Cytomegalovirus Cell-Mediated Immunity

NCT00815165 | Completed

• 2 other identifiers: 06-0043N01AI80007C
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 2

Brief Summary

Cytomegalovirus (CMV) is an important cause of illness and occasional deaths in infants who catch the virus before they are born, in newborns, and in children and adults who have weak immune systems. The purpose of this study is to look at how the CMV vaccine works in the blood. This study is being done along with the main CMV gB/MF59 vaccine study that looks at how the overall body reacts to the vaccine. Participants will include up to 100 healthy adolescent female subjects aged 12 to 17 years who were vaccinated in study 04-039 and 100 subjects that were screened for 04-039 to participate as controls. Study procedures will include up to 6 blood draws taken over a 13 month period. Participation will be about 31 months (unless the patient enrolls into the shedding study).

Conditions

Cytomegalovirus Infections

Keywords

cytomegalovirus, CMV, cell-mediated immunity, children, sub-study

Outcome Measures

Primary Outcomes (1)

• Immunogenicity based on cytomegalovirus (CMV) specific cell-mediated immunity.

  Measured 30 days after the first dose, 30 days after the second dose, 30 days after the third dose and 7 months after the third dose of vaccine.

Study Arms (2)

Protocol 04-039 subjects

At least 50 and maximum of 100 healthy adolescent female subjects aged 12-17 years who were vaccinated in protocol 04-039 will be enrolled.

Positive and Negative Controls

Approximately 100 screened subjects will be enrolled to serve as positive and negative controls.

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

A convenience sample of up to 100 healthy participants, ages 12-17 years, who were vaccinated in 04-039. Additionally, 100 screened subjects enrolled to serve as positive/negative controls.

You may qualify if:

• Parent/legal guardian and subjects who understand and sign the assent as well as consent forms for this study.
• Subjects who qualify for the Division of Microbiology and Infectious Diseases, NIAID, NIH (DMID) study 04-039, "A Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Safety and Efficacy of the Cytomegalovirus gB/MF59 Vaccine in Preventing Systemic Cytomegalovirus Infection in Healthy Adolescent," will be eligible for the initial pre-vaccination blood draw.

You may not qualify if:

• All subjects who are ineligible for the main DMID 04-039 study will not be eligible for the cell-mediated immunity sub-study.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

Cincinnati Children's Hospital Medical Center - Infectious Diseases

Cincinnati, Ohio, 45229-3026, United States

Location

Vanderbilt University - Pediatric - Infectious Diseases

Nashville, Tennessee, 37232-0011, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood.

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2008
• First Posted: December 29, 2008
• Study Start: June 1, 2006
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: September 9, 2013

Record last verified: 2013-09

Locations

US (2)