralgia |
|
| SAE |
|
|
| Day 29 |
|
|
| Day 57 |
|
|