Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 COVID-19 Vaccine in Adults Aged 18 Years and Older

Study at a glance

From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Phase 2a, Randomized, Observer-Blind, Placebo Controlled, Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 SARS-COV-2 Vaccine in Adults Aged 18 Years and Older

ClinicalTrials.gov ID

NCT04405076

Acronym / sponsor ID

mRNA-1273-P201

Conditions

SARS-CoV-2

Keywords

mRNA-1273, mRNA-1273 vaccine, mRNA-1273.351, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA

Phase

Phase 2

Study type

Interventional

Recruitment status

Completed

Enrolment

660 participants (actual)

Lead sponsor

ModernaTX, Inc.Industry (pharma, biotech, devices)

Collaborators

Biomedical Advanced Research and Development Authority

Study start

29 May 2020 (actual)

Primary completion

28 Oct 2021 (actual)

Study completion

28 Oct 2021 (actual)

First posted

28 May 2020 (actual)

Results

Posted 30 Dec 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Prevention

Allocation

Randomised

Intervention model

Sequential

Masking

Double blind (participant, investigator)

Number of arms

9

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)

   Time frame: 7 days post-vaccination

   Solicited ARs, including local and systemic ARs were collected in the eDiary. Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. All solicited ARs (local and systemic) considered causally related to injection. ARs were graded 0-4 as reviewed and confirmed by Investigator; lower score indicates lower severity and a higher score indicates greater severity. Note, not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.

2. Number of Participants With Unsolicited AEs

   Time frame: Up to 28 days post-vaccination

   An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent AE (TEAE) was defined as any event not present before exposure to vaccine or any event already present that worsens in intensity or frequency after exposure. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsens from baseline and is considered clinically significant in the medical and scientific judgment of the Investigator. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study (up to Month 15), regardless of causality, is located in the Reported "Adverse Events" section.

3. Number of Participants With Medically-Attended Adverse Events (MAAEs)

   Time frame: Up to Month 15

   An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner (HCP). A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.

4. Number of Participants With SAEs

   Time frame: Up to Month 15

   An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.

5. Part A: Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-COV-2)-Specific Binding Antibody (bAb) as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)

   Time frame: Days 1 (Baseline), 29, 43, 57, and 209

   The geometric mean (GM) level of VAC58 spike immunoglobulin G (IgG) antibodies, as measured by ELISA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ. Values that were greater than the upper limit of quantification (ULOQ) were converted to the ULOQ if actual values were not available. LLOQ was 1 and ULOQ was 2052. The 95% confidence intervals (CIs) were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, respectively, then back transformed to the original scale for presentation.

6. Part B: Level of SARS-CoV-2-Specific bAb as Measured by ELISA

   Time frame: Days 1 (Baseline) and 29

   The GM level of VAC65 spike IgG antibodies, as measured by ELISA specific to the SARS-CoV-2 spike protein is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ are converted to the ULOQ. LLOQ was 1 and ULOQ was 2052. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, respectively, then back transformed to the original scale for presentation. The PP Set included participants with a study injection, required baseline data, had postinjection results at timepoint of primary interest for immunogenicity analysis, no major protocol deviations impacting immune response, and didn't have SARS-CoV-2.

7. Part C: Level of SARS-CoV-2-Specific bAb as Measured by MSD

   Time frame: Days 1 (Baseline), 8, 15, and 29

   The GM level of SARS-CoV-2 protein antibody against B.1.351, as measured by MSD MULTIPLEX is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ. Values that were greater than the ULOQ are converted to the ULOQ. LLOQ was 18 and ULOQ was 4200000. The 95% CIs were calculated based on the t-distribution of the log-transformed values or the difference in the log-transformed values for GM value, respectively, then back transformed to the original scale for presentation.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2022.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 36376733Kirste I, Hortsch S, Grunert VP, Legault H, Maglinao M, Eichenlaub U, Kashlan B, Pajon R, Jochum S. Quantifying the Vaccine-Induced Humoral Immune Response to Spike-Receptor Binding Domain as a Surrogate for Neutralization Testing Following mRNA-1273 (Spikevax) Vaccination Against COVID-19. Infect Dis Ther. 2023 Jan;12(1):177-191. doi: 10.1007/s40121-022-00711-y. Epub 2022 Nov 15.
• Derived from this study: PubMed 36202997Chalkias S, Eder F, Essink B, Khetan S, Nestorova B, Feng J, Chen X, Chang Y, Zhou H, Montefiori D, Edwards DK, Girard B, Pajon R, Dutko FJ, Leav B, Walsh SR, Baden LR, Miller JM, Das R. Safety, immunogenicity and antibody persistence of a bivalent Beta-containing booster vaccine against COVID-19: a phase 2/3 trial. Nat Med. 2022 Nov;28(11):2388-2397. doi: 10.1038/s41591-022-02031-7. Epub 2022 Oct 6.
• Derived from this study: PubMed 35241844Chu L, Vrbicky K, Montefiori D, Huang W, Nestorova B, Chang Y, Carfi A, Edwards DK, Oestreicher J, Legault H, Dutko FJ, Girard B, Pajon R, Miller JM, Das R, Leav B, McPhee R. Immune response to SARS-CoV-2 after a booster of mRNA-1273: an open-label phase 2 trial. Nat Med. 2022 May;28(5):1042-1049. doi: 10.1038/s41591-022-01739-w. Epub 2022 Mar 3.
• Derived from this study: PubMed 34526698Choi A, Koch M, Wu K, Chu L, Ma L, Hill A, Nunna N, Huang W, Oestreicher J, Colpitts T, Bennett H, Legault H, Paila Y, Nestorova B, Ding B, Montefiori D, Pajon R, Miller JM, Leav B, Carfi A, McPhee R, Edwards DK. Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis. Nat Med. 2021 Nov;27(11):2025-2031. doi: 10.1038/s41591-021-01527-y. Epub 2021 Sep 15.
• Derived from this study: PubMed 33707061Chu L, McPhee R, Huang W, Bennett H, Pajon R, Nestorova B, Leav B; mRNA-1273 Study Group. A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine. Vaccine. 2021 May 12;39(20):2791-2799. doi: 10.1016/j.vaccine.2021.02.007. Epub 2021 Feb 9.
• Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

8 sites in 1 country: see every site and its status.