Staphylococcal InfectionsPhase 1NCT01324440
Safety, Tolerability, and Immunogenicity of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine With or Without Merck Aluminum Adjuvant (V710-002)
A Phase 1 study testing V710 (30 µg) with MAA and V710 (30 µg) without MAA in people with Staphylococcal Infections, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study was to evaluate the safety, tolerability, and immunogenicity of the Merck 0657nI S. aureus vaccine (V710) either with or without Merck Aluminum Adjuvant (MAA). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Staphylococcal Infections
- What is being tested?
- V710 (30 µg) with MAA and V710 (30 µg) without MAA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Oct 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant was in good physical health
- Participant was able to understand study procedures and agreed to participate in the study by providing written informed consent.
- Participant was willing and able to participate in the entire study duration planned for up to 12 months (~360 days).
- Female participants of reproductive potential were required to have a negative urine pregnancy test immediately prior to study vaccination. Female participants of reproductive potential must have used an acceptable method of birth control for 2 weeks prior to enrollment, and agreed to use an acceptable method of birth control for 1 month after vaccination.
Who cannot join
- Participant suffered from a chronic skin condition that predisposed the individual to the development of chronic skin or soft-tissue infections (e.g., psoriasis, chronic granulomatous disease, atopic dermatitis).
- Participant developed a serious infection (e.g., bacteremia, pneumonia, mediastinitis) attributed to S. aureus in the 12 months prior to screening.
- Participant had a history of anaphylaxis to aluminum-containing adjuvant or other vaccine components.
- Participant had a temperature of ≥100.4ºF (≥38.0ºC), oral equivalent, within 48 hours prior to receipt of V710.
- Participant had received a live virus vaccine within 30 days prior to receipt of V710 or was scheduled to receive vaccination with a live virus vaccine within 30 days following study entry.
- Participant had received any other licensed vaccine (including non-live virus vaccines) within 14 days prior to receipt of V710 or was scheduled to receive any other licensed vaccine (including non-live virus vaccines) within 30 days following study entry.
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- Participant had received V710 in a prior clinical study (Merck V710 Protocol 001).
- Participant was administered immunoglobulin or blood product within 90 days prior to receipt of V710 or was scheduled to receive such products within 30 days following study entry.
- Participant had received treatment with systemic (intramuscular, oral, or intravenous) corticosteroids or another immunosuppressive medication (e.g., calcineurin inhibitors, mycophenolate, azathioprine) or biological agents (e.g., rituximab) in the 14 days prior to receipt of V710 or was anticipated to receive such medications for a chronic medical condition during the course of the study.
- Participant had a condition that required active medical intervention or monitoring to avert serious danger to the participant's health or well-being, such as diabetes mellitus, autoimmune disease, or clinically significant chronic medical conditions that were 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.
- Participant had known or suspected impairment of immunologic function including, but not limited to, the following conditions: autoimmune disease, diabetes mellitus, endstage renal disease, hepatic insufficiency/cirrhosis, splenectomy, or human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS).
- Participant had a condition in which repeated venipuncture or injections posed more than minimal risk for the subject, such as hemophilia, other severe coagulation disorders, or significantly impaired venous access.
- Participant was pregnant or breastfeeding, or planning to conceive within the 12-month study duration period.
- Participant had clinically significant abnormalities based on the participant or physical examination.
- Participant had recent history (within the past 5 years) or current evidence of drug or alcohol abuse.
- Participant had 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.
- Participant was legally or mentally incapacitated.
- Participant had participated in another clinical study in the past 4 weeks, or participant planned to participate in a treatment-based study or study in which an invasive procedure was to be performed during the first 3 months of this study (through Day 84).
- Participant had a history of any condition which, in the opinion of the investigator, posed an additional risk for the subject or confounded the results of the study.
About this study
Official title: A Randomized, Multicenter, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine With Merck Aluminum Adjuvant or Without Merck Aluminum Adjuvant in Healthy Adults 18 to 70 Years of Age
The purpose of this study was to evaluate the safety, tolerability, and immunogenicity of the Merck 0657nI S. aureus vaccine (V710) either with or without Merck Aluminum Adjuvant (MAA).
- Conditions
- Staphylococcal Infections
- Being tested
- V710 (30 µg) with MAA, V710 (30 µg) without MAA
- Keywords
- Bacterial Vaccines, Staphylococcus Aureus, Adjuvanted Vaccine
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V710 (30 µg) with MAABiological
Single 0.5-mL injection (30-µg) of V710 with MAA, intramuscularly
V710 (30 µg) without MAABiological
Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| V710 without MAA | Experimental | Not described Receives: Biological: V710 (30 µg) without MAA |
| V710 with MAA | Active comparator | Not described Receives: Biological: V710 (30 µg) with MAA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Positive Immune Response, Defined as a Change in Antibody Level Greater Than or Equal to a 2-fold-rise at Day 14 Compared to Baseline
Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.
Measured: Baseline and Day 14 postvaccination
Geometric Mean Antibody Concentrations (GMC)
Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.
Measured: Day 14 postvaccination
Change in Antibody Concentration (Titer) at Day 14 Compared to Baseline, Expressed as the Geometric Mean Fold-rise (GMFR)
Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.
The GMFR is the ratio of the antibody concentration at Day 14 to the antibody concentration at baseline.
Measured: Baseline and Day 14 postvaccination
Number of Vaccine-related Serious Adverse Experiences
Investigators were instructed to determine the seriousness and causality (relatedness to test vaccine) of each AE based on criteria defined in the protocol:
A serious adverse event (SAE) is any AE that:
- results in death,
- is life threatening,
- results in a persistent or significant disability/incapacity,
- results in or prolongs an existing inpatient hospitalization,
- is a congenital anomaly/birth defect,
- is a cancer,
- is an overdose,
- or is another important medical event that may require medical or surgical intervention to prevent one of the outcomes listed above.
Measured: Up to Day 360 postvaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startSep 2006
- Primary completionOct 2007
- Study completionOct 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 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
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324440
- Sponsor's protocol ID
- V710-002
- Status last verified
- Mar 2015
- First submitted
- 24 Feb 2011
- Last updated
- 10 Apr 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine With Merck Aluminum Adjuvant or Without Merck Aluminum Adjuvant in Healthy Adults 18 to 70 Years of Age
- ClinicalTrials.gov ID
- NCT01324440
- Acronym / sponsor ID
- V710-002
- Conditions
- Staphylococcal Infections
- Keywords
- Bacterial Vaccines, Staphylococcus Aureus, Adjuvanted Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Posted 17 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the safety, tolerability, and immunogenicity of the Merck 0657nI S. aureus vaccine (V710) either with or without Merck Aluminum Adjuvant (MAA).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V710 without MAA | Experimental | Biological: V710 (30 µg) without MAA |
| V710 with MAA | Active comparator | Biological: V710 (30 µg) with MAA |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant was in good physical health
- Participant was able to understand study procedures and agreed to participate in the study by providing written informed consent.
- Participant was willing and able to participate in the entire study duration planned for up to 12 months (~360 days).
- Female participants of reproductive potential were required to have a negative urine pregnancy test immediately prior to study vaccination. Female participants of reproductive potential must have used an acceptable method of birth control for 2 weeks prior to enrollment, and agreed to use an acceptable method of birth control for 1 month after vaccination.
Key exclusion criteria (19 listed)
- Participant suffered from a chronic skin condition that predisposed the individual to the development of chronic skin or soft-tissue infections (e.g., psoriasis, chronic granulomatous disease, atopic dermatitis).
- Participant developed a serious infection (e.g., bacteremia, pneumonia, mediastinitis) attributed to S. aureus in the 12 months prior to screening.
- Participant had a history of anaphylaxis to aluminum-containing adjuvant or other vaccine components.
- Participant had a temperature of ≥100.4ºF (≥38.0ºC), oral equivalent, within 48 hours prior to receipt of V710.
- Participant had received a live virus vaccine within 30 days prior to receipt of V710 or was 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 |
|---|---|---|
| V710 (30 µg) with MAASingle 0.5-mL injection (30-µg) of V710 with MAA, intramuscularly | Biological | V710 with MAA |
| V710 (30 µg) without MAASingle 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly | Biological | V710 without MAA |
Primary outcome
Number of Participants With a Positive Immune Response, Defined as a Change in Antibody Level Greater Than or Equal to a 2-fold-rise at Day 14 Compared to Baseline
Time frame: Baseline and Day 14 postvaccination
Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.
Geometric Mean Antibody Concentrations (GMC)
Time frame: Day 14 postvaccination
Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.
Change in Antibody Concentration (Titer) at Day 14 Compared to Baseline, Expressed as the Geometric Mean Fold-rise (GMFR)
Time frame: Baseline and Day 14 postvaccination
Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay. The GMFR is the ratio of the antibody concentration at Day 14 to the antibody concentration at baseline.
Number of Vaccine-related Serious Adverse Experiences
Time frame: Up to Day 360 postvaccination
Investigators were instructed to determine the seriousness and causality (relatedness to test vaccine) of each AE based on criteria defined in the protocol: A serious adverse event (SAE) is any AE that: * results in death, * is life threatening, * results in a persistent or significant disability/incapacity, * results in or prolongs an existing inpatient hospitalization, * is a congenital anomaly/birth defect, * is a cancer, * is an overdose, * or is another important medical event that may require medical or surgical intervention to prevent one of the outcomes listed above.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 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.
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 1 study testing V710 (30 µg) with MAA and V710 (30 µg) without MAA 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 4 inclusion and 19 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 10 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. 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 17 Oct 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?
Number of Participants With a Positive Immune Response, Defined as a Change in Antibody Level Greater Than or Equal to a 2-fold-rise at Day 14 Compared to Baseline (time frame: Baseline and Day 14 postvaccination). 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 NCT01324440, 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 10 Apr 2015.