A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults

Influenza Clinical Trial

Official title:

Phase 2, Open-Label Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 and Comparator Seasonal Influenza Vaccines in Healthy Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05606965
• Other study ID #: mRNA-CRID-003
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 2, 2022
• Est. completion date: August 9, 2024

Study information

• Verified date: March 2024
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of the study is to evaluate the safety, reactogenicity, and the humoral immunogenicity of mRNA-1010 and comparator influenza vaccines against homologous influenza A and B strains at Day 29.

Description:

The study consists of two parts. Part A of the study was conducted for the 2022-23 influenza season. Part B of the study will be conducted in 2023-24 influenza season.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 98
• Est. completion date: August 9, 2024
• Est. primary completion date: August 9, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Part A only: Body mass index (BMI) of 18 kilograms (kg)/meter (m)^2 to < 40 kg/m^2 at the screening visit. There will be no BMI requirement for inclusion in Part B.
• Female participants of childbearing potential: has a negative pregnancy test on the day of vaccination (D1); practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days before D1; has agreed to continue adequate contraception through 3 months after vaccine administration; and is not currently breastfeeding.

Exclusion Criteria:

• Acutely ill or febrile (temperature = 38.0°Celsius (C)/100.4° Fahrenheit (F) hours before or at the D1 vaccination visit. Participants meeting this criterion may be rescheduled within the 28-day screening window.
• Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
• Reported history of congenital or acquired immunodeficiency, immunocompromising or immunosuppressive condition, asplenia, or history of recurrent severe infections. Certain immune-mediated conditions that are stable and well-controlled (for example, Hashimoto's thyroid disease) or that do not require systemic immunosuppressive therapy may be permitted at the discretion of the Investigator.
• Dermatologic conditions that could affect local solicited AR assessments (tattoos, psoriatic patches or vitiligo affecting skin over the deltoid injection site area).
• Has received systemic immunosuppressants (for glucocorticoids = 10 mg/day of prednisone or equivalent) for > 14 days in total within 180 days before vaccination visit (D1) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study (including intra-articular steroid injections). Inhaled, nasal, and topical steroids are allowed.
• Has received systemic immunoglobulins or long-acting biological therapies that may suppress or alter immune responses (for example, Infliximab®) or blood products within 90 days before the vaccination visit or plans to receive them during the study.
• Has a history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA or influenza vaccines or any components of the mRNA or influenza vaccines, including egg protein. Other protocol-defined inclusion/exclusion criteria apply.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• mRNA-1010
Sterile liquid for injection
• Egg-based Quadrivalent Influenza Vaccine
Sterile suspension for injection
• Adjuvanted Quadrivalent Influenza Vaccine
Sterile injectable emulsion
• Inactivated Influenza Vaccine
Sterile suspension for injection

Locations

Country	Name	City	State
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)		Up to Day 7 (7 days after vaccination)
Primary	Number of Unsolicited Adverse Events (AEs)		Up to Day 28 (28 days after vaccination)
Primary	Number of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs), and AEs Leading to Discontinuation		Day 1 through Day 181
Primary	Change from Baseline in Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutinin Inhibition (HAI) Assay		Baseline, Day 29
Primary	Change from Baseline in Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay		Baseline, Day 29
Primary	Percentage of Participants with Seroresponse, as Measured by HAI Assay	Seroresponse is defined as a Day 29 titer > 1:40 if baseline is < 1:10 or a minimum 4-fold rise if baseline is >1:10 in anti-HA antibodies measured by HAI assay.	Day 29
Secondary	Change from Baseline in GMT of Anti-HA Antibodies at Days 121 and 181, as Measured by HAI Assay or Microneutralization (MN) Assay		Baseline, Days 121 and 181
Secondary	Change from Baseline in GMFR of Anti-HA Antibodies at Days 121 and 181, as Measured by HAI Assay or MN Assay		Baseline, Days 121 and 181