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

NCT00303069 | Completed Phase 1 Results DMC

• 3 other identifiers: V710-001Formally IRB#06020112010_523
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Staphylococcal Infections

Keywords

S. aureus;; Vaccine; FIM

Outcome Measures

Primary Outcomes (2)

• 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).

  Through Day 84 postvaccination

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

  Baseline and Day 14 postvaccination

Secondary Outcomes (1)

• Number of Participants With ≥2-fold Rise in Antibody Titer From Baseline at Day 7 Postvaccination

  Baseline and Day 7 postvaccination

Study Arms (4)

V710 5 μg

EXPERIMENTAL

V710 S. aureus vaccine

Biological: V710

V710 30 μg

EXPERIMENTAL

V710 S. aureus vaccine

Biological: V710

V710 90 μg

EXPERIMENTAL

V710 S. aureus vaccine

Biological: V710

Placebo

PLACEBO COMPARATOR

Placebo

Biological: Comparator: Placebo

Interventions

V710 BIOLOGICAL

Single dose of V710 (at dosages of 5 μg, 30 μg, or 90 μg) intramuscularly

V710 30 μg; V710 5 μg; V710 90 μg

Comparator: Placebo BIOLOGICAL

Single dose of saline placebo intramuscularly

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 20943877 RESULT

MeSH Terms

Conditions

Staphylococcal Infections

Interventions

V710 vaccine

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@spcorp.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2006
• First Posted: March 15, 2006
• Study Start: November 1, 2005
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: July 22, 2015
• Results First Posted: October 20, 2010

Record last verified: 2015-06