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

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS Policlinico S. Matteo
• Treatments: Immunoglobulins

Criteria

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