Overview

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