Staphylococcus AureusPhase 2/3NCT00518687

Efficacy, Immunogenicity, and Safety of a Single Dose of V710 in Adult Patients Scheduled for Cardiothoracic Surgery (V710-003 AM2)

A Phase 2/3 study testing V710 in people with Staphylococcus Aureus and Bacteremia, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This study will assess the efficacy of a single dose of V710 vaccine to prevent serious Staphylococcus aureus infections following elective cardiothoracic surgery. The study will also evaluate the immune response and general safety of the V710 vaccine. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Staphylococcus Aureus, Bacteremia, Mediastinitis
What is being tested?: V710
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 8,031 participants
Where: No sites listed yet
Study dates: Dec 2007to Aug 2011
Phase: Phase 2/3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant is scheduled to undergo cardiothoracic surgery involving a full median sternotomy (not including cardiac transplantation surgery) within 14 to 60 days after vaccination.
Female participants of reproductive potential are required to have a negative urine or serum pregnancy test immediately prior to study vaccination and must use an acceptable form of birth control.

Who cannot join

Participants had an invasive Staphylococcus aureus infection within the past 3 months prior to study entry.
A realistic (>50%) possibility that cardiothoracic surgery will be necessary sooner than 10 days after vaccination.
Participant is planning to undergo cardiac transplantation surgery or sternal debridement to remedy an infection resulting from a prior cardiothoracic surgery.
Participant has any type of ventricular-assist device in place at the time of study entry.
Participant has a history of anaphylaxis to any of the vaccine components.
Participant received V710 vaccine, any other investigational Staphylococcus aureus vaccine, or investigational Staphylococcus aureus antibodies.

Show all 9Show fewer

Participant has a temperature of ≥100.4ºF (≥38.0ºC), oral equivalent, within 48 hours prior to study vaccination.
Participant has impairment of the immune system.
Participant has a medical condition in which the expected survival is less than 90 days.

About this study

Official title: A Randomized, Multicenter, Double-Blind, Group-Sequential Study to Evaluate the Efficacy, Immunogenicity, and Safety of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine (V710) in Adult Patients Scheduled for Cardiothoracic Surgery

Conditions: Staphylococcus Aureus, Bacteremia, Mediastinitis
Being tested: V710, Placebo
Medical subject headings: Staphylococcal Infections, Bacteremia, Mediastinitis

What participants receive

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

V710Biological
Also called Merck 0657nI Staphylococcus aureus vaccine
0.5-mL single injection of V710 (60 µg)
PlaceboBiological
0.5-mL single injection of matching placebo

Study groups in NCT00518687
Study group	Role	What they receive
V710 60 µg	Experimental	Not described Receives: Biological: V710
Placebo	Placebo comparator	Not described Receives: Biological: Placebo

What is being measured

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

Number of Participants With Staphylococcus Aureus Bacteremia and/or Deep Sternal Wound Infection
Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the Centers for Disease Control (CDC) Guidelines for Nosocomial infections (Garner JS, Jarvis WS, Emori TG, et al. CDC definitions for nosocomial infections. APIC Infect Control App Epidemiol 1996;A1-20). Bacteremia was defined as ≥1 positive blood culture for S. aureus regardless of the presence of clinical symptoms. A Staphylococcus aureus deep sternal wound infection included mediastinitis or a deep incisional surgical-site infection involving the sternal wound.
Measured: Up to 90 days after surgery
Incidence Rate of Vaccine-related Serious Adverse Experiences
Vaccine-related adverse experiences were those deemed by the investigator to be possibly, probably, or definitely vaccine related. A serious adverse experience was any adverse experience occurring at any dose that 1) resulted in death, 2) was life threatening, 3) resulted in a persistent or significant disability/incapacity, 4) resulted in or prolonged an existing inpatient hospitalization, 5) was a congenital anomaly/birth defect, 6) was a cancer, 7) was an overdose, or 8) jeopardized the participant and required medical or surgical intervention.
Measured: Up to 360 days after surgery

Secondary outcomes (2)

Number of Participants With Invasive Staphylococcus Aureus Infection
Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the CDC Guidelines for Nosocomial infections. An invasive Staphylococcus infection included bacteremia, deep sternal wound infection, deep-tissue organ/space infection at another surgical site, or any other deep-tissue infection.
Measured: Up to 90 days after surgery
Number of Participants With Surgical-site Staphylococcus Aureus Infection
Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the CDC Guidelines for Nosocomial infections. A Staphylococcus infection surgical-site infection included any superficial incisional, deep incisional, or organ/space infection at the sternal site, the vascular harvest (donor) site, or any other site at which the surgery was performed.
Measured: Up to 90 days after surgery

Timeline

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

Dec 2007Aug 2011

First posted21 Aug 2007 (estimated)
Study startDec 2007
Primary completionAug 2011
Study completionAug 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Staphylococcus AureusStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2/3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 8,031 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00518687
Sponsor's protocol ID: V710-003
Other IDs: 2007_523
Status last verified: Oct 2015
First submitted: 17 Aug 2007
Last updated: 2 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Fowler VG, Allen KB, Moreira ED, Moustafa M, Isgro F, Boucher HW, Corey GR, Carmeli Y, Betts R, Hartzel JS, Chan IS, McNeely TB, Kartsonis NA, Guris D, Onorato MT, Smugar SS, DiNubile MJ, Sobanjo-ter Meulen A. Effect of an investigational vaccine for preventing Staphylococcus aureus infections after cardiothoracic surgery: a randomized trial. JAMA. 2013 Apr 3;309(13):1368-78. doi: 10.1001/jama.2013.3010.
PubMed 23549582

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Study of the Nasal Intracellular Reservoir of Staphylococcus Aureus in Patients With S. Aureus Bacteremia
Bacteria Infection Mechanism
Not yet recruiting
Farm-originated Antimicrobial Resistance Modeling: Exploring Humans-to-Animal Dissemination
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A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Not yet recruiting
Bacterial Decolonization to Prevent Severe Radiation Dermatitis in Head and Neck Squamous Cell Carcinoma
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All Staphylococcus Aureus trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multicenter, Double-Blind, Group-Sequential Study to Evaluate the Efficacy, Immunogenicity, and Safety of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine (V710) in Adult Patients Scheduled for Cardiothoracic Surgery
ClinicalTrials.gov ID: NCT00518687
Acronym / sponsor ID: V710-003
Conditions: Staphylococcus Aureus, Bacteremia, Mediastinitis
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 8,031 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 21 Aug 2007 (estimated)
Results: Posted 5 Nov 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
V710 60 µg	Experimental	Biological: V710
Placebo	Placebo comparator	Biological: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Participant is scheduled to undergo cardiothoracic surgery involving a full median sternotomy (not including cardiac transplantation surgery) within 14 to 60 days after vaccination.
Female participants of reproductive potential are required to have a negative urine or serum pregnancy test immediately prior to study vaccination and must use an acceptable form of birth control.

Key exclusion criteria (9 listed)

Participants had an invasive Staphylococcus aureus infection within the past 3 months prior to study entry.
A realistic (>50%) possibility that cardiothoracic surgery will be necessary sooner than 10 days after vaccination.
Participant is planning to undergo cardiac transplantation surgery or sternal debridement to remedy an infection resulting from a prior cardiothoracic surgery.
Participant has any type of ventricular-assist device in place at the time of study entry.
Participant has a history of anaphylaxis to any of the vaccine components.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
V710Also: Merck 0657nI Staphylococcus aureus vaccine0.5-mL single injection of V710 (60 µg)	Biological	V710 60 µg
Placebo0.5-mL single injection of matching placebo	Biological	Placebo

Primary outcome

Number of Participants With Staphylococcus Aureus Bacteremia and/or Deep Sternal Wound Infection
Time frame: Up to 90 days after surgery
Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the Centers for Disease Control (CDC) Guidelines for Nosocomial infections (Garner JS, Jarvis WS, Emori TG, et al. CDC definitions for nosocomial infections. APIC Infect Control App Epidemiol 1996;A1-20). Bacteremia was defined as ≥1 positive blood culture for S. aureus regardless of the presence of clinical symptoms. A Staphylococcus aureus deep sternal wound infection included mediastinitis or a deep incisional surgical-site infection involving the sternal wound.
Incidence Rate of Vaccine-related Serious Adverse Experiences
Time frame: Up to 360 days after surgery
Vaccine-related adverse experiences were those deemed by the investigator to be possibly, probably, or definitely vaccine related. A serious adverse experience was any adverse experience occurring at any dose that 1) resulted in death, 2) was life threatening, 3) resulted in a persistent or significant disability/incapacity, 4) resulted in or prolonged an existing inpatient hospitalization, 5) was a congenital anomaly/birth defect, 6) was a cancer, 7) was an overdose, or 8) jeopardized the participant and required medical or surgical intervention.

2 secondary outcomes

Number of Participants With Invasive Staphylococcus Aureus Infection
Time frame: Up to 90 days after surgery
Number of Participants With Surgical-site Staphylococcus Aureus Infection
Time frame: Up to 90 days after surgery

Results and safety

Results posted to the registry on 5 Nov 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
V710 60 µg	4,005	2,568
Placebo	4,005	2,585

Primary outcome: Number of Participants With Staphylococcus Aureus Bacteremia and/or Deep Sternal Wound Infection

Time frame: Up to 90 days after surgery. Number. Unit: participants

Measure	V710 60 µg n = 3528	Placebo n = 3517
Value	22	27

V710 60 µg vs Placebo: Vaccine Efficacy (VE): 18.5 (95% CI -48.6 to 55.8), p = 0.584, Exact 1-sided binomial test

Population analysed: The population analyzed was the full analysis set: participants who were vaccinated and subsequently underwent cardiothoracic surgery involving full median sternotomy at least 14 days and at most 60 days after vaccination

Primary outcome: Incidence Rate of Vaccine-related Serious Adverse Experiences

Time frame: Up to 360 days after surgery. Number. Unit: Events per 100 person-years

Measure	V710 60 µg n = 3958	Placebo n = 3967
Value	0.0	0.0

V710 60 µg vs Placebo: Estimated rate difference: 0.0 (95% CI -0.1 to 0.1), p = 0.997, Miettinen and Nurminen

Population analysed: The population analyzed included all vaccinated participants with follow-up results

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: All serious adverse events (SAEs): through Day 14 after vaccination; vaccine-related SAEs, SAEs resulting in death, and SAEs involving infection diagnosis: through Day 360 after surgery; other adverse events (AEs): through Day 14 after vaccination. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
V710 (60 µg) Lyophilized	291 of 3,958 (7.4%)	749 of 3,958 (18.9%)	Not reported
Placebo	274 of 3,967 (6.9%)	343 of 3,967 (8.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23549582Fowler VG, Allen KB, Moreira ED, Moustafa M, Isgro F, Boucher HW, Corey GR, Carmeli Y, Betts R, Hartzel JS, Chan IS, McNeely TB, Kartsonis NA, Guris D, Onorato MT, Smugar SS, DiNubile MJ, Sobanjo-ter Meulen A. Effect of an investigational vaccine for preventing Staphylococcus aureus infections after cardiothoracic surgery: a randomized trial. JAMA. 2013 Apr 3;309(13):1368-78. doi: 10.1001/jama.2013.3010.

Related trials for Staphylococcus Aureus

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing V710 in people with Staphylococcus Aureus and Bacteremia, 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 9 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: stopped early, as of the sponsor's last update on 2 Oct 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 5 Nov 2012). 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?

Number of Participants With Staphylococcus Aureus Bacteremia and/or Deep Sternal Wound Infection (time frame: Up to 90 days after surgery). 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 NCT00518687, 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 2 Oct 2015.