TY - JOUR
T1 - Varicella zoster immune globulin (human) (VARIZIG) in immunocompromised patients
T2 - a subgroup analysis for safety and outcomes from a large, expanded-access program
AU - Gans, Hayley
AU - Chemaly, Roy F.
N1 - Funding Information:
This work was supported by Cangene Corporation, Winnipeg, Canada (manufacturer and initial owner of VARIZIG [varicella zoster immune globulin (human)]). Cangene was involved in study design and conduct. Saol Therapeutics funded the subsequent independent data analysis, interpretation, medical writing support, and participated in the decision to submit the article for publication. Saol was involved in the review of the article for medical accuracy, but the final content was left to the discretion of the authors.
Funding Information:
HG has received funding/grant support from National Vaccine Program Office, National Institutes of Health, and honorarium for consultancy from US Department of Health and Human Services. RFC has received funding/grant support paid to his institution from Merck, Chimerix, Viracor, Oxford Immunotec, Xenex, Gilead, Ansun Pharmaceuticals, Shire/Takeda, and AiCuris, and honorarium for consultancy from Xenex, Merck, Chimerix, Shire/Takeda, Ansun Pharmaceuticals, Pulmotec, Clinigen, Oxford Immunotec, ReViral, Kyorin, Genentech, and Janssen.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - 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.
AB - 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.
KW - Immunocompromised
KW - Transplant
KW - Varicella
KW - Varicella zoster immune globulin
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U2 - 10.1186/s12879-020-05656-6
DO - 10.1186/s12879-020-05656-6
M3 - Article
C2 - 33430796
AN - SCOPUS:85099196965
SN - 1471-2334
VL - 21
JO - BMC Infectious Diseases
JF - BMC Infectious Diseases
IS - 1
M1 - 46
ER -