A Sourcing Study to Collect Human Blood Samples From Healthy Adults

A Sourcing Study to Collect Human Biological (Serum) Samples From Healthy Adults

The purpose of this study was to collect large volumes of matched pairs of pre- and post-vaccination sera from healthy subjects who administered GlaxoSmithKline (GSK) Biologicals' vaccine against meningitis- MenACWY vaccine (Menveo) or rMenB+OMV NZ vaccine (Bexsero), which serves for the development, qualification, validation, and maintenance of immunological assays which supports the preclinical research activities and clinical development of GSK Biologicals' vaccines. The safety of the subjects given one of the two vaccines (Bexsero or Menveo), as per the recommended dosage and schedule were assessed during their participation in the study.

Study Overview

• Status: Completed
• Conditions: Meningitis, Meningococcal
• Intervention / Treatment: Biological: rMenB+OMV NZ vaccine; Biological: Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)

• Study Type: Interventional
• Enrollment (Actual): 1021
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2010
      • GSK Investigational Site
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • GSK Investigational Site
  • Victoria
    • Geelong, Victoria, Australia, 3220
      • GSK Investigational Site
    • Melbourne, Victoria, Australia, 3004
      • GSK Investigational Site
  • Western Australia
    • Spearwood, Western Australia, Australia, 6163
      • GSK Investigational Site
• Germany
  • Bayern
    • Wuerzburg, Bayern, Germany, 97070
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Written informed consent obtained from the subject prior to performing any study specific procedure.
• A male or female between, and including, 18 and 50 years of age at the time of the first study visit.
• Healthy subjects as established by medical history and clinical examination before entering into the study. Healthy subjects with no medical conditions that, in the opinion of the investigator, prevents the subject from participating in the study.
• Subjects must weigh at least 110 pounds (50 kg), but not to present obesity (BMI < 32kg/m2).
• Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.

• Female subjects of childbearing potential may be enrolled in the study, if the subject:

  • has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test on the day of vaccination and
  • has agreed to continue adequate contraception during the entire treatment period and for 1 month, after completion of the vaccination series.

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 resulting from:

  • Clinical conditions.
  • Systemic administration of corticosteroids (PO/IV/IM) within 90 days prior to informed consent.
  • Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
• 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.
• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
• Any history of meningococcal vaccination or meningococcal and gonorrhoea diseases.
• Enrolment in any activity requiring a blood donation greater than 50 mL during the period starting 30 days before the first study visit (Day -83, Day -60 or Day -30) or for the duration of the study period.
• Administration of long-acting immune-modifying drugs at any time during the study period
• Subjects with blood disorders.
• Subjects with a history of difficulty in providing blood samples
• Any antibiotic intake 7 days prior to blood collection.
• Subjects who donated >450 mL of blood within 60 days prior to any blood collection visits.
• Subjects who lost >200 mL during a single apheresis or who lost red blood cells on more than one occasion during apheresis within the previous 60 days.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product
• Ongoing anaemia as indicated by haemoglobin values below the lower limit of the laboratory-specified reference range. If the finger prick method demonstrates an anaemia, no further protocol procedures will be performed, and the subject will be referred for appropriate medical management. The subject may participate in this study following therapy and evidence that the anaemia has been resolved.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.
• Any confirmed or suspected immunosuppressive or immunodeficiency condition based on medical history and physical examination
• Family history of congenital or hereditary immunodeficiency.
• Serious chronic illness.
• History of chronic alcohol consumption and/or drug abuse.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rMenB+OMV NZ Group; Participants vaccinated intramuscularly with Bexsero vaccine at Day 1 and Day 61 and blood samples were collected at Day -83, Day 8, and Day 98.	Biological: rMenB+OMV NZ vaccine; Two doses of rMenB+OMV NZ vaccine were administered intramuscularly at Day 1 and Day 61.; Other Names: Bexsero
Experimental: MenACWY 1 Group; Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -83, Day 8, and Day 151.	Biological: Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY); One dose of MenACWY vaccine were administered intramuscularly at Day 1.; Other Names: Menveo
Experimental: MenACWY 2 Group; Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -60, Day 31, and Day 151.	Biological: Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY); One dose of MenACWY vaccine were administered intramuscularly at Day 1.; Other Names: Menveo
Experimental: MenACWY 3 Group; Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.	Biological: Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY); One dose of MenACWY vaccine were administered intramuscularly at Day 1.; Other Names: Menveo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Human Blood Samples Collected for Conversion Into Serum at Day -83	The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines [Australian Red Cross, 2016], blood samples were collected with the minimum interval of approximately 90 days. For Day -83, blood samples were collected only for rMenB+OMV NZ group and MenACWY 1 group.	At Day -83 [83 days before first vaccination (Day 1)]
Number of Human Blood Samples Collected for Conversion Into Serum at Day 8	The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines [Australian Red Cross, 2016], blood samples were collected with the minimum interval of approximately 90 days. For Day 8, blood samples were collected only for rMenB+OMV NZ group and MenACWY 1 group.	At Day 8
Number of Human Blood Samples Collected for Conversion Into Serum at Day 98	The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines [Australian Red Cross, 2016], blood samples were collected with the minimum interval of approximately 90 days. For Day 98, blood samples were collected only for rMenB+OMV NZ group.	At Day 98
Number of Human Blood Samples Collected for Conversion Into Serum at Day 151	The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines [Australian Red Cross, 2016], blood samples were collected with the minimum interval of approximately 90 days. For Day 151, blood samples were collected only for MenACWY 1, 2 and 3 group.	At Day 151
Number of Human Blood Samples Collected for Conversion Into Serum at Day -60	The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines [Australian Red Cross, 2016], blood samples were collected with the minimum interval of approximately 90 days. For Day -60, blood samples were collected only for MenACWY 2 group.	At Day -60 [60 days before first vaccination (Day 1)]
Number of Human Blood Samples Collected for Conversion Into Serum at Day 31	The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines [Australian Red Cross, 2016], blood samples were collected with the minimum interval of approximately 90 days. For Day 31, blood samples were collected only for MenACWY 2 group.	At Day 31
Number of Human Blood Samples Collected for Conversion Into Serum at Day-30	The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines [Australian Red Cross, 2016], blood samples were collected with the minimum interval of approximately 90 days. For Day -30, blood samples were collected only for MenACWY 3 group.	At Day -30 [30 days before first vaccination (Day 1)]
Number of Human Blood Samples Collected for Conversion Into Serum at Day 61	The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines [Australian Red Cross, 2016], blood samples were collected with the minimum interval of approximately 90 days. For Day 61, blood samples were collected only for MenACWY 3 group.	At Day 61

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Atleast One Serious Adverse Events (SAEs) Related to Vaccination	An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, results in disability/incapacity in a subject or is a congenital anomaly/ birth defect in the offspring of a study subject. AE(s) considered as SAE(s) also include invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalization, as per the medical or scientific judgement of the physician. Related=AE assessed by the investigator as related to the vaccination.	Throughout the study period (approximately 4 years)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2018
• Primary Completion (Actual): May 27, 2022
• Study Completion (Actual): May 27, 2022

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (Actual): April 11, 2018

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Meningococcal disease; Immunological assays; Human blood donors; Meningococcal vaccination
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Meningococcal Infections; Neisseriaceae Infections; Neuroinflammatory Diseases; Meningitis, Meningococcal; Meningitis; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 207911; 2017-002919-33 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes