A Study to Evaluate the Immunogenicity and Safety of mRNA Vaccine Boosters for SARS-CoV-2 (COVID-19) Variants
Summary
This is a study to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1273.211, mRNA-1273, mRNA-1273.617.2, mRNA-1273.213, mRNA-1273.529, mRNA-1273.214, mRNA-1273.222, mRNA-1273.815, and mRNA-1273.231 administered as booster doses.
Timeline
- Start
- 2021-05-28
- Primary completion
- 2023-11-17
- Completion
- 2023-11-17
Outcome
Met primary endpoint
paper Bivalent Omicron BA.4/BA.5-containing mRNA-1273.222 elicited superior nAb responses against BA.4/BA.5 versus mRNA-1273 and noninferior responses against ancestral SARS-CoV-2 (D614G) at day 29 post boost in participants without detectable prior SARS-CoV-2 infection. PMID 37653342 ↗
paper Day 29 seroresponses against Omicron BA.4/BA.5 were higher for mRNA-1273.222 than for mRNA-1273 and similar against ancestral SARS-CoV-2 (D614G), both meeting noninferiority criterion. PMID 37653342 ↗
paper CONCLUSIONS: The bivalent omicron-containing vaccine mRNA-1273.214 elicited neutralizing antibody responses against omicron that were superior to those with mRNA-1273, without evident safety concerns. PMID 36112399 ↗
Publications
- Chalkias S, Whatley JL, Eder F, Essink B, Khetan S, Bradley P, Brosz A, McGhee N, Tomassini JE, Chen X, Zhao X, Sutherland A, Shen X, Girard B, Edwards DK, Feng J, Zhou H, Walsh S, Montefiori DC, Baden LR, Miller JM, Das R. Original SARS-CoV-2 monovalent and Omicron BA.4/BA.5 bivalent COVID-19 mRNA vaccines: phase 2/3 trial interim results. Nat Med. 2023 Sep;29(9):2325-2333. doi: 10.1038/s41591-023-02517-y. Epub 2023 Aug 31.
- Chalkias S, Harper C, Vrbicky K, Walsh SR, Essink B, Brosz A, McGhee N, Tomassini JE, Chen X, Chang Y, Sutherland A, Montefiori DC, Girard B, Edwards DK, Feng J, Zhou H, Baden LR, Miller JM, Das R. A Bivalent Omicron-Containing Booster Vaccine against Covid-19. N Engl J Med. 2022 Oct 6;387(14):1279-1291. doi: 10.1056/NEJMoa2208343. Epub 2022 Sep 16.
- Chalkias S, Schwartz H, Nestorova B, Feng J, Chang Y, Zhou H, Dutko FJ, Edwards DK, Montefiori D, Pajon R, Leav B, Miller JM, Das R. Safety and Immunogenicity of a 100 mug mRNA-1273 Vaccine Booster for Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). medRxiv [Preprint]. 2022 Mar 7:2022.03.04.22271830. doi: 10.1101/2022.03.04.22271830.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | mRNA-1273 | Messenger RNA (mRNA) | 50 ug | Intramuscular |
| Subject | mRNA-1273 | Messenger RNA (mRNA) | 100 ug | Intramuscular |
| Subject | mRNA-1273.211 | Unknown | 50 ug | Intramuscular |
| Subject | mRNA-1273.211 | Unknown | 100 ug | Intramuscular |
| Subject | mRNA-1273.213 | Unknown | 50 ug | Intramuscular |
| Subject | mRNA-1273.213 | Unknown | 100 ug | Intramuscular |
| Subject | mRNA-1273.214 | Messenger RNA (mRNA) | 50 ug | Intramuscular |
| Subject | mRNA-1273.222 | Vaccine | 50 ug | Intramuscular |
| Subject | mRNA-1273.231 | Unknown | 50 ug | Intramuscular |
| Subject | mRNA-1273.529 | Messenger RNA (mRNA) | 50 ug | Intramuscular |
| Subject | mRNA-1273.617.2 | Messenger RNA (mRNA) | 50 ug | Intramuscular |
| Subject | mRNA-1273.617.2 | Messenger RNA (mRNA) | 100 ug | Intramuscular |
| Subject | mRNA-1273.815 | Messenger RNA (mRNA) | 50 ug | Intramuscular |