A Phase 2a, Randomized, Observer-Blind, Placebo Controlled, Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 SARS-COV-2 Vaccine in Adults Aged 18 Years and Older
Latest Information Update: 02 Jan 2023
At a glance
- Drugs Elasomeran (Primary) ; MRNA 1273 351 (Primary)
- Indications COVID 2019 infections
- Focus Adverse reactions; Pharmacodynamics; Proof of concept; Registrational
- Sponsors Moderna Therapeutics
- 15 Nov 2022 Results (n=593) assessing the combined utility of the Elecsys Anti-SARS-CoV-2 S (ACOV2S) and the Elecsys Anti-SARS-CoV-2 (ACOV2N) assays using samples from the mRNA-1273 (Spikevax), published in the Infectious Diseases and Therapy.
- 01 May 2022 Results (n=344) from the part B of the study evaluating the safety and immunogenicity of a booster injection of 50 microg mRNA-1273 vaccine, published in the Nature Medicine.
- 07 Jan 2022 According to a Moderna Therapeutics media release, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older.
Most Recent Events
Trial Overview
Purpose
This dose-confirmation, phase II clinical study is designed to assess the safety, reactogenicity, and immunogenicity of 2 dose levels of mRNA-1273 SARS-COV-2 vaccine in adults 18 years of age or older.
Comments
According to a Moderna Therapeutics media release, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older.
According to a Food and Drug Administration media release, the U.S. Food and Drug Administration amended the emergency use authorizations (EUA) for Moderna vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices will meet later today to discuss further clinical recommendations.
According to a Moderna Therapeutics media release, the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted to recommend the use of a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level for people aged 65 and older; people aged 18 to 64 who are at high risk of severe COVID-19; and people aged 18 to 64 with frequent institutional or occupational exposure to SARS-CoV-2 under the Emergency Use Authorization issued by US FDA. The positive vote was unanimous with 15 ACIP members recommending the booster.
According to a Moderna Therapeutics media release, the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant an Emergency Use Authorization (EUA) for a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg dose level for people aged 65 and older; people aged 18 to 64 who are at high risk of severe COVID-19; and people aged 18 to 64 whose exposure to COVID-19 puts them at risk for COVID-19 complications or severe illness, the VRBPAC based its recommendation on the totality of scientific evidence, including a data analysis from this trial.
According to a Food and Drug Administration media release, on 14 Oct 2021, the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss newly available data for an amendment to the emergency use authorization of the Moderna COVID-19 Vaccine for the administration of a booster dose, in individuals 18 years of age and older.
According to a Moderna Therapeutics media release, the company has submitted data for a conditional marketing approval (CMA) with the European Medicines Agency (EMA) for the evaluation of a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg dose level, based on data from this study and additional analyses.
Primary Endpoints
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
description: Solicited ARs, including local and systemic ARs were collected in the eDiary. Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. All solicited ARs (local and systemic) considered causally related to injection. ARs were graded 0-4 as reviewed and confirmed by Investigator; lower score indicates lower severity and a higher score indicates greater severity. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
time_frame: 7 days post-vaccination
Number of Participants With Unsolicited AEs
description: An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent AE (TEAE) was defined as any event not present before exposure to vaccine or any event already present that worsens in intensity or frequency after exposure. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsens from baseline and is considered clinically significant in the medical and scientific judgment of the Investigator. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Month 15), regardless of causality, is located in the Reported "Adverse Events" section.
time_frame: Up to 28 days post-vaccination
Number of Participants With Medically-Attended Adverse Events (MAAEs)
description: An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner (HCP). A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
time_frame: Up to Month 15
Number of Participants With SAEs
description: An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
time_frame: Up to Month 15
Change from Baseline in the Measure of Clinical Safety Laboratory Values in Cohort 2
time_frame: Part A: Baseline, 1 month after last vaccination
Number of Participants with Abnormalities in Blood Pressure, Temperature, HR, or Respiratory Rate
time_frame: Up to Month 15
Number of Participants with Abnormalities in Physical Examinations
time_frame: Up to Month 15
Level of SARS-CoV-2-Specific Binding Antibody (bAb) as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
time_frame: Day 1 through 6 months after last vaccination
Part A: Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-COV-2)-Specific Binding Antibody (bAb) as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
description: The geometric mean (GM) level of VAC58 spike immunoglobulin G (IgG) antibodies, as measured by ELISA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ. Values that were greater than the upper limit of quantification (ULOQ) were converted to the ULOQ if actual values were not available. LLOQ was 1 and ULOQ was 2052. The 95% confidence intervals (CIs) were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, respectively, then back transformed to the original scale for presentation.
time_frame: Days 1 (Baseline), 29, 43, 57, and 209
Part B: Level of SARS-CoV-2-Specific bAb as Measured by ELISA
description: The GM level of VAC65 spike IgG antibodies, as measured by ELISA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ are converted to the ULOQ. LLOQ was 1 and ULOQ was 2052. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, respectively, then back transformed to the original scale for presentation. The PP Set included participants with a study injection, required baseline data, had postinjection results at timepoint of primary interest for immunogenicity analysis, no major protocol deviations impacting immune response, and didn't have SARS-CoV-2.
time_frame: Days 1 (Baseline) and 29
Part C: Level of SARS-CoV-2-Specific bAb as Measured by MSD
description: The GM level of SARS-CoV-2 protein antibody against B.1.351, as measured by MSD MULTIPLEX is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ are converted to the ULOQ. LLOQ was 18 and ULOQ was 4200000. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, respectively, then back transformed to the original scale for presentation.
time_frame: Days 1 (Baseline), 8, 15, and 29
Other Endpoints
Part A: Titer of SARS-CoV-2-Specific Neutralizing Antibody (nAb)
description: The GM titer (microneutralization [MN] and MN50) of serum nAb against SARS-CoV-2 as measured by live virus MN assays is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ. For MN, LLOQ was 40 and ULOQ was 1280 at Days 1 (Baseline), 29, 43, and 57. For MN50, LLOQ was 91.10 and ULOQ was 2031.87 at Days 1 (Baseline), 29, 43, and 57. For MN, LLOQ was 160 and ULOQ was 1280 at Day 209. For MN50, LLOQ was 318.46 and ULOQ was 1917.83 at Day 209. The 95% CI was calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM titer, then back transformed to the original scale for presentation.
time_frame: Days 1 (Baseline), 29, 43, 57, and 209
Part B: Titer of SARS-CoV-2-Specific nAb
description: The GM titer (50% inhibitory dose [ID50], 80% inhibitory dose [ID80]) of nAb against SARS-CoV-2 pseudotyped viruses as measured by pseudovirus nAb assay is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ if actual values were not available. LLOQ was 18.5 and ULOQ was 45118 for IC50. LLOQ was 14.3 and ULOQ was 10232 for ID80. The 95% CI was calculated based on the t-distribution of the log-transformed values for GM titer, then back transformed to the original scale for presentation. The PP Set included participants with a study injection, required baseline data, had postinjection results at timepoint of primary interest for immunogenicity analysis, no major protocol deviations impacting immune response, and didn't have SARS-CoV-2.
time_frame: Days 1 (Baseline), 29, and 181
Part C: Titer of SARS-CoV-2-Specific nAb
description: The GM titer (ID50, ID80) of nAb against SARS-CoV-2 pseudotyped viruses (original strain and beta variant [B.1.351]) as measured by pseudovirus nAb assay is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ if actual values were not available. For NAb ID50 Titers, LLOQ was 18.5 and ULOQ was 45118. For NAb ID80 Titers, LLOQ was 14.3 and ULOQ was 10232. For NAb ID50 Titers against B.1.351, LLOQ was 19.5 and ULOQ was 385.7. For NAb ID80 Titers against B.1.351, LLOQ was 12.5 and ULOQ was 102.2. The 95% CI was calculated based on the t-distribution of the log-transformed values for GM titer, then back transformed to the original scale for presentation.
time_frame: Days 1 (Baseline), 8, 15, 29, and 181
Part A: Percentage of Participants With Seroconversion From Baseline
description: Based on MN titers and MN50 titers of serum nAb against SARS-CoV-2 as measured by live virus MN assays, percentage of participants with seroconversion from baseline are reported with 2-sided 95% CI using the Clopper-Pearson method at each post-baseline timepoint. Seroconversion at a participant level was defined as a change of nAb titer from below the limit of detection (LOD) or LLOQ to equal to or above LOD or LLOQ (respectively), or a 4-times or higher titer ratio in participants with pre-existing nAb titers. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ were converted to the ULOQ. For MN, LLOQ was 40 and ULOQ was 1280. For MN50, LLOQ was 91.10 and ULOQ was 2031.87.
time_frame: Days 29, 43, and 57
Part B: Percentage of Participants With Seroconversion From Baseline
description: Based on ID50 and ID80 titers of nAb against SARS-CoV-2 pseudotyped viruses as measured by pseudovirus nAb assay, % of participants with seroconversion from baseline reported with 2-sided 95% CI using Clopper-Pearson method at each postbaseline timepoint. Seroconversion at participant level defined as change of nAb titer from below LOD or LLOQ to equal to or above LOD or LLOQ (respectively) or 4-times or higher titer ratio in participants with preexisting nAb titers. Antibody values ULOQ converted to ULOQ. LLOQ: 18.5 and ULOQ: 45118 for IC50. LLOQ: 14.3 and ULOQ: 10232 for ID80. 95% CI calculated based on t-distribution of log-transformed values for GMT, then back transformed to original scale for presentation. PP Set: participants with a study injection, required baseline data, had postinjection results at timepoint of primary interest for immunogenicity analysis, no major protocol deviations impacting immune response, and didn't have SARS-CoV-2.
time_frame: Days 29 and 181
Part C: Percentage of Participants With Seroconversion From Baseline
description: Based on ID50 titers and ID80 titers of nAb against SARS-CoV-2 pseudotyped viruses (original strain and beta variant [B.1.351]) as measured by pseudovirus nAb assay, percentage of participants with seroconversion from baseline are reported with 2-sided 95% CI using Clopper-Pearson method at each post-baseline timepoint. Seroconversion at participant level defined as a change of nAb titer from below LOD or LLOQ ≥LOD or LLOQ (respectively), or a 4-times or higher titer ratio in participants with pre-existing nAb titers. Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values >ULOQ were converted to ULOQ. NAb ID50 Titers: LLOQ was 18.5 and ULOQ was 45118. NAb ID80 Titers: LLOQ was 14.3 and ULOQ was 10232. NAb ID50 Titers against B.1.351: LLOQ was 19.5 and ULOQ was 385.7. NAb ID80 Titers against B.1.351: LLOQ was 12.5 and ULOQ was 102.2. 95% CI calculated based on t-distribution of log-transformed values for GMT, then back transformed to original scale for presentation.
time_frame: Days 8, 15, 29, and 181 [1]
Diseases Treated
| Indication | Qualifiers | Patient Segments |
|---|---|---|
| COVID 2019 infections | prevention | - |
Biomarker
| NCT Number | Biomarker Name | Biomarker Function |
|---|---|---|
| NCT04405076 | FSH | Eligibility Criteria |
| vitronectin | Detailed Description |
Subjects
- Subject Type patients
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Number
Planned: 660
Actual: 660
- Sex male & female
- Age Group ≥ 18 years; adult
Patient Inclusion Criteria
Key Each participant must meet all of the following criteria during the screening period and at Day 1, unless noted otherwise, to be enrolled in this study: 1. Male or female, 18 years of age or older at the time of consent (Screening Visit, Day 0). For Part B, participants must have been previously enrolled in the mRNA-1273 P201 study. 2. Understands and agrees to comply with the study procedures and provides written informed consent. 3. According to the assessment of the investigator, is in good general health and can comply with study procedures. 4. Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥12 consecutive months prior to Screening (Day 0) without an alternative medical cause). A follicle-stimulating hormone (FSH) level may be measured at the discretion of the investigator to confirm postmenopausal status. 5. Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria: - Has a negative pregnancy test at Screening (Day 0) and on the day of the first injection (Day 1). - Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (Day 1). - Has agreed to continue adequate contraception through 3 months following the second injection (Day 29). - Is not currently breastfeeding. Adequate female contraception is defined as consistent and correct use of a Food and Drug Administration (FDA) approved contraceptive method in accordance with the product label. For example: - Barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide - Intrauterine device - Prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or IM route - Sterilization of a female participant's monogamous male partner prior to entry into the study Note: periodic abstinence (for example, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 6. Male participants engaging in activity that could result in pregnancy of sexual partners must agree to practice adequate contraception from the time of the first injection and through 3 months after the last injection. Adequate contraception for male participants is defined as: - Monogamous relationship with a female partner using an intrauterine device or hormonal contraception (described above) - Use of barrier methods and spermicide - History of surgical sterilization - Male participants with partners who have become pregnant prior to Screening are eligible to participate in the study. Additional Key Inclusion Criteria for Part C 1. Participants must have been previously enrolled in the mRNA-1273-P301 study and must have received 2 doses of mRNA-1273 in Part A, has been unblinded and aware of their actual treatment in Study mRNA-1273-P301, must have been compliant in Study mRNA-1273-P301 (was not withdrawn or discontinued early), and has been at least 6 months since their second dose in Study mRNA-1273-P301 prior to enrollment in this part. Key
Patient Exclusion Criteria
Participants meeting any of the following criteria at the Screening Visit (Day 0) or at Day 1, unless noted otherwise, will be excluded from the study: 1. Pregnant or breastfeeding. 2. Is acutely ill or febrile 24 hours prior to or at the Screening Visit (Day 0). Fever is defined as a body temperature ≥38.0°Celsius/100.4°Fahrenheit. Participants meeting this criterion may be rescheduled within the relevant window periods. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. 3. Current treatment with investigational agents for prophylaxis against COVID-19. 4. Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator's judgment. 5. Is a healthcare worker or a member of an emergency response team. 6. Current use of any inhaled substance (for example, tobacco or cannabis smoke, nicotine vapors). 7. History of chronic smoking (≥1 cigarette a day) within 1 year of the Screening Visit (Day 0). 8. History of illegal substance use or alcohol abuse within the past 2 years. This exclusion does not apply to historical cannabis use that was formerly illegal in the participant's state but is legal at the time of Screening. 9. Known history of hypertension, or systolic blood pressure >150 millimeter of mercury (mmHg) in participants in Cohort 1 (≥18 to <55 years old) or systolic blood pressure >160 mmHg in participants in Cohort 2 (≥55 years old) at the Screening Visit (Day 0). 10. Known history of hypotension or systolic blood pressure <85 mmHg at the Screening Visit (Day 0). 11. Diabetes mellitus 12. Diagnosis of chronic pulmonary disease (for example, chronic obstructive pulmonary disease, asthma) 13. Chronic cardiovascular disease 14. Resides in a nursing home 15. Grade 1 or higher toxicity on clinical safety laboratory testing at the Screening Visit (Day 0) 16. Current or previous diagnosis of immunocompromising condition, immune-mediated disease, or other immunosuppressive condition. 17. Received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to the Screening Visit (Day 0) (for corticosteroids ≥20 milligrams (mg)/day of prednisone equivalent). Topical tacrolimus is allowed if not used within 14 days prior to the Screening Visit (Day 0). 18. Anticipating the need for immunosuppressive treatment at any time during participation in the study. 19. Positive serology for hepatitis B virus surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) type 1 or 2 antibodies identified at the Screening Visit (Day 0). 20. History of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine. 21. Bleeding disorder considered a contraindication to IM injection or phlebotomy. 22. Diagnosis of malignancy within previous 10 years (excluding non-melanoma skin cancer). 23. Has received or plans to receive a licensed vaccine ≤28 days prior to the first injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after any study injection. Licensed influenza vaccines may be received more than 14 days before or after any study injection. 24. Receipt of systemic immunoglobulins or blood products within 3 months prior to the Screening Visit (Day 0) or plans for receipt during the study. 25. Has donated ≥450 mL of blood products within 28 days prior to the Screening Visit (Day 0) or plans to donate blood products during the study. 26. Participated in an interventional clinical study (other than mRNA-1273 P301) within 28 days prior to the Screening Visit (Day 0) or plans to do so while participating in this study. 27. Is an immediate family member or household member of study personnel Additional Key Exclusion Criteria for Part C 1. Is SARS-CoV-2 positive by Reverse transcription polymerase chain reaction (RT-PCR) (central or local testing) at baseline or at any time during the mRNA-1273-P301 study regardless of the presence or absence of symptoms consistent with COVID-19. 2. Had any SAE in the mRNA-1273-P301 study.
Trial Details
Identifiers
| Identifier | Owner |
|---|---|
| NCT04405076 | ClinicalTrials.gov: US National Institutes of Health |
| mRNA1273P201 | - |
| 75A50120C00034 | - |
Organisations
- Sponsors Moderna Therapeutics
- Affiliations Moderna Therapeutics
Trial Dates
-
Initiation Dates
Actual : 29 May 2020
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Primary Completion Dates
Planned : 31 Oct 2021
Actual : 28 Oct 2021
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End Dates
Planned : 31 Oct 2021
Actual : 28 Oct 2021
Other Details
- Design double-blind; multicentre; open; prospective; randomised; sequential
- Phase of Trial Phase II
- Location USA
- Focus Adverse reactions; Pharmacodynamics; Proof of concept; Registrational
Interventions
| Drugs | Route | Formulation |
|---|---|---|
| ElasomeranPrimary Drug | Intramuscular | Injection |
| MRNA 1273 351Primary Drug | Intramuscular | Injection |
Placebo (Part A) and mRNA-1273 100 ug (Part B) - Participants Aged 18-54 years
Part A: Participants aged 18-54 years will receive 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29. Part B: Participants aged 18-54 who choose to be unblinded and received mRNA-1273-matching placebo during Part A, will receive 1 IM injection of 100 ug mRNA-1273 on Day 1 and Day 29. Biological: Biological: mRNA-1273 (Sterile liquid for injection) Biological: Placebo (0.9% sodium chloride (normal saline) injection)
Placebo (Part A) and mRNA-1273 100 ug (Part B) - Participants Aged 55+ years
Part A: Participants aged 55+ years will receive 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29. Part B: Participants aged 55+ years who choose to be unblinded and received mRNA-1273-matching placebo during Part A, will receive 1 IM injection of 100 ug mRNA-1273 on Day 1 and Day 29. Biological: Biological: mRNA-1273 (Sterile liquid for injection) Biological: Placebo (0.9% sodium chloride (normal saline) injection)
mRNA-1273/mRNA-1273.351 mixture (Part C)
Part C: Participants will receive 1 IM booster dose of 50 ug of mRNA-1273/mRNA-1273.351 mixture on Day 1. Biological: Biological: mRNA-1273 (Sterile liquid for injection) Biological: mRNA-1273.351 (Sterile liquid for injection)
mRNA-1273: Dose 100 ug - Participants Aged 18-54 years
Part A: Participants aged 18-54 years will receive 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29. Part B: Participants aged 18-54 years who choose to be unblinded and received 100 ug mRNA-1273 during Part A, will receive 1 IM injection of mRNA-1273 (booster dose) on Day 1. Biological: Biological: mRNA-1273 (Sterile liquid for injection)
mRNA-1273: Dose 100 ug - Participants Aged 55+ years
Part A: Participants aged 55+ years will receive 1 IM injection of 100 ug mRNA-1273 on Day 1 and on Day 29. Part B: Participants aged 55+ years who choose to be unblinded and received 100 ug mRNA-1273 during Part A, will receive 1 IM injection of mRNA-1273 (booster dose) on Day 1. Biological: Biological: mRNA-1273 (Sterile liquid for injection)
mRNA-1273: Dose 50 microgram (ug) - Participants Aged 18-54 years
Part A: Participants aged 18-54 years will receive 1 intramuscular (IM) injection of 50 ug mRNA-1273 on Day 1 and on Day 29. Part B: Participants aged 18-54 years who choose to be unblinded and received 50 ug mRNA-1273 during Part A, will receive 1 IM injection of mRNA-1273 (booster dose) on Day 1. Biological: Biological: mRNA-1273 (Sterile liquid for injection)
mRNA-1273: Dose 50 ug - Participants Aged 55+ years
Part A: Participants aged 55+ years will receive 1 IM injection of 50 ug mRNA-1273 on Day 1 and on Day 29. Part B: Participants aged 55+ years who choose to be unblinded and received 50 ug mRNA-1273 during Part A, will receive 1 IM injection of mRNA-1273 (booster dose) on Day 1. Biological: Biological: mRNA-1273 (Sterile liquid for injection)
mRNA 1273.351 20 ug (Part C)
Part C: Participants will receive 1 IM booster dose of 20 ug of mRNA 1273.351 on Day 1. Biological: mRNA-1273.351 (Sterile liquid for injection)
mRNA 1273.351 50 ug (Part C)
Part C: Participants will receive 1 IM booster dose of 50 ug of mRNA 1273.351 on Day 1. Biological: mRNA-1273.351 (Sterile liquid for injection)
Results
Publications
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Chu L, Vrbicky K, Montefiori D, Huang W, Nestorova B, Chang Y, et al. Immune response to SARS-CoV-2 after a booster of mRNA-1273: an open-label phase 2 trial. Nature-Med 2022;28(5):1042-1049.
PubMed | CrossRef Fulltext -
Chu L, McPhee R, Huang W, Bennett H, Pajon R, Nestorova B, et al. A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine. Vaccine 2021;.
PubMed | CrossRef Fulltext -
Choi A, Koch M, Wu K, Chu L, Ma L, Hill A, et al. Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis. Nature-Med 2021;27(11):2025-2031.
PubMed | CrossRef Fulltext -
Kirste I, Hortsch S, Grunert VP, Legault H, Maglinao M, Eichenlaub U, et al. Quantifying the Vaccine-Induced Humoral Immune Response to Spike-Receptor Binding Domain as a Surrogate for Neutralization Testing Following mRNA-1273 (Spikevax) Vaccination Against COVID-19. Infect-Dis-Therapy 2022;1-15.
PubMed | CrossRef Fulltext
Trial Centres
Investigators
| Investigator | Centre Name | Trial Centre Country |
|---|---|---|
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Advanced Clinical Research/Velocity, Benchmark Research, Heartland Research Associates, Meridian Clinical Research, Trial Management Associates | USA |
|
Moderna Clinical Trials
855-663-6762
show details
clinicaltrials@modernatx.com |
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Centres
| Centre Name | Location | Trial Centre Country |
|---|---|---|
| - |
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| Advanced Clinical Research/Velocity | West Jordan, Utah | USA |
| Benchmark Research | Austin, Texas | USA |
| Benchmark Research | San Angelo, Texas | USA |
| Biomedical Advanced Research and Development Authority |
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| Heartland Research Associates | Kansas City, Missouri | USA |
| Heartland Research Associates | Newton, Kansas | USA |
| Meridian Clinical Research | Dakota Dunes, South Dakota | USA |
| Meridian Clinical Research | Norfolk, Nebraska | USA |
| Meridian Clinical Research | Omaha, Nebraska | USA |
| Meridian Clinical Research | Savannah, Georgia | USA |
| ModernaTX, Inc. |
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| Trial Management Associates | Wilmington, North Carolina | USA |
Trial History
| Event Date | Event Type | Comment |
|---|---|---|
| 02 Jan 2023 | Other trial event | Last checked against the ClinicalTrials.gov record. Updated 02 Jan 2023 |
| 15 Nov 2022 | Results | Results (n=593) assessing the combined utility of the Elecsys Anti-SARS-CoV-2 S (ACOV2S) and the Elecsys Anti-SARS-CoV-2 (ACOV2N) assays using samples from the mRNA-1273 (Spikevax), published in the Infectious Diseases and Therapy. Updated 18 Nov 2022 |
| 01 May 2022 | Results | Results (n=344) from the part B of the study evaluating the safety and immunogenicity of a booster injection of 50 microg mRNA-1273 vaccine, published in the Nature Medicine. Updated 02 Jun 2022 |
| 07 Jan 2022 | Other trial event | According to a Moderna Therapeutics media release, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older. Updated 13 Jan 2022 |
| 27 Nov 2021 | Status change - completed | Status changed from active, no longer recruiting to completed. Updated 01 Dec 2021 |
| 19 Nov 2021 | Other trial event | According to a Food and Drug Administration media release, The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices will meet later today to discuss further clinical recommendations. Updated 03 Dec 2021 |
| 19 Nov 2021 | Other trial event | According to a Food and Drug Administration media release, the U.S. Food and Drug Administration amended the emergency use authorizations (EUA) for Moderna vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. Updated 03 Dec 2021 |
| 01 Nov 2021 | Interim results | Results of an exploratory analysis of the preliminary safety and immunogenicity of single booster doses of mRNA1273 (50 microgram), modified mRNA1273-351 (20 or 50 microgram) encoding the S protein of B1-351 and multivalent mRNA1273-211 (1:1 mix of mRNA1273 (25 microgram) and mRNA1273-351 (25 microgram), published in the Nature Medicine. Updated 30 Dec 2021 |
| 21 Oct 2021 | Other trial event | According to a Moderna Therapeutics media release, the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted to recommend the use of a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level for people aged 65 and older; people aged 18 to 64 who are at high risk of severe COVID-19; and people aged 18 to 64 with frequent institutional or occupational exposure to SARS-CoV-2 under the Emergency Use Authorization issued by US FDA. Updated 26 Oct 2021 |
| 14 Oct 2021 | Other trial event | According to a Moderna Therapeutics media release, the USFDA Vaccines and Related Biological Products Advisory Committee recommended that the FDA grant an Emergency Use Authorization for a booster dose of the Moderna COVID19 vaccine at the 50 µg dose level for people aged 65 and older; people aged 18 to 64 who are at high risk of severe COVID-19; and people aged 18 to 64 whose exposure to COVID19 puts them at risk for COVID 19 complications or severe illness based on this trial. Updated 21 Oct 2021 |
| 01 Oct 2021 | Other trial event | According to a Food and Drug Administration media release, on 14 Oct 2021, the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss newly available data for an amendment to the emergency use authorization of the Moderna COVID-19 Vaccine for the administration of a booster dose, in individuals 18 years of age and older. Updated 08 Oct 2021 |
| 28 Sep 2021 | Completion date | Planned End Date changed from 1 Nov 2021 to 31 Oct 2021. Updated 06 Oct 2021 |
| 28 Sep 2021 | Other trial event | Planned primary completion date changed from 1 Nov 2021 to 31 Oct 2021. Updated 06 Oct 2021 |
| 27 Sep 2021 | Other trial event | According to a Moderna Therapeutics media release, the EMA has started evaluating an application for the use of a booster dose of Spikevax to be given at least 6 months after the second dose in people aged 12 years and older. The EMA's human medicines committee (CHMP) will carry out an accelerated assessment of data submitted by the company that markets Spikevax (Moderna), including results from this trial. Updated 29 Sep 2021 |
| 03 Sep 2021 | Other trial event | According to a Moderna Therapeutics media release, the company has submitted data for a conditional marketing approval (CMA) with the European Medicines Agency (EMA) for the evaluation of a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg dose level, based on data from this study and additional analyses. Updated 07 Sep 2021 |
| 12 May 2021 | Other trial event | According to a Moderna media release, A manuscript describing these preliminary results was submitted as a preprint to medRxiv and will be submitted for peer-reviewed publication upon completion of the multivalent mRNA-1273.211 booster arm. Updated 25 May 2021 |
| 05 May 2021 | Biomarker Update | Biomarkers information updated Updated 17 Sep 2021 |
| 03 May 2021 | Completion date | Planned End Date changed from 6 Oct 2021 to 1 Nov 2021. Updated 07 May 2021 |
| 03 May 2021 | Other trial event | Planned primary completion date changed from 31 Mar 2021 to 1 Nov 2021. Updated 07 May 2021 |
| 22 Mar 2021 | Protocol amendment | Protocol amended to include Part C (a proof-of-concept rollover) study to evaluate a vaccine to treat mutations of SARS-CoV2, such as the S-protein of the B.1.351 variant. Anticipated enrolment of patients increased from 600 to 660. Number of study treatment arms increased from 6 to 9. Updated 25 Mar 2021 |
| 22 Mar 2021 | Other trial event | Planned number of patients changed from 600 to 660. Updated 25 Mar 2021 |
| 09 Feb 2021 | Interim results | A preliminary results published in the Vaccine Updated 17 Mar 2021 |
| 08 Feb 2021 | Protocol amendment | Time frame for primary and secondary outcome measures amended. Updated 12 Feb 2021 |
| 08 Feb 2021 | Completion date | Planned End Date changed from 31 Aug 2021 to 6 Oct 2021. Updated 12 Feb 2021 |
| 15 Jan 2021 | Completion date | Planned End Date changed from 1 Aug 2021 to 31 Aug 2021. Updated 22 Jan 2021 |
| 15 Jan 2021 | Other trial event | Planned primary completion date changed from 1 Mar 2021 to 31 Mar 2021. Updated 22 Jan 2021 |
| 27 Jul 2020 | Other trial event | According to a Moderna Therapeutics media release, PPD supported the Phase 2 study for this vaccine program. Updated 30 Jul 2020 |
| 08 Jul 2020 | Other trial event | According to a Moderna Therapeutics media release, the cohort of an older adults (n=300) has now been fully enrolled in this study. Updated 13 Jul 2020 |
| 08 Jul 2020 | Other trial event | According to a Moderna Therapeutics media release, on 25 June 2020, after reviewing the safety data from the sentinel cohort of older adults, the Data and Safety Monitoring Committee recommended to proceed with enrollment of this study. Updated 13 Jul 2020 |
| 08 Jul 2020 | Status change - active, no longer recruiting | Status changed from recruiting to active, no longer recruiting, according to a Moderna Therapeutics media release. Updated 13 Jul 2020 |
| 11 Jun 2020 | Other trial event | According to a Moderna Therapeutics media release, the first cohort of healthy adults ages 18-54 years (n=300) in this study is fully enrolled. The sentinel participants in the cohort of older adults ages 55 years and above (n=50) is fully enrolled. Updated 17 Jun 2020 |
| 01 Jun 2020 | Other trial event | New source identified and integrate (ClinicalTrials.gov: US National Institutes of Health: NCT04405076). Updated 01 Jun 2020 |
| 01 Jun 2020 | Status change - recruiting | Status changed from planning to recruiting. Updated 01 Jun 2020 |
| 29 May 2020 | Other trial event | According to a Moderna Therapeutics media release, first participants in each age cohort have been dosed. Updated 05 Jun 2020 |
| 18 May 2020 | Protocol amendment | According to a Moderna Therapeutics media release, based on the interim results from phase I trial, the study will be amended to study two dose levels, 50 µg and 100 µg, with the aim of selecting a dose for pivotal studies. Updated 22 May 2020 |
| 07 May 2020 | Other trial event | According to a Moderna Therapeutics media release, the U.S. Food and Drug Administration (FDA) has completed the review of Investigational New Drug (IND) application allowing company to initiate this study. The company expected to initiate this study shortly. Updated 12 May 2020 |
| 27 Apr 2020 | Other trial event | According to a Moderna Therapeutics, the company has submitted an Investigational New Drug application to the U.S. Food and Drug Administration (FDA) for the company's mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2) to evaluate mRNA-1273 in Phase 2 and late-stage studies if supported by safety data from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Updated 04 May 2020 |
| 27 Apr 2020 | Other trial event | According to a Moderna Therapeutics, The company intends to enroll 600 healthy participants across two cohorts of adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300). Participants will be followed through 12 months after the second vaccination. Updated 04 May 2020 |
| 27 Apr 2020 | Other trial event | According to a Moderna Therapeutics, the company has received initial feedback from the FDA on the design of the planned Phase 2 study. Updated 04 May 2020 |
| 27 Apr 2020 | Other trial event | According to a Moderna Therapeutics, Funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, supported the planning for these studies and also will support the late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacturing. Updated 04 May 2020 |
| 16 Apr 2020 | Other trial event | According to a Modern Therapeutics, Phase 2 study expected to begin in Q2 2020, following safety data from ongoing Phase 1 study Updated 20 Apr 2020 |
| 18 Mar 2020 | New trial record | New trial record Updated 18 Mar 2020 |
| 16 Mar 2020 | Other trial event | According to a Modern Therapeutics, the company is actively preparing for a potential Phase 2 study under its own IND which could begin in a few months. Updated 18 Mar 2020 |
Table of Contents
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