Drugs / mRNA-1647
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05397223 | May 2022 → Feb 2026 | COVID-19, cytomegalovirus infection, influenza, respiratory syncytial virus infectious disease | ModernaTX, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05105048 | Nov 2021 → Aug 2023 | cytomegalovirus infection | ModernaTX, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03382405 | Nov 2017 → Oct 2020 | cytomegalovirus infection | ModernaTX, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05575492 | Nov 2022 → May 2026 | cytomegalovirus infection | ModernaTX, Inc. | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT06133010 | Feb 2024 → Feb 2027 | cytomegalovirus infection | ModernaTX, Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT05683457 | Apr 2023 → Aug 2026 overdue | cytomegalovirus infection | ModernaTX, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04232280 | Jan 2020 → Jan 2023 | cytomegalovirus infection | ModernaTX, Inc. | Completed | No outcome recorded |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT05085366 | Oct 2021 → Nov 2025 | cytomegalovirus infection | ModernaTX, Inc. | Terminated | Missed primary |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT04975893 Background | Jun 2021 → Jan 2026 | cytomegalovirus infection | ModernaTX, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2025-10-22 | ModernaTX, Inc. | Results Moderna Announces Phase 3 Study of Investigational Cytomegalovirus (CMV) Vaccine Did Not Meet Primary Efficacy Endpoint q4web.com ↗
The study did not meet its primary efficacy endpoint of preventing CMV infection in seronegative female participants of childbearing age (16-40 years of age). |
| 2022-03-24 | ModernaTX, Inc. | Results Moderna Announces Clinical and Program Updates at 3rd Annual Vaccines Day q4web.com ↗
In a Phase 2 study, the CMV vaccine (mRNA-1647) was observed to be generally well tolerated and interim data demonstrates strong immunogenicity. |
| 2021-04-14 | ModernaTX, Inc. | Results Moderna Announces Clinical Progress from its Industry-Leading mRNA Vaccine Franchise and Continues Investments to Accelerate Pipeline Development q4web.com ↗
The Company is also announcing new positive interim Phase 1 data from its Respiratory Syncytial Virus (RSV) vaccine candidate (mRNA-1345) and new 7-month interim Phase 2 data from its cytomegalovirus (CMV) vaccine candidate. |
| 2020-09-17 | ModernaTX, Inc. | Results Moderna Announces Progress Across Broad Portfolio and all Three Clinical Stage Therapeutic Areas at 2020 R&D Day q4web.com ↗
Positive interim analysis from Phase 2 study of CMV vaccine candidate (mRNA-1647); Phase 3 study of mRNA-1647 to begin in 2021 at 100 μg dose |
| 2020-01-09 | ModernaTX, Inc. | Results Moderna Announces Additional Positive Phase 1 Data from Cytomegalovirus (CMV) Vaccine (mRNA-1647) and First Participant Dosed in Phase 2 Study q4web.com ↗
Additionally, the Company announced that the first participant was dosed in the Phase 2 dose-confirmation study. |
| 2019-09-12 | ModernaTX, Inc. | Results Moderna Announces Positive Phase 1 Results for the First Systemic Messenger RNA Therapeutic Encoding a Secreted Protein (mRNA-1944) q4web.com ↗
R&D Day Webcast Today Moderna also announced positive interim Phase 1 data for mRNA-1647 (cytomegalovirus or CMV vaccine) today. |
| 2019-09-12 | ModernaTX, Inc. | Results Moderna Announces Positive Interim Results from Phase 1 Cytomegalovirus (CMV) Vaccine (mRNA-1647) Study and Progress Toward Phase 2 and Pivotal Trials q4web.com ↗
Vaccination immunized seronegative participants to levels consistent with or above seropositive titers and boosted baseline titers in seropositive participants |
| 2018-02-20 | ModernaTX, Inc. | Results Newly Published Data Highlight Moderna’s mRNA Platform in Advancing Prophylactic Vaccine for Cytomegalovirus (CMV) Infections modernatx.com ↗
The newly published data showed that Moderna’s mRNA encoding CMV glycoproteins gB and pentameric complex (PC), encapsulated in its delivery system, produced potent and durable neutralizing antibody titers in immunized mice and non-human primates. |
All press releases naming this drug 9 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | mRNA-1647 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05397223 ↗ |
| Modality | Messenger RNA (mRNA) | “mRNA-1647 is an investigational mRNA-based vaccine against cytomegalovirus (CMV)” PMID 38526054 ↗ Mar 2024 |
| Route | Intramuscular | “Participants will receive mRNA-1647 vaccine at Dose Level A by intramuscular (IM) injection” NCT04232280 ↗ |