Journal Article

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

Govender, Niresha, Olugbosi, Morounfolu, Slobod, Karen, Wittke, Frederick, Dull, Peter M., Narasimhan, Vas, Jose, Lisa, Meulen, Ajoke Sobanjo-ter, Koen, Anthonet, Baker, Sherryl, Cutland, Clare L., Madhi, Shabir A.

2017

Overview

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. 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. 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. 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. NCT01193920.

• Publisher: Oxford University Press
• Subject: Age / and Commentaries / Antibodies / Antibodies, Bacterial - biosynthesis / Antibodies, Bacterial - blood / Antibodies, Bacterial - immunology / ARTICLES AND COMMENTARIES / Babies / Bacterial Proteins - administration & dosage / Bacterial Proteins - chemistry / Bacterial Proteins - immunology / Birth / Diphtheria / Diphtheria-Tetanus-Pertussis Vaccine - administration & dosage / Diphtheria-Tetanus-Pertussis Vaccine - immunology / Female / Glycoconjugates / Haemophilus Vaccines - administration & dosage / Haemophilus Vaccines - immunology / Humans / Immune response / Immune system / Immunity, Maternally-Acquired / Immunization / Immunization Schedule / Immunization, Secondary / Immunogenicity, Vaccine / Infant / Infants / Kinetics / Male / Mothers / Pertussis / Pneumococcal Vaccines - administration & dosage / Pneumococcal Vaccines - adverse effects / Pneumococcal Vaccines - immunology / Polysaccharides - administration & dosage / Polysaccharides - immunology / Pregnancy / Serotypes / Streptococcus / Streptococcus agalactiae - chemistry / Streptococcus agalactiae - immunology / Streptococcus infections / Tetanus / Vaccination / Vaccines / Vaccines, Combined - administration & dosage / Vaccines, Combined - immunology / Vaccines, Conjugate - administration & dosage / Vaccines, Conjugate - adverse effects / Vaccines, Conjugate - immunology