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Evaluation of Safety, Immune-Response and Efficacy of GSK Biologicals' EBV (Epstein Barr Virus) Vaccine (268664).

Primary Purpose

Epstein Barr Virus (EBV) Infection

Status

Completed

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

EBV vaccine (268664)

About this trial

This is an interventional prevention trial for Epstein Barr Virus (EBV) Infection focused on measuring Epstein Barr Virus, Belgium, Infectious mononucleosis

Eligibility Criteria

16 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy adolescent/adult subjects between and including 16 and 25 years of age at the time of screening.
- Written informed consent obtained from the subject prior to enrolment.
- Seronegative for EBV antibody.

Exclusion Criteria:

Administration of immunoglobulin and/or any blood products within the three months (90 days) preceding the first dose of study vaccine or planned administration during the study period.
- Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- Family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures, with the exception of a single febrile seizure during childhood.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- History of intravenous drug abuse within the past 2 years.
- Known or suspected allergy to any vaccine component.

Sites / Locations

GSK Clinical Trials Call Center

Outcomes

Primary Outcome Measures

Attack rates of infectious mononucleosis over 18 months after Dose 2

Secondary Outcome Measures

Solicited symptoms (Day 0-7); unsolicited AEs (Day 0-29 ); SAEs (full study)

Full Information

NCT ID

NCT00430534

First Posted

February 1, 2007

Last Updated

February 1, 2007

Sponsor

Henogen

1. Study Identification

Unique Protocol Identification Number

NCT00430534

Brief Title

Evaluation of Safety, Immune-Response and Efficacy of GSK Biologicals' EBV (Epstein Barr Virus) Vaccine (268664).

Official Title

To Evaluate the Safety, Immunogenicity and Efficacy of GSK Biologicals' EBV Vaccine (268664) in Healthy Seronegative Adolescents/Adults When Injected Intramuscularly According to a 0-1-5 Month Schedule in Belgium.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2007

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Henogen

4. Oversight

5. Study Description

Brief Summary

To evaluate the safety, immune-response and efficacy of GSK Biologicals' EBV vaccine in a population at risk of developing infectious mononucleosis. Each subject will receive three doses of vaccine or placebo during the study period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epstein Barr Virus (EBV) Infection

Keywords

Epstein Barr Virus, Belgium, Infectious mononucleosis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

200 (false)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

EBV vaccine (268664)

Primary Outcome Measure Information:

Title

Attack rates of infectious mononucleosis over 18 months after Dose 2

Secondary Outcome Measure Information:

Title

Solicited symptoms (Day 0-7); unsolicited AEs (Day 0-29 ); SAEs (full study)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy adolescent/adult subjects between and including 16 and 25 years of age at the time of screening. Written informed consent obtained from the subject prior to enrolment. Seronegative for EBV antibody. Exclusion Criteria: Administration of immunoglobulin and/or any blood products within the three months (90 days) preceding the first dose of study vaccine or planned administration during the study period. Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. Family history of congenital or hereditary immunodeficiency. Major congenital defects or serious chronic illness. History of any neurologic disorders or seizures, with the exception of a single febrile seizure during childhood. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. History of intravenous drug abuse within the past 2 years. Known or suspected allergy to any vaccine component.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Henogen

Official's Role

Study Director

Facility Information:

Facility Name

GSK Clinical Trials Call Center

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

12. IPD Sharing Statement

Citations:

PubMed Identifier

18190254

Citation

Sokal EM, Hoppenbrouwers K, Vandermeulen C, Moutschen M, Leonard P, Moreels A, Haumont M, Bollen A, Smets F, Denis M. Recombinant gp350 vaccine for infectious mononucleosis: a phase 2, randomized, double-blind, placebo-controlled trial to evaluate the safety, immunogenicity, and efficacy of an Epstein-Barr virus vaccine in healthy young adults. J Infect Dis. 2007 Dec 15;196(12):1749-53. doi: 10.1086/523813.

Results Reference

derived

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Evaluation of Safety, Immune-Response and Efficacy of GSK Biologicals' EBV (Epstein Barr Virus) Vaccine (268664).

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