Safety, Tolerability, and Immunogenicity of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine With or Without Merck Aluminum Adjuvant (V710-002)

Staphylococcal Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01324440
• Other study ID #: V710-002
• Status: Completed
• Phase: Phase 1
• First received: February 24, 2011
• Last updated: March 23, 2015
• Start date: September 2006
• Est. completion date: October 2007

Study information

• Verified date: March 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria:

• 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.

Exclusion criteria:

• 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.

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Staphylococcal Infections

Intervention

Biological:
• V710 (30 µg) with MAA
Single 0.5-mL injection (30-µg) of V710 with MAA, intramuscularly
• V710 (30 µg) without MAA
Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and Day 14 postvaccination	No
Primary	Geometric Mean Antibody Concentrations (GMC)	Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.	Day 14 postvaccination	No
Primary	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.	Baseline and Day 14 postvaccination	No
Primary	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.	Up to Day 360 postvaccination	Yes