Congenital Cytomegalovirus Infection Clinical Trial
Official title:
A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Prophylactic Cytomegalovirus Plasmid DNA Vaccine in Healthy Adults
If the participant decides to take part in the study, the participant will need to do the
following:
Visit the study clinic up to 10 times and be available for a reasonable amount of follow up
phone calls to see how the participant is doing.
The participant will receive three doses of vaccine injected into the muscle of the upper
arm. After each injection the participant will be asked to remain at the study site for at
least 30 minutes after the participant receives the study vaccine.
The results of all of the participants blood tests, just like all other laboratory test
results, will be provided to the Investigators, Sponsor, and vaccine developer. Positive HIV
and viral hepatitis test results will be reportable to local health authorities according to
local laws.
The participant will be asked to refrain from excessive physical activities and alcohol
consumption within 2 days before each clinic visit to avoid possible confusing effects on
laboratory tests.
Up to 10 normal healthy adult female subjects 18 to 35 years of age will be enrolled in this
trial. A total of 3 injections of the vaccine will be given at Days 0, 28 (+4 days), and 56
(+4 days). There are follow-up visits 7 days after each vaccination, one follow-up visit 28
days after the 3rd (last) vaccination, and a final visit 3 months later. Blood and urine
samples will be collected at each vaccination and follow-up visit. The participant will be
asked to complete a telephone call follow-up at 1 year after receiving the last vaccination.
Participants will be required to complete subject diary cards throughout the study until the
telephone call follow-up at approximately Day 420 (i.e., 12 months following the 3rd and
final dose scheduled for Day 56). Diary cards will be reviewed with the study staff at each
visit and during the Day 420 telephone call.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01923636 -
Prognostic Value of Neonatal Markers for the Development of Neurosensorial Sequelae in Children Infected by Cytomegalovirus in Utero
|
N/A | |
| Recruiting |
NCT03973359 -
Epidemiology and Prevention of Congenital HCMV in Immune Mothers. Congenital HCMV Infection Lombardy
|
N/A | |
| Completed |
NCT02005822 -
Congenital Cytomegalovirus: Efficacy of Antiviral Treatment
|
Phase 3 | |
| Completed |
NCT02139423 -
Diagnosis of Congenital CMV Infection in Neonates Who Failed Newborn Hearing Screening
|
N/A | |
| Completed |
NCT02351102 -
Valacyclovir to Prevent Vertical Transmission of Cytomegalovirus After Maternal Primary Infection During Pregnancy
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT05170269 -
Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection, GW ≤ 14 (PreCyssion)
|
Phase 3 | |
| Not yet recruiting |
NCT06118515 -
A Safety Assessment of Oral Letermovir in Infants With Symptomatic Congenital Cytomegalovirus
|
Phase 1 | |
| Completed |
NCT02782988 -
Assesment of Olfactory Disorders and Performance of a New Olfactory Test in Children With Congenital CMV
|
||
| Completed |
NCT02645396 -
A Cohort Study of Congenital Cytomegalovirus Infection Among Pregnant Women and Their Newborns in China
|
||
| Terminated |
NCT01655212 -
Congenital Cytomegalovirus: Efficacy of Antiviral Treatment in a Randomized Controlled Trial
|
Phase 3 | |
| Completed |
NCT02710864 -
A Cross-sectional Study of Congenital Cytomegalovirus Infection in Newborns in China
|
||
| Completed |
NCT05754879 -
Diagnosis of Congenital Cytomegalovirus Infection in Newborn With Particular Risk
|
||
| Terminated |
NCT03301415 -
Asymptomatic Congenital CMV Treatment
|
Phase 2 | |
| Completed |
NCT01376778 -
A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV)
|
Phase 3 |