A Study of an Investigational mRNA-1273.815 COVID-19 Vaccine in Previously Vaccinated Adults

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06354998
• Other study ID #: mRNA-1273-P401
• Status: Recruiting
• Phase: Phase 3
• Start date: April 8, 2024
• Est. completion date: June 1, 2024

Study information

• Verified date: April 2024
• Source: ModernaTX, Inc.
• Contact: Moderna Clinical Trials Support Center
• Phone: 1-877-777-7187
• Email: clinicaltrials[@]modernatx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2

Intervention

Biological:
• Investigational mRNA-1273.815
Sterile solution for injection
• Licensed Spikevax Vaccine
Commercially available formulation

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

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