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Infections, CytomegalovirusPhase 1NCT00435396

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

A Phase 1 study testing GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A in people with Infections, Cytomegalovirus, run by GlaxoSmithKline at 2 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for
Infections, Cytomegalovirus
What is being tested?
GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesBelgium
Study dates
22 Feb 2007to 27 Aug 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • History of malignancy
  • Acute disease at the time of enrollment.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Hepatomegaly, right upper quadrant abdominal pain or tenderness.
  • Decreased renal function
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
  • History of chronic alcohol consumption and/or drug abuse.

Trial locations and contacts

2 sites in 1 country.

Belgium2 sites

  • GSK Investigational Site

    La Louvière, 7100

  • GSK Investigational Site

    Wilrijk, 2610

Other trials in Belgium

About this study

Official title: A Phase I, Open-label, Vaccination Study to Evaluate the Safety and Immunogenicity of the GSK Biologicals Recombinant CMV gB Sub-unit Vaccine GSK1492903A in CMV-seronegative Healthy Male Adult Subjects

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.

Read the detailed description

The protocol posting has been amended to reflect changes as a consequence of an amendment to the protocol. The section impacted by the change is Key inclusion \& exclusion criteria. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Being tested
GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A
Medical subject headings
Cytomegalovirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903ABiological

    Intramuscular injection, 3 doses

Study groups in NCT00435396
Study groupRoleWhat they receive
Group AExperimentalNot described
Receives: Biological: GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: During a 7 days follow-up after each vaccination

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

    Measured: During a 31 days follow-up period after each vaccination

  3. Occurrence and relationship to vaccination of any SAEs.

    Measured: Throughout the study period

  4. Haematological and biochemical parameters.

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

Secondary outcomes (7)

  1. Anti-gB antibody avidity in all groups;

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

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

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

  3. Anti-CMV tegument proteins antibody response in all groups;

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

  4. 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;

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

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

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

  6. Anti-glycoprotein B (gB) antibody concentrations in all groups;

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

  7. Anti-CMV Western Blot in all groups.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2007 (estimated)
  2. Study start22 Feb 2007
  3. Primary completion27 Aug 2008
  4. Study completion27 Aug 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00435396
Sponsor's protocol ID
108890
Other IDs
109211
Status last verified
May 2017
First submitted
14 Feb 2007
Last updated
30 May 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A in people with Infections, Cytomegalovirus, run by GlaxoSmithKline at 2 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence, intensity and relationship to vaccination of solicited local and general AEs. (time frame: During a 7 days follow-up after each vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00435396.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.

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