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Cited by 744Respiratory viral infections researchNeonatal Respiratory Health ResearchImmunodeficiency and Autoimmune Disorders

Prophylactic Administration of Respiratory Syncytial Virus Immune Globulin to High-Risk Infants and Young Children

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Groothuis, Jessie R., Simoes, Eric, Levin, Myron J., Hall, Caroline B., Long, Christine E., Rodriguez, William J., Arrobio, Julita, Meissner, H. Cody +7 more·1993·New England Journal of Medicine
DOI 10.1056/nejm199311183292102
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Abstract

BACKGROUND: Infants with cardiac disease or prematurity are at risk for severe illness caused by respiratory syncytial virus. Immune globulin with a high titer of antibodies against respiratory syncytial virus may offer infants and young children at risk protection from this serious, common respiratory illness. METHODS: We studied 249 infants and young children (mean age, eight months) who had bronchopulmonary dysplasia due to prematurity (n = 102), congenital heart disease (n = 87), or prematurity alone (n = 60). Respiratory syncytial virus immune globulin was given monthly to some of these children in either a high dose (750 mg per kilogram of body weight; n = 81) or low dose (150 mg per kilogram; n = 79); 89 controls received no immune globulin. Group assignments were random. Assessments of respiratory illness and management were conducted without knowledge of the children's group assignments. RESULTS: There were 64 episodes of respiratory syncytial virus infection: 19 in the high-dose group, 16 in the low-dose group, and 29 in the control group. In the high-dose group there were fewer lower respiratory tract infections (7, vs. 20 in the control group; P = 0.01), fewer hospitalizations (6, vs. 18 in the control group; P = 0.02), fewer hospital days (43, vs. 128 in the control group; P = 0.02), fewer days in the intensive care unit (P = 0.05), and less use of ribavirin (P = 0.05). In the low-dose group there was a significant reduction only in the number of days in the intensive care unit (P = 0.03). Adverse events during the 580 infusions were generally mild and included fluid overload (in five children), oxygen desaturation (eight), and fever (six). Six children died: three in the high-dose group, three in the low-dose group, and none in the control group (P = 0.15), but no death was attributed to the use of immune globulin or to illness caused by respiratory syncytial virus. CONCLUSIONS: Administration of high doses of respiratory syncytial virus immune globulin is a safe and effective means of preventing lower respiratory tract infection in infants and young children at high risk for this disease.

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  • The neutralization titers elicited by LNP/RNA are above the titer of 380 that correlates with protection in cotton rats and similar to passively acquired serum neutralizing titers that correlate with protection of human infants from severe RSV disease.

    “The neutralization titers elicited by LNP/RNA are above the titer of 380 that correlates with protection in cotton rats (30) and similar to passively acquired serum neutralizing titers that correlate with protection of human infants from severe RSV disease (31,32).”

    From Nonviral delivery of self-amplifying RNA vaccines (2012) · cites this paper as [31]

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Research works printed but not linked: 4

  1. [4]4. Appendix N: prospects for immunizing against respiratory syncytial virus. In: New vaccine development: establishing priorities. Vol. I. Diseases of importance in the United States. Washington, D.C.: National Academic Press, 1985:397-410. -
  2. [27]27. Groothuis JR, Levin MJ, Rodriguez W, et al. Use of intravenous gamma obs iy i td cy tial virus: safety and pharmacokinetics: the RSVIG Study Group. Antimicrob Agents Chemother 1991;35:1469-73.
  3. [34]34. Simoes EAF, Groothuis JR, Levin MJ, et al. Standard (IGIV) vs RSV enriched (RSVIG) intravenous immune globulin for RSV immunoprophylaxis. Pediatr Res 1993;33:183A. abstract.
  4. [44]44. Connors M, Collins PL, Firestone CY, et al. Cotton rats previously immunized with a chimeric RSV FG glycoprotein develop enhanced pulmonary - atoo on on on o n o ing immunization with vaccinia-RSV recombinants or RSV. Vaccine 1992;10:475-84. Autumn Scene, Oregon <!-- image -->

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Authors
Groothuis, J. R., Simoes, E., Levin, M. J., Hall, C. B., Long, C. E., Rodriguez, W. J., Arrobio, J., Meissner, H. C., Fulton, D. R., Welliver, R. C., Tristram, D. A., Siber, G. R., Prince, G. A., Van Raden, M., & Hemming, V. G.
Affiliations
  • University of Colorado Anschutz (US)
  • Strong Memorial Hospital (US)
  • Children's National (US)
  • Tufts University (US)
  • University at Buffalo, State University of New York (US)
  • Massachusetts Department of Public Health (US)
  • Uniformed Services University of the Health Sciences (US)
ORCID
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
1993-11-18
Volume
329
Issue
21
Pages
1524-1530
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejm199311183292102
OpenAlex
W2328116798
Cited by
744
References
42
Citations by year
2026: 4 · 2025: 12 · 2024: 5 · 2023: 13 · 2022: 12 · 2021: 17 · 2020: 14 · 2019: 21 · 2018: 11 · 2017: 17 · 2016: 20 · 2015: 23 · 2014: 16 · 2013: 19 · 2012: 14
FWCI
26.07
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • U.S. Public Health Service (N01-A1-82520)
  • National Center for Research Resources (M01 RR-00044, M01RR000044, RR-69)
Topics
  • Health Sciences › Medicine › Epidemiology › Respiratory viral infections research
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Neonatal Respiratory Health Research
  • Life Sciences › Immunology and Microbiology › Immunology › Immunodeficiency and Autoimmune Disorders
Keywords
respiratory syncytial virus, prophylaxis, bronchopulmonary dysplasia, preterm birth, congenital heart disease, lower respiratory tract infection, hospitalization, intensive care unit admission, ribavirin, adverse events, infants and young children
MeSH terms
Antibodies, Viral, Bronchopulmonary Dysplasia, Female, Heart Defects, Congenital, Humans, Immunization, Passive, Infant, Infant, Newborn, Infant, Premature, Infant, Premature, Diseases, Male, Opportunistic Infections, Respiratory Syncytial Viruses, Risk Factors, Logistic Models, Immunoglobulins, Intravenous, Respiratory Syncytial Virus Infections

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