Led by Dr. Geeta Swamy, Senior Associate Dean for Regulatory Oversight & Research Initiatives in Clinical Research, the DVTU has conducted numerous studies in our maternal/fetal medicine department. Dr. Swamy provides strategic vision and oversight of the regulatory components of the Duke Human Research Protection Program and assists with the development of broad-based research initiatives and other activities to support Duke’s growing clinical research enterprise.
To date, the DVTU has conducted studies assessing novel vaccines, treatment and post-licensure vaccine safety. The current studies Dr. Swamy leads are below:
- Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of NTM-1632: Dr. Swamy and Dr. Vern Juel are leading a study to evaluate NTM-1632 in three dose cohorts (A: 0.033 mg/kg, B: 0.165 mg/kg, and C: 0.33 mg/kg). NTM-1632 is a mixture of three monoclonal antibodies designed to treat botulinum neurotoxin BoNT/B poisoning in adults. Further information about the trial can be found at clinicaltrials.gov.
- Safety and Efficacy of the RSV F Vaccine to Protect Infants via Maternal Immunization: Dr. Swamy is participating in a Phase 3 study to evaluate the safety and immunogenicity of Novavax RSV-F protein nanoparticle vaccine, with aluminum, in healthy pregnant women. This study is international and will be enrolling 8,255 pregnant women. The study will also evaluate the levels of RSV serotype-specific antibodies in infants, and placental transfer from the pregnant women to the infant. Further information about the trial can be found at clinicaltrials.gov.
- Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women: Dr. Swamy is participating in a pilot study to assess the safety and immunogenicity of sequential vs. simulatneous co-administration of US-licensed Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed and inactivated influenza vaccine in 40 pregnant women. Further information can be found at clinicaltrials.gov.