Trial reportThe Journal of infectious diseases2025
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.
Trial report in The Journal of infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04766086 (A PHASE 2B, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE WHEN ADMINISTERED CONCOMITANTLY WITH TETANUS, DIPHTHERIA, AND ACELLULAR PERTUSSIS VACCINE), which is not on this map. Cited by 5 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.
A phase 2b, placebo-controlled, randomized, observer-blinded trial to evaluate the safety, tolerability, and immunogenicity of a multivalent group b streptococcus vaccine when administered concomitantly with tetanus, diphtheria, and acellular pertussis vaccine (tdap) in healthy nonpregnant women 18 through 49 years of age
Who cites it
5 citing papers in PubMed.
- Maternal 6-valent group B Streptococcus vaccine in non-pregnant and pregnant females: a randomized phase 1/2 trial.Nature medicine · 2026Trial
- Whole-genome characterization of neonatal group B Streptococcus infection isolates and contemporaneous maternal colonizing isolates in Southwest China.Frontiers in microbiology · 2026Article
- New Strategies for Preventing Perinatal Group B Streptococcus (GBS) Infections.Pathogens (Basel, Switzerland) · 2025Review
- Landscape analysis of pregnancy exposure registries in low- and middle-income countries: a scoping review.BMJ open · 2025Article
- Preclinical Immunogenicity of a 6-Valent GBS Glycoconjugate Vaccine from a Repeat-Dose GLP Toxicology Study.Vaccines · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
Abstract
backgroundMaternal group B Streptococcus (GBS) infection is associated with substantial risk of preterm birth and infant mortality. Preventive approaches to protect infants from GBS infection are needed.
methodsIn this phase 2b randomized study, healthy nonpregnant 18- to 49-year-old females were randomized 1:1:1 to receive the investigational 6-valent GBS polysaccharide conjugate vaccine (GBS6) and concomitant tetanus, diphtheria, and acellular pertussis vaccine (Tdap) (GBS6 + Tdap), GBS6 and placebo (GBS6 + placebo), or Tdap and placebo (Tdap + placebo). Primary safety endpoints included reactogenicity events within 7 days and adverse events (AEs) through 1 month after vaccination. Primary immunogenicity objectives were to describe immune responses induced by GBS6 + Tdap versus Tdap + placebo and versus GBS6 + placebo for pertussis, tetanus, and diphtheria Tdap antigens and the 6 GBS6 antigens.
resultsOverall, 304 participants received study vaccination. Most reactogenicity events were mild or moderate in severity and balanced across vaccine groups. Frequency of AEs was ≤8.1% across vaccine groups. One month after vaccination, the proportion of participants achieving antibody concentrations ≥0.1 IU/mL for tetanus and diphtheria antigens was 100% in both the GBS6 + Tdap and Tdap + placebo groups. Immune responses to pertussis antigens were lower in the GBS6 + Tdap group compared to the Tdap + placebo group, with geometric mean ratios <0.6. No consistent effect on immune responses against each of the GBS6 serotypes after concomitant administration with Tdap was observed.
conclusionsGBS6 and Tdap administered concomitantly and alone were safe and well tolerated in healthy nonpregnant individuals. Similar immune responses were observed for Tdap when administered with GBS6 or when administered alone. These results will likely inform future studies in pregnant individuals. Clinical Trials Registration. NCT04766086.
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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.