Clinical trial NCT03493919: A Sourcing Study to Collect Human Blood Samples From Healthy Adults
Official title: A Sourcing Study to Collect Human Biological (Serum) Samples From Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meningitis, Meningococcal
Keywords: Immunological assays
Human blood donors
Meningococcal vaccination
Meningococcal disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2018-04-11
Enrollment: 1021
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Number of Human Blood Samples Collected for Conversion Into Serum at Day -83
timeFrame: At Day -83 [83 days before first vaccination (Day 1)]
measure: Number of Human Blood Samples Collected for Conversion Into Serum at Day 8
timeFrame: At Day 8
measure: Number of Human Blood Samples Collected for Conversion Into Serum at Day 98
timeFrame: At Day 98
measure: Number of Human Blood Samples Collected for Conversion Into Serum at Day 151
timeFrame: At Day 151
measure: Number of Human Blood Samples Collected for Conversion Into Serum at Day -60
timeFrame: At Day -60 [60 days before first vaccination (Day 1)]
measure: Number of Human Blood Samples Collected for Conversion Into Serum at Day 31
timeFrame: At Day 31
measure: Number of Human Blood Samples Collected for Conversion Into Serum at Day-30
timeFrame: At Day -30 [30 days before first vaccination (Day 1)]
measure: Number of Human Blood Samples Collected for Conversion Into Serum at Day 61
timeFrame: At Day 61
Secondary outcomes:
measure: Number of Participants With Atleast One Serious Adverse Events (SAEs) Related to Vaccination
timeFrame: Throughout the study period (approximately 4 years)
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Adelaide
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Geelong
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Melbourne
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Spearwood
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Wuerzburg
country: Germany
facility: GSK Investigational Site
state: Bayern
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: