A Study to Evaluate the Safety of the Respiratory Syncytial Virus Vaccine MEDI7510 in Older Adults
NCT ID: NCT02115815
Last Updated: 2016-10-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
246 participants
INTERVENTIONAL
2014-04-30
2015-06-30
Brief Summary
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Detailed Description
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Approximately 146 participants will be enrolled at 3 US study centers and randomized in a 5:1 ratio by cohort as described below:
Cohort 1: RSV sF 20 microgram (mcg) (n=20) or placebo (n=4) Cohort 1a: MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A (GLA) + 2% weight per volume stable emulsion (n=20) or placebo (n=4) Cohort 2: RSV sF 50 mcg (n=20) or placebo (n=4) Cohort 2a: MEDI7510 (50 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A (GLA) + 2% weight per volume stable emulsion (n=20) or placebo (n=4) Cohort 3: 80 mcg RSV sF (n=20) or placebo (n=4) Cohort 3a: MEDI7510 (80 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A (GLA) + 2% weight per volume stable emulsion (n=20) or placebo (n=4)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Placebo
Sterile saline for human use from commercial source, liquid
Placebo
Participants will receive placebo (sterile saline for human use from commercial source liquid) on Day 1.
RSV sF 20 mcg
Participants will receive single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
RSV sF 20 mcg
Participants will receive single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
MEDI7510 (20 mcg RSV sF)
Participants will receive single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A \[GLA\] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
MEDI7510 (20 mcg RSV sF)
Participants will receive single dose of MEDI7510 containing 20 mcg RSV sF by intramuscular injection on Day 1.
RSV sF 50 mcg
Participants will receive single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
RSV sF 50 mcg
Participants will receive single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
MEDI7510 (50 mcg RSV sF)
Participants will receive single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
MEDI7510 (50 mcg RSV sF)
Participants will receive single dose of MEDI7510 containing 50 mcg RSV sF by intramuscular injection on Day 1.
RSV sF 80 mcg
Participants will receive single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
RSV sF 80 mcg
Participants will receive single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
MEDI7510 (80 mcg RSV sF)
Participants will receive a single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
MEDI7510 (80 mcg RSV sF)
Participants will receive single dose of MEDI7510 containing 80 mcg RSV sF by intramuscular injection on Day 1.
Interventions
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Placebo
Participants will receive placebo (sterile saline for human use from commercial source liquid) on Day 1.
RSV sF 20 mcg
Participants will receive single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
MEDI7510 (20 mcg RSV sF)
Participants will receive single dose of MEDI7510 containing 20 mcg RSV sF by intramuscular injection on Day 1.
RSV sF 50 mcg
Participants will receive single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
MEDI7510 (50 mcg RSV sF)
Participants will receive single dose of MEDI7510 containing 50 mcg RSV sF by intramuscular injection on Day 1.
RSV sF 80 mcg
Participants will receive single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
MEDI7510 (80 mcg RSV sF)
Participants will receive single dose of MEDI7510 containing 80 mcg RSV sF by intramuscular injection on Day 1.
Eligibility Criteria
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Inclusion Criteria
* Written informed consent and any locally required authorization obtained prior to any protocol related procedures
* Ambulatory or ambulatory with assistance (not institutionalized, bedridden, or homebound
* Weight at or above 110 Pounds (lbs)
* Hemoglobin within normal range for age and gender
Exclusion Criteria
* Pregnancy or potential to become pregnant during the study. Females who have had a menstrual period within the 12 months prior to study enrollment or are undergoing any fertility treatment or who plan to undergo fertility treatments during the study period are excluded
* Any unstable chronic medical condition, including one that has resulted in change in therapy (medication or other) in the 30 days prior to randomization or hospitalization in the previous year or might be predicted to result in hospitalization in the year after enrollment. Participant with severe, untreated or uncontrolled underlying medical disease that might either compromise participant safety or affect the ability to assess safety of the investigational product are excluded
* Clinically significant abnormalities in Screening laboratory assessments or Screening electrocardiogram (ECG)
* History of hepatitis B or hepatitis C infection
* Cognitive disorder such that informed consent cannot be obtained directly from the participant
* Previous vaccination against respiratory syncytial virus (RSV)
* History of allergy to eggs in adulthood
* History of or current autoimmune disorder
* Immunosuppression caused by disease, including human immunodeficiency virus (HIV), or medications. Any oral prednisone dosing within 30 days of enrollment or planned dosing within the 360-day follow-up period would disqualify.
* History of splenectomy or of condition affecting splenic function
* History of cancer within preceding 5 years other than treated non-melanoma skin cancer
* Body Mass Index 40 or higher
* Significant infection or other acute illness, including fever over 100 fahrenheit (F) on the day prior to or day of randomization
* Receipt of any nonstudy vaccine within 30 days prior to study dosing or expected receipt of nonstudy vaccine within 30 days after study dosing
* Receipt of any investigational product in the 90 days prior to randomization or expected receipt of investigational product during the period of study follow-up
* Receipt of immunoglobulins or blood products within 4 months of study dosing (120 days) or expected receipt of investigational product during the period of study follow-up
* History of thrombocytopenia or bleeding disorder or use of anticoagulants. Participants receiving drugs with anti-platelet activity such as nonsteroidal antiinflammatory drugs, clopidogrel or aspirin are not excluded
* Expected receipt of antipyretic or analgesic medication on a daily or every other day basis from randomization through 72 hours after receipt of investigational product (IP) \[a daily dose of 163 milligram (mg) or higher is not considered a contraindication to enrollment\]
* Participants who have significant scarring, tattoos, abrasions, cuts, or infections over the deltoid region of both arms that, in the principle investigator's (PI) opinion, could interfere with evaluation of injection site local reactions
* Concurrent enrollment in another clinical study that involves any invasive clinical procedure, including phlebotomy
* History of alcohol or drug abuse or psychiatric disorder that in the PI's opinion would affect the participants safety or compliance with study
* Employees of individuals directly involved with the conduct of the study, individuals who themselves are involved with the conduct of the study, or immediate family members of such individuals.
60 Years
99 Years
ALL
Yes
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Eric Sheldon, MD
Role: PRINCIPAL_INVESTIGATOR
Miami Research Associates
Craig Curtis, MD
Role: PRINCIPAL_INVESTIGATOR
Compass Research
Steven Bart, MD
Role: PRINCIPAL_INVESTIGATOR
Accelovance
Judith Falloon, MD
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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Miami Research Associates
Miami, Florida, United States
Compass Research
Orlando, Florida, United States
Accelovance, Inc
Rockville, Maryland, United States
Countries
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References
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Falloon J, Ji F, Curtis C, Bart S, Sheldon E, Krieger D, Dubovsky F, Lambert S, Takas T, Villafana T, Esser MT. A phase 1a, first-in-human, randomized study of a respiratory syncytial virus F protein vaccine with and without a toll-like receptor-4 agonist and stable emulsion adjuvant. Vaccine. 2016 May 27;34(25):2847-54. doi: 10.1016/j.vaccine.2016.04.002. Epub 2016 Apr 19.
Related Links
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CD-VA-MEDI7510-1134 Redacted Protocol
Other Identifiers
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BB-IND 15947
Identifier Type: OTHER
Identifier Source: secondary_id
CD-VA-MEDI7510-1134
Identifier Type: -
Identifier Source: org_study_id
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