Safety of Herpes Zoster Subunit (HZ/su) Vaccine During Pregnancy in Adult Women With Immunocompromised Conditions

Study Overview
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Brief Summary
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The purpose of this postmarketing commitment safety study is to evaluate the real-world safety of HZ/su vaccine during pregnancy in immunodeficient or immunosuppressed adult pregnant women between 18 and 49 years of age in the United States. The primary outcome of interest is major congenital malformations (MCMs).

Official Title
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Post Marketing Commitment Safety Study of HZ/su to Evaluate Pregnancy Exposures and Outcomes in Immunodeficient or Immunosuppressed Women Between 18 and 49 Years of Age

Conditions
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Herpes Zoster

Intervention / Treatment
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* Other: Data collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant who is pregnant with a pregnancy start date between July 1, 2021 and June 30, 2026. Live births are to be followed for 1 year. Participant is a female aged 18-49 years on the pregnancy start date. Participant meets study definition of systemic lupus erythematosus (SLE), multiple sclerosis (MS), rheumatoid arthritis (RA), inflammatory bowel disease (IBD), psoriasis (PsO)/psoriatic arthritis (PsA), solid organ transplant (SOT), stem cell transplant (SCT), hematologic malignancies (HM), solid tumors (ST), or human immunodeficiency virus (HIV). Codes for immunocompromised (IC) conditions will be identified in the health plan claims of the Distributed Research Network (DRN) during the period 273 days prior to the pregnancy start date through the first trimester (98 days after the pregnancy start date). Diagnoses recorded through the first trimester will be included to account for women who may not have frequent visits prior to pregnancy and may have a more complete assessment of medical conditions during the first prenatal care visit. Participant has at least 273 days of continuous health plan enrollment with medical and drug benefits prior to the start of pregnancy through the delivery date, with gaps of up to 45 days in coverage being permitted. The 273-day pre-pregnancy period through the first trimester (a period of 98 days after the pregnancy start date) was chosen to allow identification of potential confounders of interest. In Sentinel projects, gaps of 45 days or less in health plan enrolment are typically considered administrative gaps (and not lapses in health plan coverage) and ignored. Exclusion Criteria: Participant was exposed to a medication(s) that presents a known increased risk for fetal malformations. Participant delivered an infant identified as having a chromosomal or genetic anomaly. Ectopic pregnancies, molar pregnancies or induced abortions. Multigestation (e.g., twin) pregnancies.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HZ/su-Exposed Group<br>Pregnant adult women diagnosed with immunocompromised (IC) conditions exposed to HZ/su vaccine during pregnancy. | Other: Data collection<br>* This study will be conducted using data provided by U.S. Data Partners in the FDA's Sentinel System. Three Data Partners will participate in this study: CVS Health Clinical Trial Services (CTS), HealthCore, Inc., and Optum.<br>|
| Comparison (Unexposed) Group<br>Pregnant adult women diagnosed with immunocompromised (IC) conditions who were not vaccinated with HZ/su vaccine (i.e., not receiving at least one dose of HZ/su vaccine during pregnancy). | Other: Data collection<br>* This study will be conducted using data provided by U.S. Data Partners in the FDA's Sentinel System. Three Data Partners will participate in this study: CVS Health Clinical Trial Services (CTS), HealthCore, Inc., and Optum.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Major Congenital Malformations (MCMs) | The prevalence of MCMs among live births from women with immunocompromised conditions exposed to HZ/su vaccine compared to those not exposed to HZ/su vaccine during pregnancy is evaluated. An MCM (birth defect or structural defect) is defined as a defect, which has either cosmetic or functional significance to the child. | From birth up to 1 year of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of additional infant/birth outcomes | The prevalence of additional infant/birth outcomes (preterm birth, small for gestational age [SGA], low birthweight [LBW], neonatal intensive care unit [NICU] admission, neonatal death) among live births in women with immunocompromised conditions exposed to HZ/su vaccine versus those not exposed to HZ/su vaccine during pregnancy is assessed. | Within 30 days after the infant's date of birth | 
| Prevalence of pregnancy outcomes | The prevalence of pregnancy outcomes that include non-live birth (stillbirth and spontaneous abortion) among non-livebirth pregnancies in women with immunocompromised conditions exposed to HZ/su vaccine versus those not exposed to HZ/su vaccine during pregnancy is assessed. | At or after 20 weeks gestation but prior to delivery (stillbirth) and prior to 20 weeks gestation (spontaneous abortion) | 
| Prevalence of pregnancy complications | The prevalence of pregnancy complications (placental abruption, preeclampsia and eclampsia) among livebirth and non-livebirth pregnancies in women with immunocompromised conditions exposed to HZ/su vaccine versus those not exposed to HZ/su vaccine during pregnancy is assessed. | From 20 weeks gestation through the date of delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety study, Post-authorization safety study, Pregnant women, Herpes Zoster, Recombinant, Zoster vaccine, Targeted