HealthyPhase 1NCT00822757

Safety and Immunogenicity Study of V710 Lyophilized Formulation (V710-004)

A Phase 1 study testing Comparator: V710 in people with Healthy, run by Merck Sharp & Dohme LLC.

Completed

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

Trial summary

This study is being performed to evaluate a single 60 Mcg dose of lyophilized formulation of Merck Staphylococcus aureus vaccine (V710) in healthy subjects. This study is intended to provide necessary safety and immunogenicity data for the lyophilized formulation of V710 prior to its subsequent evaluation in patients… Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Comparator: V710
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 51 participants
Where: No sites listed yet
Study dates: Aug 2007to Dec 2007
Phase: Phase 1
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

18 to 80 years of age
Good physical health based upon medical history and physical examination
Willing and able to participate in the entire study duration
Female subject with a negative urine pregnancy test immediately prior to study vaccination

Who cannot join

Chronic skin infections or a chronic skin condition (e.g. psoriasis)
Serious S. aureus infection in the last 12 months
Allergy to aluminum-containing substance taken in the body or to any other vaccine component
Oral temperature equal to or greater than 100.4ºF (38.0ºC), within the past 2 days
Participation in a prior V710 vaccine clinical study
Participation in any other clinical study in the past 4 weeks, or during the 3-month study duration

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Single Dose of the Lyophilized Formulation of Merck Staphylococcus Aureus Vaccine (V710) in Healthy Adults

Conditions: Healthy
Being tested: Comparator: V710, Comparator: placebo
Keywords: study in healthy subjects

What participants receive

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

Comparator: V710Biological
Single dose V710 (60 Mcg/0.5 mL) by intramuscular injection.
Comparator: placeboBiological
Single dose of buffered saline placebo (0.5 mL) by intramuscular injection.

Study groups in NCT00822757
Study group	Role	What they receive
1	Experimental	V710 Receives: Biological: Comparator: V710
2	Placebo comparator	Placebo Receives: Biological: Comparator: placebo

What is being measured

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

Geometric Mean Fold-rise (GMFR) After the Administration of the Lyophilized Formulation of V710 (60 mcg).
Participants whose geometric mean fold-rise (GMFR) in anti-0657n IgG was measured 14 days after a single dose of the lyophilized formulation of V710 (60 mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0651nI S. aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) prevaccination (pre)/14 days postvaccination (postvac).
Measured: Prevaccination to 14 days postvaccination

Timeline

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

Aug 2007Dec 2007

First posted14 Jan 2009 (estimated)
Study startAug 2007
Primary completionOct 2007
Study completionDec 2007

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 HealthyStudies 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 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00822757
Sponsor's protocol ID: V710-004
Other IDs: 2007_531
Status last verified: Oct 2015
First submitted: 13 Jan 2009
Last updated: 2 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Harro CD, Betts RF, Hartzel JS, Onorato MT, Lipka J, Smugar SS, Kartsonis NA. The immunogenicity and safety of different formulations of a novel Staphylococcus aureus vaccine (V710): results of two Phase I studies. Vaccine. 2012 Feb 21;30(9):1729-36. doi: 10.1016/j.vaccine.2011.12.045. Epub 2011 Dec 20.
PubMed 22192849

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

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All Healthy 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, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Single Dose of the Lyophilized Formulation of Merck Staphylococcus Aureus Vaccine (V710) in Healthy Adults
ClinicalTrials.gov ID: NCT00822757
Acronym / sponsor ID: V710-004
Conditions: Healthy
Keywords: study in healthy subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Aug 2007
Primary completion: Oct 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 14 Jan 2009 (estimated)
Results: Posted 21 Nov 2011

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: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Biological: Comparator: V710V710
2	Placebo comparator	Biological: Comparator: placeboPlacebo

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

18 to 80 years of age
Good physical health based upon medical history and physical examination
Willing and able to participate in the entire study duration
Female subject with a negative urine pregnancy test immediately prior to study vaccination

Key exclusion criteria (6 listed)

Chronic skin infections or a chronic skin condition (e.g. psoriasis)
Serious S. aureus infection in the last 12 months
Allergy to aluminum-containing substance taken in the body or to any other vaccine component
Oral temperature equal to or greater than 100.4ºF (38.0ºC), within the past 2 days
Participation in a prior V710 vaccine clinical study

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
Comparator: V710Single dose V710 (60 Mcg/0.5 mL) by intramuscular injection.	Biological	1
Comparator: placeboSingle dose of buffered saline placebo (0.5 mL) by intramuscular injection.	Biological	2

Primary outcome

Geometric Mean Fold-rise (GMFR) After the Administration of the Lyophilized Formulation of V710 (60 mcg).
Time frame: Prevaccination to 14 days postvaccination
Participants whose geometric mean fold-rise (GMFR) in anti-0657n IgG was measured 14 days after a single dose of the lyophilized formulation of V710 (60 mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0651nI S. aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) prevaccination (pre)/14 days postvaccination (postvac).

Results and safety

Results posted to the registry on 21 Nov 2011, 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 mcg) Lyophilized	41	41
Placebo	10	10

Primary outcome: Geometric Mean Fold-rise (GMFR) After the Administration of the Lyophilized Formulation of V710 (60 mcg).

Time frame: Prevaccination to 14 days postvaccination. Geometric mean (95% Confidence Interval). Unit: Ratio

Measure	V710 (60 mcg) Lyophilized n = 41	Placebo n = 10
Value	5.3 (3.8 to 7.2)	1.0 (0.9 to 1.0)

Adverse events

Time frame: All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study). Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
V710 (60 mcg) Lyophilized	0 of 41 (0%)	15 of 41 (36.6%)	Not reported
Placebo	0 of 10 (0%)	3 of 10 (30%)	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.
Results publication: PubMed 22192849Harro CD, Betts RF, Hartzel JS, Onorato MT, Lipka J, Smugar SS, Kartsonis NA. The immunogenicity and safety of different formulations of a novel Staphylococcus aureus vaccine (V710): results of two Phase I studies. Vaccine. 2012 Feb 21;30(9):1729-36. doi: 10.1016/j.vaccine.2011.12.045. Epub 2011 Dec 20.

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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.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Comparator: V710 in people with Healthy, 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 4 inclusion and 6 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 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 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?

Yes. Results are posted in the registry (first posted 21 Nov 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) After the Administration of the Lyophilized Formulation of V710 (60 mcg). (time frame: Prevaccination to 14 days postvaccination). 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 NCT00822757, 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.