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Cytomegalovirus (CMV) Vaccines: Reinfection and Antigenic Variation

NCT03443791 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-12-04

No results posted yet for this study

Summary

The objectives of the protocol are to determine if a structured cognitive-behavioral interventional counseling of pregnant women can limit acquisition of human cytomegalovirus (HCMV) during pregnancy that we believe, will in turn decrease the incidence of congenital HCMV infections in this highly seroimmune population. Previously, investigators have demonstrated the success of a similar approach in pregnant women without previous evidence of HCMV infection (non-immune women) but to date, there is no evidence that such an approach will alter the incidence of congenital HCMV infections in seroimmune women. This protocol will take advantage of recently derived data in this maternal population that has identified sources HCMV exposure in women in this population and thus provided new insight into targeted counseling interventions that could limit maternal acquisition of HCMV. The primary endpoints of this study will be a 50% reduction in the overall incidence of congenital HCMV infections in this maternal population with secondary endpoints being efficient uptake of behavioral recommendations and modifications of simple hygiene behaviors that have previously been shown to decrease exposure and acquisition of HCMV.

Conditions

  • Cmv Congenital
  • CMV Viremia

Interventions

DIAGNOSTIC_TEST

Women Enrolled

Diagnostic Testing will be performed. Results of individual test results will determine the degree of intervention offered.

DIAGNOSTIC_TEST

Newborns of Female Study Participants

Newborns will be tested after birth as soon as possible for CMV positivity.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • William J. Britt, MD · The University of Alabama at Birmingham

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Hour
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2025-12-01
Completion
2025-12-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03443791 on ClinicalTrials.gov