SARS-CoV-2 Clinical Trial
Official title:
Randomized, Observer-Blind, Active-Controlled, Clinical Trial to Assess the Immunogenicity of an Investigational mRNA-1273.815 COVID-19 Vaccine in Previously Vaccinated Adults
Verified date | June 2024 |
Source | ModernaTX, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate immune responses of an Investigational mRNA-1273.815 vaccine against the Omicron subvariant strain (XBB.1.5) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Status | Completed |
Enrollment | 215 |
Est. completion date | May 10, 2024 |
Est. primary completion date | May 10, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Participants of childbearing potential may be enrolled in the study if the participant fulfills all of the following criteria: 1. Has a negative pregnancy test on the day of injection prior to vaccine dose being administered (Day 1). 2. Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1. 3. Has agreed to continue using an effective contraception through 2 weeks following injection. 4. Is not currently breastfeeding. Exclusion Criteria: - Has known history of SARS-CoV-2 infection within 3 months prior to enrollment. - Currently has symptomatic acute or unstable chronic disease requiring medical or surgical care, to include significant change in therapy or hospitalization for worsening disease, at the discretion of the Investigator. - 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. - Reported history of congenital or acquired immunodeficiency (for example, human immunodeficiency virus), immunosuppressive condition, asplenia, or recurrent severe infections disease. - Has known or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reaction to the vaccine or its excipients. - Receipt of the following: 1. COVID-19 vaccine within 3 months prior to enrollment 2. Any other licensed vaccine within 28 days before or 2 weeks after the study injection, with the exception of influenza vaccines, which may be given 14 days before or after receipt of a study vaccine. 3. Systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening (for corticosteroids =10 milligrams/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. Note: Inhaled, nasal, and topical steroids are allowed. 4. Systemic immunoglobulins or blood products within 3 months prior to Screening or plans for receipt during the study. - Has donated =450 milliliters of blood products within 28 days prior to Screening or plans to donate blood products during the study. - Has participated in an interventional clinical study within 28 days prior to Screening or 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. |
Country | Name | City | State |
---|---|---|---|
Australia | Paratus Brisbane | Brisbane | Queensland |
Australia | Emeritus Melbourne | Camberwell | Victoria |
Australia | Paratus Canberra | Canberra | Australian Capital Territory |
Australia | Holdsworth House | Darlinghurst | New South Wales |
Australia | AusTrials Sunshine Hospital | Melbourne | Victoria |
Australia | USC Morayfield | Morayfield | Queensland |
Australia | University of the Sunshine Coast, South Bank | South Brisbane | Queensland |
Lead Sponsor | Collaborator |
---|---|
ModernaTX, Inc. |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Geometric Mean of Neutralizing Antibodies (nAbs) Against SARS-CoV-2-specific Strain at Day 15 | Day 15 | ||
Secondary | Number of Participants with Serious Adverse Events (SAEs), Adverse Events (AEs) of Special Interest (AESIs), and AEs Leading to Withdrawal From the Study | Day 1 through Day 15 | ||
Secondary | Seroresponse Rate of nAb Against the SARS-CoV-2-specific Strain at Day 15 | Seroresponse is defined as nAb value change from baseline (preinjection Day 1) below the lower limit of quantitation (LLOQ) to =4 × LLOQ, or at least a 4-fold rise if baseline is =LLOQ. | Day 15 | |
Secondary | Geometric Mean Ratio of nAb Against the SARS-CoV-2-specific Strain for Investigational mRNA-1273.815 Over the Licensed Spikevax Vaccine at Day 15 | Geometric mean ratio is calculated as the ratio of the geometric mean titer of nAb in the Investigational mRNA-1273.815 treatment group to the licensed Spikevax vaccine treatment group. | Day 15 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT06039449 -
A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2
|
Phase 3 | |
Completed |
NCT04512079 -
FREEDOM COVID-19 Anticoagulation Strategy
|
Phase 4 | |
Completed |
NCT04527471 -
Pilot Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19
|
Phase 2 | |
Recruiting |
NCT05584202 -
Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19) Vaccine in Infants
|
Phase 2 | |
Completed |
NCT04579549 -
Repeat Testing for SARS-CoV-2
|
N/A | |
Active, not recruiting |
NCT05547243 -
A Cohort Study of COVID-19 mRNA Vaccine, Bivalent in Participants in China
|
N/A | |
Recruiting |
NCT04747574 -
Evaluation of the Safety of CD24-Exosomes in Patients With COVID-19 Infection
|
Phase 1 | |
Recruiting |
NCT04613310 -
PCR and Rapid Diagnostic Test on Saliva and Nasopharyngeal Swabs for the Detection of SARS-CoV-2 (COVID-19)
|
N/A | |
Completed |
NCT04515147 -
A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19
|
Phase 2 | |
Terminated |
NCT04447404 -
DUR-928 in Subjects With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury
|
Phase 2 | |
Withdrawn |
NCT04388709 -
Interferon Lambda Therapy for COVID-19
|
Phase 2 | |
Active, not recruiting |
NCT05550142 -
A Preliminary Exploratory Cohort Study of SARS-CoV-2 Variant (Omicron BA.5) mRNA Vaccine in Participants Aged 18 Years and Over in China
|
N/A | |
Completed |
NCT04620798 -
Longitudinal COVID-19 Antibody Testing in Indiana University Undergraduate Students
|
N/A | |
Active, not recruiting |
NCT05547256 -
A Preliminary Exploratory Cohort Study of COVID-19 mRNA Vaccine, Bivalent in Participants Aged 18 Years and Over in China
|
N/A | |
Completed |
NCT04561102 -
Evaluation of the COVIDSeq Test in Nasal Swab and Saliva From a COVID-19 Asymptomatic Population
|
||
Completed |
NCT04452604 -
Multicentric Registry of Patients With Acute Leukemia Infected by COVID-19
|
||
Completed |
NCT05366322 -
A Study to Compare mRNA-1273 Versus BNT162b2 COVID-19 Vaccines Among Immunocompromised Adults
|
||
Terminated |
NCT04958304 -
Moderna COVID-19 Vaccine mRNA-1273 Observational Pregnancy Outcome Study
|
||
Completed |
NCT04526769 -
Detecting SARS-CoV-2 in Tears
|
||
Completed |
NCT04690413 -
NOWDx Test for the Detection of Antibodies to COVID-19
|
N/A |