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.
A phase 1a, first time in human, double-blind, randomized, placebo-controlled, cohort escalation study evaluating the safety and tolerability of a single ascending intramuscular dose of RSV sF or MEDI7510 or placebo. 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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
246
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.
Miami Research Associates
Miami, Florida, United States
Compass Research
Orlando, Florida, United States
Accelovance, Inc
Rockville, Maryland, United States
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.
Time frame: 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.
Time frame: 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.
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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.
Time frame: From Day 1 to Day 361
Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
RSV neutralizing antibody titers were measured using green fluorescent protein tagged RSV A 2
Time frame: 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
RSV neutralizing antibody titers were measured using green fluorescent protein tagged RSV A 2.
Time frame: 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
Seroresponse defined as a greater than or equal to (\>=) 4-fold rise from baseline.
Time frame: 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
Anti F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform.
Time frame: 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
Anti F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform.
Time frame: Day 29, 61, 91, 181, 271 and 361
Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay
Seroresponse defined as a greater than or equal to (\>=) 4-fold rise from baseline.
Time frame: Day 29
Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT)
The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides.
Time frame: Baseline (Day 1), Day 8 and 29
Post-dose Geometric Mean Fold Rises (GMFRs) of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT)
The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides.
Time frame: Day 8 and 29
Percentage of Participants Who Experience a Post-dose 3-fold Cell-mediated Immune Response to RSV F on Day 8
Seroresponse defined as a greater than or equal to (\>=) 3-fold rise from baseline
Time frame: Day 8