Antibody Kinetics and Response to Routine Vaccinations in Infants Born to Women Who Received an Investigational Trivalent Group B Streptococcus Polysaccharide CRM197-Conjugate Vaccine During Pregnancy

Autor: Morounfolu Olugbosi, Niresha Govender, Karen S. Slobod, Anthonet Koen, Clare L. Cutland, Sherryl Baker, Vas Narasimhan, Frederick Wittke, Shabir A. Madhi, Ajoke Sobanjo-ter Meulen, Lisa Jose, Peter M. Dull
Jazyk: angličtina
Rok vydání: 2017
Předmět:
0301 basic medicine
Male
routine immunization
medicine.disease_cause
Group B
Pneumococcal Vaccines
0302 clinical medicine
Immunogenicity
Vaccine
Pregnancy
030212 general & internal medicine
Articles and Commentaries
reproductive and urinary physiology
Haemophilus Vaccines
infants
Vaccination
Antibodies
Bacterial
Infectious Diseases
Female
medicine.drug
antenatal vaccination
Microbiology (medical)
medicine.medical_specialty
Diphtheria vaccine
030106 microbiology
Immunization
Secondary
Mothers
Streptococcus agalactiae
03 medical and health sciences
Bacterial Proteins
Conjugate vaccine
Polysaccharides
Internal medicine
medicine
Humans
Vaccines
Combined
Diphtheria-Tetanus-Pertussis Vaccine
Immunization Schedule
Diphtheria toxin
Vaccines
Conjugate
business.industry
Diphtheria
Infant
medicine.disease
bacterial infections and mycoses
Kinetics
Immunization
Immunology
bacteria
group B Streptococcus conjugate vaccine
business
Immunity
Maternally-Acquired
Zdroj: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
ISSN: 1537-6591
1058-4838
Popis: Group B Streptococcus (GBS)–specific antibodies were detectable in 3-month-old infants of mothers having received an investigational trivalent GBS vaccine during pregnancy. Maternal GBS vaccination did not have a clinically meaningful impact on immune responses to diphtheria or pneumococcal pediatric vaccination.
Background Maternal vaccination against group B Streptococcus (GBS) might provide protection against invasive GBS disease in infants. We investigated the kinetics of transplacentally transferred GBS serotype-specific capsular antibodies in the infants and their immune response to diphtheria toxoid and pneumococcal vaccination. Methods This phase 1b/2, observer-blind, single-center study (NCT01193920) enrolled infants born to women previously randomized (1:1:1:1) to receive either GBS vaccine at dosages of 0.5, 2.5, or 5.0 μg of each of 3 CRM197-glycoconjugates (serotypes Ia, Ib, and III), or placebo. Infants received routine immunization: combination diphtheria vaccine (diphtheria-tetanus-acellular pertussis–inactivated poliovirus/Haemophilus influenzae type b vaccine; age 6/10/ 14 weeks) and 13-valent pneumococcal CRM197-conjugate vaccine (PCV13; age 6/14 weeks and 9 months). Antibody levels were assessed at birth, day (D) 43, and D91 for GBS serotypes; 1 month postdose 3 (D127) for diphtheria; and 1 month postprimary (D127) and postbooster (D301) doses for pneumococcal serotypes. Results Of 317 infants enrolled, 295 completed the study. In infants of GBS vaccine recipients, GBS serotype-specific antibody geometric mean concentrations were significantly higher than in the placebo group at all timepoints and predictably decreased to 41%–61% and 26%–76% of birth levels by D43 and D91, respectively. Across all groups, ≥95% of infants were seroprotected against diphtheria at D127 and ≥91% of infants had seroprotective antibody levels against each PCV13 pneumococcal serotype at D301. Conclusions Maternal vaccination with an investigational CRM197-glycoconjugate GBS vaccine elicited higher GBS serotype-specific antibody levels in infants until 90 days of age, compared with a placebo group, and did not affect infant immune responses to diphtheria toxoid and pneumococcal vaccination. Clinical Trials Registration NCT01193920.
Databáze: OpenAIRE
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