A Study to Evaluate the Safety of the Respiratory Syncytial Virus Vaccine MEDI7510 in Older Adults
A Phase 1a Study to Evaluate the Safety of the Respiratory Syncytial Virus Vaccine MEDI7510 in Older Adults
2 other identifiers
interventional
246
1 country
3
Brief Summary
The purpose of this study is to determine if the administration of single ascending intramuscular doses of the RSV sF antigen or MEDI7510 will be safe and well tolerated in adults 60 years or older who are healthy or who have stable, chronic underlying medical conditions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2014
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 3, 2014
CompletedFirst Posted
Study publicly available on registry
April 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
October 21, 2016
CompletedOctober 21, 2016
August 1, 2016
1.2 years
April 3, 2014
July 15, 2016
August 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Participants With Solicited Symptoms
Solicited symptoms: tenderness or soreness at site of injection, pain at site of injection, fatigue or tiredness, headache, generalized muscle aches, swelling at the site of injection, redness at the site of injection, fever greater than or equal to (\>=) 100.4 degrees F by any route from Day 1 to Day 7.
Day 1 to Day 7
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study product and Day 361 that were absent before treatment or that worsened relative to pretreatment state.
From Day 1 to Day 28
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent New Onset Chronic Disease (NOCDs)
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study product and Day 361 that were absent before treatment or that worsened relative to pretreatment state. An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. A NOCD was a newly diagnosed medical condition that is of a chronic, ongoing nature. It was observed after receiving investigational product and was assessed by investigator as medically significant.
From Day 1 to Day 361
Secondary Outcomes (9)
Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
Baseline (Day 1), Day 29, 61, 91, 181, 271 and 361
Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
Day 29, 61, 91, 181, 271 and 361
Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
Day 29
Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay
Baseline (Day 1), Day 29, 61, 91, 181, 271 and 361
Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay
Day 29, 61, 91, 181, 271 and 361
- +4 more secondary outcomes
Study Arms (7)
Placebo
PLACEBO COMPARATORSterile saline for human use from commercial source, liquid
RSV sF 20 mcg
EXPERIMENTALParticipants will receive single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
MEDI7510 (20 mcg RSV sF)
EXPERIMENTALParticipants 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.
RSV sF 50 mcg
EXPERIMENTALParticipants will receive single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
MEDI7510 (50 mcg RSV sF)
EXPERIMENTALParticipants 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.
RSV sF 80 mcg
EXPERIMENTALParticipants will receive single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
MEDI7510 (80 mcg RSV sF)
EXPERIMENTALParticipants 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.
Interventions
Participants will receive placebo (sterile saline for human use from commercial source liquid) on Day 1.
Participants will receive single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
Participants will receive single dose of MEDI7510 containing 20 mcg RSV sF by intramuscular injection on Day 1.
Participants will receive single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
Participants will receive single dose of MEDI7510 containing 50 mcg RSV sF by intramuscular injection on Day 1.
Participants will receive single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
Participants will receive single dose of MEDI7510 containing 80 mcg RSV sF by intramuscular injection on Day 1.
Eligibility Criteria
You may qualify if:
- Age greater than or equal to 60 years
- 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
You may not qualify if:
- History of allergy to any component of the vaccine
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (3)
Miami Research Associates
Miami, Florida, 33143, United States
Compass Research
Orlando, Florida, 32806, United States
Accelovance, Inc
Rockville, Maryland, 20850, United States
Related Publications (1)
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.
PMID: 27102821RESULT
Related Links
Results Point of Contact
- Title
- Judith Falloon, MD
- Organization
- MedImmune, LLC
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Sheldon, MD
Miami Research Associates
- PRINCIPAL INVESTIGATOR
Craig Curtis, MD
Compass Research
- PRINCIPAL INVESTIGATOR
Steven Bart, MD
Accelovance
- STUDY DIRECTOR
Judith Falloon, MD
MedImmune LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2014
First Posted
April 16, 2014
Study Start
April 1, 2014
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
October 21, 2016
Results First Posted
October 21, 2016
Record last verified: 2016-08