Clinical trial NCT06585241: A Study to Investigate the Immunogenicity of mRNA COVID-19 Variant-containing Vaccine Formulations in Adults to Prevent COVID-19
Official title: A Phase 3b/4, Open-label Study to Assess the Immunogenicity of mRNA COVID-19 Variant-containing Vaccine Formulations in Previously Vaccinated Adults Aged ≥18 Years
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: SARS-CoV-2
Keywords: mRNA-1273
mRNA-1273 vaccine
SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
Virus Diseases
Messenger RNA
COVID-19
COVID-19 Vaccine
Variant
Moderna
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a Phase 3b/4 open-label study.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the immunogenicity of mRNA COVID-19 variant-containing vaccine formulations against the vaccine matched variants and newly emerged variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in previously vaccinated adults.


Eligibility criteria: Inclusion Criteria:

* Participants had previous mRNA COVID-19 vaccination.
* Able to comply with study procedures based on the assessment of the Investigator.
* 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 the Screening Visit and on the day of vaccination prior to vaccine dose being administered on 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 dose.
  * Has agreed to continue adequate contraception through 28 days following vaccine administration.

Exclusion Criteria:

* History of SARS-CoV-2 infection within 3 months prior to enrollment.
* Is acutely ill or febrile (temperature 38.0°Celsius/100.4°Fahrenheit) less than 72 hours prior to or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the Screening window.
* History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable, or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures.
* History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic.
* Receipt of COVID-19 vaccine within 3 months prior to enrollment.
* Receipt of any licensed non-COVID-19 vaccine within 28 days before or planned receipt within 28 days after the study intervention, except an influenza vaccine, which may be given 14 days before or after receipt of the study intervention.
* Receipt of systemic immunosuppressants or immune-modifying drugs for \>14 days total, within 6 months prior to Screening or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
* Receipt of systemic immunoglobulins or blood products within 3 months prior to the Screening Visit or plans for receipt during the study.
* Has donated ≥450 milliliters of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.

Primary outcomes:
measure: Geometric Mean Value of Neutralizing Antibody Against COVID-19 Variants
timeFrame: Day 29
measure: Geometric Mean Fold Rise of Neutralizing Antibody Against COVID-19 Variants
timeFrame: Day 29
Secondary outcomes:
measure: Number of Participants with Serious Adverse Events (AEs), AEs Leading to Study Withdrawal, and AEs of Special Interest
timeFrame: Day 1 through Day 29
Other outcomes:
Locations:
city: Decatur
country: United States
facility: CenExel iResearch, LLC
state: Georgia
Study officials:
References: