Study to Evaluate Safety and Immunogenicity of the GSK Bio CMV Vaccine in CMV-seronegative Healthy Male Adult Subjects

NCT00435396 | Completed Phase 1

• 2 other identifiers: 108890109211
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This will be the first time in humans (FTIH) study with the GSK Bio recombinant gB antigen to evaluate safety and immunogenicity of this CMV candidate vaccine with a proprietary GSK adjuvant system. The vaccine will be administered to young male healthy subjects at 0, 1 and 6 months. The trial will assess the safety and immunogenicity of the candidate CMV vaccine. An additional secondary objective of this trial is to identify and validate a test which will be able to differentiate between previous CMV infection and CMV vaccination. Subjects will be followed for a total of 2 years.

Conditions

Infections, Cytomegalovirus

Outcome Measures

Primary Outcomes (4)

• Occurrence, intensity and relationship to vaccination of solicited local and general AEs.

  During a 7 days follow-up after each vaccination

• Occurrence, intensity and relationship to vaccination of unsolicited AEs.

  During a 31 days follow-up period after each vaccination

• Occurrence and relationship to vaccination of any SAEs.

  Throughout the study period

• Haematological and biochemical parameters.

  At months 0, 1, 2, 6, 7 12 and 24

Secondary Outcomes (7)

• Anti-gB antibody avidity in all groups;

  At months 0, 1, 2, 6, 7 12 and 24

• Neutralizing anti-cytomegalovirus (CMV) antibody response in all groups

  At months 0, 1, 2, 6, 7, 12 and 24;

• Anti-CMV tegument proteins antibody response in all groups;

  At months 0, 1, 2, 6, 7, 12 and 24;

• Frequencies of CD4/CD8 T-cells with antigen-specific IFN-g, IL-2, TNF-a and/or CD40L secretion/expression to gB as determined by ICS in all groups;

  At months 0, 1, 2, 6, 7, 12 and 24

• Anti-Herpes simplex virus (HSV) gD antibody response in all groups.

  At months 0, 1, 2, 6, 7, 12 and 24

Study Arms (1)

Group A

EXPERIMENTAL

Biological: GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A

Interventions

GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A BIOLOGICAL

Intramuscular injection, 3 doses

Group A

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
• Male between, and including, 18 and 40 years of age at the time of the first vaccination.
• Written informed consent obtained from the subject.
• The subject consents to being informed of his CMV and HSV serostatus.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Seronegative for CMV.
• Previously completed routine childhood vaccinations to the best of his knowledge.

You may not qualify if:

• The HSV serologic status.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Any chronic drug therapy to be continued during the study period.
• Receipt of live attenuated vaccines within 30 days of study vaccine administration.
• Receipt of medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) or allergy treatment with antigen injections within 14 days of study vaccine administration.
• Prior receipt of the adjuvant or any of its components being used in this study.
• Previous vaccination against CMV.
• History of recurrent herpes simplex infection (more than 1 episode per year).
• Any confirmed or suspected immunosuppressive or immunodeficient condition
• Hepatitis B infection or hepatitis C infection.
• A family history of congenital or hereditary immunodeficiency.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Major congenital defects or serious chronic illness including but not limited to diabetes mellitus and thyroid disease
• History of any neurologic disorders or seizures except people with febrile convulsions before the age of 5.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

La Louvière, 7100, Belgium

Location

GSK Investigational Site

Wilrijk, 2610, Belgium

Location

Related Links

• Results for study 108890 can be found on the GSK Clinical Study Register

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2007
• First Posted: February 15, 2007
• Study Start: February 22, 2007
• Primary Completion: August 27, 2008
• Study Completion: August 27, 2008
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

BE (2)