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Staphylococcus Aureus InfectionPhase 2NCT00572910

A Study to Evaluate the Safety and Immunogenicity of V710 in Adults With Kidney Disease on Hemodialysis (V710-005)(COMPLETED)

A Phase 2 study of Staphylococcus Aureus Infection, run by Merck Sharp & Dohme LLC.

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 is a study to evaluate the safety and immunogenicity of V710 with and without Merck Aluminum Adjuvant (MAA) in adult participants with end-stage kidney disease who are on hemodialysis. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Staphylococcus Aureus Infection
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
206 participants
Where
No sites listed yet
Study dates
Aug 2008to Jan 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with end stage kidney disease and is on hemodialysis
  • Female patients who are able to have children must have a negative urine pregnancy tests

Who cannot join

  • Developed a serious infection within the past 12 months; allergy to the components of the vaccine
  • Has been vaccinated with a live virus within the past 30 days or are scheduled to be vaccinated with a live virus in the next 60 days
  • Received V710 vaccine before

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of Merck Staphylococcus Aureus Vaccine (V710) in Adult Patients With End-Stage Renal Disease on Chronic Hemodialysis

This is a study to evaluate the safety and immunogenicity of V710 with and without Merck Aluminum Adjuvant (MAA) in adult participants with end-stage kidney disease who are on hemodialysis.

Being tested
Comparator: Placebo (PBO), V710 Comparator: Placebo (PBO)
Medical subject headings
Staphylococcal Infections

What participants receive

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

  • Comparator: Placebo (PBO)Biological

    Group 6: Placebo (PBO / PBO / PBO)

  • V710 Comparator: Placebo (PBO)Biological

    Group 5A: V710 (90 mcg / 90 mcg / 90 mcg) with MAA

    Group 5B: V710 (90 mcg / 90 mcg / PBO) with MAA

  • V710 Comparator: Placebo (PBO)Biological

    Group 4A: V710 (60 mcg / PBO / 60 mcg) with MAA

    Group 4B: V710 (60 mcg / PBO / PBO) with MAA

  • V710 Comparator: Placebo (PBO)Biological

    Group 3A: V710 (60 mcg / 60 mcg / 60 mcg) with MAA

    Group 3B: V710 (60 mcg / 60 mcg / PBO) with MAA

  • V710 Comparator: Placebo (PBO)Biological

    Group 2A: V710 (60 mcg / PBO / 60 mcg) without MAA

    Group 2B: V710 (60 mcg / PBO / PBO) without MAA

  • V710 Comparator: Placebo (PBO)Biological

    Group 1A: V710 (60 mcg / 60 mcg / 60 mcg) without MAA

    Group 1B: V710 (60 mcg / 60 mcg / PBO) without MAA

Study groups in NCT00572910
Study groupRoleWhat they receive
V710 - Group 1ExperimentalV710 (60 mcg without MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
Receives: Biological: V710 Comparator: Placebo (PBO)
V710 - Group 2ExperimentalV710 (60 mcg without MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180.
Receives: Biological: V710 Comparator: Placebo (PBO)
V710 - Group 3ExperimentalV710 (60 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
Receives: Biological: V710 Comparator: Placebo (PBO)
V710 - Group 4ExperimentalV710 (60 mcg with MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180.
Receives: Biological: V710 Comparator: Placebo (PBO)
V710 - Group 5ExperimentalV710 (90 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
Receives: Biological: V710 Comparator: Placebo (PBO)
Group 6Placebo comparatorPlacebo on Day 1, 28 and 180.
Receives: Biological: Comparator: Placebo (PBO)

What is being measured

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

  1. Geometric Mean Fold-rise (GMFR) in 0657n-specific Immunoglobulin G (IgG) Antibody Concentration From Baseline to 28 Days After the Administration of the Second V710 Vaccination

    Participants whose GMFR in anti-0657n IgG antibody concentration was measured by the LUMINEX™ assay from Baseline to 28 days after the administration of the second vaccination of V710 for the 3 groups receiving 2 doses of V710 (60 mcg without MAA) Group 1, (60 mcg with MAA) Group 3 and (90 mcg with MAA) Group 5.

    Measured: Prevaccination to 56 days postvaccination

  2. Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE)

    Participants with Adverse Experiences (AE) / Serious Adverse Experiences (SAE) occurring Day 1 through Day 14 following vaccinations 1, 2, and 3.

    Participants with specific SAEs including any vaccine-related SAEs, any SAEs involving a Staphylococcus aureus (S. aureus) infection, or any AEs leading to death occurring Day 1 through Day 360 following vaccination.

    Measured: Days 1-14 following each vaccination for any AE/SAE and Days 1-360 for any vaccine-related SAEs, S. aureus SAEs, or deaths.

Secondary outcomes (4)

  1. GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 28 After the Administration of the First V710 Vaccination

    Participants whose GMFR in anti-0657n IgG antibody concentration was measured from Baseline to Day 28 for the 3 Groups receiving 1 dose of V710 (60 mcg without MAA) Group 1 and 2 combined, (60 mcg with MAA) Group 3 and 4 combined and (90 mcg with MAA) Group 5.

    Measured: Prevaccination to 28 days postvaccination

  2. GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 180 After the Administration of the First V710 Vaccination

    Participants whose GMFR in anti-0657n IgG antibody concentration was measured from Baseline to Day 180 for the 3 Groups receiving 2 doses of V710 28 days apart (60 mcg without MAA) Group 1, (60 mcg with MAA) Group 3 and (90 mcg with MAA) Group 5.

    Measured: Prevaccination to 180 days postvaccination

  3. GMFR in 0657n-specific IgG Antibody Concentration From Baseline to 56 Days After the Administration of a Single V710 Vaccination

    Participants whose GMFR in 0657n-specific IgG antibody concentration from Baseline to Day 56 for the 2 Groups receiving a single dose of V710 (60 mcg without MAA followed by Placebo 28 Days later) Group 2, and (60 mcg with MAA followed by Placebo 28 days later) Group 4.

    Measured: Prevaccination to 56 days postvaccination

  4. GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints

    Participants whose GMFR in 0657n-specific IgG antibody concentration from baseline through Day 360 for all groups (including Days 28, 56, 84,180, 210, 270, and 360) to assess the durability and kinetics of the immune response.

    Measured: Prevaccination to 360 days post vaccination

Timeline

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

  1. First posted13 Dec 2007 (estimated)
  2. Study startAug 2008
  3. Primary completionJan 2010
  4. Study completionJan 2010

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00572910
Sponsor's protocol ID
V710-005
Other IDs
2007_609
Status last verified
Mar 2015
First submitted
11 Dec 2007
Last updated
3 Apr 2015

Publications

  • Moustafa M, Aronoff GR, Chandran C, Hartzel JS, Smugar SS, Galphin CM, Mailloux LU, Brown E, Dinubile MJ, Kartsonis NA, Guris D. Phase IIa study of the immunogenicity and safety of the novel Staphylococcus aureus vaccine V710 in adults with end-stage renal disease receiving hemodialysis. Clin Vaccine Immunol. 2012 Sep;19(9):1509-16. doi: 10.1128/CVI.00034-12. Epub 2012 Jul 25.

    PubMed 22837094

Questions about this trial

What is this clinical trial studying?

A Phase 2 study of Staphylococcus Aureus Infection, run by Merck Sharp & Dohme LLC.

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 2 inclusion and 3 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 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Geometric Mean Fold-rise (GMFR) in 0657n-specific Immunoglobulin G (IgG) Antibody Concentration From Baseline to 28 Days After the Administration of the Second V710 Vaccination (time frame: Prevaccination to 56 days postvaccination). The study lists 2 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 NCT00572910, which also lists 1 linked publication.

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 3 Apr 2015.

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