Staphylococcal InfectionsPhase 1NCT00303069

V710 First-In-Man (FIM) Study (V710-001)

A Phase 1 study testing V710 in people with Staphylococcal Infections, 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

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Staphylococcal Infections
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: 124 participants
Where: No sites listed yet
Study dates: Nov 2005to Jul 2006
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subject is 18 to 55 years of age
Subject is in good physical health based upon medical history, physical examination, and screening laboratory studies. NOTE: Lab studies will only be collected in Panel A, the dose-escalating portion of the study
Subject is able to understand study procedures and agrees to participate in the study by providing written informed consent
Subject is willing and able to participate in the entire study duration planned for 3 months (~84 days)
Female subjects are required to have a negative urine pregnancy test immediately prior to study vaccination. Female subjects of childbearing potential must have been using an acceptable method of birth control for 2 weeks prior to enrollment, and agree to use an acceptable method of birth control for 1 month after vaccination. (Acceptable methods of birth control include use of hormonal contraceptives, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, tubal ligation, condoms, or abstinence)

Who cannot join

Subject suffers from a chronic skin condition that predisposes the individual to the development of chronic skin or soft-tissue infections (e.g., psoriasis, chronic granulomatous disease).
Subject developed a serious infection (e.g., bacteremia, pneumonia, mediastinitis) attributed to S. aureus in the 12 months prior to screening
Subject has a history of anaphylaxis to aluminum-containing adjuvant or other vaccine components
Subject has a temperature of ≥100.4ºF (≥38.0ºC), oral equivalent, within 48 hours prior to receipt of 0657nI S. aureus vaccine/placebo
Subject has received a live virus vaccine within 30 days prior to receipt of 0657nI S. aureus vaccine/placebo or is scheduled to receive vaccination with a live virus vaccine within 30 days following study entry
Subject has received any other licensed vaccine (including non-live virus vaccines) within 14 days prior to receipt of 0657nI S. aureus vaccine/placebo or is scheduled to receive any other licensed vaccine (including non-live virus vaccines) within 30 days following study entry. (Note: Influenza vaccines may be administered during the study, but must be given at least 7 days prior to receipt of the study vaccine or at least 15 days after receipt of the study vaccine)

Show all 18Show fewer

Subject was administered immunoglobulin or blood product within 90 days prior to receipt of 0657nI S. aureus vaccine/placebo or is scheduled to receive such products within 30 days following study entry
Subject has received treatment with systemic (intramuscular, oral, or intravenous) corticosteroids or another immunosuppressive medication (e.g., calcineurin inhibitors, mycophenolate, azathioprine) in the 14 days prior to receipt of 0657nI S. aureus vaccine/placebo or is anticipated to receive such medications for a chronic medical condition during the course of the study
Subject has a condition that requires active medical intervention or monitoring to avert serious danger to the subject's health or well-being, such as diabetes mellitus, autoimmune disease, or clinically significant chronic medical conditions that are considered progressive, including but not limited to: coronary artery disease, congestive heart failure, cardiomyopathy, progressive valvular heart disease, chronic obstructive pulmonary disease, pulmonary fibrosis, active peptic ulcer disease, chronic renal disease, chronic hepatic disease, multiple sclerosis, progressive neuropathies, or seizure disorder requiring therapy in the past 3 years
Subject has known or suspected impairment of immunologic function including, but not limited to, the following conditions: autoimmune disease, diabetes mellitus, end-stage renal disease, hepatic insufficiency/cirrhosis, splenectomy, or HIV/AIDS
Subject has a condition in which repeated venipuncture or injections pose more than minimal risk for the subject, such as hemophilia, other severe coagulation disorders, or significantly impaired venous access
Subject is currently pregnant or breastfeeding, or planning to conceive within the 3-month study duration period
Subject has clinically significant abnormalities based on the subject's medical history, physical examination, or screening laboratory studies (as described in Appendix 1 of the Multicenter protocol). NOTE: Lab studies will only be collected in Panel A, the dose escalating portion of the study
Subject has recent history (within the past 5 years) or current evidence of drug or alcohol abuse
Subject has a major psychiatric illness, including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, or any subject with suicidal ideation within the previous 3 years
Subject is legally or mentally incapacitated
Subject has participated in another clinical study in the past 4 weeks, or plans to participate in a treatment-based study or study in which an invasive procedure is to be performed while enrolled in this study. NOTE: Participation in a safety surveillance study is acceptable
Subject has a history of any condition which, in the opinion of the investigator, may pose an additional risk for the subject or confound the results of the study

About this study

Official title: A Sequential-Panel, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine in Healthy Adults 18 to 55 Years of Age

This is a randomized, Multicenter, double-blind (subject, investigator, and Merck Research Laboratories (MRL) clinical personnel directly involved in the study), placebo-controlled, dose-ranging study in healthy adults 18 to 55 years of age. It is the first in man (FIM) study evaluating the tolerability and immunogenicity of the 0657nI S. aureus vaccine. For this Phase I study, approximately 120 healthy adults will be enrolled in the study and randomized to receive a single 0.5 mL vaccination of either 0657nI S. aureus vaccine (3 different dosage levels of 5 μg, 30 μg or 90 μg of the 0657nI vaccine) or saline placebo. Vaccine/placebo will be administered intramuscularly (IM) in the deltoid muscle. Because this study will be the first study evaluating the tolerability and immunogenicity of 0657nI S. aureus vaccine in humans, a dose-escalation phase will be conducted in a small number of subjects randomized in a 3:1 ratio (n=36, consisting of 9 subjects for each of 3 vaccine dosage levels and 9 placebo subjects) to evaluate the vaccine safety at increasing dose levels of the 0657nI protein in Panel A, before expanding the enrollment to the remaining 84 subjects in Panel B.

Read the detailed description

Depending on when the subject is enrolled into the study, the following will be completed: The subject will receive a single injection of SAV or placebo (an inactive substance) in the deltoid muscle of the upper arm. The subject will then be watched for 30 minutes after vaccination to monitor for allergic reactions. The subject will be asked to visit the study doctor either 6 or 9 times during the 3-month study period. Once enrolled, the subject will have blood drawn before receiving the vaccine (baseline) and up to 7 times after that at each of the required visits. The blood will be used for tests and/or for testing the subject's body's immune response to the SAV, to see if the subjects have developed immunity to S. aureus and if immunity continues up to 84 days. A Vaccination Report Card (VRC) will be provided to all participants. The participant will be asked to record oral temperatures and any reactions that occur at the SAV injection site every day for 5 days after vaccination. The participant will also be asked to record any physical adverse effects that they may experience, including headaches, nausea, muscle pain or aches, and fatigue every day for 14 days after vaccination. In additional all medications (including over the counter medications) taken during the 14 days post vaccination will be recorded and the VRC will be returned to the research staff after 14 days.

Conditions: Staphylococcal Infections
Being tested: V710, Comparator: Placebo
Keywords: S. aureus;, Vaccine, FIM
Medical subject headings: Staphylococcal Infections

What participants receive

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

V710Biological
Single dose of V710 (at dosages of 5 μg, 30 μg, or 90 μg) intramuscularly
Comparator: PlaceboBiological
Single dose of saline placebo intramuscularly

Study groups in NCT00303069
Study group	Role	What they receive
V710 5 μg	Experimental	V710 S. aureus vaccine Receives: Biological: V710
V710 30 μg	Experimental	V710 S. aureus vaccine Receives: Biological: V710
V710 90 μg	Experimental	V710 S. aureus vaccine Receives: Biological: V710
Placebo	Placebo comparator	Placebo Receives: Biological: Comparator: Placebo

What is being measured

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

Number of Vaccine-related Serious Adverse Experiences Following Vaccination
Participants with a serious vaccine-related adverse experiences (AE) (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).
Measured: Through Day 84 postvaccination
Number of Participants With ≥2-fold Rise in Antibody Titer From Baseline at Day 14 Postvaccination
Measured: Baseline and Day 14 postvaccination

Secondary outcomes (1)

Number of Participants With ≥2-fold Rise in Antibody Titer From Baseline at Day 7 Postvaccination
Measured: Baseline and Day 7 postvaccination

Timeline

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

Nov 2005Jul 2006

First posted15 Mar 2006 (estimated)
Study startNov 2005
Primary completionJul 2006
Study completionJul 2006

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 Staphylococcal InfectionsStudies 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: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00303069
Sponsor's protocol ID: V710-001
Other IDs: Formally IRB#0602011, 2010_523
Status last verified: Jun 2015
First submitted: 13 Mar 2006
Last updated: 22 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Harro C, Betts R, Orenstein W, Kwak EJ, Greenberg HE, Onorato MT, Hartzel J, Lipka J, DiNubile MJ, Kartsonis N. Safety and immunogenicity of a novel Staphylococcus aureus vaccine: results from the first study of the vaccine dose range in humans. Clin Vaccine Immunol. 2010 Dec;17(12):1868-74. doi: 10.1128/CVI.00356-10. Epub 2010 Oct 13.
PubMed 20943877

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 Staphylococcal Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Sequential-Panel, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine in Healthy Adults 18 to 55 Years of Age
ClinicalTrials.gov ID: NCT00303069
Acronym / sponsor ID: V710-001
Conditions: Staphylococcal Infections
Keywords: S. aureus;, Vaccine, FIM
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Nov 2005
Primary completion: Jul 2006 (actual)
Study completion: Jul 2006 (actual)
First posted: 15 Mar 2006 (estimated)
Results: Posted 20 Oct 2010

Clinical summary

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

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
V710 5 μg	Experimental	Biological: V710V710 S. aureus vaccine
V710 30 μg	Experimental	Biological: V710V710 S. aureus vaccine
V710 90 μg	Experimental	Biological: V710V710 S. aureus vaccine
Placebo	Placebo comparator	Biological: Comparator: PlaceboPlacebo

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Subject is 18 to 55 years of age
Subject is in good physical health based upon medical history, physical examination, and screening laboratory studies. NOTE: Lab studies will only be collected in Panel A, the dose-escalating portion of the study
Subject is able to understand study procedures and agrees to participate in the study by providing written informed consent
Subject is willing and able to participate in the entire study duration planned for 3 months (~84 days)
Female subjects are required to have a negative urine pregnancy test immediately prior to study vaccination. Female subjects of childbearing potential must have been using an acceptable method of birth control for 2 weeks prior to enrollment, and agree to use an acceptable method of birth control for 1 month after vaccination. (Acceptable methods of birth control include use of hormonal contraceptives, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, tubal ligation, condoms, or abstinence)

Key exclusion criteria (18 listed)

Subject suffers from a chronic skin condition that predisposes the individual to the development of chronic skin or soft-tissue infections (e.g., psoriasis, chronic granulomatous disease).
Subject developed a serious infection (e.g., bacteremia, pneumonia, mediastinitis) attributed to S. aureus in the 12 months prior to screening
Subject has a history of anaphylaxis to aluminum-containing adjuvant or other vaccine components
Subject has a temperature of ≥100.4ºF (≥38.0ºC), oral equivalent, within 48 hours prior to receipt of 0657nI S. aureus vaccine/placebo
Subject has received a live virus vaccine within 30 days prior to receipt of 0657nI S. aureus vaccine/placebo or is scheduled to receive vaccination with a live virus vaccine within 30 days following study entry

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
V710Single dose of V710 (at dosages of 5 μg, 30 μg, or 90 μg) intramuscularly	Biological	V710 30 μg, V710 5 μg, V710 90 μg
Comparator: PlaceboSingle dose of saline placebo intramuscularly	Biological	Placebo

Primary outcome

Number of Vaccine-related Serious Adverse Experiences Following Vaccination
Time frame: Through Day 84 postvaccination
Participants with a serious vaccine-related adverse experiences (AE) (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).
Number of Participants With ≥2-fold Rise in Antibody Titer From Baseline at Day 14 Postvaccination
Time frame: Baseline and Day 14 postvaccination

1 secondary outcome

Number of Participants With ≥2-fold Rise in Antibody Titer From Baseline at Day 7 Postvaccination
Time frame: Baseline and Day 7 postvaccination

Results and safety

Results posted to the registry on 20 Oct 2010, 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 5 μg	31	29
V710 30 μg	28	28
V710 90 μg	34	33
Placebo	31	29

Primary outcome: Number of Vaccine-related Serious Adverse Experiences Following Vaccination

Time frame: Through Day 84 postvaccination. Number. Unit: Participants

Measure	V710 5 μg n = 31	V710 30 μg n = 28	V710 90 μg n = 34	Placebo n = 31
Experienced a vaccine-related SAE	0	0	0	0
Did not experience a vaccine-related SAE	31	28	34	31

Population analysed: The population analyzed included all subjects who were randomized, vaccinated, and had safety follow-up.

Primary outcome: Number of Participants With ≥2-fold Rise in Antibody Titer From Baseline at Day 14 Postvaccination

Time frame: Baseline and Day 14 postvaccination. Number. Unit: Participants

Measure	V710 5 μg n = 31	V710 30 μg n = 28	V710 90 μg n = 31	Placebo n = 28
Fold-rise in antibody titer ≥2	9	24	27	1
Fold-rise in antibody titer <2	22	4	4	27

V710 90 μg vs Placebo: Risk Difference (RD): 84.5 (95% CI 65.2 to 93.6), p <0.001, Chi-squared
V710 30 μg vs Placebo: Risk Difference (RD): 81.6 (95% CI 61.6 to 92.0), p <0.01, Chi-squared
V710 5 μg vs Placebo: Risk Difference (RD): 25.0 (95% CI 6.7 to 43.8), p <0.001, Chi-squared

Population analysed: The population analyzed was the per-protocol population, excluding subjects identified as protocol violators. Subjects who were found to have deviated from the protocol procedures were evaluated to determine if they should be excluded from the per-protocol analyses. These evaluations were made prior to study unblinding on a case by case basis.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Following vaccination, all subjects in this study were followed for all clinical adverse experiences for 14 days postvaccination, and for vaccine-related serious adverse experiences and deaths for 84 days postvaccination (entire duration of the study).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
V710 5 μg	0 of 31 (0%)	18 of 31 (58.1%)	Not reported
V710 30 μg	0 of 28 (0%)	19 of 28 (67.9%)	Not reported
V710 90 μg	0 of 34 (0%)	28 of 34 (82.4%)	Not reported
Placebo	0 of 31 (0%)	17 of 31 (54.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20943877Harro C, Betts R, Orenstein W, Kwak EJ, Greenberg HE, Onorato MT, Hartzel J, Lipka J, DiNubile MJ, Kartsonis N. Safety and immunogenicity of a novel Staphylococcus aureus vaccine: results from the first study of the vaccine dose range in humans. Clin Vaccine Immunol. 2010 Dec;17(12):1868-74. doi: 10.1128/CVI.00356-10. Epub 2010 Oct 13.

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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 V710 in people with Staphylococcal Infections, 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 5 inclusion and 18 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 22 Jul 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 20 Oct 2010). 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 Vaccine-related Serious Adverse Experiences Following Vaccination (time frame: Through Day 84 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 NCT00303069, 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 22 Jul 2015.