Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection, GW ≤ 14 (PreCyssion)

Inclusion Criteria: * Written informed consent obtained from subjects indicating that they understand the purpose of and procedures required for the trial and are willing to participate in it * Pregnant women, age 18 to 45 years * Pregnant women at trial entry with gestational age ≤14 weeks; pregnancy after in-vitro fertilization permitted * Detection of early primary CMV infection Exclusion Criteria: * Women with current multiple pregnancy * History of severe pre-eclampsia or severe gestational hypertension (GHTN), which required medical intervention. Definition according to AWMF guideline (AWMF, 2019) * Presence of severe disease impairing course of pregnancy (e.g. diabetes, epilepsy, cancer) * Congenital or acquired autoimmune disease * Known immunosuppressive (e.g., transplanted patients) or immunodeficient condition * Known infection with hepatitis B or C, or HIV from the medical history or active infection at screening as assessed by respective virus serology * Maternal CMV infection prior to this pregnancy (preconceptional CMV infection) * Covid-19 infection at time of inclusion * Any signs or symptoms indicating an increased risk of abortion or premature labor or has known negative effect on fetus with exception of a CMV infection * Active infection according to TORCH serology with exception of CMV in the assessment of the investigator * Known major fetal anomalies or demise * Intolerance to proteins of human origin or known allergic reactions to components of the trial product * Selective absolute IgA deficiency or known antibodies to IgA * Known pre-existing clinically relevant risk factors for thrombotic events * Known renal insufficiency with serum creatinine levels \>1.4 mg/dL and proteinuria (albuminuria) at screening (≥30 mg/dL or dipstick reading of 1+ and greater) * Participation in another clinical trial within 90 days before entering the trial or during the trial * Women who are dependent on trial site staff, on Biotest AG or its authorized representatives * Inability or lacking motivation to participate in the trial * Medical condition, laboratory finding, or physical examination finding that in the opinion of the investigator precludes participationInability or lacking motivation to participate in the trial * Eligibility for a subgroup where enrollment was stopped