Sponsor decision

A phase 3, open-label, single-arm, prospective, multi-center trial of Cytotect CP Biotest (BT097) for prevention of maternal-fetal CMV transmission after primary maternal CMV infection. The main purpose of the trial is to demonstrate efficacy and safety of Cytotect CP Biotest in preventing maternal-fetal transmission of cytomegalovirus (CMV).

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

Pregnant women