drugset / Trial / NCT03382405
Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus Vaccines mRNA-1647 and mRNA-1443 in Healthy Adults
RandomizedParallel-groupDouble-blindPrevention
Summary
This clinical study will assess the safety, reactogenicity and immunogenicity of mRNA-1647 and mRNA-1443 cytomegalovirus vaccines in healthy adults
Timeline
- Start
- 2017-11-13
- Primary completion
- 2020-10-28
- Completion
- 2020-10-28
Publications
- Wu K, Hou YJ, Makrinos D, Liu R, Zhu A, Koch M, Yu W-H, Paila YD, Chandramouli S, Panther L, Henry C, DiPiazza A, Carfi A. Characterization of humoral and cellular immunologic responses to an mRNA-based human cytomegalovirus vaccine from a phase 1 trial of healthy adults. J Virol. 2024 Apr 16;98(4):e0160323. doi: 10.1128/jvi.01603-23. Epub 2024 Mar 25.
- Fierro C, Brune D, Shaw M, Schwartz H, Knightly C, Lin J, Carfi A, Natenshon A, Kalidindi S, Reuter C, Miller J, Panther L. Safety and Immunogenicity of a Messenger RNA-Based Cytomegalovirus Vaccine in Healthy Adults: Results From a Phase 1 Randomized Clinical Trial. J Infect Dis. 2024 Sep 23;230(3):e668-e678. doi: 10.1093/infdis/jiae114.
- Hu X, Karthigeyan KP, Herbek S, Valencia SM, Jenks JA, Webster H, Miller IG, Connors M, Pollara J, Andy C, Gerber LM, Walter EB, Edwards KM, Bernstein DI, Hou J, Koch M, Panther L, Carfi A, Wu K, Permar SR. Human Cytomegalovirus mRNA-1647 Vaccine Candidate Elicits Potent and Broad Neutralization and Higher Antibody-Dependent Cellular Cytotoxicity Responses Than the gB/MF59 Vaccine. J Infect Dis. 2024 Aug 16;230(2):455-466. doi: 10.1093/infdis/jiad593.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | mRNA-1443 | Vaccine | — | — |
| Subject | mRNA-1647 | Messenger RNA (mRNA) | 30 ug | — |
| Subject | mRNA-1647 | Messenger RNA (mRNA) | 90 ug | — |
| Subject | mRNA-1647 | Messenger RNA (mRNA) | 180 ug | — |
| Subject | mRNA-1647 | Messenger RNA (mRNA) | 300 ug | — |