Level of Maternal Antibody Required to Protect Neonates against Early-Onset Disease Caused by Group B Streptococcus Type Ia: A Multicenter, Seroepidemiology Study
Because of the difficulty of conducting efficacy trials of vaccines against group B streptococcus (GBS), the licensure of these vaccines may have to rely on studies that measure vaccine-induced antibody levels that correlate with protection. This study estimates the level of maternal antibody requir...
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Published in | The Journal of infectious diseases Vol. 184; no. 8; pp. 1022 - 1028 |
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Main Authors | , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Chicago, IL
The University of Chicago Press
15.10.2001
University of Chicago Press |
Subjects | |
Online Access | Get full text |
ISSN | 0022-1899 1537-6613 |
DOI | 10.1086/323350 |
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Abstract | Because of the difficulty of conducting efficacy trials of vaccines against group B streptococcus (GBS), the licensure of these vaccines may have to rely on studies that measure vaccine-induced antibody levels that correlate with protection. This study estimates the level of maternal antibody required to protect neonates against early-onset disease (EOD) caused by GBS type Ia. Levels of maternal serum IgG GBS Ia antibodies, measured by ELISAs in 45 case patients (neonates with EOD caused by GBS Ia) and in 319 control subjects (neonates colonized by GBS Ia but without EOD) born at ⩾34 weeks gestation were compared. The probability of developing EOD declined with increasing maternal levels of IgG GBS Ia antibody (P=.03). Neonates whose mothers had levels of IgG GBS Ia antibody ⩾5 μg/mL had an 88% lower risk (95% confidence interval, 7%–98%) of developing type-specific EOD, compared with those whose mothers had levels <0.5 μg/mL. A vaccine that induces IgG GBS Ia antibody levels ⩾5 μg/mL in mothers can be predicted to confer a high degree of type-specific immunity to EOD to their infants |
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AbstractList | Because of the difficulty of conducting efficacy trials of vaccines against group B streptococcus (GBS), the licensure of these vaccines may have to rely on studies that measure vaccine-induced antibody levels that correlate with protection. This study estimates the level of maternal antibody required to protect neonates against early-onset disease (EOD) caused by GBS type Ia. Levels of maternal serum IgG GBS Ia antibodies, measured by ELISAs in 45 case patients (neonates with EOD caused by GBS Ia) and in 319 control subjects (neonates colonized by GBS Ia but without EOD) born at greater than or equal to 34 weeks gestation were compared. The probability of developing EOD declined with increasing maternal levels of IgG GBS Ia antibody (P = .03). Neonates whose mothers had levels of IgG GBS Ia antibody greater than or equal to 5 mu g/mL had an 88% lower risk (95% confidence interval, 7%-98%) of developing type-specific EOD, compared with those whose mothers had levels <0.5 mu g/mL. A vaccine that induces IgG GBS Ia antibody levels greater than or equal to 5 mu g/mL in mothers can be predicted to confer a high degree of type-specific immunity to EOD to their infants. Because of the difficulty of conducting efficacy trials of vaccines against group B streptococcus (GBS), the licensure of these vaccines may have to rely on studies that measure vaccine-induced antibody levels that correlate with protection. This study estimates the level of maternal antibody required to protect neonates against early-onset disease (EOD) caused by GBS type Ia. Levels of maternal serum IgG GBS Ia antibodies, measured by ELISAs in 45 case patients (neonates with EOD caused by GBS Ia) and in 319 control subjects (neonates colonized by GBS Ia but without EOD) born at ⩾34 weeks gestation were compared. The probability of developing EOD declined with increasing maternal levels of IgG GBS Ia antibody (P=.03). Neonates whose mothers had levels of IgG GBS Ia antibody ⩾5 μg/mL had an 88% lower risk (95% confidence interval, 7%-98%) of developing type-specific EOD, compared with those whose mothers had levels <0.5 μg/mL. A vaccine that induces IgG GBS Ia antibody levels ⩾5 μg/mL in mothers can be predicted to confer a high degree of type-specific immunity to EOD to their infants Because of the difficulty of conducting efficacy trials of vaccines against group B streptococcus (GBS), the licensure of these vaccines may have to rely on studies that measure vaccine-induced antibody levels that correlate with protection. This study estimates the level of maternal antibody required to protect neonates against early-onset disease (EOD) caused by GBS type Ia. Levels of maternal serum IgG GBS Ia antibodies, measured by ELISAs in 45 case patients (neonates with EOD caused by GBS Ia) and in 319 control subjects (neonates colonized by GBS Ia but without EOD) born at > or =34 weeks gestation were compared. The probability of developing EOD declined with increasing maternal levels of IgG GBS Ia antibody (P = .03). Neonates whose mothers had levels of IgG GBS Ia antibody > or =5 microg/mL had an 88% lower risk (95% confidence interval, 7%-98%) of developing type-specific EOD, compared with those whose mothers had levels < 0.5 microg/mL. A vaccine that induces IgG GBS Ia antibody levels > or =5 microg/mL in mothers can be predicted to confer a high degree of type-specific immunity to EOD to their infants. Because of the difficulty of conducting efficacy trials of vaccines against group B streptococcus (GBS), the licensure of these vaccines may have to rely on studies that measure vaccine-induced antibody levels that correlate with protection. This study estimates the level of maternal antibody required to protect neonates against early-onset disease (EOD) caused by GBS type Ia. Levels of maternal serum IgG GBS Ia antibodies, measured by ELISAs in 45 case patients (neonates with EOD caused by GBS Ia) and in 319 control subjects (neonates colonized by GBS Ia but without EOD) born at > or =34 weeks gestation were compared. The probability of developing EOD declined with increasing maternal levels of IgG GBS Ia antibody (P = .03). Neonates whose mothers had levels of IgG GBS Ia antibody > or =5 microg/mL had an 88% lower risk (95% confidence interval, 7%-98%) of developing type-specific EOD, compared with those whose mothers had levels < 0.5 microg/mL. A vaccine that induces IgG GBS Ia antibody levels > or =5 microg/mL in mothers can be predicted to confer a high degree of type-specific immunity to EOD to their infants.Because of the difficulty of conducting efficacy trials of vaccines against group B streptococcus (GBS), the licensure of these vaccines may have to rely on studies that measure vaccine-induced antibody levels that correlate with protection. This study estimates the level of maternal antibody required to protect neonates against early-onset disease (EOD) caused by GBS type Ia. Levels of maternal serum IgG GBS Ia antibodies, measured by ELISAs in 45 case patients (neonates with EOD caused by GBS Ia) and in 319 control subjects (neonates colonized by GBS Ia but without EOD) born at > or =34 weeks gestation were compared. The probability of developing EOD declined with increasing maternal levels of IgG GBS Ia antibody (P = .03). Neonates whose mothers had levels of IgG GBS Ia antibody > or =5 microg/mL had an 88% lower risk (95% confidence interval, 7%-98%) of developing type-specific EOD, compared with those whose mothers had levels < 0.5 microg/mL. A vaccine that induces IgG GBS Ia antibody levels > or =5 microg/mL in mothers can be predicted to confer a high degree of type-specific immunity to EOD to their infants. |
Author | Brenner, Ruth A. Bhushan, Reva Lin, Feng-Ying C. Philips, Joseph B. Weisman, Leonard E. Fitzgerald, Geri Azimi, Parvin H. Rhoads, George G. Troendle, James Moyer, Patricia Concepcion, Nelydia F. Clark, Penny Regan, Joan Clemens, John D. Frasch, Carl E. Gray, Barry M. |
Author_xml | – sequence: 1 givenname: Feng-Ying C. surname: Lin fullname: Lin, Feng-Ying C. email: Link@exchange.nih.gov organization: National Institute of Child Health and Human Development, National Institutes of Health – sequence: 2 givenname: Joseph B. surname: Philips fullname: Philips, Joseph B. organization: Department of Pediatrics, University of Alabama at Birmingham – sequence: 3 givenname: Parvin H. surname: Azimi fullname: Azimi, Parvin H. organization: Children's Hospital Medical Center of Northern California, Oakland – sequence: 4 givenname: Leonard E. surname: Weisman fullname: Weisman, Leonard E. organization: Baylor College of Medicine, Houston, Texas – sequence: 5 givenname: Penny surname: Clark fullname: Clark, Penny organization: Department of Obstetrics and Gynecology, University of Florida, Gainesville – sequence: 6 givenname: George G. surname: Rhoads fullname: Rhoads, George G. organization: Department of Environmental and Community Medicine, University of Medicine and Dentistry of New Jersey, Piscataway – sequence: 7 givenname: Joan surname: Regan fullname: Regan, Joan organization: Columbia University Health Sciences, New York, New York – sequence: 8 givenname: Nelydia F. surname: Concepcion fullname: Concepcion, Nelydia F. organization: Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda – sequence: 9 givenname: Carl E. surname: Frasch fullname: Frasch, Carl E. organization: Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda – sequence: 10 givenname: James surname: Troendle fullname: Troendle, James organization: National Institute of Child Health and Human Development, National Institutes of Health – sequence: 11 givenname: Ruth A. surname: Brenner fullname: Brenner, Ruth A. organization: National Institute of Child Health and Human Development, National Institutes of Health – sequence: 12 givenname: Barry M. surname: Gray fullname: Gray, Barry M. organization: Department of Pediatrics, University of Alabama at Birmingham – sequence: 13 givenname: Reva surname: Bhushan fullname: Bhushan, Reva organization: Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda – sequence: 14 givenname: Geri surname: Fitzgerald fullname: Fitzgerald, Geri organization: Westat, Rockville, Maryland – sequence: 15 givenname: Patricia surname: Moyer fullname: Moyer, Patricia organization: National Institute of Child Health and Human Development, National Institutes of Health – sequence: 16 givenname: John D. surname: Clemens fullname: Clemens, John D. organization: National Institute of Child Health and Human Development, National Institutes of Health |
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Keywords | Human Antibody Multicenter study IgG Infant Vaccine Infection Streptococcaceae Specificity Streptococcal infection Streptococcus B Streptococcus A Bacteriosis Bacteria Micrococcales Serum ELISA assay |
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SubjectTerms | Age of Onset Antibodies, Bacterial - blood Bacterial diseases Biological and medical sciences Female Fetal Blood - immunology Human bacterial diseases Human viral diseases Humans Immunity, Maternally-Acquired Immunoglobulin G - blood Infant, Newborn Infectious diseases Medical sciences Predictive Value of Tests Pregnancy Pregnancy Complications - immunology Staphylococcal infections, streptococcal infections, pneumococcal infections Streptococcal Infections - immunology Streptococcal Infections - prevention & control Streptococcus Streptococcus agalactiae - immunology Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids |
Title | Level of Maternal Antibody Required to Protect Neonates against Early-Onset Disease Caused by Group B Streptococcus Type Ia: A Multicenter, Seroepidemiology Study |
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