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Cytomegalovirus (CMV) Vaccines: Reinfection and Antigenic Variation (CMV)

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ClinicalTrials.gov Identifier: NCT03443791
Recruitment Status : Not yet recruiting
First Posted : February 23, 2018
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
William J. Britt, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE February 19, 2018
First Posted Date  ICMJE February 23, 2018
Last Update Posted Date September 24, 2019
Estimated Study Start Date  ICMJE January 1, 2020
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2018)
A 50% reduction in the overall incidence of congenital HCMV infections in this maternal population [ Time Frame: baseline through 48 months ]
Participants will be tested using urine and blood to determine positivity for CMV
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03443791 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2018)
efficient uptake of behavioral recommendations and modifications of simple hygiene behaviors [ Time Frame: baseline through 48 months ]
Participants are educated on personal hygiene behaviors which have previously been shown to decrease exposure and acquisition of HCMV. Study visits will included survey for these questions.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cytomegalovirus (CMV) Vaccines: Reinfection and Antigenic Variation
Official Title  ICMJE Cytomegalovirus (CMV) Vaccines: Reinfection and Antigenic Variation
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.
Detailed Description

The proposed cognitive-behavioral intervention protocol to modify the risk of exposure and acquisition of HCMV in pregnant women will include a two components. The first component of the trial will consist of a pilot study in which 100 women enrolled in the parent study will be asked to participate in this substudy. We will target women with young children in the household and households with more than 5 inhabitants as these two characteristics have been shown to be associated with virus excretion in pregnant women in this population, and by inference, exposure and acquisition of HCMV during pregnancy in this maternal population. Women will be counseled at enrollment utilizing both a brief counseling session that will provide basic information about HCMV and congenital HCMV (cCMV) infections, and an individualized behavioral skills session. A take home packet describing the; (i) cCMV infections, (ii) routes of virus acquisition/spread and measures to limit virus spread, and (iii) guidance in behavior modifications to reduce risk of exposures and infection with HCMV will be provided. Enrollees will be seen during their following prenatal visits and asked to complete a questionnaire that will include a self-assessment of adherence to recommended risk reduction behaviors, understanding of routes of HCMV transmission, and importantly, the burden of introducing recommended risk reduction practices into their daily routines. In addition, we will poll these women on the most effective components of the cognitive-behavioral intervention pilot. Data derived from these questionnaires will represent the outcome of this pilot study and will permit us to modify the strategy that will be deployed in the larger intervention trial.

The second component will consist of a larger trial of cognitive-behavioral intervention trial to limit HCMV exposure and acquisition in pregnant women in this maternal population. Women \ will complete a standard questionnaire that will provide demographics such as description of housing, number of people in household, number and ages of children. Information will also be gathered on number and age of sexual partners, previous STIs, and if partner currently resides in household. Standard of care counseling will include discussion of sources of infections and routes of acquisition. After enrollment, women will be randomized to standard of care of counseling or the HCMV exposure risk reduction intervention strategy by assignment of every other enrollee to the intervention cohort. Women enrolled in the exposure risk reduction intervention will receive standard of care and receive an individualized behavioral skills session from a trained nurse or health educator (see following section). As part of enrollment in this study, all women will provide permission to screen their newborn infants or any specimens from miscarriages or fetal loss for HCMV infection. Samples of prenatal blood specimens collected as part of routine care will be stored for future use and enrollment saliva swab, vaginal swab, and urine will be obtained and stored for studies of viral load and baseline viral genomic diversity. The behavioral intervention group will also watch a short video detailing basic information about HCMV, the natural history of HCMV infections (sources and routes of transmission), and consequences of maternal infection during pregnancy to the outcomes of pregnancy. Within this video will be explicit and specific descriptions of exposures, such as kissing young children on the mouth, handling objects that have been or could have been in the mouths of young children, and the importance of hygiene after exposure to urine during diaper changing. After viewing the video, a nurse (or health educator) specifically trained to reinforce the information in the video will provide a brief behavioral skills session, and distribute a take home packet containing an information pamphlet. Study participants will receive weekly brief text messages for the initial 12 weeks to deliver reminders of recommended behaviors to limit risks of exposures. To power this study for a 50% difference in the outcome of pregnancy (delivery of a infant with cCMV infection) in a population with the incidence of cCMV of 0.6%, we have estimated that 4300 women will be required. Between the two hospitals and clinics that serve the population in this study, approximately 4700 deliveries take place per year. Our plan is to enroll patients over 2 years, thus we believe that we can enroll 5,000 women in this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Cmv Congenital
  • CMV Viremia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: women enrolled
    pregnant women enrolled in trial
    Intervention: Diagnostic Test: Women Enrolled
  • newborns of female study participants
    newborns will be tested to determine if virus is present.
    Intervention: Diagnostic Test: Newborns of Female Study Participants
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 23, 2019)
200
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2018)
8400
Estimated Study Completion Date  ICMJE December 1, 2023
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion:

  • 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

Exclusion:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Marisa Mussi-Pinhata, MD 551636022479 mussi.pinhata@pq.cnpq.br
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03443791
Other Study ID Numbers  ICMJE IRB-010810006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party William J. Britt, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William J. Britt, MD The University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP