Varicella zoster immune globulin (human) (VARIZIG) in immunocompromised patients: a subgroup analysis for safety and outcomes from a large, expanded-access program.

Abstract

BACKGROUND:

Immunocompromised children and adults are at increased risk for severe disease and death following varicella zoster virus infection. Varicella zoster immune globulin (human) (VARIZIG) is recommended for post-exposure prophylaxis to prevent or attenuate varicella infection in high-risk individuals.

METHODS:

An open-label, expanded-access program provided VARIZIG to high-risk individuals exposed to varicella or herpes zoster. Immunocompromised participants were stratified by type of immunocompromising condition ("oncologic immunodeficiency", "primary immunodeficiency", "solid organ transplant" [SOT], "hematopoietic cell transplant" [HCT], and "other"). Patient characteristics, type of exposure and varicella outcome, and safety data were assessed.

RESULTS:

This analysis included 40 adults (primary [n = 6] or oncologic [n = 10] immunodeficiencies, history of SOT [n = 5] or HCT [n = 6], and other [n = 13]), and 263 children (primary [n = 13] or oncologic [n = 152] immunodeficiencies, history of SOT [n = 36] or HCT [n = 17], and other [n = 45]). Among adults and children, 48% vs 72% were exposed to varicella, 38% vs 16% were exposed to herpes zoster, and 15% vs 12% had an unspecified exposure. Overall incidence of varicella infection in adults after VARIZIG use was 6%; incidence of varicella infection in children after VARIZIG use was 7%. Similar rates were noted in each subgroup. Most cases of varicella were mild, with two children developing > 100 lesions and no cases of varicella-related pneumonia or encephalitis. Varicella-related hospitalizations occurred primarily in children with oncologic immunodeficiencies. One serious adverse event (serum sickness) was considered related to VARIZIG and occurred in a child with oncologic immunodeficiency. There were no varicella- or VARIZIG-related deaths.

CONCLUSIONS:

These data indicate that VARIZIG may reduce severity of varicella in immunocompromised children and adults.

TRIAL REGISTRATION:

This study was retrospectively registered with the public clinical trial identification NCT00338442 at https://www.clinicaltrials.gov on 20 June 2006.

• Authors: Hayley Gans, Roy F Chemaly
• Journal: BMC infectious diseases (BMC Infect Dis) Vol. 21 Issue 1 Pg. 46 (Jan 11 2021) ISSN: 1471-2334 [Electronic] England
• PMID: 33430796 (Publication Type: Journal Article)

Chemical References

• Immune Sera
• varicella-zoster immune globulin

Topics

• Adolescent
• Adult
• Aged
• Child
• Child, Preschool
• Female
• Herpes Zoster (epidemiology, immunology, prevention & control, virology)
• Herpesvirus 3, Human (immunology)
• Humans
• Immune Sera
• Immunization, Passive (methods)
• Immunocompromised Host
• Incidence
• Infant
• Infant, Newborn
• Male
• Middle Aged
• Post-Exposure Prophylaxis (methods)
• Treatment Outcome
• United States (epidemiology)
• Young Adult