Phase 2
Completed N=836
A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health
Extraintestinal Pathogenic Escherichia Coli Prevention
Source: ClinicalTrials.gov NCT03819049 ↗
Enrolled (actual)
836
Serious AEs
2.4%
Results posted
Jun 2024
Primary outcomePrimary: Cohort 1: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 14 Days After Vaccination on Day 1 — 46; 54; 60; 15 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cohort 1: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 14 Days After Vaccination on Day 1 |
46; 54; 60; 15; 40 | — |
| PRIMARY Cohort 1: Number of Participants With Solicited Systemic Adverse Events (AEs) Collected for 14 Days After Vaccination on Day 1 |
41; 47; 47; 17; 26 | — |
| PRIMARY Cohort 1: Number of Participants With Unsolicited Adverse Events (AEs) up to 29 Days After Vaccination on Day 1 |
25; 21; 23; 9; 15 | — |
| PRIMARY Cohort 1: Number of Participants With Serious Adverse Events (SAEs) up to Day 181 |
2; 2; 0; 0; 1 | — |
| PRIMARY Cohort 2: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Collected for 14 Days After Vaccination on Day 1 |
139; 22 | — |
| PRIMARY Cohort 2: Number of Participants With Solicited Systemic Adverse Events (AEs) Collected for 14 Days After Vaccination on Day 1 |
139; 53 | — |
| PRIMARY Cohort 2: Number of Participants With Unsolicited Adverse Events (AEs) 29 Days After Vaccination on Day 1 |
79; 36 | — |
| PRIMARY Cohort 2: Number of Participants With Serious Adverse Events (SAEs) up to Day 181 |
9; 6 | — |
| PRIMARY 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 |
5350535.1; 6358232.9; 6421446.5; 6930697.9; 1606747.3; 4873016.8 | — |
| PRIMARY 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 |
4.41; 5.33; 5.26; 6.00; 1.26; 9.54 | — |
| PRIMARY 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 |
78.2; 84.7; 82.0; 81.3; 9.8; 56.4 | — |
| PRIMARY 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 |
654.3; 764.2; 1129.5; 1377.3; 244.6; 5538.4 | — |
| PRIMARY Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 15 |
2.67; 4.29; 6.14; 5.34; 1.18; 14.39 | — |
| PRIMARY 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 |
49.5; 70.4; 72.0; 75.0; 13.7; 28.7 | — |
| PRIMARY 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 |
6341302.4; 1762724.3; 5957433.5; 749984.6; 3537556.6; 805295.5 | — |
| PRIMARY Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline For Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 30 |
4.40; 1.02; 8.18; 0.98; 5.31; 1.09 | — |
| PRIMARY 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 |
78.3; 1.6; 54.7; 0.8; 89.1; 1.6 | — |
| PRIMARY 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 |
703.0; 492.4; 3523.2; 502.4; 803.9; 178.7 | — |
| PRIMARY Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Day 30 |
1.81; 1.23; 8.04; 1.07; 4.26; 0.98 | — |
| PRIMARY 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 |
41.5; 22.9; 17.8; 2.9; 81.0; 18.6 | — |
| SECONDARY Cohort 1: Correlation Between the Multiplex ECL-Based Immunoassay and the MOPA Functional Titers by Serotypes on Day 15 |
0.62; 0.51; 0.63; 0.57; 0.51; 0.72 | — |
| SECONDARY 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 |
5112484.0; 6188073.3; 6383997.2; 6070942.6; 1794173.8; 4748963.2 | — |
| SECONDARY Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 30 and 181 |
4.05; 5.17; 5.28; 5.54; 1.31; 9.16 | — |
| SECONDARY Cohort 1: 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 Days 30 and 181 |
78.8; 82.8; 80.8; 77.1; 12.5; 53.5 | — |
| SECONDARY Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 30 and 181 |
1.58; 0.65; 11.86; 0.67; 3.62; 1.59 | — |
| SECONDARY Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 30 and 181 |
485.7; 452.6; 517.3; 815.3; 300.8; 2189.0 | — |
| SECONDARY Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 30 and 181 |
33.7; 11.1; 24.2; 0.0; 80.0; 0.0 | — |
| SECONDARY Cohort 1: Number of Participants With Serious Adverse Events (SAEs) Related to Study Vaccine or Study Procedure From Day 182 up to End of Study (Day 1826) |
0; 0; 0; 0; 0 | — |
| SECONDARY Cohort 1: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826 |
3934158.7; 1605160.3; 3045758.4; 1143355.0; 2796702.3; 1226079.9 | — |
| SECONDARY Cohort 1: 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 Days 366, 731, 1096, 1461 and 1826 |
70.4; 5.3; 58.1; 8.6; 56.1; 9.4 | — |
| SECONDARY Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 366, 731, 1096, 1461 and 1826 |
3.57; 1.10; 2.74; 0.82; 2.52; 0.82 | — |
| SECONDARY Cohort 1: Geometric Mean Titer (GMT) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461 |
266.6; 187.9; 198.0; 379.5; 229.2; 278.9 | — |
| SECONDARY Cohort 1: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype Specific Antibodies as Measured by MOPA on Days 366, 731, 1096, and 1461 |
0.90; 0.62; 0.71; 0.91; 0.80; 0.69 | — |
| SECONDARY Cohort 1: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Days 366, 731, 1096, and 1461 |
8.7; 0.0; 6.8; 14.3; 10.9; 0.0 | — |
| SECONDARY Cohort 2: Correlation Between the Multiplex ECL-Based Immunoassay and the MOPA Functional Titers by Serotype on Day 30 |
0.35; 0.20; 0.59; 0.47; 0.61; 0.20 | — |
| SECONDARY Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total Immunoglobulin G (IgG) Serum Antibodies as Measured by Multiplex ECL Based Immunoassay on Days 15 and 181 |
6440111.0; 1683620.1; 5984689.5; 758680.9; 3674695.0; 752878.3 | — |
| SECONDARY Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Days 15 and 181 |
4.40; 0.99; 7.96; 0.99; 5.45; 1.02 | — |
| SECONDARY Cohort 2: Percentage of Participants With a >= 2-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181 |
76.3; 0; 88.9; 0.8; 81.8; 1.5 | — |
| SECONDARY Cohort 2: Percentage of Participants With a >= 4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Days 15 and 181 |
54.5; 0; 77.9; 0.8; 60.9; 0.8 | — |
| SECONDARY Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total IgG Serum Antibodies Against Specified Antigens Measured by MOPA on Day 181 |
411.3; 334.1; 1684.8; 352.1; 591.2; 204.3 | — |
| SECONDARY Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 181 |
22.1; 12.5; 8.5; 1.4; 64.7; 12.5 | — |
| SECONDARY Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by MOPA on Day 181 |
1.07; 0.80; 3.94; 0.80; 3.16; 1.15 | — |
| SECONDARY Cohort 2: Number of Participants With Serious Adverse Events (SAEs) Related to Study Vaccine or Study Procedure From Day 182 up to End of Study (Day 1826) |
0; 0 | — |
| SECONDARY Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Antibodies Against Specified Antigens Measured by Multiplex ECL Based Immunoassay on Day 366 |
4022674.3; 1425709.7; 4539197.6; 945957.9; 1877926.0; 781470.1 | — |
| SECONDARY Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by Multiplex ECL Based Immunoassay on Day 366 |
62.4; 7.0; 34.9; 0.0; 81.6; 18.6 | — |
| SECONDARY Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by Multiplex ECL Based Immunoassay on Day 366 |
2.77; 0.83; 6.05; 1.21; 2.82; 1.04 | — |
| SECONDARY Cohort 2: Geometric Mean Titers (GMTs) of Serotype-specific Total IgG Serum Antibodies Against Specified Antigens Measured by MOPA on Day 366 |
376.0; 368.5; 1167.9; 395.5; 398.1; 191.7 | — |
| SECONDARY Cohort 2: Geometric Mean Ratio (GMR) of Fold Changes From Baseline for Serotype-specific Antibodies Measured by MOPA on Day 366 |
0.99; 0.84; 2.70; 0.78; 2.14; 1.04 | — |
| SECONDARY Cohort 2: Percentage of Participants With a >= 2-Fold and >=4-Fold Increase in Serotype-specific Serum Antibody Titers Measured by MOPA on Day 366 |
22.6; 12.3; 5.6; 2.7; 54.0; 11.0 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03819049). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.