Phase 2, Open-Label Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 and Comparator Seasonal Influenza Vaccines in Healthy Adults
Overview
- Phase
- Phase 2
- Intervention
- mRNA-1010
- Conditions
- Influenza
- Sponsor
- ModernaTX, Inc.
- Enrollment
- 172
- Locations
- 1
- Primary Endpoint
- Parts A, B, and C: Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief 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.
Detailed Description
The study consists of 3 parts. Part A of the study was conducted for the 2022-23 influenza season. Part B of the study was conducted in 2023-24 influenza season. Part C of the study will be conducted in 2024-25 influenza season.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults 18-50 years (Study Parts A, B, and C) and 65-80 years (Study Parts A and B only) of age at the time of consent (Screening Visit).
- •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 and Part C.
- •A person of childbearing potential (POCBP): has a negative highly sensitive pregnancy test at the Screening Visit and before each administration of study intervention; must use a contraceptive method that is highly effective from at least 28 days prior to Day 1 (Baseline) to at least 3 months after the last study intervention; and is not currently pregnant or 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, immunocompromizing 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.
Arms & Interventions
Parts A and B - Arm 1: mRNA-1010 (Age Group 18-50 years)
Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
Intervention: mRNA-1010
Parts A and B - Arm 2: Egg-based Quadrivalent Influenza Vaccine (Age Group 18-50 years)
Participants will receive a single dose of egg-based quadrivalent influenza vaccine by IM injection on Day 1.
Intervention: Egg-based Quadrivalent Influenza Vaccine
Parts A and B - Arm 3: Adjuvanted Quadrivalent Influenza Vaccine (Age Group 65-80 years)
Participants will receive a single dose of adjuvanted quadrivalent influenza vaccine by IM injection on Day 1.
Intervention: Adjuvanted Quadrivalent Influenza Vaccine
Parts A and B - Arm 4: Inactivated Influenza Vaccine (Age Group 65-80 years)
Participants will receive a single dose of inactivated influenza vaccine by IM injection on Day 1.
Intervention: Inactivated Influenza Vaccine
Parts A and B - Arm 5: mRNA-1010 (Age Group 65-80 years)
Participants will receive a single dose of mRNA-1010 by IM injection on Day 1.
Intervention: mRNA-1010
Part C - Arm 1: mRNA-1010 and mRNA-1345 (Age Group 18-50 years)
Participants will receive one dose of mRNA-1010 concomitantly injected with one dose of mRNA-1345 in the contralateral arm at Day 1.
Intervention: mRNA-1010
Part C - Arm 1: mRNA-1010 and mRNA-1345 (Age Group 18-50 years)
Participants will receive one dose of mRNA-1010 concomitantly injected with one dose of mRNA-1345 in the contralateral arm at Day 1.
Intervention: mRNA-1345
Part C - Arm 2: mRNA-1010 and mRNA-1345 (Age Group 18-50 years)
Participants will receive one dose of mRNA-1010 at Day 1 followed by one dose of mRNA-1345 in the contralateral arm at Day 29.
Intervention: mRNA-1010
Part C - Arm 2: mRNA-1010 and mRNA-1345 (Age Group 18-50 years)
Participants will receive one dose of mRNA-1010 at Day 1 followed by one dose of mRNA-1345 in the contralateral arm at Day 29.
Intervention: mRNA-1345
Part C - Arm 3: mRNA-1045 (Age Group 18-50 years)
Participants will receive a single dose of mRNA-1045 by IM injection on Day 1.
Intervention: mRNA-1045
Outcomes
Primary Outcomes
Parts A, B, and C: Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Time Frame: Up to Day 7 (7 days after vaccination)
Parts A, B, and C: Number of Unsolicited Adverse Events (AEs)
Time Frame: Up to Day 28 (28 days after vaccination)
Parts A, B, and C: Number of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs), and AEs Leading to Discontinuation
Time Frame: Day 1 through Day 181
Parts A, B, and C: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutinin Inhibition (HAI) Assay
Time Frame: Day 29
Part C: GMT of Anti-Respiratory Syncytial Virus (RSV) Antibodies at Day 29, as Measured by Microneutralization Assay for RSV A and B
Time Frame: Day 29
Parts A, B, and C: Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay
Time Frame: Baseline, Day 29
Part C: GMFR of Anti-RSV Antibodies at Day 29, as Measured by Microneutralization Assay
Time Frame: Baseline, Day 29
Parts A, B, and C: Percentage of Participants with Seroresponse at Day 29, as Measured by HAI Assay
Time Frame: Day 29
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.
Part C: Percentage of Participants with Seroresponse at Day 29, as Measured by RSV Neutralization Assay
Time Frame: Day 29
Seroresponse is defined as post-baseline titer ≥4-fold if baseline is ≥LLOQ or ≥4×LLOQ if baseline titer is \<LLOQ in neutralizing antibody titers measured by RSV neutralization assay, at Day 29.
Secondary Outcomes
- Parts A and B: GMT of Anti-HA Antibodies at Days 121 and 181, as Measured by HAI Assay or Microneutralization Assay(Days 121 and 181)
- Part C: GMT of Anti-HA Antibodies at Days 57, 121, and 181, as Measured by HAI Assay or Microneutralization Assay(Days 57, 121, and 181)
- Parts A and B: GMFR of Anti-HA Antibodies at Days 121 and 181, as Measured by HAI Assay or MN Assay(Baseline, Days 121 and 181)
- Part C: GMFR of Anti-HA Antibodies at Days 57, 121, and 181, as Measured by HAI Assay or MN Assay(Baseline, Days 57, 121, and 181)
- Part C: Percentage of Participants with Seroresponse at Days 57, 121, and 181, as Measured by HAI Assay(Days 57, 121, and 181)
- Part C: Percentage of Participants with Seroresponse at Days 57, 121, and 181, as Measured by RSV Neutralization Assay(Days 57, 121, and 181)