Efficacy Study of Human Cytomegalovirus (HCMV) Hyperimmune Globulin to Prevent Congenital HCMV Infection

Fondazione IRCCS Policlinico San Matteo di Pavia124 enrolled

Overview

The aim of this trial is to verify, under controlled conditions, the reported efficacy of human cytomegalovirus (HCMV)-specific hyperimmune globulin administration to pregnant women suffering from primary HCMV infection for the prevention of intrauterine HCMV transmission.

HCMV is the leading infectious cause of mental retardation and deafness in infants with congenital HCMV infection. Primary HCMV infections during pregnancy carry the highest risk of fetal infection and disease. No intervention of proven efficacy is available in case of primary HCMV infection in pregnancy. However, a study published in 2005 (Nigro et al., NEJM 353:1350-62, 2005) reported that in pregnant women with primary HCMV infection treated with HCMV-specific hyperimmune globulin (Cytotect®, Biotest) the risk of transmitting the infection to the fetus was reduced from 40% to 16%. Unfortunately, since the study was conducted with inadequate controls, the actual efficacy of hyperimmune globulin could not be properly assessed. In the present randomized, double-blind, placebo-controlled, multicenter trial pregnant women with ascertained primary HCMV infection at 4-26 weeks of gestation will be randomized to receive Cytotect® or placebo intravenously within 6 weeks after the presumed onset of infection. Primary efficacy parameter will be the number of HCMV-infected newborns or fetuses.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

124

Conditions

Cytomegalovirus Infection

Interventions

HCMV-specific hyperimmune globulin (Cytotect®)DRUG

100U (2.0ml)/Kg i.v. every 4 weeks up to 38 weeks' gestation or HCMV-positive amniocentesis or pregnancy termination.

Isotonic solution of sodium chloride (placebo)DRUG

2.0ml/Kg i.v. every 4 weeks until 38 weeks'gestation or HCMV-positive amniocentesis or pregnancy termination

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * pregnant women (in vitro fertilization permitted) * \>= 18 years of age * primary HCMV infection at 5-26 weeks' gestation * \<= 6 weeks from presumed onset of infection * gestational age between 5-32 weeks' gestation * written informed consent Exclusion Criteria: * multiple pregnancy * history of HIV or HBV or HCV infection * known immunodeficiency or immunosuppression * congenital or acquired autoimmune disease * known intolerance to protein of human origin * known intolerance to immune globulin * history of adverse effects to vaccination * hypersensitivity to human immune globulin (pathological IgG or IgA deficiences) * renal failure * serious organic or psychiatric disease * lack of motivation to participate in the study * women unable to satisfy study requirements * women not willing or unable to provide written informed consent * women not willing to give consent to transmission of anonymised data

Locations (11)

Dipartimento di Ostetricia e Ginecologia, Ospedali Riuniti

Bergamo, Italy

Medicina dell'Età Prenatale, Ospedale Policlinico S.Orsola

Bologna, Italy

Medicina Materno-Fetale, Spedali Civili

Brescia, Italy

Outcomes

Primary Outcomes

Evidence of congenital HCMV infection in the fetus/newborn

Time frame: At amniocentesis and/or within one week after birth

Secondary Outcomes

HCMV-specific immune response (humoral and cell-mediated)

Time frame: 36-48 months

Virological and histological findings in placentas

Time frame: 36-48 months

Clinical outcome of newborns with congenital HCMV infection

Time frame: within 2 weeks after birth

Safety of Cytotect in the mother and newborn

Time frame: within 24 hours after delivery

Data from ClinicalTrials.gov

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