Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133497
Status:
COMPLETED
Last Update Posted:
2017-07-06
First Post:
2005-08-19
Brief Title:
gBMF59 Vaccine in Preventing Cytomegalovirus Infection in Healthy Adolescent Females
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Phase II Study to Assess the Safety and Efficacy of the Cytomegalovirus gBMF59 Vaccine in Preventing Systemic Cytomegalovirus Infection in Healthy Adolescent Females
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to test the safety of and the bodys response to an experimental cytomegalovirus CMV vaccine called gBMF59 vaccine Participants will include approximately 400 healthy females ages 12-17 recruited from adolescent clinics at Cincinnati Childrens Hospital Medical Center Vanderbilt University Medical Center Baylor College of Medicine University of Texas School of Public Health Houston and the University of Texas Medical Branch at Galveston Participants will receive 3 doses of vaccine or placebo saltwater on a 0 1 and 6 month schedule Study procedures will include blood and urine samples Participants will complete a diary recording temperatures and any side effects experienced Subjects will be involved in study related procedures for up to 31 months
Detailed Description:
This is a randomized double-blind placebo-controlled phase II study to assess the safety and efficacy of the cytomegalovirus glycoprotein B gBMF59 vaccine in preventing systemic cytomegalovirus infection CMV in healthy adolescent females The study interventions include intramuscular IM injection of the investigational vaccine CMV gBmicrofluidized adjuvant 59 MF59 delivered as 20 micrograms in 05 mL of vaccine or IM injection of 05 mL of saline placebo Subjects will be randomized 11 to receive vaccine or saline placebo The primary efficacy objective is to assess whether injection with 3 doses of the CMV gBMF59 vaccine will reduce the acquisition of a systemic CMV infection in healthy CMV-seronegative adolescent females This will be accomplished by comparing the rates of acquisition of systemic CMV infection defined as detection of CMV in the urine or blood between the placebo and CMV vaccine recipients beginning 1 month after the third dose of vaccine The primary safety objective is to assess the local and systemic effects of immunization and adverse events AE with the CMV gBMF59 vaccine when administered to female adolescents on a 0- 1- and 6-month schedule This will be assessed by comparing the rates of specific local and systemic reactogenicity events and AEs between the vaccine and placebo groups The endpoint for this trial will be a systemic infection which will be defined as identification of CMV from the urine chosen because it is the most common site for isolation of CMV or blood chosen because it is the most likely route by which CMV reaches the fetus Approximately 2400 healthy females age 12 to 17 years at time of initial enrollment will be recruited in order to obtain approximately 400 CMV-seronegative subjects for the vaccine trial Collection of sera will occur at Screening Study Day 0 Month 6 Month 7 and every 3 months after Month 7 Collection of urine will occur at Study Day 0 Month 1 Month 2 Month 6 Month 7 and every 3 months after Month 7 Safetyreactogenicity monitoring will consist of solicited signs and symptoms self-reported by memory aid on the day of vaccination and for 6 follow-up days Unsolicited symptoms will be collected for the 30-day period 2 days after each vaccination and followed to adequate resolution or stabilization The study duration for each subject will be 31 months 7 months on the study with 24 months of follow-up beginning 1 month after the last injection There will be 14 scheduled visits This study is linked to DMID protocol 06-0043
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None