Cytomegalovirus (CMV) Vaccines: Reinfection and Antigenic Variation

NCT03443791 | Completed DMC

• 1 other identifier: IRB-010810006
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

CMV; Congenital Birth; Infectious Diseases

Outcome Measures

Primary Outcomes (1)

• A 50% reduction in the overall incidence of congenital HCMV infections in this maternal population

  Participants will be tested using urine and blood to determine positivity for CMV

  baseline through 60 months

Secondary Outcomes (1)

• efficient uptake of behavioral recommendations and modifications of simple hygiene behaviors

  baseline through 60 months

Study Arms (2)

women enrolled

EXPERIMENTAL

pregnant women enrolled in trial

Diagnostic Test: Women Enrolled

newborns of female study participants

OTHER

newborns will be tested to determine if virus is present.

Diagnostic Test: Newborns of Female Study Participants

Interventions

Women Enrolled DIAGNOSTIC_TEST

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

women enrolled

Newborns of Female Study Participants DIAGNOSTIC_TEST

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

newborns of female study participants

Eligibility Criteria

• Age: 1 Hour - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women in Ribeirao Preto who receive maternity care through the Hospital Das Clinicas, University of São Paulo and the Mater Hospital
• enrollment in prenatal care before 23 weeks gestation

You may not qualify if:

• late enrollment in prenatal care, after 23 weeks gestation
• known major fetal anomalies or demise
• planned termination of pregnancy
• intention of the patient to deliver at a non-study hospital
• referral for high risk prenatal care

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Sao Paulo

São Paulo, Brazil

Location

MeSH Terms

Conditions

Cytomegalovirus Infections; Communicable Diseases

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• William J. Britt, MD

  The University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: February 23, 2018
• Study Start: September 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

BR (1)