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A Study to Evaluate the Efficacy of MEDI7510 in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02508194
Recruitment Status : Terminated (Year 1 of study completed. No enrollment planned for Year 2 of study.)
First Posted : July 24, 2015
Results First Posted : December 20, 2017
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Tracking Information
First Submitted Date  ICMJE July 22, 2015
First Posted Date  ICMJE July 24, 2015
Results First Submitted Date  ICMJE August 7, 2017
Results First Posted Date  ICMJE December 20, 2017
Last Update Posted Date December 26, 2017
Actual Study Start Date  ICMJE September 29, 2015
Actual Primary Completion Date September 9, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2017)
Percentage of Participants Who Had a First Episode of Acute Respiratory Syncytial Virus-Associated Respiratory Illness (ARA-RI) During Respiratory Syncytial Virus (RSV) Surveillance Period in Season 1 [ Time Frame: Day 14 after dosing through end of surveillance period (approximately 7 months) ]
ARA-RI was defined as an event in which a participant met specified clinical criteria and the event was laboratory-confirmed to be RSV-related. The specified clinical criteria included a minimum of 1 symptom from any 2 of the 3 symptom columns: one symptom from upper respiratory symptom column and one symptom from lower respiratory symptom column; one symptom from upper respiratory symptom column and one symptom from systemic symptom column; or one symptom from lower respiratory column and one from systemic symptom column and laboratory confirmation of RSV on at least 1 sample obtained between Day 1 to Day 8 of illness. The surveillance period was approximately 7 months and Season 1 was approximately 1 year.
Original Primary Outcome Measures  ICMJE
 (submitted: July 22, 2015)
The incidence of the first episode of acute RSV associated respiratory illness (ARA-RI) observed during the surveillance period in Season 1. [ Time Frame: Day 14 after dosing through End of RSV Season 1 visit ]
To assess the efficacy of a single IM dose of MEDI7510 for prevention of ARA-RI in adults at least 60 years of age in Season 1.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2017)
  • Percentage of Participants Who Had a RSV Polymerase Chain Reaction (PCR)-Positive Respiratory Illness During the RSV Surveillance Period in Season 1 [ Time Frame: Day 14 after dosing through end of surveillance period (approximately 7 months) ]
    Detection of RSV was done by PCR method by using any respiratory sample. The incidence of RSV PCR-positive respiratory illness during the RSV surveillance period was evaluated. The surveillance period was approximately 7 months and Season 1 was approximately 1 year.
  • Geometric Mean Responses (GMRs) of Serum Antibodies Concentration Against RSV by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay [ Time Frame: Day 1, Day 29, and End of Season 1 (approximately 1 year) ]
    Anti-F IgG antibodies concentration were determined by a multiplex IgG assay developed on the Meso Scale discovery platform. It was calculated as: anti-log2 [mean (log2 xi)], where "xi" is an antibodies concentration of participants. The Season 1 was approximately 1 year.
  • Geometric Mean Fold Change of Serum Antibodies Concentration Against RSV by Anti-F IgG Assay [ Time Frame: Day 29 and End of Season 1 (approximately 1 year) ]
    Anti-F IgG antibodies concentration was determined by a multiplex IgG assay developed on the Meso Scale discovery platform. It was calculated as: anti-log2 [mean (log2 yi)], where "yi" is the post dose antibody concentration or T-cell count fold change from baseline for each participant. The Season 1 was approximately 1 year.
  • Percentage of Participants Who Had a Post-dose Seroresponse to RSV as Measured by Anti-F IgG Assay [ Time Frame: Day 29 and End of Season 1 (approximately 1 year) ]
    Anti-F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform. Seroresponse was defined as a greater than or equal to (>=) 3-fold rise of serum antibodies against RSV from baseline. The Season 1 was approximately 1 year.
  • Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine [ Time Frame: Day 1 (post-dose) and Day 29 of Season 1 ]
    GMT was calculated as: anti-log2 [mean (log2 xi)], where "xi" is an antibodies concentration of participants. GMTs of strain-Specific HAI antibodies (H1N1, H3N2, B Brisbane, and B Phuket) were reported. The Season 1 was approximately 1 year.
  • Post-dose Geometric Mean Fold Change of Strain-Specific HAI Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine [ Time Frame: Day 29 of Season 1 ]
    Geometric mean fold change was calculated as: anti-log2 [mean (log2 yi)], where "yi" is the post dose antibody concentration or T-cell count fold change from baseline for each participant. Geometric mean fold change of strain-specific HAI antibodies (H1N1, H3N2, B BRISBANE, and B PHUKET) were reported. The Season 1 was approximately 1 year.
  • Percentage of Participants Who Had a Strain-specific Post-dose Seroresponse to HAI Antibody [ Time Frame: Day 29 of Season 1 ]
    Seroresponse was defined as a >= 4-fold rise of strain-specific HAI antibodies (H1N1, H3N2, B BRISBANE, and B PHUKET) from baseline. The Season 1 was approximately 1 year.
  • Post-dose GMTs of Serum Antibodies Against RSV by Microneutralization Assay [ Time Frame: Day 29 and End of Season 1 (approximately 1 year) ]
    Microneutralization assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. GMT was to be calculated as: anti-log2 [mean (log2 xi)], where "xi" is an antibodies concentration of participants. The Season 1 was approximately 1 year.
  • Post-dose Geometric Mean Fold Change of Serum Antibodies Against RSV by Microneutralization Assay [ Time Frame: Day 29 and End of Season 1 (approximately 1 year) ]
    Microneutralization assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Geometric mean fold change was to be calculated as: anti-log2 [mean (log2 yi)], where "yi" is the post dose antibody concentration or T-cell count fold rise from baseline for each participant. The Season 1 was approximately 1 year.
  • Percentage of Participants Who Had a Post-dose Seroresponse to RSV by Microneutralization Assay [ Time Frame: Day 29 and End of Season 1 (approximately 1 year) ]
    Microneutralization assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Seroresponse was defined as a >= 3-fold rise of Serum Antibodies against RSV from baseline. The Season 1 was approximately 1 year.
  • Post-dose Geometric Mean Concentration (GMC) of Palivizumab Competitive Antibodies as Measured by a Palivizumab Competitive Enzyme Linked Immunosorbent Assay (cELISA) [ Time Frame: Day 29 and End of Season 1 (approximately 1 year) ]
    Palivizumab cELISA assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. GMC was to be calculated as: anti-log2 [mean (log2 xi)], where "xi" is an antibodies concentration of participants. The Season 1 was approximately 1 year.
  • Post-dose Geometric Mean Fold Change of Palivizumab Competitive Antibodies as Measured by a Palivizumab cELISA [ Time Frame: Day 29 and End of Season 1 (approximately 1 year) ]
    Palivizumab cELISA assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Geometric mean fold change was to be calculated as: anti-log2 [mean (log2 yi)], where "yi" is the post dose antibody concentration or T-cell count fold rise from baseline for each participant. The Season 1 was approximately 1 year.
  • Percentage of Participants Who Had a Post-dose Seroresponse to RSV as Measured by a Palivizumab cELISA [ Time Frame: Day 29 and End of Season 1 (approximately 1 year) ]
    Palivizumab cELISA assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Seroresponse was defined as a >= 3-fold rise of Serum Antibodies against RSV from baseline. The Season 1 was approximately 1 year.
  • Number of Participants With Any Solicited Symptoms [ Time Frame: Day 1 (post-dose) through Day 7 ]
    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 >= 100.4 degrees Fahrenheit by any route from Day 1 to Day 7.
  • Number of Participants With Treatment-Emergent Adverse Events [ Time Frame: Day 1 (post-dose) through Day 29 ]
    An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent events were between administration of study drug and Day 29 that were absent before treatment or that worsened relative to pre-treatment state.
  • 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) [ Time Frame: Day 1 (post-dose) through end of Season 1 (approximately 1 year) ]
    An 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 drug and approximately 1 year follow up that were absent before treatment or that worsened relative to pretreatment state. An adverse event of special interest was one of scientific and medical interest specific to understanding of study drug 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 study drug and was assessed by investigator as medically significant. The Season 1 was approximately 1 year.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2015)
  • The occurrence of all solicited symptoms [ Time Frame: Day 1 (dosing) through Day 7 ]
    The following solicited symptoms will be recorded: Pain at the injection site; tenderness or soreness at the injection site; redness at the injection site; swelling at the injection site; fever greater than/equal to 100.4 degrees F; headache, generalized muscle aches, fatigue or tiredness.
  • The incidence of RSV PCR-positive respiratory illness during the RSV surveillance period in Season 1. [ Time Frame: Day 14 after dosing through Final RSV Season 1 visit ]
    Assessment of the incidence of RSV polymerase chain reaction (PCR)-positive respiratory illness in Season 1
  • The post-dose geometric mean titers (GMTs) and geometric mean fold rises (GMFRs) from baseline of strain-specific hemagglutination inhibition (HAI) antibodies to influenza antigens contained in the seasonal influenza vaccine. [ Time Frame: Day 1 (dosing) through Day 29 ]
    Immunogenicity of inactivated influenza vaccine (IIV) alone compared to administered with MEDI7510 for subjects in the IIV immunogenicity subset
  • Measuring the immune response to MEDI7510 in Seasons 1 and 2 in the RSV immunogenicity subset. [ Time Frame: Day 1 (dosing) through last contact Season 2 ]
    To assess the immune response of MEDI7510 in Season 1 and Season 2.
  • The occurrence of treatment-emergent adverse events [ Time Frame: Day 1 dosing through Day 29 visit ]
    The proportion of subjects experiencing treatment emergent adverse events from the time of IP administration through the Day 29 visit.
  • The occurrence of treatment-emergent serious adverse events, new onset chronic disease and adverse events of special interest [ Time Frame: Day 1 (dosing) through Final Contact. ]
    The proportion of subjects experiencing TESAEs, NOCDs and TEAESIs from the time of IP administration through final contact.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy of MEDI7510 in Older Adults
Official Title  ICMJE A Phase 2b Randomized, Double-blind Study to Evaluate the Efficacy of MEDI7510 for the Prevention of Acute Respiratory Syncytial Virus-associated Respiratory Illness in Older Adults
Brief Summary This study will be the first assessment of the efficacy of MEDI7510 for the prevention of respiratory syncytial virus (RSV) disease. It will also provide estimates of vaccine efficacy and of endpoint incidence in the placebo arm. It will also assess the safety and immunogenicity of concurrent dosing of MEDI7510 and IIV to expand on the observations made in the Phase 1b study of MEDI7510. It will also expand the safety database of participants dosed with MEDI7510. The study will also assess the immune response to MEDI7510 in Season 1 and Season 2.
Detailed Description

A Phase 2b, double-blind, randomized, and controlled study to evaluate the efficacy of MEDI7510 in approximately 1,900 adult participants, globally, 60 years or older. Participants will be randomized in a 1:1 ratio to receive a single intramuscular dose of each of 2 study vaccines in contralateral arms: MEDI7510 + IIV or placebo + IIV in Season 1.

Participants who receive MEDI7510 in the Northern Hemisphere will be re-randomized and blinded in Season 2 to receive either MEDI7510 + IIV or placebo + IIV in a 1:1 ratio. Clinical efficacy will not be assessed in Season 2; however the safety of revaccination will be assessed in Season 2.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Respiratory Syncytial Virus
Intervention  ICMJE
  • Biological: MEDI7510
    RSV soluble fusion protein (sF) antigen plus glucopyranosyl lipid A in stable emulsion (GLA-SE) adjuvant
  • Biological: IIV
    Marketed Inactivated Influenza Vaccine
  • Other: Placebo
    Sterile Saline
Study Arms  ICMJE
  • Active Comparator: Placebo + Inactivated Influenza Vaccine (IIV)
    Participants received a single intramuscular (IM) injection of placebo (matched with MEDI7510) in one arm and single IM injection of (IIV) in the contralateral arm.
    Interventions:
    • Biological: IIV
    • Other: Placebo
  • Experimental: MEDI7510 + IIV
    Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.
    Interventions:
    • Biological: MEDI7510
    • Biological: IIV
Publications * Falloon J, Yu J, Esser MT, Villafana T, Yu L, Dubovsky F, Takas T, Levin MJ, Falsey AR. An Adjuvanted, Postfusion F Protein-Based Vaccine Did Not Prevent Respiratory Syncytial Virus Illness in Older Adults. J Infect Dis. 2017 Dec 12;216(11):1362-1370. doi: 10.1093/infdis/jix503.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 22, 2015)
1900
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 7, 2016
Actual Primary Completion Date September 9, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 60 years at the time of screening.
  • Medically stable such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the subject appears likely to be able to remain in follow-up through the end of protocol-specified follow-up.
  • (Season 2): Subject received MEDI7510 and IIV in the Northern Hemisphere in Season 1.

Exclusion Criteria:

  • History of allergy to any component of the vaccine.
  • Receipt of seasonal influenza vaccine within 6 months prior to Season 1 dosing.
  • History of allergy to or intolerance of IIV.
  • Pregnancy or potential to become pregnant during the study. Females who (1) have had a menstrual period within the 12 months prior to study enrollment or (2) are undergoing any fertility treatment or who plan to undergo fertility treatments during the study period are excluded.
  • History of Guillain-Barré syndrome.
  • Previous vaccination against RSV.
  • History of allergy to eggs in adulthood.
  • History of or current autoimmune disorder, with the exception of stable, treated hypothyroidism caused by autoimmune thyroiditis, which is acceptable.
  • Immunosuppression caused by disease, including human immunodeficiency virus infection (assessed by history), or medications. Any receipt of oral or intravenous glucocorticoid therapy within 30 days prior to enrollment or planned dosing within the follow-up period would disqualify. Topical, intranasal, inhaled, or intra-articular corticosteroids do not disqualify. Expected need for immunosuppressive medications during the follow-up period would disqualify.
  • History of cancer within preceding 5 years other than treated non-melanoma skin cancer, locally-treated cervical cancer or in situ carcinoma of the breast.
  • Receipt of any non-study vaccine within 28 days prior to study dosing or expected receipt of non-study vaccine prior to the Day 29 visit in Season 1.
  • Receipt of any investigational product (IP) in the 90 days prior to randomization or expected receipt of IP 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 immunoglobulins or blood products during the period of study follow-up.
  • Current bleeding or clotting disorder including use of anticoagulants other than drugs with anti-platelet activity (such as nonsteroidal anti-inflammatory drugs, clopidogrel, ticagrelor or aspirin).
  • History of alcohol or drug abuse or psychiatric disorder that, in the opinion of the investigator, would affect the subject's safety or compliance with study.
  • (Season 2): Related Grade 3 or 4 adverse event (AE) including Grade 3 or 4 local reaction to either MEDI7510 or IIV, any adverse event of special interest (AESI) for an adjuvanted vaccine, or any related serious adverse event (SAE).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Chile,   Estonia,   Latvia,   Lithuania,   South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02508194
Other Study ID Numbers  ICMJE D4420C00005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MedImmune LLC
Study Sponsor  ICMJE MedImmune LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account MedImmune LLC
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP