Clinical trial NCT01099488: A Study in Healthy Adults Having Received a Single Vaccine Administration to Support the Development of Immunological Assays
Official title: A Study in Healthy Adults Having Received a Single Vaccine Administration to Support the Development of Immunological Assays
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunologic Tests
Keywords: Immunological assays
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-04-07
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to develop immunological assays on blood samples.

Detailed description: This is a clinical study in which there is no vaccine administered. It is designed for research purposes such as developing immunological assays.

Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g. return for follow-up visits).
* A male or female between, and including, 18 and 50 years of age at study start.
* A subject having received a Yellow Fever (YF) vaccine on the day of study entry.
* Written informed consent obtained from the subject.
* Healthy subjects as established by medical history and clinical examination performed on the day of YF vaccination.
* Female subjects of non-childbearing potential may be enrolled in the study.
* Female subjects of childbearing potential may be enrolled in the study, if the subject:

  * has practiced adequate contraception for 30 days prior to study start, and
  * has agreed to continue adequate contraception during the entire study period.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding study start, or planned use during the study period.
* Concurrently participating in another clinical study, within 3 months preceding study start and at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
* Clinically significant anaemia or any known condition as per medical history that would preclude the drawing of blood as described in the protocol.
* Known previous infection with YF virus.
* Previous vaccination against YF more than approximately 5 hours before the blood sampling at Visit 1.
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the study start or planned administration during the study period.
* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs (including chloroquine) within six months prior to the study start. For corticosteroids, this will mean prednisone ≥ 10mg/day, or equivalent. Inhaled and topical steroids are allowed.
* Receipt of live attenuated vaccines other than the YF vaccine during the period beginning 30 days preceding the blood sampling at Visit 1 or planned use during the study up to the blood sampling at Visit 2.
* Receipt of inactivated influenza vaccines (seasonal or pandemic) during the period beginning 21 days preceding the blood sampling at Visit 1 or planned use during the study up to the blood sampling at Visit 2.
* History of malignancy (unless there has been surgical excision followed by a sufficient observation period, of at least 5 years, to give a reasonable assurance of sustained cure and which, in the estimate of the investigator, is not likely to recur during the study period).
* Any confirmed or suspected immunosuppressive or immunodeficient condition (including HIV, hepatitis B and hepatitis C), based on medical history and physical examination (no laboratory testing required).
* Family history of congenital or hereditary immunodeficiency.
* Major congenital defects or serious chronic illness.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination and medical history.
* Acute disease and/or fever at the time of enrolment.
* Known pregnant or lactating female, as per medical records.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
* History of chronic alcohol consumption and/or drug abuse.
* Any condition that may preclude the compliance to the study protocol.

Primary outcomes:
measure: Frequency of CD8+ T-cells at protocol-defined time points.
timeFrame: At Day 0, Day 14 and Day 180.
Secondary outcomes:
measure: Frequency of CD4+ T-cells response at protocol-defined time points.
timeFrame: At Day 0, Day 14 and Day 180.
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: GSK Investigational Site
city: Mons
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: