PF-06760805 / Pfizer - LARVOL DELTA

Safety and immunogenicity of GBS6 in pregnant women living with and without HIV and their infants in Uganda (PREPARE WP4): a double-blind, randomised, placebo-controlled, phase 2 clinical trial. (PubMed, Lancet Infect Dis) - P2 | "GBS6 elicited anti-capsular polysaccharide conjugate antibodies against group B streptococcus in pregnant women that were transferred to their infants, with no evidence of a difference irrespective of HIV status. No statistically significant difference was seen in pregnant women living with HIV compared with pregnant women not living with HIV or their infants in either safety or immunogenicity, suggesting that this vaccine could be used safely in pregnant women living with HIV."

Journal • P2 data • Human Immunodeficiency Virus • Infectious Disease • Tetanus

Maternal 6-valent group B Streptococcus vaccine in non-pregnant and pregnant females: a randomized phase 1/2 trial. (PubMed, Nat Med) - P2 | "These data support continuing clinical investigation of maternal GBS6 vaccination. ClinicalTrials.gov identifier: NCT03765073 ."

Journal • P1/2 data • Infectious Disease • Septic Shock

CLINICAL CHARACTERISTICS, OUTCOMES AND MOLECULAR EPIDEMIOLOGY OF GROUP B STREPTOCOCCAL DISEASE IN YOUNG INFANTS IN THE NETHERLANDS. (PubMed, J Infect) - "GBS disease in young infants remains associated with high morbidity and mortality. Limited adherence to intrapartum antibiotic prophylaxis highlights prevention gaps and supports maternal GBS vaccination."

Journal • CNS Disorders • Infectious Disease • Septic Shock

Group B streptococcal disease in infants 0-3 months in The Netherlands, 1987-2023: a nationwide genomic and epidemiological surveillance study. (PubMed, Lancet Reg Health Eur) - "The GBS6 and GBS-AlpN vaccines would potentially prevent >96% of cases. Netherlands Organisation for Health Research and Development (ZonMW) and ItsME foundation."

Journal • CNS Disorders • Infectious Disease • Septic Shock

C1091009: A Study to Learn About Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Infants (clinicaltrialsregister.eu) - P2/3 | N=764 | Recruiting | Sponsor: Pfizer Inc.

New P2/3 trial

BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies (clinicaltrials.gov) - P3 | N=6000 | Recruiting | Sponsor: Pfizer

New P3 trial

Serum-equivalency comparison, detection, and quantification of Group B Streptococcus anti-capsular polysaccharide antibodies from dried blood spots. (PubMed, Hum Vaccin Immunother) - "Conversion factors were applied to four serotypes (II, III, IV, and V) that did not meet the criteria for slope, intercept, or both. This demonstration of equivalency between DBS and serum supports the hypothesis that DBS is a suitable testing matrix from which to elucidate anti-CPS IgG concentrations in seroepidemiological and vaccine evaluation studies."

Journal

Safety and immunogenicity of a booster dose of a novel hexavalent group B streptococcus conjugate vaccine in healthy, non-pregnant adults: a phase 2, open-label extension of a phase 1/2 randomised controlled trial. (PubMed, Lancet Infect Dis) - P2 | "The results of this study showed that a single 20 μg booster dose of GBS6 given approximately 2 years after a primary dose to healthy, non-pregnant adults was safe and elicited robust immune responses that were consistently higher than those after the primary dose. As there is precedent for repeat doses of vaccines to augment or sustain circulating antibodies available for placental transfer with each pregnancy, results from this study might inform decisions around future dosing strategies for GBS6 for maternal immunisation with subsequent pregnancies should GBS6 be approved for use in pregnancy."

Journal • P1/2 data • P2 data • Pain

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. (PubMed, J Infect Dis) - P2 | "GBS6 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. (NCT04766086)."

Journal • P2b data • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus

Distribution of group B streptococci serotypes on women nasopharynx. (PubMed, Braz J Infect Dis) - "The results also highlight the importance of developing preventive strategies focused on upper respiratory tract colonization. Additionally, the potential introduction of the GBS6 vaccine could provide significant coverage against circulating GBS serotypes."

Journal • Infectious Disease

Immune Response Predictive of Potential Efficacy for Infants through a Maternal Multivalent Group B Streptococcus Vaccine. (ACOG 2024) - "360 Maternal participants were enrolled. GBS6 induced robust maternal antibody response to all six vaccine serotypes. Infants born to GBS6-vaccinated mothers had higher anti-CPS IgG geometric mean concentrations at birth compared to placebo, with the highest among 20 µg GBS6 recipients.Proportions of adverse and serious adverse events were similar among all groups."

Clinical

Trial to Evaluate the Safety, Tolerability, and Immunogenicity of A Multivalent Group B Streptococcus Vaccine When Administered Concomitantly With Tdap in Healthy Nonpregnant Women (clinicaltrials.gov) - P2 | N=306 | Completed | Sponsor: Pfizer | Phase classification: P2b ➔ P2

Phase classification • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus

Association between anti-capsular IgG levels at birth and risk of invasive group B streptococcus disease in Finnish newborns: a retrospective case-control study. (PubMed, Lancet Microbe) - "Higher neonatal anti-capsular polysaccharide serum IgG concentration at birth correlated with reduced risk of infant group B streptococcus disease in Finland. Based on these results, a maternal group B streptococcus capsular conjugate vaccine currently in development is predicted to be efficacious."

Journal • Retrospective data • Infectious Disease

Interlaboratory comparison of a multiplex immunoassay that measures human serum IgG antibodies against six-group B streptococcus polysaccharides. (PubMed, Hum Vaccin Immunother) - "Additionally, anti-CPS IgG concentrations for the 44-member human serum panel were established. The results of this study showed assay robustness and that the resultant anti-CPS IgG concentrations were reproducible across laboratories for the six GBS CPS serotypes when the standardized assay was used."

Journal

Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Nonpregnant Women And Pregnant Women And Their Infants (clinicaltrials.gov) - P2 | N=1214 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease

Clinical Trial Investigating the Safety and Immunogenicity of GBS6 in Pregnant Women With and Without HIV (PREPARE) (clinicaltrials.gov) - P2 | N=300 | Active, not recruiting | Sponsor: St George's, University of London | Trial completion date: Sep 2024 ➔ Sep 2025 | Trial primary completion date: Sep 2024 ➔ Sep 2025

Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

Clinical Trial Investigating the Safety and Immunogenicity of GBS6 in Pregnant Women (PREPARE) (clinicaltrials.gov) - P2 | N=300 | Active, not recruiting | Sponsor: St George's, University of London | Recruiting ➔ Active, not recruiting

Enrollment closed • Human Immunodeficiency Virus • Infectious Disease

Potential for Maternally Administered Vaccine for Infant Group B Streptococcus. (PubMed, N Engl J Med) - P2 | "GBS6 elicited anti-CPS antibodies against group B streptococcus in pregnant women that were transferred to infants at levels associated with a reduced risk of invasive group B streptococcal disease. (Funded by Pfizer and the Bill and Melinda Gates Foundation; C1091002 ClinicalTrials.gov number, NCT03765073.)."

Journal • Gastroenterology

Trial to Evaluate the Safety, Tolerability, and Immunogenicity of A Multivalent Group B Streptococcus Vaccine When Administered Concomitantly With Tdap in Healthy Nonpregnant Women (clinicaltrials.gov) - P2b | N=306 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed | N=53 ➔ 306

Enrollment change • Trial completion • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus

PREPARE: A Placebo Controlled Clinical Trial Investigating the Safety and Immunogenicity of GBS6 in Pregnant Women (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: St George's, University of London

New P2 trial • Human Immunodeficiency Virus • Infectious Disease

Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Nonpregnant Women And Pregnant Women And Their Infants (clinicaltrials.gov) - P2 | N=1201 | Active, not recruiting | Sponsor: Pfizer | N=639 ➔ 1201

Enrollment change • Infectious Disease

Trial to Evaluate the Safety, Tolerability, and Immunogenicity of A Multivalent Group B Streptococcus Vaccine When Administered Concomitantly With Tdap in Healthy Nonpregnant Women (clinicaltrials.gov) - P2b | N=53 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting | N=306 ➔ 53

Enrollment change • Enrollment closed • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus

Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Nonpregnant Women And Pregnant Women And Their Infants (clinicaltrials.gov) - P2 | N=614 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease

Trial to Evaluate the Safety, Tolerability, and Immunogenicity of A Multivalent Group B Streptococcus Vaccine When Administered Concomitantly With Tdap in Healthy Nonpregnant Women (clinicaltrials.gov) - P2b | N=300 | Recruiting | Sponsor: Pfizer | Trial completion date: Nov 2022 ➔ Apr 2023 | Trial primary completion date: Nov 2022 ➔ Apr 2023

Trial completion date • Trial primary completion date • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus

A Phase 2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Booster Dose of a Group B Streptococcus 6-Valent Polysaccharide Conjugate Vaccine (GBS6) (IDWeek 2022) - No abstract available

Clinical • P2 data • Infectious Disease