Safety, immunogenicity, and preliminary clinical efficacy of a vaccine against extraintestinal pathogenic Escherichia coli in women with a history of recurrent urinary tract infection: a randomised, single-blind, placebo-controlled phase 1b trial
Escherichia coli infections are increasing worldwide in community and hospital settings. The E coli O-antigen is a promising vaccine target. We aimed to assess the safety and immunogenicity of a bioconjugate vaccine containing the O-antigens of four E coli serotypes (ExPEC4V). In this multicentre ph...
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| Veröffentlicht in: | The Lancet infectious diseases Jg. 17; H. 5; S. 528 - 537 |
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| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Sprache: | Englisch |
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United States
Elsevier Ltd
01.05.2017
Elsevier Limited |
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| ISSN: | 1473-3099, 1474-4457, 1474-4457 |
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| Abstract | Escherichia coli infections are increasing worldwide in community and hospital settings. The E coli O-antigen is a promising vaccine target. We aimed to assess the safety and immunogenicity of a bioconjugate vaccine containing the O-antigens of four E coli serotypes (ExPEC4V).
In this multicentre phase 1b, first-in-human, single-blind, placebo-controlled trial, we randomly assigned (1:1) healthy adult women with a history of recurrent urinary tract infection (UTI) to receive a single injection of either intramuscular ExPEC4V or placebo. The primary outcome was the incidence of adverse events among vaccine and placebo recipients throughout the study. Secondary outcomes included immunogenicity and antibody functionality, and the incidence of UTIs caused by E coli vaccine serotypes in each group. This study is registered with ClinicalTrials.gov, number NCT02289794.
Between Jan 20, 2014, and Aug 27, 2014, 93 women received target-dose ExPEC4V and 95 received placebo. The vaccine was well tolerated: no vaccine-related serious adverse events occurred. Overall, 56 (60%) target-dose vaccines and 47 (49%) placebo recipients experienced at least one adverse event that was possibly, probably, or certainly related to injection. Vaccination induced significant IgG responses for all serotypes: at day 30 compared with baseline, O1A titres were 4·6 times higher, O2 titres were 9·4 times higher, O6A titres were 4·9 times higher, and O25B titres were 5·9 times higher (overall p<0·0001). Immune responses persisted at 270 days but were lower than those at 30 days. Opsonophagocytic killing activity showed antibody functionality. No reduction in the incidence of UTIs with 103 or more colony-forming units per mL of vaccine-serotype E coli was noted in the vaccine compared with the placebo group (0·149 mean episodes vs 0·146 mean episodes; p=0·522). In post-hoc exploratory analyses of UTIs with higher bacterial counts (≥105 colony-forming units per mL), the number of vaccine serotype UTIs did not differ significantly between groups (0·046 mean episodes in the vaccine group vs 0·110 mean episodes in the placebo group; p=0·074). However, significantly fewer UTIs caused by E coli of any serotype were noted in the vaccine group compared with the placebo group (0·207 mean episodes vs 0·463 mean episodes; p=0·002).
This tetravalent E coli bioconjugate vaccine candidate was well tolerated and elicited functional antibody responses against all vaccine serotypes. Phase 2 studies have been initiated to confirm these findings.
GlycoVaxyn, Janssen Vaccines. |
|---|---|
| AbstractList | Escherichia coli infections are increasing worldwide in community and hospital settings. The E coli O-antigen is a promising vaccine target. We aimed to assess the safety and immunogenicity of a bioconjugate vaccine containing the O-antigens of four E coli serotypes (ExPEC4V).
In this multicentre phase 1b, first-in-human, single-blind, placebo-controlled trial, we randomly assigned (1:1) healthy adult women with a history of recurrent urinary tract infection (UTI) to receive a single injection of either intramuscular ExPEC4V or placebo. The primary outcome was the incidence of adverse events among vaccine and placebo recipients throughout the study. Secondary outcomes included immunogenicity and antibody functionality, and the incidence of UTIs caused by E coli vaccine serotypes in each group. This study is registered with ClinicalTrials.gov, number NCT02289794.
Between Jan 20, 2014, and Aug 27, 2014, 93 women received target-dose ExPEC4V and 95 received placebo. The vaccine was well tolerated: no vaccine-related serious adverse events occurred. Overall, 56 (60%) target-dose vaccines and 47 (49%) placebo recipients experienced at least one adverse event that was possibly, probably, or certainly related to injection. Vaccination induced significant IgG responses for all serotypes: at day 30 compared with baseline, O1A titres were 4·6 times higher, O2 titres were 9·4 times higher, O6A titres were 4·9 times higher, and O25B titres were 5·9 times higher (overall p<0·0001). Immune responses persisted at 270 days but were lower than those at 30 days. Opsonophagocytic killing activity showed antibody functionality. No reduction in the incidence of UTIs with 103 or more colony-forming units per mL of vaccine-serotype E coli was noted in the vaccine compared with the placebo group (0·149 mean episodes vs 0·146 mean episodes; p=0·522). In post-hoc exploratory analyses of UTIs with higher bacterial counts (≥105 colony-forming units per mL), the number of vaccine serotype UTIs did not differ significantly between groups (0·046 mean episodes in the vaccine group vs 0·110 mean episodes in the placebo group; p=0·074). However, significantly fewer UTIs caused by E coli of any serotype were noted in the vaccine group compared with the placebo group (0·207 mean episodes vs 0·463 mean episodes; p=0·002).
This tetravalent E coli bioconjugate vaccine candidate was well tolerated and elicited functional antibody responses against all vaccine serotypes. Phase 2 studies have been initiated to confirm these findings.
GlycoVaxyn, Janssen Vaccines. Escherichia coli infections are increasing worldwide in community and hospital settings. The E coli O-antigen is a promising vaccine target. We aimed to assess the safety and immunogenicity of a bioconjugate vaccine containing the O-antigens of four E coli serotypes (ExPEC4V). In this multicentre phase 1b, first-in-human, single-blind, placebo-controlled trial, we randomly assigned (1:1) healthy adult women with a history of recurrent urinary tract infection (UTI) to receive a single injection of either intramuscular ExPEC4V or placebo. The primary outcome was the incidence of adverse events among vaccine and placebo recipients throughout the study. Secondary outcomes included immunogenicity and antibody functionality, and the incidence of UTIs caused by E coli vaccine serotypes in each group. This study is registered with ClinicalTrials.gov, number NCT02289794. Between Jan 20, 2014, and Aug 27, 2014, 93 women received target-dose ExPEC4V and 95 received placebo. The vaccine was well tolerated: no vaccine-related serious adverse events occurred. Overall, 56 (60%) target-dose vaccines and 47 (49%) placebo recipients experienced at least one adverse event that was possibly, probably, or certainly related to injection. Vaccination induced significant IgG responses for all serotypes: at day 30 compared with baseline, O1A titres were 4·6 times higher, O2 titres were 9·4 times higher, O6A titres were 4·9 times higher, and O25B titres were 5·9 times higher (overall p<0·0001). Immune responses persisted at 270 days but were lower than those at 30 days. Opsonophagocytic killing activity showed antibody functionality. No reduction in the incidence of UTIs with 10 or more colony-forming units per mL of vaccine-serotype E coli was noted in the vaccine compared with the placebo group (0·149 mean episodes vs 0·146 mean episodes; p=0·522). In post-hoc exploratory analyses of UTIs with higher bacterial counts (≥10 colony-forming units per mL), the number of vaccine serotype UTIs did not differ significantly between groups (0·046 mean episodes in the vaccine group vs 0·110 mean episodes in the placebo group; p=0·074). However, significantly fewer UTIs caused by E coli of any serotype were noted in the vaccine group compared with the placebo group (0·207 mean episodes vs 0·463 mean episodes; p=0·002). This tetravalent E coli bioconjugate vaccine candidate was well tolerated and elicited functional antibody responses against all vaccine serotypes. Phase 2 studies have been initiated to confirm these findings. GlycoVaxyn, Janssen Vaccines. Summary Background Escherichia coli infections are increasing worldwide in community and hospital settings. The E coli O-antigen is a promising vaccine target. We aimed to assess the safety and immunogenicity of a bioconjugate vaccine containing the O-antigens of four E coli serotypes (ExPEC4V). Methods In this multicentre phase 1b, first-in-human, single-blind, placebo-controlled trial, we randomly assigned (1:1) healthy adult women with a history of recurrent urinary tract infection (UTI) to receive a single injection of either intramuscular ExPEC4V or placebo. The primary outcome was the incidence of adverse events among vaccine and placebo recipients throughout the study. Secondary outcomes included immunogenicity and antibody functionality, and the incidence of UTIs caused by E coli vaccine serotypes in each group. This study is registered with ClinicalTrials.gov , number NCT02289794. Findings Between Jan 20, 2014, and Aug 27, 2014, 93 women received target-dose ExPEC4V and 95 received placebo. The vaccine was well tolerated: no vaccine-related serious adverse events occurred. Overall, 56 (60%) target-dose vaccines and 47 (49%) placebo recipients experienced at least one adverse event that was possibly, probably, or certainly related to injection. Vaccination induced significant IgG responses for all serotypes: at day 30 compared with baseline, O1A titres were 4·6 times higher, O2 titres were 9·4 times higher, O6A titres were 4·9 times higher, and O25B titres were 5·9 times higher (overall p<0·0001). Immune responses persisted at 270 days but were lower than those at 30 days. Opsonophagocytic killing activity showed antibody functionality. No reduction in the incidence of UTIs with 103 or more colony-forming units per mL of vaccine-serotype E coli was noted in the vaccine compared with the placebo group (0·149 mean episodes vs 0·146 mean episodes; p=0·522). In post-hoc exploratory analyses of UTIs with higher bacterial counts (≥105 colony-forming units per mL), the number of vaccine serotype UTIs did not differ significantly between groups (0·046 mean episodes in the vaccine group vs 0·110 mean episodes in the placebo group; p=0·074). However, significantly fewer UTIs caused by E coli of any serotype were noted in the vaccine group compared with the placebo group (0·207 mean episodes vs 0·463 mean episodes; p=0·002). Interpretation This tetravalent E coli bioconjugate vaccine candidate was well tolerated and elicited functional antibody responses against all vaccine serotypes. Phase 2 studies have been initiated to confirm these findings. Funding GlycoVaxyn, Janssen Vaccines. Escherichia coli infections are increasing worldwide in community and hospital settings. The E coli O-antigen is a promising vaccine target. We aimed to assess the safety and immunogenicity of a bioconjugate vaccine containing the O-antigens of four E coli serotypes (ExPEC4V).BACKGROUNDEscherichia coli infections are increasing worldwide in community and hospital settings. The E coli O-antigen is a promising vaccine target. We aimed to assess the safety and immunogenicity of a bioconjugate vaccine containing the O-antigens of four E coli serotypes (ExPEC4V).In this multicentre phase 1b, first-in-human, single-blind, placebo-controlled trial, we randomly assigned (1:1) healthy adult women with a history of recurrent urinary tract infection (UTI) to receive a single injection of either intramuscular ExPEC4V or placebo. The primary outcome was the incidence of adverse events among vaccine and placebo recipients throughout the study. Secondary outcomes included immunogenicity and antibody functionality, and the incidence of UTIs caused by E coli vaccine serotypes in each group. This study is registered with ClinicalTrials.gov, number NCT02289794.METHODSIn this multicentre phase 1b, first-in-human, single-blind, placebo-controlled trial, we randomly assigned (1:1) healthy adult women with a history of recurrent urinary tract infection (UTI) to receive a single injection of either intramuscular ExPEC4V or placebo. The primary outcome was the incidence of adverse events among vaccine and placebo recipients throughout the study. Secondary outcomes included immunogenicity and antibody functionality, and the incidence of UTIs caused by E coli vaccine serotypes in each group. This study is registered with ClinicalTrials.gov, number NCT02289794.Between Jan 20, 2014, and Aug 27, 2014, 93 women received target-dose ExPEC4V and 95 received placebo. The vaccine was well tolerated: no vaccine-related serious adverse events occurred. Overall, 56 (60%) target-dose vaccines and 47 (49%) placebo recipients experienced at least one adverse event that was possibly, probably, or certainly related to injection. Vaccination induced significant IgG responses for all serotypes: at day 30 compared with baseline, O1A titres were 4·6 times higher, O2 titres were 9·4 times higher, O6A titres were 4·9 times higher, and O25B titres were 5·9 times higher (overall p<0·0001). Immune responses persisted at 270 days but were lower than those at 30 days. Opsonophagocytic killing activity showed antibody functionality. No reduction in the incidence of UTIs with 103 or more colony-forming units per mL of vaccine-serotype E coli was noted in the vaccine compared with the placebo group (0·149 mean episodes vs 0·146 mean episodes; p=0·522). In post-hoc exploratory analyses of UTIs with higher bacterial counts (≥105 colony-forming units per mL), the number of vaccine serotype UTIs did not differ significantly between groups (0·046 mean episodes in the vaccine group vs 0·110 mean episodes in the placebo group; p=0·074). However, significantly fewer UTIs caused by E coli of any serotype were noted in the vaccine group compared with the placebo group (0·207 mean episodes vs 0·463 mean episodes; p=0·002).FINDINGSBetween Jan 20, 2014, and Aug 27, 2014, 93 women received target-dose ExPEC4V and 95 received placebo. The vaccine was well tolerated: no vaccine-related serious adverse events occurred. Overall, 56 (60%) target-dose vaccines and 47 (49%) placebo recipients experienced at least one adverse event that was possibly, probably, or certainly related to injection. Vaccination induced significant IgG responses for all serotypes: at day 30 compared with baseline, O1A titres were 4·6 times higher, O2 titres were 9·4 times higher, O6A titres were 4·9 times higher, and O25B titres were 5·9 times higher (overall p<0·0001). Immune responses persisted at 270 days but were lower than those at 30 days. Opsonophagocytic killing activity showed antibody functionality. No reduction in the incidence of UTIs with 103 or more colony-forming units per mL of vaccine-serotype E coli was noted in the vaccine compared with the placebo group (0·149 mean episodes vs 0·146 mean episodes; p=0·522). In post-hoc exploratory analyses of UTIs with higher bacterial counts (≥105 colony-forming units per mL), the number of vaccine serotype UTIs did not differ significantly between groups (0·046 mean episodes in the vaccine group vs 0·110 mean episodes in the placebo group; p=0·074). However, significantly fewer UTIs caused by E coli of any serotype were noted in the vaccine group compared with the placebo group (0·207 mean episodes vs 0·463 mean episodes; p=0·002).This tetravalent E coli bioconjugate vaccine candidate was well tolerated and elicited functional antibody responses against all vaccine serotypes. Phase 2 studies have been initiated to confirm these findings.INTERPRETATIONThis tetravalent E coli bioconjugate vaccine candidate was well tolerated and elicited functional antibody responses against all vaccine serotypes. Phase 2 studies have been initiated to confirm these findings.GlycoVaxyn, Janssen Vaccines.FUNDINGGlycoVaxyn, Janssen Vaccines. Escherichia coliinfections are increasing worldwide in community and hospital settings. TheE coliO-antigen is a promising vaccine target. We aimed to assess the safety and immunogenicity of a bioconjugate vaccine containing the O-antigens of fourE coliserotypes (ExPEC4V). Methods In this multicentre phase 1b, first-in-human, single-blind, placebo-controlled trial, we randomly assigned (1:1) healthy adult women with a history of recurrent urinary tract infection (UTI) to receive a single injection of either intramuscular ExPEC4V or placebo. The primary outcome was the incidence of adverse events among vaccine and placebo recipients throughout the study. Secondary outcomes included immunogenicity and antibody functionality, and the incidence of UTIs caused byE colivaccine serotypes in each group. This study is registered withClinicalTrials.gov, numberNCT02289794. Findings Between Jan 20, 2014, and Aug 27, 2014, 93 women received target-dose ExPEC4V and 95 received placebo. The vaccine was well tolerated: no vaccine-related serious adverse events occurred. Overall, 56 (60%) target-dose vaccines and 47 (49%) placebo recipients experienced at least one adverse event that was possibly, probably, or certainly related to injection. Vaccination induced significant IgG responses for all serotypes: at day 30 compared with baseline, O1A titres were 4·6 times higher, O2 titres were 9·4 times higher, O6A titres were 4·9 times higher, and O25B titres were 5·9 times higher (overall p<0·0001). Immune responses persisted at 270 days but were lower than those at 30 days. Opsonophagocytic killing activity showed antibody functionality. No reduction in the incidence of UTIs with 103or more colony-forming units per mL of vaccine-serotypeE coliwas noted in the vaccine compared with the placebo group (0·149 mean episodesvs0·146 mean episodes; p=0·522). In post-hoc exploratory analyses of UTIs with higher bacterial counts (>=105colony-forming units per mL), the number of vaccine serotype UTIs did not differ significantly between groups (0·046 mean episodes in the vaccine groupvs0·110 mean episodes in the placebo group; p=0·074). However, significantly fewer UTIs caused byE coliof any serotype were noted in the vaccine group compared with the placebo group (0·207 mean episodesvs0·463 mean episodes; p=0·002). Interpretation This tetravalentE colibioconjugate vaccine candidate was well tolerated and elicited functional antibody responses against all vaccine serotypes. Phase 2 studies have been initiated to confirm these findings. Funding GlycoVaxyn, Janssen Vaccines. |
| Author | Hornacek, Alena de Vallière, Serge Kuhn, Anette Dreyer, Anita M Viereck, Volker Kavvadias, Tilemachos Kling, Kerstin Davies, Todd Hatz, Christoph Fonck, Veronica Gambillara Fae, Kellen Poolman, Jan van den Dobbelsteen, Germie Abbanat, Darren Frölich, Rahel Bernasconi, Enos van den Nieuwenhof, Ingrid Alaimo, Cristina Gröger, Sabine Harbarth, Stephan Thoelen, Stefan Ryu, Gloria Martin, Patricia Huttner, Angela Hülder, Tanja Scheiner, David |
| Author_xml | – sequence: 1 givenname: Angela surname: Huttner fullname: Huttner, Angela email: angela.huttner@hcuge.ch organization: Infection Control Program, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland – sequence: 2 givenname: Christoph surname: Hatz fullname: Hatz, Christoph organization: Epidemiology, Biostatistics and Prevention Institute, Zurich University, Zurich, Switzerland – sequence: 3 givenname: Germie surname: van den Dobbelsteen fullname: van den Dobbelsteen, Germie organization: Bacterial Vaccines Discovery & Early Development, Janssen Vaccines and Prevention, Leiden, Netherlands – sequence: 4 givenname: Darren surname: Abbanat fullname: Abbanat, Darren organization: Janssen Research and Development, Raritan, NJ, USA – sequence: 5 givenname: Alena surname: Hornacek fullname: Hornacek, Alena organization: LimmaTech Biologics, Schlieren, Switzerland – sequence: 6 givenname: Rahel surname: Frölich fullname: Frölich, Rahel organization: LimmaTech Biologics, Schlieren, Switzerland – sequence: 7 givenname: Anita M surname: Dreyer fullname: Dreyer, Anita M organization: LimmaTech Biologics, Schlieren, Switzerland – sequence: 8 givenname: Patricia surname: Martin fullname: Martin, Patricia organization: LimmaTech Biologics, Schlieren, Switzerland – sequence: 9 givenname: Todd surname: Davies fullname: Davies, Todd organization: Janssen Research and Development, Raritan, NJ, USA – sequence: 10 givenname: Kellen surname: Fae fullname: Fae, Kellen organization: Bacterial Vaccines Discovery & Early Development, Janssen Vaccines and Prevention, Leiden, Netherlands – sequence: 11 givenname: Ingrid surname: van den Nieuwenhof fullname: van den Nieuwenhof, Ingrid organization: Bacterial Vaccines Discovery & Early Development, Janssen Vaccines and Prevention, Leiden, Netherlands – sequence: 12 givenname: Stefan surname: Thoelen fullname: Thoelen, Stefan organization: Bacterial Vaccines Discovery & Early Development, Janssen Vaccines and Prevention, Leiden, Netherlands – sequence: 13 givenname: Serge surname: de Vallière fullname: de Vallière, Serge organization: Policlinique Médicale Universitaire and Service of Infectious Diseases, University Hospital Lausanne, Lausanne, Switzerland – sequence: 14 givenname: Anette surname: Kuhn fullname: Kuhn, Anette organization: Universitätsklinik für Frauenheilkunde, University Hospital Bern, Bern, Switzerland – sequence: 15 givenname: Enos surname: Bernasconi fullname: Bernasconi, Enos organization: Ospedale Regionale di Lugano, Lugano, Switzerland – sequence: 16 givenname: Volker surname: Viereck fullname: Viereck, Volker organization: Blasen-und Beckenbodenzentrum, Kantonsspital Frauenfeld, Frauenfeld, Switzerland – sequence: 17 givenname: Tilemachos surname: Kavvadias fullname: Kavvadias, Tilemachos organization: Frauenklinik, University Hospital Basel, Basel, Switzerland – sequence: 18 givenname: Kerstin surname: Kling fullname: Kling, Kerstin organization: Swiss Tropical and Public Health Institute, Basel University, Basel, Switzerland – sequence: 19 givenname: Gloria surname: Ryu fullname: Ryu, Gloria organization: Frauenklinik, Kantonsspital Aarau, Aarau, Switzerland – sequence: 20 givenname: Tanja surname: Hülder fullname: Hülder, Tanja organization: Frauenklinik, Kantonsspital St Gallen, St Gallen, Switzerland – sequence: 21 givenname: Sabine surname: Gröger fullname: Gröger, Sabine organization: Neue Frauenklinik, Luzerner Kantonsspital, Lucerne, Switzerland – sequence: 22 givenname: David surname: Scheiner fullname: Scheiner, David organization: Department of Gynecology, University Hospital Zurich, Zurich, Switzerland – sequence: 23 givenname: Cristina surname: Alaimo fullname: Alaimo, Cristina organization: LimmaTech Biologics, Schlieren, Switzerland – sequence: 24 givenname: Stephan surname: Harbarth fullname: Harbarth, Stephan organization: Infection Control Program, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland – sequence: 25 givenname: Jan surname: Poolman fullname: Poolman, Jan organization: Bacterial Vaccines Discovery & Early Development, Janssen Vaccines and Prevention, Leiden, Netherlands – sequence: 26 givenname: Veronica Gambillara surname: Fonck fullname: Fonck, Veronica Gambillara organization: LimmaTech Biologics, Schlieren, Switzerland |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/28238601$$D View this record in MEDLINE/PubMed |
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| Snippet | Escherichia coli infections are increasing worldwide in community and hospital settings. The E coli O-antigen is a promising vaccine target. We aimed to assess... Summary Background Escherichia coli infections are increasing worldwide in community and hospital settings. The E coli O-antigen is a promising vaccine target.... Escherichia coliinfections are increasing worldwide in community and hospital settings. TheE coliO-antigen is a promising vaccine target. We aimed to assess... |
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| SubjectTerms | Adult Aged Antibodies Antigens Bacteria E coli Epidemiology Escherichia coli Escherichia coli Vaccines - administration & dosage Escherichia coli Vaccines - therapeutic use Extraintestinal Pathogenic Escherichia coli - isolation & purification Female Humans Immune response Immunogenicity Immunogenicity, Vaccine Incidence Infections Infectious Disease Infectious diseases Injection Investigations Middle Aged Pathogens Safety Single-Blind Method Treatment Outcome Urinary tract infections Urinary Tract Infections - prevention & control Vaccination - methods Vaccines |
| Title | Safety, immunogenicity, and preliminary clinical efficacy of a vaccine against extraintestinal pathogenic Escherichia coli in women with a history of recurrent urinary tract infection: a randomised, single-blind, placebo-controlled phase 1b trial |
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