A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health

NCT03819049 | Completed Phase 1 Results DMC FDA Drug

• 3 other identifiers: CR108580VAC52416BAC10012020-000657-27
• Study Type: interventional
• Target: 836
• Locations: 5 countries
• Sites: 29

Brief Summary

The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of 3 different doses of ExPEC10V and to select the optimal dose for further clinical development (Cohort 1). Cohort 2 is aimed to expand the dataset supporting the short- and long-term safety and immunogenicity of the optimal dose of ExPEC10V, selected from the primary analysis results of Cohort 1. Cohort 2 will include participants in stable health with a history of urinary tract infection (UTI) in the past 5 years and will be included in the study to support the plan for late stage development of ExPEC vaccine.

Conditions

Extraintestinal Pathogenic Escherichia Coli Prevention

Outcome Measures

Primary Outcomes (20)

• Cohort 1: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 14 Days After Vaccination on Day 1

  Number of participants with solicited local AEs for 14 days after vaccination on Day 1 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local (injection site) AEs included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site). All solicited AEs at the injection site (local) were considered related to the study vaccine administration.

  Up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15)

• Cohort 1: Number of Participants With Solicited Systemic Adverse Events (AEs) Collected for 14 Days After Vaccination on Day 1

  Number of participants with solicited systemic AEs 14 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. Solicited systemic AEs included fatigue, headache, nausea, fever and myalgia, for which participants were specifically questioned and which were noted by participants in their participant diary for 14 days post-vaccination (day of vaccination and the subsequent 14 days).

  Up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15)

• Cohort 1: Number of Participants With Unsolicited Adverse Events (AEs) up to 29 Days After Vaccination on Day 1

  Number of participants with unsolicited AEs up to 29 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  Up to 29 days post vaccination on Day 1 (from Day 1 up to Day 30)

• Cohort 1: Number of Participants With Serious Adverse Events (SAEs) up to Day 181

  Number of participants with SAEs up to Day 181 were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

  Day 1 (post vaccination) up to Day 181

• Cohort 2: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Collected for 14 Days After Vaccination on Day 1

  Number of participants with solicited local AEs for 14 days after vaccination on Day 1 were reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local (injection site) AEs included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site). All solicited AEs at the injection site (local) were considered related to the study vaccine administration.

  Up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15)

• Cohort 2: Number of Participants With Solicited Systemic Adverse Events (AEs) Collected for 14 Days After Vaccination on Day 1

  Number of participants with solicited systemic AEs 14 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. Solicited systemic AEs included fatigue, headache, nausea, fever and myalgia, for which participants were specifically questioned and which were noted by participants in their participant diary for 14 days post-vaccination (day of vaccination and the subsequent 14 days).

  Up to 14 days post vaccination on Day 1 (from Day 1 up to Day 15)

• Cohort 2: Number of Participants With Unsolicited Adverse Events (AEs) 29 Days After Vaccination on Day 1

  Number of participants with unsolicited AEs up to 29 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

  Up to 29 days post vaccination on Day 1 (from Day 1 up to Day 30)

• Cohort 2: Number of Participants With Serious Adverse Events (SAEs) up to Day 181

  Number of participants with SAEs up to Day 181 were reported. An AE was any untoward medical occurrence in a clinical study administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

  Day 1 (post vaccination) up to Day 181

• Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex Electrochemiluminescent (ECL) Based Immunoassay on Day 15

  GMTs of serotype-specific total IgG serum antibodies as measured by multiplex ECL based immunoassay were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and exotoxin protein A (EPA) were determined in serum from collected blood samples.

  Day 15

• Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by Multiplex ECL Based Immunoassay on Day 15

  GMR of fold changes from baseline for serotype specific antibodies as measured by multiplex ECL based immunoassay on Day 15 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples by multiplex ECL based immunoassay. GMR of fold change from baseline was calculated as the ratio of GMTs on Day 15 and pre-vaccination (on Day 1).

  Baseline (Day 1, pre-vaccination) and Day 15

• Cohort 1: Percentage of Participants With a Greater Than or Equal to (>=) 2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Day 15

  Percentage of participants with a \>=2-fold and \>=4-fold increase from baseline in serotype specific serum antibody titers as measured by multiplex ECL based immunoassay on Day 15 was reported. The fold (\>=2-fold and \>=4-fold) increase from baseline to Day 15 for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA was calculated as the ratio of titer values of serum antibody on Day 15 and pre-vaccination (on day 1) that is Day 15/Day 1.

  Baseline (Day 1, pre-vaccination) and Day 15

• Cohort 1: Geometric Mean Titers (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex Opsonophagocytic Assay (MOPA) on Day 15

  GMTs of serotype-specific total IgG serum antibodies as measured by MOPA were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples.

  Day 15

• Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 15

  GMR of fold changes from baseline for serotype specific antibodies as measured by MOPA on Day 15 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples by MOPA. GMR of fold change from baseline was calculated as the ratio of GMTs on Day 15 and pre-vaccination (on Day 1).

  Baseline (Day 1, pre-vaccination), Day 15

• Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 15

  Percentage of participants with a \>=2-fold and \>=4-fold increase from baseline in serotype specific serum antibody titers as measured by MOPA on Day 15 was reported. The fold (\>=2-fold and \>=4-fold) increase from baseline to Day 15 for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, and O75 was calculated as the ratio of titer values of serum antibody on Day 15 and pre-vaccination (on day 1) that is, Day 15/Day 1.

  Baseline (Day 1, pre-vaccination) and Day 15

• Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Day 30

  GMTs of serotype-specific total IgG serum antibodies as measured by multiplex ECL based immunoassay were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples.

  At Day 30

• Cohort 2: Geometric Mean Ratio (GMR) of Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 30

  GMR of fold changes from baseline for serotype specific antibodies as measured by multiplex ECL based immunoassay on Day 30 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA were determined in serum from collected blood samples by multiplex ECL based immunoassay. GMR of fold change from baseline was calculated as the ratio of GMTs on Day 30 and pre-vaccination (on Day 1).

  Baseline (Day 1, pre-vaccination) and Day 30

• Cohort 2: Percentage of Participants With a >=2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Day 30

  Percentage of participants with a \>=2-fold and \>=4-fold increase from baseline in serotype specific serum antibody titers as measured by multiplex ECL based immunoassay on Day 30 was reported. The fold (\>=2-fold and \>=4-fold) increase from baseline to Day 30 for the serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, O75 and EPA was calculated as the ratio of titer values of serum antibody on Day 30 and pre-vaccination (on day 1) that is, Day 30/Day 1.

  Baseline (Day 1, pre-vaccination) and Day 30

• Cohort 2: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex Opsonophagocytic Assay (MOPA) on Day 30

  GMTs of serotype-specific total IgG serum antibodies as measured by MOPA were reported. GMTs for each antigen serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75 were determined in serum from collected blood samples. For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype.

  At Day 30

• Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 30

  GMR of fold changes from baseline for serotype specific antibodies as measured by MOPA on Day 30 were reported. GMR for each antigen serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 were determined in serum from collected blood samples by MOPA. GMR of fold change from baseline was calculated as the ratio of GMTs on Day 30 and pre-vaccination (on Day 1). For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype.

  Baseline (Day 1, pre-vaccination) and Day 30

• Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibodies Titers Measured by MOPA on Day 30

  Percentage of participants with a \>=2-fold and \>=4-fold increase from baseline in serotype specific serum antibodies titers as measured by MOPA on Day 30 was reported. The fold (\>=2-fold and \>=4-fold) increase from baseline to Day 30 for the serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 was calculated as the ratio of titer values of serum antibodies on Day 30 and pre-vaccination (on day 1) that is, Day 30/Day 1. For serotype O8 functional IgG serum antibodies were not evaluated as the assay was not able to detect vaccine-induced functional antibodies against the O8 serotype.

  Baseline (Day 1, pre-vaccination) and Day 30

Secondary Outcomes (28)

• Cohort 1: Correlation Between the Multiplex ECL-Based Immunoassay and the MOPA Functional Titers by Serotypes on Day 15

  Day 15

• Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181

  Days 30 and 181

• Cohort 1: Percentage of Participants With a Greater Than or Equal to (>=) 2-Fold and >=4-Fold Increase From Baseline in Serotype Specific Serum Antibody Titers as Measured by Multiplex ECL Based Immunoassay on Days 30 and 181

  Day 1 (pre-vaccination) and Days 30 and 181

• Cohort 1: Geometric Mean Ratio (GMR) of Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 30 and 181

  Baseline (Day 1, pre-vaccination) and Days 30 and 181

• Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex Opsonophagocytic Assay (MOPA) on Days 30 and 181

  At Days 30 and 181

Study Arms (7)

Cohort 1: ExPEC10V (Low Dose)

EXPERIMENTAL

Participants will be randomized to receive a single intramuscular (IM) injection of low dose ExPEC10V on Day 1.

Biological: ExPEC10V

Cohort 1: ExPEC10V (Medium dose)

EXPERIMENTAL

Participants will be randomized to receive a single IM injection of medium dose ExPEC10V on Day 1.

Biological: ExPEC10V

Cohort 1: ExPEC10V (High dose)

EXPERIMENTAL

Participants will be randomized to receive a single IM injection of high dose ExPEC10V on Day 1.

Biological: ExPEC10V

Cohort 1: ExPEC4V

EXPERIMENTAL

Participants will be randomized to receive a single IM injection of ExPEC4V on Day 1.

Biological: ExPEC4V

Cohort 1: Prevnar 13

EXPERIMENTAL

Participants will be randomized to receive a single IM injection of Prevnar 13 on Day 1.

Biological: Prevnar 13

Cohort 2: ExPEC10V

EXPERIMENTAL

Participants will be randomized to receive a single IM injection of selected dose of ExPEC10V on Day 1. The ExPEC10V dose used in Cohort 2 will be based on the primary analysis (Day 30) results of Cohort 1.

Biological: ExPEC10V

Cohort 2: Placebo

PLACEBO COMPARATOR

Participants will be randomized to receive a single IM injection of matching placebo on Day 1.

Biological: Placebo

Interventions

ExPEC10V BIOLOGICAL

Participants will receive a single IM injection of ExPEC10V (1 of 3 doses \[low or medium or high\]) in Cohort 1 and ExPEC10V selected dose (based on the primary analysis results of Cohort 1) in Cohort 2 on Day 1.

Also known as: VAC52416

Cohort 1: ExPEC10V (High dose); Cohort 1: ExPEC10V (Low Dose); Cohort 1: ExPEC10V (Medium dose); Cohort 2: ExPEC10V

ExPEC4V BIOLOGICAL

Participants will receive a single IM injection of ExPEC4V on Day 1.

Also known as: JNJ-63871860

Cohort 1: ExPEC4V

Prevnar 13 BIOLOGICAL

Participants will receive a single IM injection of Prevnar 13 on Day 1.

Cohort 1: Prevnar 13

Placebo BIOLOGICAL

Participants will receive single IM injection of matching placebo on Day 1.

Cohort 2: Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have a body mass index (BMI) of greater than (\>) 18.5 or less than 40 kilogram per meter square (kg/m\^2)
• Before randomization, a woman must be: postmenopausal - A postmenopausal state is defined as no menses for 12 months without an alternative medical cause; or not intending to conceive by any methods
• Must be healthy or medically stable
• Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
• Willing and able to adhere to the lifestyle restrictions specified in this protocol
• Agrees not to donate blood until 12 weeks after receiving the study vaccine

You may not qualify if:

• Acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than equal to \>=38.0 degree Celsius (100.4 degree Fahrenheit) within 24 hours prior to the administration of study vaccine, or, applicable for Cohort 2 only, an ongoing or suspected symptomatic urinary tract infection (UTI); enrollment at a later date is permitted (provided the screening window of 28 days is respected)
• History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
• Known allergies, hypersensitivity, or intolerance to ExPEC10V or its excipients
• Applicable for Cohort 1 only: known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the active control vaccines)
• Contraindication to intramuscular (IM) injections and blood draws example, bleeding disorders
• Abnormal function of the immune system
• Has had major psychiatric illness and/or drug substance or alcohol abuse in the past 12 months

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (29)

Optimal Research

Huntsville, Alabama, 35802, United States

Location

Optimal Research

Melbourne, Florida, 32934, United States

Location

Qps-Mra, Llc

Miami, Florida, 33143, United States

Location

Optimal Research

Peoria, Illinois, 61614, United States

Location

Synexus Clinical Research US Inc

Evansville, Indiana, 47714, United States

Location

Johnson County Clin-Trials

Lenexa, Kansas, 66219, United States

Location

Synexus Clinical Research US Inc

Richfield, Minnesota, 55432, United States

Location

Synexus Clinical Research US Inc

Manhattan, New York, 10017, United States

Location

Rochester Clinical Research, Inc

Rochester, New York, 14609, United States

Location

Synexus Clinical Research US Inc

Akron, Ohio, 44311, United States

Location

Synexus Clinical Research US Inc

Columbus, Ohio, 43212, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

Anima

Alken, 3570, Belgium

Location

ATC Pharma

Liège, 4000, Belgium

Location

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Location

CHU Nantes

Nantes, 44093, France

Location

Hopital Cochin

Paris, 75014, France

Location

APHP - Hopital Bichat - Claude Bernard

Paris, 75018, France

Location

CHU Lyon Sud

Pierre-Bénite, 69495, France

Location

Chu Rennes Hopital Pontchaillou

Rennes, 35000, France

Location

CHRU Tours Hopital Bretonneau

Tours, 37000, France

Location

EB Flevo Research

Almere Stad, 1311 RL, Netherlands

Location

PRA Health Sciences

Groningen, NZ 9728, Netherlands

Location

Hosp. Del Mar

Barcelona, 08003, Spain

Location

Hosp Reina Sofia

Córdoba, 14004, Spain

Location

Hosp. Univ. de La Princesa

Madrid, 28006, Spain

Location

Hosp. Univ. La Paz

Madrid, 28046, Spain

Location

Hosp. Univ. Marques de Valdecilla

Santander, 39008, Spain

Location

Hosp. Virgen Macarena

Seville, 41009, Spain

Location

Related Publications (1)

• Fierro CA, Sarnecki M, Spiessens B, Go O, Day TA, Davies TA, van den Dobbelsteen G, Poolman J, Abbanat D, Haazen W. A randomized phase 1/2a trial of ExPEC10V vaccine in adults with a history of UTI. NPJ Vaccines. 2024 Jun 14;9(1):106. doi: 10.1038/s41541-024-00885-1.

  PMID: 38877036 DERIVED

MeSH Terms

Interventions

13-valent pneumococcal vaccine

Results Point of Contact

• Title: Trial Physician
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: January 28, 2019
• Study Start: June 6, 2019
• Primary Completion: June 8, 2021
• Study Completion: December 18, 2024
• Last Updated: May 25, 2025
• Results First Posted: June 25, 2024

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (12); NL (2); BE (3); FR (6); ES (6)