Phase 1
N=80
Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine
Infections, Meningococcal
Bottom Line
View on ClinicalTrials.gov: NCT02639351 ↗Enrolled (actual)
80
Serious AEs
1.3%
Results posted
Jun 2019
Primary outcome: Primary: Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153R (Biological); Investigational MenC-CRM adjuavnted with 25 ug of LHD153R (Biological); Investigational MenC-CRM adjuavnted with 50 ug of LHD153R (Biological); Investigational MenC-CRM adjuavnted with 100 ug of LHD153R (Biological); Meningococcal C-CRM Conjugate Vaccine (MenC-CRM) (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Any Solicited Local and Systemic AEs |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Any Solicited Local and Systemic AEs |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Any Solicited Local and Systemic AEs |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Any Solicited Local and Systemic AEs |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Any Solicited Local and Systemic AEs |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Any Unsolicited AEs |
4; 2; 1; 4; 4 | — |
| PRIMARY Number of Subjects With Any Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Study Withdrawal, New Onset of Chronic Disease (NOCDs) and Adverse Events of Special Interest (AESIs). |
0; 0; 0; 0; 1; 6 | — |
| PRIMARY Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. |
0; 0; 0; 0; 1; 5 | — |
| PRIMARY Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. |
0; 0; 0; 0; 1; 5 | — |
| PRIMARY Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. |
138.07; 136.77; 136.73; 138.29; 137.06; 4.253 | — |
| PRIMARY Changes in Clinical Serum Chemistry Parameters |
-0.202; 0.348; 0.200; 1.075; -0.058 | — |
| PRIMARY Changes in Clinical Serum Chemistry Parameters |
-0.202; 0.348; 0.200; 1.075; -0.058 | — |
| PRIMARY Changes in Clinical Serum Chemistry Parameters |
-0.202; 0.348; 0.200; 1.075; -0.058 | — |
| PRIMARY Absolute Values for Clinical Serum Chemistry Parameters-Creatinine |
77.52; 72.25; 80.43; 74.43; 74.29 | — |
| PRIMARY Changes in Clinical Serum Chemistry Parameters |
-0.202; 0.348; 0.200; 1.075; -0.058 | — |
| PRIMARY Changes in Clinical Serum Chemistry Parameters |
-0.202; 0.348; 0.200; 1.075; -0.058 | — |
| PRIMARY Changes in Clinical Serum Chemistry Parameters |
-0.202; 0.348; 0.200; 1.075; -0.058 | — |
| PRIMARY Absolute Values for Clinical Serum Chemistry Parameters- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) |
26.75; 20.17; 21.14; 22.97; 25.86; 23.30 | — |
| PRIMARY Changes in Clinical Serum Chemistry Parameters |
-0.202; 0.348; 0.200; 1.075; -0.058 | — |
| PRIMARY Changes in Clinical Serum Chemistry Parameters |
-0.202; 0.348; 0.200; 1.075; -0.058 | — |
| PRIMARY Changes in Clinical Serum Chemistry Parameters |
-0.202; 0.348; 0.200; 1.075; -0.058 | — |
| PRIMARY Absolute Values for Clinical Serum Chemistry Parameters- C-reactive Protein (CRP) |
1.382; 0.928; 1.049; 2.337; 1.243 | — |
| PRIMARY Changes in Clinical Serum Chemistry Parameters |
-0.202; 0.348; 0.200; 1.075; -0.058 | — |
| PRIMARY Changes in Clinical Serum Chemistry Parameters |
-0.202; 0.348; 0.200; 1.075; -0.058 | — |
| PRIMARY Changes in Clinical Serum Chemistry Parameters |
-0.202; 0.348; 0.200; 1.075; -0.058 | — |
| PRIMARY Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. |
0.033; 0.034; 0.033; 0.030; 0.029; 0.128 | — |
| PRIMARY Changes in Hematology Parameters |
1.2; 5.4; 5.4; 3.1; 1.6 | — |
| PRIMARY Changes in Hematology Parameters |
1.2; 5.4; 5.4; 3.1; 1.6 | — |
| PRIMARY Changes in Hematology Parameters |
1.2; 5.4; 5.4; 3.1; 1.6 | — |
| PRIMARY Absolute Values for Hematology Parameters- Red Blood Cells (RBC) |
4.777; 4.598; 4.724; 4.676; 4.773 | — |
| PRIMARY Changes in Hematology Parameters |
1.2; 5.4; 5.4; 3.1; 1.6 | — |
| PRIMARY Changes in Hematology Parameters |
1.2; 5.4; 5.4; 3.1; 1.6 | — |
| PRIMARY Changes in Hematology Parameters |
1.2; 5.4; 5.4; 3.1; 1.6 | — |
| PRIMARY Absolute Values for Hematology Parameters- Hematocrit |
0.428; 0.415; 0.409; 0.411; 0.424 | — |
| PRIMARY Changes in Hematology Parameters |
1.2; 5.4; 5.4; 3.1; 1.6 | — |
| PRIMARY Changes in Hematology Parameters |
1.2; 5.4; 5.4; 3.1; 1.6 | — |
| PRIMARY Changes in Hematology Parameters |
1.2; 5.4; 5.4; 3.1; 1.6 | — |
| PRIMARY Absolute Values for Hematology Parameters- Hemoglobin (HGB) |
144.3; 139.2; 137.1; 139.3; 143.5 | — |
| PRIMARY Changes in Hematology Parameters |
1.2; 5.4; 5.4; 3.1; 1.6 | — |
| PRIMARY Changes in Hematology Parameters |
1.2; 5.4; 5.4; 3.1; 1.6 | — |
| PRIMARY Changes in Hematology Parameters |
1.2; 5.4; 5.4; 3.1; 1.6 | — |
| PRIMARY Absolute Values for Urinalysis Parameters- Urine Erythrocytes (Urine RBC) |
2.8; 1.3; 7.2; 20.0; 6.9 | — |
| PRIMARY Changes in Urinalysis Parameters |
0.000; 0.000; 0.000; 0.000; 0.000 | — |
| PRIMARY Changes in Urinalysis Parameters |
0.000; 0.000; 0.000; 0.000; 0.000 | — |
| PRIMARY Changes in Urinalysis Parameters |
0.000; 0.000; 0.000; 0.000; 0.000 | — |
| PRIMARY Absolute Values for Urinalysis Parameters- Urine Glucose |
0.0; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Changes in Urinalysis Parameters |
0.000; 0.000; 0.000; 0.000; 0.000 | — |
| PRIMARY Changes in Urinalysis Parameters |
0.000; 0.000; 0.000; 0.000; 0.000 | — |
| PRIMARY Changes in Urinalysis Parameters |
0.000; 0.000; 0.000; 0.000; 0.000 | — |
| PRIMARY Absolute Values for Urinalysis Parameters- Urine Protein |
0.000; 0.000; 0.000; 0.000; 0.000 | — |
| PRIMARY Changes in Urinalysis Parameters |
0.000; 0.000; 0.000; 0.000; 0.000 | — |
| PRIMARY Changes in Urinalysis Parameters |
0.000; 0.000; 0.000; 0.000; 0.000 | — |
| PRIMARY Changes in Urinalysis Parameters |
0.000; 0.000; 0.000; 0.000; 0.000 | — |
| PRIMARY Number of Subjects With Abnormal Laboratory Parameter Values |
16; 16; 14; 15; 16; 0 | — |
| PRIMARY Number of Subjects With Abnormal Laboratory Parameter Values |
16; 16; 14; 15; 16; 0 | — |
| PRIMARY Number of Subjects With Abnormal Laboratory Parameter Values |
16; 16; 14; 15; 16; 0 | — |
| PRIMARY Number of Subjects With Abnormal Laboratory Parameter Values |
16; 16; 14; 15; 16; 0 | — |
| PRIMARY Number of Subjects With Abnormal Laboratory Parameter Values |
16; 16; 14; 15; 16; 0 | — |
| PRIMARY Number of Subjects With Abnormal Laboratory Parameter Values |
16; 16; 14; 15; 16; 0 | — |
| PRIMARY Human Complement Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup C (MenC) |
11.40; 8.52; 6.09; 5.23; 6.17 | — |
| PRIMARY hSBA GMTs Against N. Meningitidis Serogroup C (MenC) |
30.86; 12.18; 13.58; 15.47; 21.30; 98.79 | — |
| PRIMARY Geometric Mean Ratio (GMR) of the Titers of Antibodies Measured by hSBA Against MenC Serogroup |
8.70; 6.52; 16.56; 10.57; 11.32 | — |
| SECONDARY hSBA GMTs Against N. Meningitidis Serogroup C (MenC) |
30.86; 12.18; 13.58; 15.47; 21.30; 98.79 | — |
| SECONDARY GMR of the GMTs of Antibodies Measured by hSBA Against MenC Serogroup |
2.93; 1.47; 2.16; 2.64; 3.35; 9.29 | — |
| SECONDARY Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroup C (MenC). |
31.3; 37.5; 31.3; 33.3; 37.5; 75.0 | — |
| SECONDARY Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA) |
0.287; 0.407; 0.207; 0.107; 0.199; 2.005 | — |
| SECONDARY Percentage of Subjects With at Least a 4-fold Increase in Antibody Concentrations to MenC as Measured by ELISA |
68.8; 50.0; 68.8; 68.8; 62.5; 93.8 | — |
Summary
Dosage-Escalation Study to Evaluate the Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine in Healthy Adults (18-45 years of age).
Eligibility Criteria
Inclusion Criteria
- Male or female individuals of 18 through 45 years of age on the day of informed consent
- Healthy volunteers with good physical and mental health status, determined on the basis of the medical history, a physical examination and the results of the screening tests as judged by the investigator
- Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry
- Individuals who can comply with study procedures including follow-up
- Individuals that are able to understand, read and write German language
- Females of childbearing potential who are using an effective birth control method which they intend to use for at least 30 days after the study vaccination.
Exclusion Criteria
- Progressive, unstable or uncontrolled clinical conditions
- Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study
- Clinical conditions representing a contraindication to intramuscular vaccination and blood draws
- Abnormal function of the immune system
- Received immunoglobulins or any blood products within 180 days prior to informed consent
- Received an investigational or non-registered medicinal product within 30 days prior to informed consent or intend to participate in another clinical study at any time during the conduct of this study
- Vulnerable subjects (e.g. persons kept in detention), study personnel or an immediate family or household member of study personnel, subjects with legal incapacity or limited legal capacity
- Any relevant deviation from the laboratory parameters at screening as judged by the investigator
- Previously received any vaccine that included a MenC antigen
- Previously suspected or confirmed disease caused by N. meningitides
- Had household contact with and/or intimate exposure to an individual with culture proven MenC
- A positive serum or urine pregnancy test prior to the study vaccine administration or are currently lactating.
- A positive drugs-of-abuse test prior to the study vaccine administration;
- Received any other vaccines within 30 days prior to enrolment in this study or who are planning to receive any vaccine within 30 days from the administration of study vaccines
- Any other condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
Data sourced from ClinicalTrials.gov (NCT02639351). 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.