Respiratory Syncytial Virus (RSV)Phase 1NCT02115815
A Study to Evaluate the Safety of the Respiratory Syncytial Virus Vaccine MEDI7510 in Older Adults
A Phase 1 study testing RSV sF 20 mcg, MEDI7510 (20 mcg RSV sF) and RSV sF 50 mcg in people with Respiratory Syncytial Virus (RSV), run by MedImmune LLC at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus (RSV)
- What is being tested?
- RSV sF 20 mcg, MEDI7510 (20 mcg RSV sF) and RSV sF 50 mcg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 246 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2014to Jun 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Miami Research Associates
Miami, Florida, 33143
Compass Research
Orlando, Florida, 32806
Accelovance, Inc
Rockville, Maryland, 20850
About this study
Official title: A Phase 1a Study to Evaluate the Safety of the Respiratory Syncytial Virus Vaccine MEDI7510 in Older Adults
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.
Read the detailed description
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)
- Conditions
- Respiratory Syncytial Virus (RSV)
- Being tested
- Placebo, RSV sF 20 mcg, MEDI7510 (20 mcg RSV sF), RSV sF 50 mcg, MEDI7510 (50 mcg RSV sF)
- Keywords
- Respiratory Syncytial Virus (RSV), MEDI7510
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
Participants will receive placebo (sterile saline for human use from commercial source liquid) on Day 1.
RSV sF 20 mcgBiological
Participants will receive single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
MEDI7510 (20 mcg RSV sF)Biological
Participants will receive single dose of MEDI7510 containing 20 mcg RSV sF by intramuscular injection on Day 1.
RSV sF 50 mcgBiological
Participants will receive single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
MEDI7510 (50 mcg RSV sF)Biological
Participants will receive single dose of MEDI7510 containing 50 mcg RSV sF by intramuscular injection on Day 1.
RSV sF 80 mcgBiological
Participants will receive single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
MEDI7510 (80 mcg RSV sF)Biological
Participants will receive single dose of MEDI7510 containing 80 mcg RSV sF by intramuscular injection on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Sterile saline for human use from commercial source, liquid Receives: Biological: Placebo |
| RSV sF 20 mcg | Experimental | Participants will receive single dose of 20 mcg RSV sF by intramuscular injection on Day 1. Receives: Biological: RSV sF 20 mcg |
| MEDI7510 (20 mcg RSV sF) | Experimental | 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. Receives: Biological: MEDI7510 (20 mcg RSV sF) |
| RSV sF 50 mcg | Experimental | Participants will receive single dose of 50 mcg RSV sF by intramuscular injection on Day 1. Receives: Biological: RSV sF 50 mcg |
| MEDI7510 (50 mcg RSV sF) | Experimental | 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. Receives: Biological: MEDI7510 (50 mcg RSV sF) |
| RSV sF 80 mcg | Experimental | Participants will receive single dose of 80 mcg RSV sF by intramuscular injection on Day 1. Receives: Biological: RSV sF 80 mcg |
| MEDI7510 (80 mcg RSV sF) | Experimental | 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. Receives: Biological: MEDI7510 (80 mcg RSV sF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
RSV neutralizing antibody titers were measured using green fluorescent protein tagged RSV A 2
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial Virus (RSV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Sheldon, MD, Principal investigator, Miami Research AssociatesCraig Curtis, MD, Principal investigator, Compass ResearchSteven Bart, MD, Principal investigator, AccelovanceJudith Falloon, MD, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115815
- Sponsor's protocol ID
- CD-VA-MEDI7510-1134
- Other IDs
- BB-IND 15947
- Status last verified
- Aug 2016
- First submitted
- 3 Apr 2014
- Last updated
- 21 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 27102821
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a Study to Evaluate the Safety of the Respiratory Syncytial Virus Vaccine MEDI7510 in Older Adults
- ClinicalTrials.gov ID
- NCT02115815
- Acronym / sponsor ID
- CD-VA-MEDI7510-1134
- Conditions
- Respiratory Syncytial Virus (RSV)
- Keywords
- Respiratory Syncytial Virus (RSV), MEDI7510
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 16 Apr 2014 (estimated)
- Results
- Posted 21 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: PlaceboSterile saline for human use from commercial source, liquid |
| RSV sF 20 mcg | Experimental | Biological: RSV sF 20 mcgParticipants will receive single dose of 20 mcg RSV sF by intramuscular injection on Day 1. |
| MEDI7510 (20 mcg RSV sF) | Experimental | Biological: 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. |
| RSV sF 50 mcg | Experimental | Biological: RSV sF 50 mcgParticipants will receive single dose of 50 mcg RSV sF by intramuscular injection on Day 1. |
| MEDI7510 (50 mcg RSV sF) | Experimental | Biological: 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. |
| RSV sF 80 mcg | Experimental | Biological: RSV sF 80 mcgParticipants will receive single dose of 80 mcg RSV sF by intramuscular injection on Day 1. |
| MEDI7510 (80 mcg RSV sF) | Experimental | Biological: 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. |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboParticipants will receive placebo (sterile saline for human use from commercial source liquid) on Day 1. | Biological | Placebo |
| RSV sF 20 mcgParticipants will receive single dose of 20 mcg RSV sF by intramuscular injection on Day 1. | Biological | RSV sF 20 mcg |
| MEDI7510 (20 mcg RSV sF)Participants will receive single dose of MEDI7510 containing 20 mcg RSV sF by intramuscular injection on Day 1. | Biological | MEDI7510 (20 mcg RSV sF) |
| RSV sF 50 mcgParticipants will receive single dose of 50 mcg RSV sF by intramuscular injection on Day 1. | Biological | RSV sF 50 mcg |
| MEDI7510 (50 mcg RSV sF)Participants will receive single dose of MEDI7510 containing 50 mcg RSV sF by intramuscular injection on Day 1. | Biological | MEDI7510 (50 mcg RSV sF) |
| RSV sF 80 mcgParticipants will receive single dose of 80 mcg RSV sF by intramuscular injection on Day 1. | Biological | RSV sF 80 mcg |
| MEDI7510 (80 mcg RSV sF)Participants will receive single dose of MEDI7510 containing 80 mcg RSV sF by intramuscular injection on Day 1. | Biological | MEDI7510 (80 mcg RSV sF) |
Primary outcome
Number of Participants With Solicited Symptoms
Time frame: Day 1 to 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 greater than or equal to (>=) 100.4 degrees F by any route from Day 1 to Day 7.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: From Day 1 to Day 28
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.
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: From Day 1 to Day 361
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.
9 secondary outcomes
Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
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
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
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
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
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
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)
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)
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
Time frame: Day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27102821Falloon 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.
- CD-VA-MEDI7510-1134 Redacted ProtocolLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Sheldon, MD principal investigator
Miami Research Associates
Craig Curtis, MD principal investigator
Compass Research
Steven Bart, MD principal investigator
Accelovance
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RSV sF 20 mcg, MEDI7510 (20 mcg RSV sF) and RSV sF 50 mcg in people with Respiratory Syncytial Virus (RSV), run by MedImmune LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Solicited Symptoms (time frame: Day 1 to Day 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02115815, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2016.