Trial reportThe Lancet. Infectious diseases2021
Safety and immunogenicity of a novel hexavalent group B streptococcus conjugate vaccine in healthy, non-pregnant adults: a phase 1/2, randomised, placebo-controlled, observer-blinded, dose-escalation trial.
Trial report in The Lancet. Infectious diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 75 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
75 citing papers in PubMed, 127 citations in OpenAlex.
- Maternal 6-valent group B Streptococcus vaccine in non-pregnant and pregnant females: a randomized phase 1/2 trial.Nature medicine · 2026Trial
- A Phase 2b Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 6-Valent Group B Streptococcus Vaccine Administered Concomitantly With Tetanus, Diphtheria, and Acellular Pertussis Vaccine in Healthy Nonpregnant Female Individuals.The Journal of infectious diseases · 2025Trial
- Time to rethink prevention of neonatal group B streptococcal disease.Seminars in immunopathology · 2026Review
- Prevalence, Serotype Distribution, and Antimicrobial Resistance ofJournal of clinical medicine · 2026Article
- Neonatal Bloodstream Infections: A Narrative Review on Diagnostic and Therapeutic Challenges and Prospects in Developing Countries.Health science reports · 2026Article
- Maternal and Newborn Group BOpen forum infectious diseases · 2026Article
- Invasive Streptococcus agalactiae infections in infants in Guangzhou, Southern China (2013-2022): molecular epidemiology and clinical management implications.BMC microbiology · 2026Article
- Genomic epidemiology of Group B Streptococcus colonization among pregnant women in Japan, 2021-2023.PloS one · 2026Article
- Serotypes, sequence types, and erythromycin resistance of maternal colonizing group BFrontiers in pediatrics · 2026Article
- Molecular Epidemiology and Antimicrobial Resistance of Group BInfection and drug resistance · 2026Article
- Whole-genome characterization of neonatal group B Streptococcus infection isolates and contemporaneous maternal colonizing isolates in Southwest China.Frontiers in microbiology · 2026Article
- Maternal Group BClinical epidemiology · 2026Article
- Economic evaluation of prenatal GBS immunization in China: A modeling analysis.Human vaccines & immunotherapeutics · 2025Article
- Serum-equivalency comparison, detection, and quantification of Group BHuman vaccines & immunotherapeutics · 2025Article
- Virulence and pathogenicity of group BVirulence · 2025Review
- Consequences of host-microbiome interactions in preterm infants.Infection and immunity · 2025Review
- Preclinical Immunogenicity of a 6-Valent GBS Glycoconjugate Vaccine from a Repeat-Dose GLP Toxicology Study.Vaccines · 2025Article
- Vaccination in pregnancy to protect the newborn.Nature reviews. Immunology · 2025Review
- Serotype distribution, virulence factors, and antimicrobial resistance profiles of Streptococcus agalactiae (Group B Streptococcus) isolated from pregnant women in the Brazilian Amazon.BMC microbiology · 2025Article
- Diversity in Naturally Acquired Immunity to Group B Streptococcus: A Comparative Study of Women From Bangladesh, Malawi, and the United Kingdom.The Journal of infectious diseases · 2025Article
15 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
15 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundGroup B streptococcus (GBS) is a major cause of invasive disease in young infants. Infants born to women with sufficient pre-existing anti-GBS capsular IgG antibodies are at reduced risk of GBS disease, making maternal immunisation a potential strategy for prevention. We aimed to assess the safety and immunogenicity of a novel hexavalent (serotypes Ia, Ib, II, III, IV, and V) GBS conjugate vaccine (GBS6).
methodsThis phase 1/2, placebo-controlled, observer-blinded, dose-escalation trial, was done at four clinical research centres in the USA (Kentucky, Georgia, and two sites in Utah). Healthy, non-pregnant adults aged 18-49 years were randomly assigned using an interactive, web-based response technology system. Within each dose group (low, medium, or high), participants in sentinel cohorts were randomly assigned 2:2:1 and expanded cohort participants were randomly assigned 4:4:1 to receive GBS6 with aluminium phosphate (AlPO
findingsBetween June 5, 2017, and June 25, 2018, 365 participants were randomly assigned and 364 (52 in each dose group) were vaccinated and included in the safety analysis. Unsolicited adverse events were reported by 15 (29%) participants in the 5 μg with AlPO
interpretationGBS6 was well tolerated in healthy adults and elicited robust immune responses for all dose levels and formulations that persisted 6 months after vaccination. This study supports further evaluation of GBS6 in pregnant women.
fundingPfizer.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.