Cytomegalovirus Clinical Trial
Official title:
A Dose Escalation Study to Assess the Safety and Immunogenicity of Four Live Attenuated Human Cytomegalovirus(HCMV) Vaccines in Healthy Adults Without Prior Immunity.
The purpose of this research study is to test the safety and tolerability of four new investigational Cytomegalovirus (CMV) vaccines (Towne-Toledo 1, 2, 3, 4) in healthy male volunteers who are CMV negative. CMV is a common virus, infecting 50-80% of adults in the United States by the age of twenty-one. CMV does not usually cause illness in adults or children. However, CMV can be a cause of deafness and mental retardation in a child if a mother is infected during pregnancy. It also can be a serious illness in patients with impaired immunity (decreased ability to fight infection).
A total of thirty six participants will be enrolled. The first 12 participants will be randomized into four groups. Four groups will receive one of the four investigational vaccines. The four investigational HCMV vaccine candidates will be administered subcutaneously to 3 volunteers at 10 pfu (the lowest dose to be used). The safety and tolerability of the four investigational HCMV vaccine candidates will be monitored closely for a period of 12 weeks following vaccination at this dose. Investigational vaccines that are found to be safe and well tolerated at a dose of 10pfu will be administered to 3 additional individuals at 102 pfu and then at 103 pfu. Safety and tolerability will be evaluated at each dose level by monitoring clinical signs and symptoms, laboratory parameters and virus detection in the blood, urine, and saliva. After the 12-week safety-monitoring period, participants will be followed for the remainder of one year to assess long-term safety and immunogenicity of the investigational vaccines. ;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT01248598 -
The Prevelance Rate of Human Cytomegalovirus (HCMV), Epstein-Barr Virus (EBV) and Human Herpes Virus (HHV-6) in a Saliva of the Patient With Periodantitis
|
N/A | |
Active, not recruiting |
NCT05575492 -
A Study of mRNA-1647 Cytomegalovirus Vaccine in Healthy Participants 9 to 15 Years of Age and Participants 16 to 25 Years of Age
|
Phase 1/Phase 2 | |
Recruiting |
NCT03665675 -
Donor Virus-Specific CMV or AdV CTL to Treat CMV or AdV Reactivation or Disease After Solid Organ or HCT
|
Early Phase 1 | |
Completed |
NCT00456664 -
CMV Disease and IRIS in HIV-1 Infected Persons
|
N/A | |
Completed |
NCT04840199 -
A Study to Evaluate the Anti-inflammatory Effects of Letermovir (Prevymis) in Adults With Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive Antiretroviral Therapy, Plus Its Effect on Chronic Inflammation, HIV Persistence and Other Clinical Outcomes.
|
Phase 2 | |
Active, not recruiting |
NCT05397223 -
A Study of Modified mRNA Vaccines in Healthy Adults
|
Phase 1 | |
Completed |
NCT02452229 -
Review of Human Herpes Viruses in Burns
|
N/A | |
Completed |
NCT01160081 -
Seroprevalence Study of Hepatitis A, Varicella-Zoster, Cytomegalovirus, Herpes Simplex and Bordetella Pertussis
|
N/A | |
Completed |
NCT00467532 -
Effect of Burn Size on Cytomegalovirus Reactivation and Correlates of T Cell Immune Function in Burned Patients
|
N/A | |
Terminated |
NCT03127787 -
Clinical Performance Evaluation of DxN CMV Assay
|
||
Completed |
NCT00366717 -
Cytomegalovirus Reactivation in Cancer Patients Receiving Chemotherapy
|
N/A | |
Completed |
NCT00815802 -
Detection of Human Cytomegalovirus in the Saliva
|
N/A | |
Completed |
NCT01646645 -
Primary Transplant Donor Derived CMVpp65 Specific T-cells for The Treatment of CMV Infection or Persistent CMV Viremia After Allogeneic Hematopoietic Stem Cell Transplantation
|
Phase 2 | |
Suspended |
NCT00668798 -
Cytomegalovirus (CMV) Transmission by Frozen Breast Milk in Preterms
|
N/A | |
Completed |
NCT00214240 -
The Impact of Cytogam® on Time to Viral Load Reduction in Kidney or Kidney/Pancreas Transplant Recipients With Clinical CMV Disease
|
N/A | |
Completed |
NCT00330018 -
Valganciclovir in Prevention of Cytomegalovirus (CMV) Reactivation Following Allogeneic-Stem Cell Transplantation (SCT)
|
Phase 3 | |
Completed |
NCT01895049 -
Comparison Between Two Tacrolimus-based Immunosuppressant Regimens and Induction With Thymoglobulin in Kidney Transplants From Deceased Donors With Expanded Criteria
|
Phase 4 | |
Completed |
NCT02083042 -
Clinical Validation of Lophius Biosciences Kit T-Track® CMV in Kidney Transplant Recipients
|
N/A | |
Completed |
NCT01162330 -
The Benefits Feasibility and Acceptability of Extended Screening Testing in Newborn Babies Who Are Referred for Further Hearing Assessment
|
N/A | |
Completed |
NCT01008540 -
Prospective Multicentric Study of Cytomegalovirus Resistance in Transplant Patients and Bone Marrow Recipients
|
N/A |