Maternal donor immune cells plus standard antiviral therapy for newborn CMV infection
Official title: A Randomized Study of Maternal Donor Derived CMV Cytotoxic T-Lymphocytes (CTLs) and Valganciclovir vs Valganciclovir in Neonates With Moderate/Severe Maternal Acquired CMV Infection
Funded at New York Medical College · NIH-11563793 · Data updated 2026-11-12
A clinical trial tests whether giving newborns with congenital CMV infection maternal donor-derived immune cells along with valganciclovir helps the baby’s immune system fight CMV better than valganciclovir alone.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | New York Medical College NIH-funded |
| Lab location | 1 site (Valhalla, United States) |
| Project start | September 1, 2023 |
| Project end | December 31, 2028 |
| Funding year | 2026 |
| Award (this year) | $324,998 |
| NIH project number | 3R01FD007837-02S1 |
| Project ID | NIH-11563793 on NIH RePORTER |
Who could benefit from this research
✓Could help
Newborns with in-utero-acquired congenital CMV infection and significant disease risk.
✕Less likely to help
Babies without CMV infection or without access to donor CTLs may not benefit.
What this research studies
This study looks at babies born with congenital CMV infection and compares two approaches: standard antiviral treatment with valganciclovir versus valganciclovir plus maternal donor cytotoxic T-lymphocytes (CTLs) to boost the baby’s CMV-specific immune response. Researchers will randomize eligible neonates to receive the combination therapy or the antiviral alone, aiming to temporary restore CD4 and CD8 T-cell immunity against CMV. The goal is to reduce CMV-related illness and improve long-term neurodevelopmental outcomes by strengthening the infant’s immune defense early in life. The study builds on prior work showing that neonatal T-cell responses are immature and that enhancing them may help control infection. Participants will be monitored for safety, viral clearance, and developmental progress over time.
Why it matters
Potential benefit: If successful, babies with congenital CMV could achieve better control of the virus and improved developmental outcomes.
How similar studies have gone: Prior data suggest that boosting CMV-specific T-cell responses can help control infection, but randomized neonatal trials are limited.
Where this research is happening
-
New York Medical College
Valhalla, United States Active
Researchers
- Principal investigator: Cairo, Mitchell S. — New York Medical College
- Study coordinator: Cairo, Mitchell S.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.