Last updated: 02/18/2020 07:40:06
Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R adjuvanted Meningococcal C-CRM197 conjugate vaccine
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Phase 1, Randomized, Observer-Blind, Dosage-Escalation Study to Evaluate the Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine Compared to Aluminium Hydroxide Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine in Healthy Adults (18-45 years of age).
Trial description: 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).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
Number of subjects with any solicited local and systemic adverse events (AEs)
Timeframe: Within 30 minutes of vaccination (Min) at Day 1
Number of subjects with any solicited local and systemic AEs
Timeframe: From Day 1 to Day 4 (excluding 30 minutes immediately after vaccination)
Number of subjects with any solicited local and systemic AEs
Timeframe: From Day 5 to Day 8
Number of subjects with any solicited local and systemic AEs
Timeframe: From Day 8 to Day 14
Number of subjects with any solicited local and systemic AEs
Timeframe: From Day 1 to Day 8 (excluding 30 minutes immediately after vaccination)
Number of subjects with any solicited local and systemic AEs
Timeframe: From Day 1 to Day 14 (excluding 30 minutes immediately after any vaccination)
Number of subjects with any unsolicited AEs
Timeframe: From Day 1 to Day 29
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).
Timeframe: From Day 1 to Day 366
Number of subjects with any SAEs, MAAEs, AEs leading to study withdrawal, NOCDs and AESIs.
Timeframe: From Day 1 to Day 29
Number of subjects with any SAEs, MAAEs, AEs leading to study withdrawal, NOCDs and AESIs.
Timeframe: From Day 29 up to study end (Day 366)
Absolute values for clinical serum chemistry parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate.
Timeframe: At Day 1 (pre-dose)
Changes in clinical serum chemistry parameters
Timeframe: At Day 1 (post-dose)
Changes in clinical serum chemistry parameters
Timeframe: At Day 8
Changes in clinical serum chemistry parameters
Timeframe: At Day 29
Absolute values for clinical serum chemistry parameters-Creatinine
Timeframe: At Day 1 (pre-dose)
Changes in clinical serum chemistry parameters
Timeframe: At Day 1 (post-dose)
Changes in clinical serum chemistry parameters
Timeframe: At Day 8
Changes in clinical serum chemistry parameters
Timeframe: At Day 29
Absolute values for clinical serum chemistry parameters- Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST)
Timeframe: At Day 1 (pre-dose)
Changes in clinical serum chemistry parameters
Timeframe: At Day 1 (post-dose)
Changes in clinical serum chemistry parameters
Timeframe: At Day 8
Changes in clinical serum chemistry parameters
Timeframe: At Day 29
Absolute values for clinical serum chemistry parameters- C-reactive protein (CRP)
Timeframe: At Day 1 (pre-dose)
Changes in clinical serum chemistry parameters
Timeframe: At Day 1 (post-dose)
Changes in clinical serum chemistry parameters
Timeframe: At Day 8
Changes in clinical serum chemistry parameters
Timeframe: At Day 29
Absolute values for hematology parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and plateletes.
Timeframe: At Day 1 (pre-dose)
Changes in hematology parameters
Timeframe: At Day 1 (post-dose)
Changes in hematology parameters
Timeframe: At Day 8
Changes in hematology parameters
Timeframe: At Day 29
Absolute values for hematology parameters- Red Blood Cells (RBC)
Timeframe: At Day 1 (pre-dose)
Changes in hematology parameters
Timeframe: At Day 1 (post-dose)
Changes in hematology parameters
Timeframe: At Day 8
Changes in hematology parameters
Timeframe: At Day 29
Absolute values for hematology parameters- Hematocrit
Timeframe: At Day 1 (pre-dose)
Changes in hematology parameters
Timeframe: At Day 1 (post-dose)
Changes in hematology parameters
Timeframe: At Day 8
Changes in hematology parameters
Timeframe: At Day 29
Absolute values for hematology parameters- Hemoglobin (HGB)
Timeframe: At Day 1 (pre-dose)
Changes in hematology parameters
Timeframe: At Day 1 (post-dose)
Changes in hematology parameters
Timeframe: At Day 8
Changes in hematology parameters
Timeframe: At Day 29
Absolute values for urinalysis parameters- Urine erythrocytes (Urine RBC)
Timeframe: At Day 1 (pre-dose)
Changes in urinalysis parameters
Timeframe: At Day 1 (post-dose)
Changes in urinalysis parameters
Timeframe: At Day 8
Changes in urinalysis parameters
Timeframe: At Day 29
Absolute values for urinalysis parameters- Urine glucose
Timeframe: At Day 1 (pre-dose)
Changes in urinalysis parameters
Timeframe: At Day 1 (post-dose)
Changes in urinalysis parameters
Timeframe: At Day 8
Changes in urinalysis parameters
Timeframe: At Day 29
Absolute values for urinalysis parameters- Urine protein
Timeframe: At Day 1 (pre-dose)
Changes in urinalysis parameters
Timeframe: At Day 1 (post-dose)
Changes in urinalysis parameters
Timeframe: At Day 8
Changes in urinalysis parameters
Timeframe: At Day 29
Number of subjects with abnormal laboratory parameter values
Timeframe: At Day 1 (post-dose)
Number of subjects with abnormal laboratory parameter values
Timeframe: At Day 8
Number of subjects with abnormal laboratory parameter values
Timeframe: At Day 29
Number of subjects with abnormal laboratory parameter values
Timeframe: At Day 1 (post-dose)
Number of subjects with abnormal laboratory parameter values
Timeframe: At Day 8
Number of subjects with abnormal laboratory parameter values
Timeframe: At Day 29
Human complement Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) against N. meningitidis serogroup C (MenC)
Timeframe: At Day 1 (pre-dose)
hSBA GMTs against N. meningitidis serogroup C (MenC)
Timeframe: At Day 29
Geometric Mean Ratio (GMR) of the titers of antibodies measured by hSBA against MenC serogroup
Timeframe: At Day 29
Secondary outcomes:
hSBA GMTs against N. meningitidis serogroup C (MenC)
Timeframe: At Day 8 and Day 181
GMR of the GMTs of antibodies measured by hSBA against MenC serogroup
Timeframe: At Day 8 and Day 181
Percentage of subjects with hSBA seroresponse against N. meningitidis serogroup C (MenC).
Timeframe: At Day 8, Day 29 and Day 181
Concentrations of antibodies against MenC serogroup measured by Enzyme Linked Immunosorbent Assay (ELISA)
Timeframe: At Day 1 (pre-dose), Day 8, Day 29 and Day 181
Percentage of subjects with at least a 4-fold increase in antibody concentrations to MenC as measured by ELISA
Timeframe: At Day 8, Day 29 and Day 181
Interventions:
Enrollment:
80
Primary completion date:
2017-31-08
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Gonzalez-Lopez A et al. (2019) Adjuvant effect of TLR7 agonist adsorbed on aluminum hydroxide (AS37): A phase I randomized, dose escalation study of an AS37-adjuvanted meningococcal C conjugated vaccine. Clin Immunol. 209:108275.
Medical condition
Infections, Meningococcal
Product
GSK3536830A, GSK3536834A
Collaborators
Not applicable
Study date(s)
March 2016 to August 2017
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 45 years
Accepts healthy volunteers
Yes
- 1. Male or female individuals of 18 through 45 years of age on the day of informed consent
- 2. 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
- 1. Progressive, unstable or uncontrolled clinical conditions
- 2. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study
Inclusion and exclusion criteria
Inclusion criteria:
- 1. Male or female individuals of 18 through 45 years of age on the day of informed consent 2. 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 3. 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 4. Individuals who can comply with study procedures including follow-up 5. Individuals that are able to understand, read and write German language 6. 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:
- 1. Progressive, unstable or uncontrolled clinical conditions 2. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study 3. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws 4. Abnormal function of the immune system 5. Received immunoglobulins or any blood products within 180 days prior to informed consent 6. 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 7. 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 8. Any relevant deviation from the laboratory parameters at screening as judged by the investigator 9. Previously received any vaccine that included a MenC antigen 10. Previously suspected or confirmed disease caused by N. meningitides 11. Had household contact with and/or intimate exposure to an individual with culture proven MenC 12. A positive serum or urine pregnancy test prior to the study vaccine administration or are currently lactating. 13. A positive drugs-of-abuse test prior to the study vaccine administration; 14. 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 15. 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.
Trial location(s)
Study documents
Statistical analysis plan
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2017-31-08
Actual study completion date
2017-31-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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