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

Launched by GLAXOSMITHKLINE · Mar 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a vaccine called HZ/su for pregnant women who have weakened immune systems. The main goal is to see if the vaccine might affect the development of babies, specifically looking for any major birth defects, also known as major congenital malformations. The trial will include women aged 18 to 49 who are pregnant between July 1, 2021, and June 30, 2026, and who have certain medical conditions that make their immune systems less effective, such as lupus, multiple sclerosis, or HIV.

To participate, women must have been enrolled in a health plan with medical coverage for at least 273 days before their pregnancy starts. They should not have any known risk factors for baby birth defects, like certain medications or genetic issues. While the trial is not yet recruiting participants, those who do join can expect to have their pregnancies and the health of their babies monitored for a full year after delivery. This study aims to provide important information about the vaccine's safety for both mothers and their babies.

Gender

FEMALE

Eligibility criteria

• 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.