A Sourcing Study to Collect Human Blood Samples From Healthy Adults

NCT03493919 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 2079112017-002919-33
• Study Type: interventional
• Target: 1,021
• Locations: 2 countries
• Sites: 6

Brief Summary

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.

Conditions

Meningitis, Meningococcal

Keywords

Immunological assays; Human blood donors; Meningococcal vaccination; Meningococcal disease

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Number of Participants With Atleast One Serious Adverse Events (SAEs) Related to Vaccination

  Throughout the study period (approximately 4 years)

Study Arms (4)

rMenB+OMV NZ Group

EXPERIMENTAL

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

MenACWY 1 Group

EXPERIMENTAL

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)

MenACWY 2 Group

EXPERIMENTAL

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)

MenACWY 3 Group

EXPERIMENTAL

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)

Interventions

rMenB+OMV NZ vaccine BIOLOGICAL

Two doses of rMenB+OMV NZ vaccine were administered intramuscularly at Day 1 and Day 61.

Also known as: Bexsero

rMenB+OMV NZ Group

Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY) BIOLOGICAL

One dose of MenACWY vaccine were administered intramuscularly at Day 1.

Also known as: Menveo

MenACWY 1 Group; MenACWY 2 Group; MenACWY 3 Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

Sydney, New South Wales, 2010, Australia

Location

GSK Investigational Site

Adelaide, South Australia, 5000, Australia

Location

GSK Investigational Site

Geelong, Victoria, 3220, Australia

Location

GSK Investigational Site

Melbourne, Victoria, 3004, Australia

Location

GSK Investigational Site

Spearwood, Western Australia, 6163, Australia

Location

GSK Investigational Site

Würzburg, Bavaria, 97070, Germany

Location

MeSH Terms

Conditions

Meningitis, Meningococcal; Meningococcal Infections

Interventions

4CMenB vaccine; MenACWY; Meningococcal Vaccines

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: April 11, 2018
• Study Start: March 8, 2018
• Primary Completion: May 27, 2022
• Study Completion: May 27, 2022
• Last Updated: July 17, 2023
• Results First Posted: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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
• 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.

Locations

DE (1); AU (5)