- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00303069
V710 First-In-Man (FIM) Study (V710-001)
June 29, 2015 updated by: Merck Sharp & Dohme LLC
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
124
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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)
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Single dose of saline placebo intramuscularly
|
Experimental: V710 5 μg
V710 S. aureus vaccine
|
Single dose of V710 (at dosages of 5 μg, 30 μg, or 90 μg) intramuscularly
|
Experimental: V710 30 μg
V710 S. aureus vaccine
|
Single dose of V710 (at dosages of 5 μg, 30 μg, or 90 μg) intramuscularly
|
Experimental: V710 90 μg
V710 S. aureus vaccine
|
Single dose of V710 (at dosages of 5 μg, 30 μg, or 90 μg) intramuscularly
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Through Day 84 postvaccination
|
Number of Participants With ≥2-fold Rise in Antibody Titer From Baseline at Day 14 Postvaccination
Time Frame: Baseline and Day 14 postvaccination
|
Baseline and Day 14 postvaccination
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants With ≥2-fold Rise in Antibody Titer From Baseline at Day 7 Postvaccination
Time Frame: Baseline and Day 7 postvaccination
|
Baseline and Day 7 postvaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (Actual)
July 1, 2006
Study Completion (Actual)
July 1, 2006
Study Registration Dates
First Submitted
March 13, 2006
First Submitted That Met QC Criteria
March 13, 2006
First Posted (Estimate)
March 15, 2006
Study Record Updates
Last Update Posted (Estimate)
July 22, 2015
Last Update Submitted That Met QC Criteria
June 29, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- V710-001
- Formally IRB#0602011
- 2010_523
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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