A Sourcing Study to Collect Human Blood Samples From Healthy Adults

• ClinicalTrials.gov Identifier: NCT03493919
• Recruitment Status: Active, not recruiting
• First Posted: April 11, 2018
• Last Update Posted: October 20, 2021
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

Brief Summary:

The purpose of this study is to collect large volumes of matched pairs of pre- and post-vaccination sera from healthy subjects who will be administered GlaxoSmithKline (GSK) Biologicals' vaccine against meningitis- MenACWY vaccine (Menveo) or rMenB+OMV NZ vaccine (Bexsero), which will serve for the development, qualification, validation and maintenance of immunological assays and will support the preclinical research activities and clinical development of GSK Biologicals' vaccines. The safety of the subjects given one of the 2 vaccines (Bexsero or Menveo), as per the recommended dosage and schedule will be assessed during their participation in the study.

Condition or disease	Intervention/treatment	Phase
Meningitis, Meningococcal	Biological: Bexsero; Biological: Menveo	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1020 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Sourcing Study to Collect Human Biological (Serum) Samples From Healthy Adults
• Actual Study Start Date: March 8, 2018
• Estimated Primary Completion Date: June 30, 2022
• Estimated Study Completion Date: June 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: rMenB+OMV NZ Group; Approximately 510 healthy subjects vaccinated intramuscularly with Bexsero vaccine at Day 1 and Day 61 and have blood collected at Day -83, Day 8 and Day 98.	Biological: Bexsero; Two doses of Bexsero will be administered on a 0,2-month schedule (Day 1 and Day 61) intramuscularly in the upper deltoid of the non-dominant arm.
Experimental: MenACWY 1 Group; Approximately 170 healthy subjects vaccinated intramuscularly with Menveo vaccine at Day 1 and have blood collected at Day -83, Day 8 and Day 151.	Biological: Menveo; One dose of Menveo vaccine will be administered intramuscularly in the upper deltoid of the non-dominant arm, at Day 1.
Experimental: MenACWY 2 Group; Approximately 170 healthy subjects vaccinated intramuscularly with Menveo vaccine at Day 1 and have blood collected at Day -60, Day 31 and Day 151.	Biological: Menveo; One dose of Menveo vaccine will be administered intramuscularly in the upper deltoid of the non-dominant arm, at Day 1.
Experimental: MenACWY 3 Group; Approximately 170 healthy subjects vaccinated intramuscularly with Menveo vaccine at Day 1 and have blood collected at Day -30, Day 61 and Day 151.	Biological: Menveo; One dose of Menveo vaccine will be administered intramuscularly in the upper deltoid of the non-dominant arm, at Day 1.

Outcome Measures

Primary Outcome Measures :

1. Collection of human blood for conversion into serum. [ Time Frame: At Visit 1 (Day -83) ]
   Blood samples collected from subjects who receive Bexsero vaccine or Menveo vaccine.
2. Collection of human blood for conversion into serum. . [ Time Frame: At Visit 5 (Day 8) ]
   Blood samples collected from subjects who receive Bexsero vaccine or Menveo vaccine.
3. Collection of human blood for conversion into serum. [ Time Frame: At Visit 8 (Day 98) ]
   Blood samples collected from subjects who receive Bexsero vaccine.
4. Collection of human blood for conversion into serum. [ Time Frame: At Visit 9 (Day 151) ]
   Blood samples collected from subjects who receive Menveo vaccine.
5. Collection of human blood for conversion into serum. [ Time Frame: At visit 2 (Day -60) ]
   Blood samples collected from subjects who receive Menveo vaccine
6. Collection of human blood for conversion into serum. [ Time Frame: At Visit 6 (Day 31) ]
   Blood samples collected from subjects who receive Menveo vaccine
7. Collection of human blood for conversion into serum. [ Time Frame: At visit 3 (Day -30) ]
   Blood samples collected from subjects who receive Menveo vaccine
8. Collection of human blood for conversion into serum. [ Time Frame: At Visit 7 (Day 61) ]
   Blood samples collected from subjects who receive Menveo vaccine

Secondary Outcome Measures :

1. Assessment of the occurrence of Serious Adverse Events (SAEs) related to vaccination [ Time Frame: Throughout the study period (approximately 8 months) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Australia, New South Wales

GSK Investigational Site

Sydney, New South Wales, Australia, 2010

Australia, South Australia

GSK Investigational Site

Adelaide, South Australia, Australia, 5000

Australia, Victoria

GSK Investigational Site

Geelong, Victoria, Australia, 3220

GSK Investigational Site

Melbourne, Victoria, Australia, 3004

Australia, Western Australia

GSK Investigational Site

Spearwood, Western Australia, Australia, 6163

Germany

GSK Investigational Site

Wuerzburg, Bayern, Germany, 97070

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT03493919
• Other Study ID Numbers: 207911; 2017-002919-33 ( EudraCT Number )
• First Posted: April 11, 2018
• Last Update Posted: October 20, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (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.
• URL: https://clinicalstudydatarequest.com

• 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

Keywords provided by GlaxoSmithKline:

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

Additional relevant MeSH terms:

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