Infections, MeningococcalPhase 1NCT02639351

Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine

A Phase 1 study testing Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153R, Investigational MenC-CRM adjuavnted with 25 ug of LHD153R and Investigational MenC-CRM adjuavnted with 50 ug of LHD153R in people with Infections, Meningococcal, run by GlaxoSmithKline at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Infections, Meningococcal
What is being tested?: Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153R, Investigational MenC-CRM adjuavnted with 25 ug of LHD153R and Investigational MenC-CRM adjuavnted with 50 ug of LHD153R
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteGermany
Study dates: 1 Mar 2016to 31 Aug 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

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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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

GSK Investigational Site
Berlin, 14050

Other trials in Germany

About this study

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).

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).

Conditions: Infections, Meningococcal
Being tested: Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153R, Investigational MenC-CRM adjuavnted with 25 ug of LHD153R, Investigational MenC-CRM adjuavnted with 50 ug of LHD153R, Investigational MenC-CRM adjuavnted with 100 ug of LHD153R, Meningococcal C-CRM Conjugate Vaccine (MenC-CRM)
Medical subject headings: Meningococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153RBiological
Intramuscular (IM) vaccination of 1 dose of 0.5 mL
Investigational MenC-CRM adjuavnted with 25 ug of LHD153RBiological
IM vaccination of 1 dose of 0.5 mL
Investigational MenC-CRM adjuavnted with 50 ug of LHD153RBiological
IM vaccination of 1 dose of 0.5 mL
Investigational MenC-CRM adjuavnted with 100 ug of LHD153RBiological
IM vaccination of 1 dose of 0.5 mL
Meningococcal C-CRM Conjugate Vaccine (MenC-CRM)Biological
IM vaccination of 1 dose of 0.5 mL

Study groups in NCT02639351
Study group	Role	What they receive
LHD153R Formulation 1 Group	Experimental	Healthy subjects aged 18 to 45 years who received a single dose of investigational MenC-CRM vaccine adjuvanted with 12.5 ug of LHD153R. Receives: Biological: Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153R
LHD153R Formulation 2 Group	Experimental	Healthy subjects aged 18 to 45 years who received a single dose of investigational MenC-CRM vaccine adjuvanted with 25 ug of LHD153R. Receives: Biological: Investigational MenC-CRM adjuavnted with 25 ug of LHD153R
LHD153R Formulation 3 Group	Experimental	Healthy subjects aged 18 to 45 years who received a single dose of investigational MenC-CRM vaccine adjuvanted with 50 ug of LHD153R. Receives: Biological: Investigational MenC-CRM adjuavnted with 50 ug of LHD153R
LHD153R Formulation 4 Group	Experimental	Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R. Receives: Biological: Investigational MenC-CRM adjuavnted with 100 ug of LHD153R
MenC Group	Active comparator	Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine. Receives: Biological: Meningococcal C-CRM Conjugate Vaccine (MenC-CRM)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs)
Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature greater than or equal to (≥) 38 degrees Celsius (°C), as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade.
Measured: Within 30 minutes of vaccination (Min) at Day 1
Number of Subjects With Any Solicited Local and Systemic AEs
Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: Analgesic/Antipyretics Use.
Measured: From Day 1 to Day 4 (excluding 30 minutes immediately after vaccination)
Number of Subjects With Any Solicited Local and Systemic AEs
Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade.
Measured: From Day 5 to Day 8
Number of Subjects With Any Solicited Local and Systemic AEs
Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: Analgesic/Antipyretics Use.
Measured: From Day 8 to Day 14
Number of Subjects With Any Solicited Local and Systemic AEs
Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: Analgesic/Antipyretics Use.
Measured: From Day 1 to Day 8 (excluding 30 minutes immediately after vaccination)
Number of Subjects With Any Solicited Local and Systemic AEs
Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: Analgesic/Antipyretics Use.
Measured: From Day 1 to Day 14 (excluding 30 minutes immediately after any vaccination)
Number of Subjects With Any Unsolicited AEs
An adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. This definition includes intercurrent illnesses or injuries and exacerbation of pre-existing conditions. Unsolicited adverse event were defined as symptoms that were not solicited using a Subject Diary and that were spontaneously communicated by a subject who has signed the informed consent. Unsolicited AEs were collected through the Day 29 visit and the analysis was performed for Day 1-29 time frame, instead of Day 1-14 as required by protocol.
Measured: 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).
SAEs are untoward medical occurrences that at any dose resulted in death,was life-threatening,required/prolonged hospitalization,persistent/significant disability/incapacity,congenital anomaly/in important \& significant medical event that could jeopardize the subject/could required intervention to prevent one of the other outcomes mentioned above.MAAEs are AEs that lead to a visit to a healthcare provider.NOCDs are adverse events that represent new diagnosis of a chronic medical condition that was not present/suspected in a subject prior to study enrolment.AESIs were defined according to MedDRA preferred terms.Certain AESIs are monitored after administration of immunostimulatory agents.These are pre-defined \& include AEs in the SOCs of Gastrointestinal disorders,Liver disorders,Metabolic diseases,Musculo-skeletal disorders,Neuroinflammatory disorders,Skin disorders,Vasculitides \& others.
Measured: From Day 1 to Day 366
Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs.
SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly or in an important and significant medical event that could jeopardize the subject or could requiered intervention to prevent one of the other outcomes mentioned above. MAAEs were defined as an AE that lead to a visit to a healthcare provider. NOCDs were defined as AEs leading to study or vaccine withdrawal. AESIs were defined according to MedDRA preferred terms.Certain AEs of special interest (AESIs) are monitored after the administration of immunostimulatory agents. These are pre-defined and include AEs in the SOCs of Gastrointestinal disorders, Liver disorders, Metabolic diseases, Musculo-skeletal disorders, Neuroinflammatory disorders, Skin disorders, Vasculitides and others
Measured: From Day 1 to Day 29
Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs.
SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly or in an important and significant medical event that could jeopardize the subject or could requiered intervention to prevent one of the other outcomes mentioned above. MAAEs were defined as an AE that lead to a visit to a healthcare provider. NOCDs were defined as AEs leading to study or vaccine withdrawal. AESIs were defined according to MedDRA preferred terms.Certain AEs of special interest (AESIs) are monitored after the administration of immunostimulatory agents. These are pre-defined and include AEs in the SOCs of Gastroin-testinal disorders, Liver disorders, Metabolic diseases, Musculo-skeletal disorders, Neuroinflammatory disorders, Skin disorders, Vasculitides and others
Measured: 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.
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameters: Na, K, Cl, BUN and bicarbonate in millimoles per liter (mmol/L).
Measured: At Day 1 (pre-dose)
Changes in Clinical Serum Chemistry Parameters
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameters: Na, K, Cl, BUN and bicarbonate in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Measured: At Day 1 (post-dose)
Changes in Clinical Serum Chemistry Parameters
Analysis was performed on blood samples collected at Day 8 for the following parameters: Na, K, Cl, BUN and bicarbonate in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Measured: At Day 8
Changes in Clinical Serum Chemistry Parameters
Analysis was performed on blood samples collected at Day 29 for the following parameters: Na, K, Cl, BUN and bicarbonate in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Measured: At Day 29
Absolute Values for Clinical Serum Chemistry Parameters-Creatinine
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: Creatinine (CREA) in micro mole per liter (μmol/L)
Measured: At Day 1 (pre-dose)
Changes in Clinical Serum Chemistry Parameters
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameter: CREA in μmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Measured: At Day 1 (post-dose)
Changes in Clinical Serum Chemistry Parameters
Analysis was performed on blood samples collected at Day 8 for the following parameter: CREA in μmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Measured: At Day 8
Changes in Clinical Serum Chemistry Parameters
Analysis was performed on blood samples collected at Day 29 for the following parameter: CREA in μmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Measured: At Day 29
Absolute Values for Clinical Serum Chemistry Parameters- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameters: ALT and AST in International Units per liter (IU/L).
Measured: At Day 1 (pre-dose)
Changes in Clinical Serum Chemistry Parameters
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameters: ALT and AST in IU/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Measured: At Day 1 (post-dose)
Changes in Clinical Serum Chemistry Parameters
Analysis was performed on blood samples collected at Day 8 for the following parameters: ALT and AST in IU/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Measured: At Day 8
Changes in Clinical Serum Chemistry Parameters
Analysis was performed on blood samples collected at Day 29 for the following parameters: ALT and AST in IU/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Measured: At Day 29
Absolute Values for Clinical Serum Chemistry Parameters- C-reactive Protein (CRP)
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: CRP in milligram per liter (mg/L).
Measured: At Day 1 (pre-dose)
Changes in Clinical Serum Chemistry Parameters
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameters: CRP in mg/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Measured: At Day 1 (post-dose)
Changes in Clinical Serum Chemistry Parameters
Analysis was performed on blood samples collected at Day 8 for the following parameter: CRP in mg/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Measured: At Day 8
Changes in Clinical Serum Chemistry Parameters
Analysis was performed on blood samples collected at Day 29 for the following parameter: CRP in mg/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Measured: At Day 29
Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes.
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets in 10^9 cells per liter (10^9/L)
Measured: At Day 1 (pre-dose)
Changes in Hematology Parameters
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets in 10^9/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Measured: At Day 1 (post-dose)
Changes in Hematology Parameters
Analysis was performed on blood samples collected at Day 8 for the following parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets in 10^9/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Measured: At Day 8
Changes in Hematology Parameters
Analysis was performed on blood samples collected at Day 29 for the following parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets in 10^9/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Measured: At Day 29
Absolute Values for Hematology Parameters- Red Blood Cells (RBC)
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: RBC in 10^12 cells per liter (10^12/L).
Measured: At Day 1 (pre-dose)
Changes in Hematology Parameters
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameter: RBC in 10^12/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Measured: At Day 1 (post-dose)
Changes in Hematology Parameters
Analysis was performed on blood samples collected at Day 8 for the following parameter: RBC in 10^12/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Measured: At Day 8
Changes in Hematology Parameters
Analysis was performed on blood samples collected at Day 29 for the following parameter: RBC in 10^12/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Measured: At Day 29
Absolute Values for Hematology Parameters- Hematocrit
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: hematocrit in liter per liter (L/L).
Measured: At Day 1 (pre-dose)
Changes in Hematology Parameters
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameter: hematocrit in L/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Measured: At Day 1 (post-dose)
Changes in Hematology Parameters
Analysis was performed on blood samples collected at Day 8 for the following parameter: hematocrit in L/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Measured: At Day 8
Changes in Hematology Parameters
Analysis was performed on blood samples collected at Day 29 for the following parameter: hematocrit in L/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Measured: At Day 29
Absolute Values for Hematology Parameters- Hemoglobin (HGB)
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: HGB in gram per liter (g/L).
Measured: At Day 1 (pre-dose)
Changes in Hematology Parameters
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameter: HGB in g/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Measured: At Day 1 (post-dose)
Changes in Hematology Parameters
Analysis was performed on blood samples collected at Day 8 for the following parameter: HGB in g/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Measured: At Day 8
Changes in Hematology Parameters
Analysis was performed on blood samples collected at Day 29 for the following parameter: HGB in g/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Measured: At Day 29
Absolute Values for Urinalysis Parameters- Urine Erythrocytes (Urine RBC)
Analysis was performed on urine samples collected at Day 1 (pre-dose) for the following parameter: Urine RBC in microliters (μL).
Measured: At Day 1 (pre-dose)
Changes in Urinalysis Parameters
Analysis was performed on urine samples collected at Day 1 (post-dose) for the following parameter: Urine RBC in μL. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Measured: At Day 1 (post-dose)
Changes in Urinalysis Parameters
Analysis was performed on urine samples collected at Day 8 for the following parameter: Urine RBC in μL. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Measured: At Day 8
Changes in Urinalysis Parameters
Analysis was performed on urine samples collected at Day 29 for the following parameter: Urine RBC in μL. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Measured: At Day 29
Absolute Values for Urinalysis Parameters- Urine Glucose
The absolute value for urinalysis was assessed for the following parameter: urine glucose in mmol/L.
Measured: At Day 1 (pre-dose)
Changes in Urinalysis Parameters
Analysis was performed on urine samples collected at Day 1 (post-dose) for the following parameter: urine glucose in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Measured: At Day 1 (post-dose)
Changes in Urinalysis Parameters
Analysis was performed on urine samples collected at Day 8 (post-dose) for the following parameter: urine glucose in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 (post-dose) results.
Measured: At Day 8
Changes in Urinalysis Parameters
Analysis was performed on urine samples collected at Day 29 (post-dose) for the following parameter: Urine glucose in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 (post-dose) results.
Measured: At Day 29
Absolute Values for Urinalysis Parameters- Urine Protein
The absolute value for urinalysis was assessed for the following parameter: urine protein in g/L
Measured: At Day 1 (pre-dose)
Changes in Urinalysis Parameters
Analysis was performed on urine samples collected at day 1 (post-dose) for the following parameter: urine protein in g/L. The change was calculated as difference between the day 1 (pre-dose) results and the day 1 (post-dose) results.
Measured: At Day 1 (post-dose)
Changes in Urinalysis Parameters
Analysis was performed on urine samples collected at day 8 (post-dose) for the following parameter: urine protein in g/L. The change was calculated as difference between the day 1 (pre-dose) results and the day 8 (post-dose) results.
Measured: At Day 8
Changes in Urinalysis Parameters
Analysis was performed on urine samples collected at day 29 (post-dose) for the following parameter: urine protein in g/L. The change was calculated as difference between the day 1 (pre-dose) results and the day 29 (post-dose) results.
Measured: At Day 29
Number of Subjects With Abnormal Laboratory Parameter Values
The abnormal laboratory parameters values were classified by the investigator as Normal (a value either low or high at baseline and normal post-baseline), High (a value either normal or low at baseline and high post-baseline), Low (a value either normal or high at baseline and low post-baseline) and No change.
Measured: At Day 1 (post-dose)
Number of Subjects With Abnormal Laboratory Parameter Values
The abnormal laboratory parameters values were classified by the investigator as Normal (a value either low or high at baseline and normal post-baseline), High (a value either normal or low at baseline and high post-baseline), Low (a value either normal or high at baseline and low post-baseline) and No change.
Measured: At Day 8
Number of Subjects With Abnormal Laboratory Parameter Values
The abnormal laboratory parameters values were classified by the investigator as Normal (a value either low or high at baseline and normal post-baseline), High (a value either normal or low at baseline and high post-baseline), Low (a value either normal or high at baseline and low post-baseline) and No change.
Measured: At Day 29
Number of Subjects With Abnormal Laboratory Parameter Values
The abnormal laboratory parameters values were defined following the FDA CBER Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" dated September 2007, or the institution's normal ranges if they differ from CBER guidance
Measured: At Day 1 (post-dose)
Number of Subjects With Abnormal Laboratory Parameter Values
The abnormal laboratory parameters values were defined following the FDA CBER Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" dated September 2007, or the institution's normal ranges if they differ from CBER guidance
Measured: At Day 8
Number of Subjects With Abnormal Laboratory Parameter Values
The abnormal laboratory parameters values were defined following the FDA CBER Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" dated September 2007, or the institution's normal ranges if they differ from CBER guidance
Measured: At Day 29
Human Complement Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup C (MenC)
The antibody concentrations were assessed by hSBA directed against MenC serogroup and expressed as GMTs.
Measured: At Day 1 (pre-dose)
hSBA GMTs Against N. Meningitidis Serogroup C (MenC)
The antibody concentrations were assessed by hSBA directed against MenC serogroup and expressed as GMTs.
Measured: At Day 29
Geometric Mean Ratio (GMR) of the Titers of Antibodies Measured by hSBA Against MenC Serogroup
GMR of GMTs of antibodies against MenC was evaluated at Day 29 relative to Day 1 (pre-dose).
Measured: At Day 29

Secondary outcomes (5)

hSBA GMTs Against N. Meningitidis Serogroup C (MenC)
The antibody concentrations were assessed by hSBA directed against MenC and expressed as GMTs.
Measured: At Day 8 and Day 181
GMR of the GMTs of Antibodies Measured by hSBA Against MenC Serogroup
GMR of GMTs of antibodies against MenC serogroup was evaluated at Day 8 and Day 181 relative to Day 1 (pre-dose).
Measured: At Day 8 and Day 181
Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroup C (MenC).
The percentage of subjects who achieved hSBA seroresponse against MenC serogroup was evaluated at Day 8, Day 29 and Day 181 after vaccination. Seroresponse was defined as a post vaccination hSBA ≥ 8 for subjects with a baseline hSBA lower than (<) 4 or had an increase of at least 4 times the baseline hSBA level for subjects with pre vaccination hSBA ≥ 4.
Measured: At Day 8, Day 29 and Day 181
Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA)
The antibody concentrations were assessed by ELISA and expressed as Geometric Mean Concentrations (GMCs) in microgram per mililiter (μg/mL).
Measured: 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
The percentage of subjects with at least a 4-fold increase in antibody concentrations to MenC serogroup as measured by ELISA were analysed at day 8, 29 and 181 relative to Day 1 (pre-dose).
Measured: At Day 8, Day 29 and Day 181

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 201631 Aug 2017

First posted24 Dec 2015 (estimated)
Study start1 Mar 2016
Primary completion31 Aug 2017
Study completion31 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Infections, MeningococcalStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02639351
Sponsor's protocol ID: 205496
Other IDs: V132_01EXP, 2014-002430-31, 2014
Status last verified: Jun 2019
First submitted: 21 Dec 2015
Last updated: 28 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Siena E, Schiavetti F, Borgogni E, Taccone M, Faenzi E, Brazzoli M, Aprea S, Bardelli M, Volpini G, Buricchi F, Sammicheli C, Tavarini S, Bechtold V, Blohmke CJ, Cardamone D, De Intinis C, Gonzalez-Lopez A, O'Hagan DT, Nuti S, Seidl C, Didierlaurent AM, Bertholet S, D'Oro U, Medini D, Finco O. Systems analysis of human responses to an aluminium hydroxide-adsorbed TLR7 agonist (AS37) adjuvanted vaccine reveals a dose-dependent and specific activation of the interferon-mediated antiviral response. Vaccine. 2023 Jan 16;41(3):724-734. doi: 10.1016/j.vaccine.2022.12.006. Epub 2022 Dec 21.
PubMed 36564274
Gonzalez-Lopez A, Oostendorp J, Koernicke T, Fadini T, D'Oro U, Baker S, O'Hagan DT, Del Giudice G, Siena E, Finco O, Medini D. 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. 2019 Dec;209:108275. doi: 10.1016/j.clim.2019.108275. Epub 2019 Oct 24.
PubMed 31669193

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See locations

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Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
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Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Meningitis, Meningococcal
RecruitingObservational study
A Study to Learn About the Safety of PENBRAYA During Pregnancy
Meningococcal Disease
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
Epidemic Meningitis, Meningococcal Vaccines

All Infections, Meningococcal trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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).
ClinicalTrials.gov ID: NCT02639351
Acronym / sponsor ID: 205496
Conditions: Infections, Meningococcal
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Mar 2016 (actual)
Primary completion: 31 Aug 2017 (actual)
Study completion: 31 Aug 2017 (actual)
First posted: 24 Dec 2015 (estimated)
Results: Posted 7 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 5

Arm	Type	Receives
LHD153R Formulation 1 Group	Experimental	Biological: Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153RHealthy subjects aged 18 to 45 years who received a single dose of investigational MenC-CRM vaccine adjuvanted with 12.5 ug of LHD153R.
LHD153R Formulation 2 Group	Experimental	Biological: Investigational MenC-CRM adjuavnted with 25 ug of LHD153RHealthy subjects aged 18 to 45 years who received a single dose of investigational MenC-CRM vaccine adjuvanted with 25 ug of LHD153R.
LHD153R Formulation 3 Group	Experimental	Biological: Investigational MenC-CRM adjuavnted with 50 ug of LHD153RHealthy subjects aged 18 to 45 years who received a single dose of investigational MenC-CRM vaccine adjuvanted with 50 ug of LHD153R.
LHD153R Formulation 4 Group	Experimental	Biological: Investigational MenC-CRM adjuavnted with 100 ug of LHD153RHealthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R.
MenC Group	Active comparator	Biological: Meningococcal C-CRM Conjugate Vaccine (MenC-CRM)Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153RIntramuscular (IM) vaccination of 1 dose of 0.5 mL	Biological	LHD153R Formulation 1 Group
Investigational MenC-CRM adjuavnted with 25 ug of LHD153RIM vaccination of 1 dose of 0.5 mL	Biological	LHD153R Formulation 2 Group
Investigational MenC-CRM adjuavnted with 50 ug of LHD153RIM vaccination of 1 dose of 0.5 mL	Biological	LHD153R Formulation 3 Group
Investigational MenC-CRM adjuavnted with 100 ug of LHD153RIM vaccination of 1 dose of 0.5 mL	Biological	LHD153R Formulation 4 Group
Meningococcal C-CRM Conjugate Vaccine (MenC-CRM)IM vaccination of 1 dose of 0.5 mL	Biological	MenC Group

Primary outcome

Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs)
Time frame: Within 30 minutes of vaccination (Min) at Day 1
Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature greater than or equal to (≥) 38 degrees Celsius (°C), as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade.
Number of Subjects With Any Solicited Local and Systemic AEs
Time frame: From Day 1 to Day 4 (excluding 30 minutes immediately after vaccination)
Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: Analgesic/Antipyretics Use.
Number of Subjects With Any Solicited Local and Systemic AEs
Time frame: From Day 5 to Day 8
Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade.
Number of Subjects With Any Solicited Local and Systemic AEs
Time frame: From Day 8 to Day 14
Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: Analgesic/Antipyretics Use.
Number of Subjects With Any Solicited Local and Systemic AEs
Time frame: From Day 1 to Day 8 (excluding 30 minutes immediately after vaccination)
Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: Analgesic/Antipyretics Use.
Number of Subjects With Any Solicited Local and Systemic AEs
Time frame: From Day 1 to Day 14 (excluding 30 minutes immediately after any vaccination)
Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: Analgesic/Antipyretics Use.
Number of Subjects With Any Unsolicited AEs
Time frame: From Day 1 to Day 29
An adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. This definition includes intercurrent illnesses or injuries and exacerbation of pre-existing conditions. Unsolicited adverse event were defined as symptoms that were not solicited using a Subject Diary and that were spontaneously communicated by a subject who has signed the informed consent. Unsolicited AEs were collected through the Day 29 visit and the analysis was performed for Day 1-29 time frame, instead of Day 1-14 as required by protocol.
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).
Time frame: From Day 1 to Day 366
SAEs are untoward medical occurrences that at any dose resulted in death,was life-threatening,required/prolonged hospitalization,persistent/significant disability/incapacity,congenital anomaly/in important \& significant medical event that could jeopardize the subject/could required intervention to prevent one of the other outcomes mentioned above.MAAEs are AEs that lead to a visit to a healthcare provider.NOCDs are adverse events that represent new diagnosis of a chronic medical condition that was not present/suspected in a subject prior to study enrolment.AESIs were defined according to MedDRA preferred terms.Certain AESIs are monitored after administration of immunostimulatory agents.These are pre-defined \& include AEs in the SOCs of Gastrointestinal disorders,Liver disorders,Metabolic diseases,Musculo-skeletal disorders,Neuroinflammatory disorders,Skin disorders,Vasculitides \& others.
Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs.
Time frame: From Day 1 to Day 29
SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly or in an important and significant medical event that could jeopardize the subject or could requiered intervention to prevent one of the other outcomes mentioned above. MAAEs were defined as an AE that lead to a visit to a healthcare provider. NOCDs were defined as AEs leading to study or vaccine withdrawal. AESIs were defined according to MedDRA preferred terms.Certain AEs of special interest (AESIs) are monitored after the administration of immunostimulatory agents. These are pre-defined and include AEs in the SOCs of Gastrointestinal disorders, Liver disorders, Metabolic diseases, Musculo-skeletal disorders, Neuroinflammatory disorders, Skin disorders, Vasculitides and others
Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs.
Time frame: From Day 29 up to study end (Day 366)
SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly or in an important and significant medical event that could jeopardize the subject or could requiered intervention to prevent one of the other outcomes mentioned above. MAAEs were defined as an AE that lead to a visit to a healthcare provider. NOCDs were defined as AEs leading to study or vaccine withdrawal. AESIs were defined according to MedDRA preferred terms.Certain AEs of special interest (AESIs) are monitored after the administration of immunostimulatory agents. These are pre-defined and include AEs in the SOCs of Gastroin-testinal disorders, Liver disorders, Metabolic diseases, Musculo-skeletal disorders, Neuroinflammatory disorders, Skin disorders, Vasculitides and others
Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate.
Time frame: At Day 1 (pre-dose)
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameters: Na, K, Cl, BUN and bicarbonate in millimoles per liter (mmol/L).
Changes in Clinical Serum Chemistry Parameters
Time frame: At Day 1 (post-dose)
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameters: Na, K, Cl, BUN and bicarbonate in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Changes in Clinical Serum Chemistry Parameters
Time frame: At Day 8
Analysis was performed on blood samples collected at Day 8 for the following parameters: Na, K, Cl, BUN and bicarbonate in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Changes in Clinical Serum Chemistry Parameters
Time frame: At Day 29
Analysis was performed on blood samples collected at Day 29 for the following parameters: Na, K, Cl, BUN and bicarbonate in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Absolute Values for Clinical Serum Chemistry Parameters-Creatinine
Time frame: At Day 1 (pre-dose)
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: Creatinine (CREA) in micro mole per liter (μmol/L)
Changes in Clinical Serum Chemistry Parameters
Time frame: At Day 1 (post-dose)
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameter: CREA in μmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Changes in Clinical Serum Chemistry Parameters
Time frame: At Day 8
Analysis was performed on blood samples collected at Day 8 for the following parameter: CREA in μmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Changes in Clinical Serum Chemistry Parameters
Time frame: At Day 29
Analysis was performed on blood samples collected at Day 29 for the following parameter: CREA in μmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Absolute Values for Clinical Serum Chemistry Parameters- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
Time frame: At Day 1 (pre-dose)
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameters: ALT and AST in International Units per liter (IU/L).
Changes in Clinical Serum Chemistry Parameters
Time frame: At Day 1 (post-dose)
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameters: ALT and AST in IU/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Changes in Clinical Serum Chemistry Parameters
Time frame: At Day 8
Analysis was performed on blood samples collected at Day 8 for the following parameters: ALT and AST in IU/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Changes in Clinical Serum Chemistry Parameters
Time frame: At Day 29
Analysis was performed on blood samples collected at Day 29 for the following parameters: ALT and AST in IU/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Absolute Values for Clinical Serum Chemistry Parameters- C-reactive Protein (CRP)
Time frame: At Day 1 (pre-dose)
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: CRP in milligram per liter (mg/L).
Changes in Clinical Serum Chemistry Parameters
Time frame: At Day 1 (post-dose)
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameters: CRP in mg/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Changes in Clinical Serum Chemistry Parameters
Time frame: At Day 8
Analysis was performed on blood samples collected at Day 8 for the following parameter: CRP in mg/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Changes in Clinical Serum Chemistry Parameters
Time frame: At Day 29
Analysis was performed on blood samples collected at Day 29 for the following parameter: CRP in mg/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes.
Time frame: At Day 1 (pre-dose)
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets in 10^9 cells per liter (10^9/L)
Changes in Hematology Parameters
Time frame: At Day 1 (post-dose)
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets in 10^9/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Changes in Hematology Parameters
Time frame: At Day 8
Analysis was performed on blood samples collected at Day 8 for the following parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets in 10^9/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Changes in Hematology Parameters
Time frame: At Day 29
Analysis was performed on blood samples collected at Day 29 for the following parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets in 10^9/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Absolute Values for Hematology Parameters- Red Blood Cells (RBC)
Time frame: At Day 1 (pre-dose)
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: RBC in 10^12 cells per liter (10^12/L).
Changes in Hematology Parameters
Time frame: At Day 1 (post-dose)
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameter: RBC in 10^12/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Changes in Hematology Parameters
Time frame: At Day 8
Analysis was performed on blood samples collected at Day 8 for the following parameter: RBC in 10^12/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Changes in Hematology Parameters
Time frame: At Day 29
Analysis was performed on blood samples collected at Day 29 for the following parameter: RBC in 10^12/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Absolute Values for Hematology Parameters- Hematocrit
Time frame: At Day 1 (pre-dose)
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: hematocrit in liter per liter (L/L).
Changes in Hematology Parameters
Time frame: At Day 1 (post-dose)
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameter: hematocrit in L/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Changes in Hematology Parameters
Time frame: At Day 8
Analysis was performed on blood samples collected at Day 8 for the following parameter: hematocrit in L/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Changes in Hematology Parameters
Time frame: At Day 29
Analysis was performed on blood samples collected at Day 29 for the following parameter: hematocrit in L/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Absolute Values for Hematology Parameters- Hemoglobin (HGB)
Time frame: At Day 1 (pre-dose)
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: HGB in gram per liter (g/L).
Changes in Hematology Parameters
Time frame: At Day 1 (post-dose)
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameter: HGB in g/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Changes in Hematology Parameters
Time frame: At Day 8
Analysis was performed on blood samples collected at Day 8 for the following parameter: HGB in g/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Changes in Hematology Parameters
Time frame: At Day 29
Analysis was performed on blood samples collected at Day 29 for the following parameter: HGB in g/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Absolute Values for Urinalysis Parameters- Urine Erythrocytes (Urine RBC)
Time frame: At Day 1 (pre-dose)
Analysis was performed on urine samples collected at Day 1 (pre-dose) for the following parameter: Urine RBC in microliters (μL).
Changes in Urinalysis Parameters
Time frame: At Day 1 (post-dose)
Analysis was performed on urine samples collected at Day 1 (post-dose) for the following parameter: Urine RBC in μL. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Changes in Urinalysis Parameters
Time frame: At Day 8
Analysis was performed on urine samples collected at Day 8 for the following parameter: Urine RBC in μL. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Changes in Urinalysis Parameters
Time frame: At Day 29
Analysis was performed on urine samples collected at Day 29 for the following parameter: Urine RBC in μL. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Absolute Values for Urinalysis Parameters- Urine Glucose
Time frame: At Day 1 (pre-dose)
The absolute value for urinalysis was assessed for the following parameter: urine glucose in mmol/L.
Changes in Urinalysis Parameters
Time frame: At Day 1 (post-dose)
Analysis was performed on urine samples collected at Day 1 (post-dose) for the following parameter: urine glucose in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Changes in Urinalysis Parameters
Time frame: At Day 8
Analysis was performed on urine samples collected at Day 8 (post-dose) for the following parameter: urine glucose in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 (post-dose) results.
Changes in Urinalysis Parameters
Time frame: At Day 29
Analysis was performed on urine samples collected at Day 29 (post-dose) for the following parameter: Urine glucose in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 (post-dose) results.
Absolute Values for Urinalysis Parameters- Urine Protein
Time frame: At Day 1 (pre-dose)
The absolute value for urinalysis was assessed for the following parameter: urine protein in g/L
Changes in Urinalysis Parameters
Time frame: At Day 1 (post-dose)
Analysis was performed on urine samples collected at day 1 (post-dose) for the following parameter: urine protein in g/L. The change was calculated as difference between the day 1 (pre-dose) results and the day 1 (post-dose) results.
Changes in Urinalysis Parameters
Time frame: At Day 8
Analysis was performed on urine samples collected at day 8 (post-dose) for the following parameter: urine protein in g/L. The change was calculated as difference between the day 1 (pre-dose) results and the day 8 (post-dose) results.
Changes in Urinalysis Parameters
Time frame: At Day 29
Analysis was performed on urine samples collected at day 29 (post-dose) for the following parameter: urine protein in g/L. The change was calculated as difference between the day 1 (pre-dose) results and the day 29 (post-dose) results.
Number of Subjects With Abnormal Laboratory Parameter Values
Time frame: At Day 1 (post-dose)
The abnormal laboratory parameters values were classified by the investigator as Normal (a value either low or high at baseline and normal post-baseline), High (a value either normal or low at baseline and high post-baseline), Low (a value either normal or high at baseline and low post-baseline) and No change.
Number of Subjects With Abnormal Laboratory Parameter Values
Time frame: At Day 8
The abnormal laboratory parameters values were classified by the investigator as Normal (a value either low or high at baseline and normal post-baseline), High (a value either normal or low at baseline and high post-baseline), Low (a value either normal or high at baseline and low post-baseline) and No change.
Number of Subjects With Abnormal Laboratory Parameter Values
Time frame: At Day 29
The abnormal laboratory parameters values were classified by the investigator as Normal (a value either low or high at baseline and normal post-baseline), High (a value either normal or low at baseline and high post-baseline), Low (a value either normal or high at baseline and low post-baseline) and No change.
Number of Subjects With Abnormal Laboratory Parameter Values
Time frame: At Day 1 (post-dose)
The abnormal laboratory parameters values were defined following the FDA CBER Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" dated September 2007, or the institution's normal ranges if they differ from CBER guidance
Number of Subjects With Abnormal Laboratory Parameter Values
Time frame: At Day 8
The abnormal laboratory parameters values were defined following the FDA CBER Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" dated September 2007, or the institution's normal ranges if they differ from CBER guidance
Number of Subjects With Abnormal Laboratory Parameter Values
Time frame: At Day 29
The abnormal laboratory parameters values were defined following the FDA CBER Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" dated September 2007, or the institution's normal ranges if they differ from CBER guidance
Human Complement Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup C (MenC)
Time frame: At Day 1 (pre-dose)
The antibody concentrations were assessed by hSBA directed against MenC serogroup and expressed as GMTs.
hSBA GMTs Against N. Meningitidis Serogroup C (MenC)
Time frame: At Day 29
The antibody concentrations were assessed by hSBA directed against MenC serogroup and expressed as GMTs.
Geometric Mean Ratio (GMR) of the Titers of Antibodies Measured by hSBA Against MenC Serogroup
Time frame: At Day 29
GMR of GMTs of antibodies against MenC was evaluated at Day 29 relative to Day 1 (pre-dose).

5 secondary outcomes

hSBA GMTs Against N. Meningitidis Serogroup C (MenC)
Time frame: At Day 8 and Day 181
GMR of the GMTs of Antibodies Measured by hSBA Against MenC Serogroup
Time frame: At Day 8 and Day 181
Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroup C (MenC).
Time frame: At Day 8, Day 29 and Day 181
Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA)
Time frame: 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
Time frame: At Day 8, Day 29 and Day 181

Results and safety

Results posted to the registry on 7 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LHD153R Formulation 1 Group	16	16
LHD153R Formulation 2 Group	16	16
LHD153R Formulation 3 Group	16	16
LHD153R Formulation 4 Group	16	16
MenC Group	16	16

Primary outcome: Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs)

Time frame: Within 30 minutes of vaccination (Min) at Day 1. Count of participants. Unit: Participants

Measure	LHD153R Formulation 1 Group n = 16	LHD153R Formulation 2 Group n = 16	LHD153R Formulation 3 Group n = 16	LHD153R Formulation 4 Group n = 16	MenC Group n = 16
Any Erythema	0	0	0	0	0
Any Induration	0	1	0	0	0
Any Pain	1	0	1	1	0
Any Swelling	0	1	0	0	0
Any Arthralgia	0	0	0	0	0
Any Chills	0	1	0	1	1
Any Diarrhea	0	0	0	0	0
Any Fatigue	0	0	0	0	0

Population analysed: Analysis was performed on the Solicited Safety Set which included all enrolled subjects who received a study vaccination and reported solicited local and systemic symptoms.

Primary outcome: Number of Subjects With Any Solicited Local and Systemic AEs

Time frame: From Day 1 to Day 4 (excluding 30 minutes immediately after vaccination). Count of participants. Unit: Participants

Measure	LHD153R Formulation 1 Group n = 16	LHD153R Formulation 2 Group n = 16	LHD153R Formulation 3 Group n = 16	LHD153R Formulation 4 Group n = 16	MenC Group n = 16
Any Erythema	0	0	0	0	0
Any Induration	0	1	0	0	0
Any Pain	16	16	16	16	16
Any Swelling	1	2	0	0	0
Any Arthralgia	0	1	0	4	0
Any Chills	0	1	1	2	0
Any Diarrhea	0	0	1	2	0
Any Fatigue	3	2	3	5	3

Population analysed: Analysis was performed on the Solicited Safety Set which included all enrolled subjects who received a study vaccination and reported local and systemic symptoms

Primary outcome: Number of Subjects With Any Solicited Local and Systemic AEs

Time frame: From Day 5 to Day 8. Count of participants. Unit: Participants

Measure	LHD153R Formulation 1 Group n = 16	LHD153R Formulation 2 Group n = 16	LHD153R Formulation 3 Group n = 16	LHD153R Formulation 4 Group n = 16	MenC Group n = 16
Any Erythema	0	0	0	0	0
Any Induration	0	0	0	0	0
Any Pain	16	16	16	16	16
Any Swelling	0	0	0	0	0
Any Arthralgia	0	0	0	0	0
Any Chills	0	0	0	2	0
Any Diarrhea	0	0	0	1	0
Any Fatigue	1	1	0	4	0

Population analysed: Analysis was performed on the Solicited Safety Set which included all enrolled subjects who received a study vaccination and reported solicited local and systemic symptoms

Primary outcome: Number of Subjects With Any Solicited Local and Systemic AEs

Time frame: From Day 8 to Day 14. Count of participants. Unit: Participants

Measure	LHD153R Formulation 1 Group n = 16	LHD153R Formulation 2 Group n = 16	LHD153R Formulation 3 Group n = 16	LHD153R Formulation 4 Group n = 16	MenC Group n = 16
Any Erythema	0	0	0	0	0
Any Induration	0	0	0	0	0
Any Pain	16	16	16	16	16
Any Swelling	0	0	0	0	0
Any Arthralgia	1	0	0	0	0
Any Chills	0	0	0	0	0
Any Diarrhea	1	0	0	0	0
Any Fatigue	2	1	0	2	0

Population analysed: Analysis was performed on the Solicited Safety Set which included all enrolled subjects who received a study vaccination and reported solicited local and systemic symptoms

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local and systemic AEs were collected from Day 1 (30 minutes) until Day 14 after vaccination. Unsolicited AEs were collected from Day 1 to Day 29. Serious AEs were collected from day 1 to study completion date (Day 366).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LHD153R Formulation 1 Group	0 of 16 (0%)	16 of 16 (100%)	0 of 16
LHD153R Formulation 2 Group	0 of 16 (0%)	16 of 16 (100%)	0 of 16
LHD153R Formulation 3 Group	0 of 16 (0%)	16 of 16 (100%)	0 of 16
LHD153R Formulation 4 Group	0 of 16 (0%)	16 of 16 (100%)	0 of 16
MenC Group	1 of 16 (6.3%)	16 of 16 (100%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36564274Siena E, Schiavetti F, Borgogni E, Taccone M, Faenzi E, Brazzoli M, Aprea S, Bardelli M, Volpini G, Buricchi F, Sammicheli C, Tavarini S, Bechtold V, Blohmke CJ, Cardamone D, De Intinis C, Gonzalez-Lopez A, O'Hagan DT, Nuti S, Seidl C, Didierlaurent AM, Bertholet S, D'Oro U, Medini D, Finco O. Systems analysis of human responses to an aluminium hydroxide-adsorbed TLR7 agonist (AS37) adjuvanted vaccine reveals a dose-dependent and specific activation of the interferon-mediated antiviral response. Vaccine. 2023 Jan 16;41(3):724-734. doi: 10.1016/j.vaccine.2022.12.006. Epub 2022 Dec 21.
Derived from this study: PubMed 31669193Gonzalez-Lopez A, Oostendorp J, Koernicke T, Fadini T, D'Oro U, Baker S, O'Hagan DT, Del Giudice G, Siena E, Finco O, Medini D. 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. 2019 Dec;209:108275. doi: 10.1016/j.clim.2019.108275. Epub 2019 Oct 24.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) (time frame: Within 30 minutes of vaccination (Min) at Day 1). The study lists 63 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02639351, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2019.