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

Phase 2

Completed

• Conditions: Cytomegalovirus Infection
• Interventions: Drug: HCMV-specific hyperimmune globulin (Cytotect®); Drug: Isotonic solution of sodium chloride (placebo)

• Registration Number: NCT00881517
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2009-04-14
• Study First Submitted QC: 2009-04-14
• Study First Posted: 2009-04-15
• Study Start: 2009-06
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-07
• Last Update Posted: 2011-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cytotect	HCMV-specific hyperimmune globulin (Cytotect®)	-
placebo	Isotonic solution of sodium chloride (placebo)	-

Primary Outcome Measures

Name	Time	Method
Evidence of congenital HCMV infection in the fetus/newborn	At amniocentesis and/or within one week after birth

Secondary Outcome Measures

Name	Time	Method
HCMV-specific immune response (humoral and cell-mediated)	36-48 months
Virological and histological findings in placentas	36-48 months
Clinical outcome of newborns with congenital HCMV infection	within 2 weeks after birth
Safety of Cytotect in the mother and newborn	within 24 hours after delivery

Trial Locations

Locations (11)

Medicina Materno-Fetale, Spedali Civili; 🇮🇹 Brescia, Italy

Clinica Ostetrica e Ginecologica, Ospedale S. Gerardo; 🇮🇹 Monza, Italy

Medicina dell'Età Prenatale, Ospedale Policlinico S.Orsola; 🇮🇹 Bologna, Italy

Dipartimento di Ostetricia e Ginecologia, Ospedali Riuniti; 🇮🇹 Bergamo, Italy

Ostetricia e Ginecologia, Ospedale V.Buzzi; 🇮🇹 Milano, Italy

UOC Malattie Infettive, IRCCS Istituto G.Gaslini; 🇮🇹 Genova, Italy

Dipartimento per la salute della donna, del bambino e del neonato. Ospedale Maggiore Policlinico Mangiagalli e Regina Elena; 🇮🇹 Milano, Italy

Struttura Semplice di Ostetricia, Ospedale Niguarda Cà Granda; 🇮🇹 Milano, Italy

Ostetricia e Ginecologia, Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy

Dipartimento di Ostetricia e Ginecologia, IRCCS Burlo Garofolo; 🇮🇹 Trieste, Italy

SCDU Ostetricia e Ginecologia a indirizzo materno fetale, Dipartimento di Discipline Ginecologiche e Ostetriche, Università di Torino; 🇮🇹 Torino, Italy