Phase 2
Completed N=100
A Study to Evaluate Safety and Immunogenicity of the ExPEC4V Clinical Trial Material After a Single Intramuscular Dose and a Second Dose 6 Months Later in Healthy Participants Aged 18 Years and Older
Healthy
Source: ClinicalTrials.gov NCT03500679 ↗
Enrolled (actual)
100
Serious AEs
3.0%
Results posted
Nov 2019
Primary outcomePrimary: Percentage of Participants With Solicited Local Adverse Events (AEs) After First Vaccination — 38.7; 20.0 Percentage of participants
Summary
The purpose of this study is to evaluate the safety/reactogenicity of the ExPEC4V clinical trial material (CTM) after the first vaccination and to evaluate the immunogenicity of the ExPEC4V CTM, as measured by the enzyme-linked immunosorbent assay (ELISA), 14 days after the first vaccination (on Day 15).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Solicited Local Adverse Events (AEs) After First Vaccination |
38.7; 20.0 | — |
| PRIMARY Percentage of Participants With Solicited Systemic Adverse Events After First Vaccination |
49.3; 20.0 | — |
| PRIMARY Percentage of Participants With Unsolicited Adverse Events After First Vaccination |
30.7; 32.0 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) After First Vaccination |
1; 1 | — |
| PRIMARY Enzyme-linked Immunosorbent Assay (ELISA) Geometric Mean Titers (GMTs) for Serotypes O1A, O2, O6A and O25B at Day 1 |
3177.8; 3113.7; 3598.1; 4127.3; 864.6; 817.9 | — |
| PRIMARY ELISA GMTs for Serotypes O1A, O2, O6A and O25B at Day 15 |
17030.3; 2838.2; 44704.8; 3761.6; 8206.6; 746.2 | — |
| PRIMARY ELISA Geometric Mean Ratio (GMR) for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1 |
5.22; 0.91; 12.06; 0.89; 8.61; 0.94 | — |
| PRIMARY Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Day 15 |
82.2; 0.0; 57.5; 0.0; 91.8; 0.0 | — |
| SECONDARY Percentage of Participants With Solicited Local Adverse Events After Second Vaccination |
45.6; 4.2 | — |
| SECONDARY Percentage of Participants With Solicited Systemic Adverse Events After Second Vaccination |
48.5; 29.2 | — |
| SECONDARY Percentage of Participants With Unsolicited Adverse Events After Second Vaccination |
11.8; 8.3 | — |
| SECONDARY Number of Participants With Serious Adverse Events After Second Vaccination |
1; 0 | — |
| SECONDARY Opsonophagocytic Killing Assay (OPKA) GMTs for Serotypes O1A, O2, O6A and O25B at Days 1 and 15 |
156.8; 173.0; 735.6; 165.3; 207.2; 295.0 | — |
| SECONDARY OPKA GMR for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1 |
3.47; 0.98; 10.78; 0.84; 2.49; 1.23 | — |
| SECONDARY Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Day 15 |
64.4; 0.0; 41.1; 0.0; 86.3; 0.0 | — |
| SECONDARY ELISA GMTs for Serotypes O1A, O2, O6A, O25B at Days 181 and 195 |
10445.0; 3245.8; 14347.1; 3214.6; 27748.0; 5187.8 | — |
| SECONDARY ELISA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 |
3.30; 1.04; 4.42; 1.03; 7.78; 1.22 | — |
| SECONDARY Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195 |
64.2; 4.2; 81.3; 0.0; 37.3; 0.00 | — |
| SECONDARY OPKA GMTs for Serotypes O1A, O2, O6A and O25B at Days 181 and 195 |
313.9; 153.1; 431.1; 151.3; 1145.3; 228.9 | — |
| SECONDARY OPKA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 |
1.77; 0.94; 2.27; 0.93; 4.98; 0.82 | — |
| SECONDARY Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195 |
38.8; 0.0; 54.7; 0.0; 14.9; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Participants who provides written informed consent and signs the informed consent form (ICF) indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study
- Participant is medically stable as confirmed by documented medical history, physical examination and vital signs. Participant may have underlying illnesses such as hypertension, diabetes, or ischemic heart disease, as long as their symptoms/signs are medically controlled. If he/she is on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination
- Participant must have a body mass index (BMI) of less than or equal to (<=)35.0 kilogram per square meter (kg/m^2)
- Contraceptive (birth control) use by woman should be consistent with local regulations regarding the acceptable methods of contraception for participant participating in clinical studies
- All females of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) at pregnancy test on Visit 1 (pre-vaccination) and Visit 4 (prior to the second vaccination)
Exclusion Criteria
- Participant with contraindication to intramuscular (IM) injections and blood draws, for example, bleeding disorders
- Participant with known allergies, hypersensitivity, or intolerance to ExPEC4V or its excipients
- Participant with abnormal function of the immune system resulting from: a) clinical conditions (for example, autoimmune disease or immunodeficiency); b) chronic or recurrent use of systemic corticosteroids; c) administration of antineoplastic and immunomodulating agents or radiotherapy
- Participant has a history of neoplastic disease (excluding non-melanoma skin cancer or carcinoma in situ of the cervix that was successfully treated) within the past 1 year or a history of any hematological malignancy
- Participant with history of acute polyneuropathy (for example, Guillain-Barre syndrome)
- Participant who has a history of an underlying clinically significant acute or (uncontrolled) chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Data sourced from ClinicalTrials.gov (NCT03500679). 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.