Safety and Immunogenicity of a Second Dose of an Investigational Maternal Trivalent Group B Streptococcus Vaccine in Nonpregnant Women 4-6 Years After a First Dose: Results From a Phase 2 Trial
| Autor: | Annelies Aerssens, Ouzama Henry, Cathy Maes, Immaculada Margarit, Geert Leroux-Roels, Giada Buffi, A. Karsten, Luca Grassano, Karen S. Slobod, Stephen Cho, Fien De Boever, Bartholomew Corsaro, Zourab Bebia |
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| Rok vydání: | 2019 |
| Předmět: |
group B streptococcus
safety Microbiology (medical) Serotype medicine.medical_specialty immunogenicity medicine.disease_cause Group B Streptococcus agalactiae Immunogenicity Vaccine Pregnancy Internal medicine Streptococcal Infections Medicine Humans Adverse effect Articles and Commentaries reproductive and urinary physiology Vaccines Streptococcus vaccine Vaccines Conjugate business.industry Streptococcus Immunogenicity Streptococcal Vaccines Infant second dose bacterial infections and mycoses Antibodies Bacterial Vaccination AcademicSubjects/MED00290 Infectious Diseases Immunization bacteria Female maternal immunization business |
| Zdroj: | Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America |
| ISSN: | 1537-6591 |
| Popis: | Background Maternal immunization against group B streptococcus (GBS) could protect infants from invasive GBS disease. Additional doses in subsequent pregnancies may be needed. We evaluated the safety and immunogenicity of a second dose of an investigational trivalent CRM197-glycoconjugate GBS vaccine (targeting serotypes Ia/Ib/III), administered to nonpregnant women 4–6 years postdose 1. Methods Healthy women either previously vaccinated with 1 dose of trivalent GBS vaccine 4–6 years before enrollment (n = 53) or never GBS vaccinated (n = 27) received a single trivalent GBS vaccine injection. Adverse events (AEs) were recorded. Serotype-specific (Ia/Ib/III) anti-GBS antibodies were measured by multiplex immunoassay prevaccination and 30/60 days postvaccination. Results AEs were reported with similar rates after a first or second dose; none were serious. Of previously GBS-vaccinated women, 92%–98% had anti-GBS concentrations that exceeded an arbitrary threshold (8 µg/mL) for each serotype 60 days postdose 2 vs 36%–56% postdose 1 in previously non–GBS-vaccinated women. Of previously GBS-vaccinated women with undetectable baseline (predose 1) anti-GBS levels, 90%–98% reached this threshold postdose 2. For each serotype, anti-GBS geometric mean concentrations (GMCs) 30/60 days postdose 2 in previously GBS-vaccinated women were ≥200-fold higher than baseline GMCs. Among women with undetectable baseline anti-GBS levels, postdose 2 GMCs in previously GBS-vaccinated women exceeded postdose 1 GMCs in previously non–GBS-vaccinated women (≥7-fold). Conclusions A second trivalent GBS vaccine dose administered 4–6 years postdose 1 was immunogenic with a favorable safety profile. Women with undetectable preexisting anti-GBS concentrations may benefit from a sufficiently spaced second vaccine dose. Clinical Trials Registration NCT02690181 A second dose of the investigational trivalent group B streptococcus (GBS) vaccine, given 4–6 years after the first dose, elicited a robust immune response for each vaccine serotype in nonpregnant women, including in those with undetectable predose 1 anti-GBS antibody levels. |
| Databáze: | OpenAIRE |
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