A Study to Evaluate the Efficacy of MEDI7510 in Older Adults

NCT02508194 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: D4420C00005
• Study Type: interventional
• Target: 1,900
• Locations: 7 countries
• Sites: 61

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.

Conditions

Respiratory Syncytial Virus

Keywords

RSV; Older adults; MEDI7510; Vaccine; Efficacy

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Day 14 after dosing through end of surveillance period (approximately 7 months)

Secondary Outcomes (16)

• Percentage of Participants Who Had a RSV Polymerase Chain Reaction (PCR)-Positive Respiratory Illness During the RSV Surveillance Period in Season 1

  Day 14 after dosing through end of surveillance period (approximately 7 months)

• Geometric Mean Responses (GMRs) of Serum Antibodies Concentration Against RSV by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay

  Day 1, Day 29, and End of Season 1 (approximately 1 year)

• Geometric Mean Fold Change of Serum Antibodies Concentration Against RSV by Anti-F IgG Assay

  Day 29 and End of Season 1 (approximately 1 year)

• Percentage of Participants Who Had a Post-dose Seroresponse to RSV as Measured by Anti-F IgG Assay

  Day 29 and End of Season 1 (approximately 1 year)

• Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine

  Day 1 (post-dose) and Day 29 of Season 1

Study Arms (2)

Placebo + Inactivated Influenza Vaccine (IIV)

ACTIVE COMPARATOR

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.

Biological: IIV; Other: Placebo

MEDI7510 + IIV

EXPERIMENTAL

Participants received a single IM injection of MEDI7510 in one arm and single IM injection of IIV in the contralateral arm.

Biological: MEDI7510; Biological: IIV

Interventions

MEDI7510 BIOLOGICAL

RSV soluble fusion protein (sF) antigen plus glucopyranosyl lipid A in stable emulsion (GLA-SE) adjuvant

MEDI7510 + IIV

IIV BIOLOGICAL

Marketed Inactivated Influenza Vaccine

MEDI7510 + IIV; Placebo + Inactivated Influenza Vaccine (IIV)

Placebo OTHER

Sterile Saline

Placebo + Inactivated Influenza Vaccine (IIV)

Eligibility Criteria

• Age: 60 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (61)

Research Site

Sacramento, California, 95864, United States

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San Francisco, California, 94108, United States

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Aurora, Colorado, 80045, United States

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Littleton, Colorado, 80127, United States

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Lady Lake, Florida, 32159, United States

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Miami, Florida, 33143, United States

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Orlando, Florida, 32806, United States

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Savannah, Georgia, 31406, United States

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Champaign, Illinois, 61820, United States

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Chicago, Illinois, 60654, United States

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Council Bluffs, Iowa, 51503, United States

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Augusta, Kansas, 67010, United States

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Wichita, Kansas, 67205, United States

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Edina, Minnesota, 55435, United States

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Cincinnati, Missouri, 45249, United States

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Kansas City, Missouri, 64114, United States

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Bellevue, Nebraska, 68005, United States

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Norfolk, Nebraska, 68701, United States

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Omaha, Nebraska, 68134, United States

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Rochester, New York, 14621, United States

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Charlotte, North Carolina, 28209, United States

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Hickory, North Carolina, 28602, United States

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Raleigh, North Carolina, 27609, United States

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Rocky Mount, North Carolina, 27804, United States

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Winston-Salem, North Carolina, 27103, United States

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Akron, Ohio, 44311, United States

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Dakota Dunes, South Dakota, 57049, United States

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Knoxville, Tennessee, 37912, United States

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Nashville, Tennessee, 37212, United States

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Murray, Utah, 84123, United States

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Brampton, Ontario, L6T 0G1, Canada

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London, Ontario, N5W 6A2, Canada

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Newmarket, Ontario, L3Y 5G8, Canada

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Toronto, Ontario, M9V 4B4, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Québec, G1W 4R4, Canada

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Santiago, 7500701, Chile

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Santiago, 8700000, Chile

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Santiago, 9340000, Chile

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Santiago, 9350079, Chile

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Temuco, 4781156, Chile

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Paide, 72713, Estonia

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Tallinn, 10117, Estonia

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Tallinn, 10128, Estonia

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Tallinn, 10617, Estonia

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Daugavpils, LV-5401, Latvia

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Jelgava, LV-3001, Latvia

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Kuldīga, LV-3301, Latvia

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Kaunas, 49449, Lithuania

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Kaunas, LT-48259, Lithuania

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Kaunas, LT50009, Lithuania

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Vilnius, 08661, Lithuania

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Vilnius, LT-01117, Lithuania

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Bellville, 7530, South Africa

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Bloemfontein, 9301, South Africa

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Cape Town, 7500, South Africa

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Johannesburg, 1818, South Africa

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Johannesburg, 2113, South Africa

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Krugersdorp, 1739, South Africa

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Pretoria, 184, South Africa

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Somerset West, 7130, South Africa

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Related Publications (2)

• Chang LA, Phung E, Crank MC, Morabito KM, Villafana T, Dubovsky F, Falloon J, Esser MT, Lin BC, Chen GL, Graham BS, Ruckwardt TJ. A prefusion-stabilized RSV F subunit vaccine elicits B cell responses with greater breadth and potency than a postfusion F vaccine. Sci Transl Med. 2022 Dec 21;14(676):eade0424. doi: 10.1126/scitranslmed.ade0424. Epub 2022 Dec 21.

  PMID: 36542692 DERIVED

• 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.

  PMID: 29029260 DERIVED

Limitations and Caveats

The study was terminated due to failure to meet the primary efficacy endpoint.

Results Point of Contact

• Title: Judith Falloon, MD
• Organization: MedImmune, LLC

clinicaltrialenquiries@medimmune.com

301-398-0000

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: July 22, 2015
• First Posted: July 24, 2015
• Study Start: September 29, 2015
• Primary Completion: September 9, 2016
• Study Completion: November 7, 2016
• Last Updated: December 26, 2017
• Results First Posted: December 20, 2017

Record last verified: 2017-12

Locations

CL (5); LA (3); LI (5); ZA (8); US (30); CA (6); ES (4)