CompletedNot Applicable

Cytomegalovirus (CMV) Vaccines: Reinfection and Antigenic Variation

Brazil200 participantsStarted 2022-09-01

Plain-language 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.

Who can participate

Age range

1 Hour – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: baseline through 60 months

Trial details

NCT IDNCT03443791

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01

View on ClinicalTrials.gov More Cmv Congenital trials