A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Vaccine Boosters

NCT05137236
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Completed
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Participants
540
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Lead sponsor
ModernaTX, Inc.
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Start date
2021-12-06
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Number of sites
17
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Summary
The main goal of Part A of this study is to assess the safety, reactogenicity, and immunogenicity of the study vaccine candidates. The main goal of Part B of this study is to assess the safety, reactogenicity, and immunogenicity of the mRNA-1283.529 booster vaccine candidate.
clinicaltrials.gov
Short title
A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Vaccine Boosters
clinicaltrials.gov
Official title
A Phase 2A, Randomized, Stratified, Observer-Blind Study to Evaluate the Immunogenicity and Safety of mRNA-1283 Vaccine Boosters for SARS-CoV-2
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Control arm
Active comparator
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Registry reports results
Yes
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Listing at source
Listed
clinicaltrials.gov
Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2023-03-23
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First posted
2021-11-30
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Registry last updated
2025-07-17
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Primary completion date
2023-03-23
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Start date
2021-12-06
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Actual participants
540
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Participants
540
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Participant count basis
Actual
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Protocol amendments
5
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Randomisation ratio
1:1:1:1
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Number of sites
17
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
ModernaTX, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05137236
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ClinicalTrials.gov ID
NCT05137236
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masking description
Part A of this study is designed as an observer-blind study. Part B of the study is designed as an open-label study.
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Parts A and B: Number of Participants With Solicited Local and Solicited Systemic Reactogenicity Adverse Reactions (ARs)

    Timeframe: Up to Day 7

    An AR is any adverse event (AE) related to the IP injection. Solicited local ARs included pain at injection site, erythema (redness) at injection site, swelling (hardness) at injection site, localized axillary swelling or tenderness ipsilateral to the injection arm, and groin or underarm swelling or tenderness ipsilateral to the side of injection. Solicited systemic ARs included headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, fever, chills, irritability/crying, sleepiness, and loss of appetite. Note, not all solicited ARs were considered AEs. The Investigator determined if solicited AR was also to be recorded as an AE. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

  2. Parts A and B: Number of Participants With Unsolicited AEs

    Timeframe: Up to Day 28

    An unsolicited AE was defined as any AE reported by the participant that was not specified as a solicited AR in the protocol or was specified as a solicited AR but started outside the protocol-defined period for reporting solicited ARs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

  3. Parts A and B: Number of Participants With Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study Participation and AEs of Special Interest (AESIs)

    Timeframe: Day 1 to Day 366

    SAEs were AEs that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly or birth defect, or was a medically important event. MAAEs were AEs that lead to an unscheduled visit to a healthcare provider. AESIs were AEs (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program for which ongoing monitoring and immediate notification by the investigator to the Sponsor was required. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

  4. Part A: Geometric Mean Titer (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Specific Neutralizing Antibody (nAb) Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351

    Timeframe: Day 29

    The GMT (50% inhibitory dose \[ID50\]) of nAb against ancestral SARS-CoV-2 and against SARS-CoV-2 variant B.1.351 are reported.

  5. Part A: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351

    Timeframe: Day 29

    The GMFR measures the changes in immunogenicity titers or levels within participants.

  6. Part A: Number of Participants With Seroresponse Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351

    Timeframe: Day 29

    Seroresponse was defined as an increase of SARS-CoV-2 specific binding antibody (bAb) level or nAb titer to at least 4x lower limit of quantification (LLOQ) if the baseline is below the LLOQ, or a 4-fold or greater rise if pre-booster ≥ LLOQ.

  7. Part B: GMT of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)

    Timeframe: Day 29

    The GMT (ID50) of nAb against SARS-CoV-2 omicron variant (B.1.1.529) are reported.

  8. Part B: GMFR of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)

    Timeframe: Day 29

    The GMFR measures the changes in immunogenicity titers or levels within participants.

  9. Part B: Number of Participants With Seroresponse Against SARS-CoV-2 Omicron Variant (B.1.1.529)

    Timeframe: Day 29

    Seroresponse was defined as an increase of SARS-CoV-2 specific bAb level or nAb titer to at least 4x LLOQ if the baseline is below the LLOQ, or a 4-fold or greater rise if pre-booster ≥ LLOQ.

  1. Part A: GMT of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351

    Timeframe: Days 1, 29, 91, 181, and 366

    The GMT (ID50) of nAb against ancestral SARS-CoV-2 and against SARS-CoV-2 Variant B.1.351 are reported.

  2. Part A: GMT of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351

    Timeframe: Days 1, 29, 91, 181, and 366

    The GMT of bAb against ancestral SARS-CoV-2 and against SARS-CoV-2 Variant B.1.351 are reported.

  3. Part B: GMT of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)

    Timeframe: Days 1, 29, 91, 181, and 366

    The GMT (ID50) of nAb against SARS-CoV-2 omicron variant (B.1.1.529) are reported.

  4. Part B: GMT of SARS-CoV-2 Specific bAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)

    Timeframe: Days 1, 29, 91, 181, and 366

    The GMT of bAb against SARS-CoV-2 omicron variant (B.1.1.529) are reported.

  5. Part A: GMFR of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351

    Timeframe: Days 29, 91, 181, and 366

    The GMFR measures the changes in immunogenicity titers or levels within participants.

  6. Part A: GMFR of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351

    Timeframe: Days 29, 91, 181, and 366

    The GMFR measures the changes in immunogenicity titers or levels within participants.

  7. Part B: GMFR of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)

    Timeframe: Days 29, 91, 181, and 366

    The GMFR measures the changes in immunogenicity titers or levels within participants.

  8. Part B: GMFR of SARS-CoV-2 Specific bAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)

    Timeframe: Days 29, 91, 181, and 366

    The GMFR measures the changes in immunogenicity titers or levels within participants.

  9. Part A: Number of Participants With Seroresponse Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351

    Timeframe: Days 29, 91, 181, and 366

    Seroresponse was defined as an increase of SARS-CoV-2 specific bAb level or nAb titer to at least 4x LLOQ if the baseline is below the LLOQ, or a 4-fold or greater rise if pre-booster ≥ LLOQ.

  10. Part B: Number of Participants With Seroresponse Against SARS-CoV-2 Omicron Variant (B.1.1.529)

    Timeframe: Days 29, 91, 181, and 366

    Seroresponse was defined as an increase of SARS-CoV-2 specific bAb level or nAb titer to at least 4x LLOQ if the baseline is below the LLOQ, or a 4-fold or greater rise if pre-booster ≥ LLOQ.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
Yes

  • Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as bilateral tubal ligation >1 year prior to screening, bilateral oophorectomy, hysterectomy, or menopause.
  • Female participants of childbearing potential may be enrolled in the study if the participant has a negative pregnancy test on the day of vaccination (Day 1), practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreed to continue adequate contraception through 3 months following the last vaccine administration, and not currently breastfeeding.
  • Participant must have received their second dose of the mRNA-1273 primary series at least 6 months prior to screening and enrollment (Part A) or have received the mRNA-1273 series and an mRNA-1273 booster dose at least 3 months prior to screening and enrollment (Part B).

  • Had significant exposure to someone with SARS-CoV-2 infection or COVID-19 in the past 14 days, defined by the US Centers for Disease Control and Prevention (CDC) as a close contact of someone who has COVID-19.
  • Is acutely ill or febrile (temperature ≥38.0 degree Celsius [°C]/100.4 degree Fahrenheit [°F]) less than 72 hours prior to or at the screening visit or Day 1.
  • 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.
  • Has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening (for corticosteroids ≥10 milligrams [mg]/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
  • Has received or plans to receive any licensed vaccine ≤28 days prior to the injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after the study injection, with the exception of influenza vaccines, which may be given 14 days before or after receipt of a study vaccine.
  • Has received systemic immunoglobulins or blood products within 3 months prior to the screening visit, or plans to receive these during the study.
  • Has donated ≥ 450 milliliters (mL) of blood products within 28 days prior to the screening visit or plans to donate blood products during the study.
  • Plans to participate in an interventional clinical trial of an investigational vaccine or drug while participating in this study.

Note: Other inclusion and exclusion criteria may apply.

Sources for eligibility
clinicaltrials.gov

  • MedPharmics, LLCPhoenix, United States
  • Research Centers of AmericaHollywood, United States
  • Precision Clinical ResearchSunrise, United States
  • Tekton ResearchChamblee, United States
  • MedPharmicsMetairie, United States
  • UMass Memorial Medical CenterWorcester, United States
  • Clinical Research Institute, Inc - CRNMinneapolis, United States
  • Meridian Clinical Research (Nebraska)Lincoln, United States
  • MedPharmics, LLC. - AlbuquerqueAlbuquerque, United States
  • Rochester Clinical Research, Inc.Rochester, United States
  • CTI Clinical Research CenterCincinnati, United States
  • Meridian Clinical Research (Cincinnati)Cincinnati, United States
  • Aventiv Research IncColumbus, United States
  • Coastal Carolina Research CenterNorth Charleston, United States
  • ACRC TrialsFrisco, United States
  • Ventavia Research GroupHouston, United States
  • Health Research of Hampton Roads Inc.Newport News, United States
Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)