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 inThe Journal of infectious diseases Vol. 184; no. 8; pp. 1022 - 1028
Main Authors Lin, Feng-Ying C., Philips, Joseph B., Azimi, Parvin H., Weisman, Leonard E., Clark, Penny, Rhoads, George G., Regan, Joan, Concepcion, Nelydia F., Frasch, Carl E., Troendle, James, Brenner, Ruth A., Gray, Barry M., Bhushan, Reva, Fitzgerald, Geri, Moyer, Patricia, Clemens, John D.
Format Journal Article
LanguageEnglish
Published Chicago, IL The University of Chicago Press 15.10.2001
University of Chicago Press
Subjects
Online AccessGet full text
ISSN0022-1899
1537-6613
DOI10.1086/323350

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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
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.
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  organization: National Institute of Child Health and Human Development, National Institutes of Health
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Issue 8
Keywords Human
Antibody
Multicenter study
IgG
Infant
Vaccine
Infection
Streptococcaceae
Specificity
Streptococcal infection
Streptococcus B
Streptococcus A
Bacteriosis
Bacteria
Micrococcales
Serum
ELISA assay
Language English
License CC BY 4.0
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ark:/67375/HXZ-DBPB87PN-J
Present affiliations: Regional Pediatric Service, Spartanberg, South Carolina (B.M.G.); Iowa State University, Ames (R.B.); International Vaccine Institute, Seoul, South Korea (J.D.C)
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PublicationTitle The Journal of infectious diseases
PublicationTitleAbbrev The Journal of Infectious Diseases
PublicationTitleAlternate The Journal of Infectious Diseases
PublicationYear 2001
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Snippet 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...
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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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Volume 184
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