Respiratory Syncytial Virus ProphylaxisPhase 1NCT00192504

Safety Study of a Monoclonal Antibody to Respiratory Syncytial Virus (RSV) in Children Hospitalized With RSV Infection

A Phase 1 study testing Motavizumab in people with Respiratory Syncytial Virus Prophylaxis, run by MedImmune LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to determine the safety of motavizumab (MEDI-524) following a single intravenous dose in children hospitalized with respiratory syncytial virus (RSV). Read more about this study

Who is it for?: Ages Up to 24 months
Conditions the study is for: Respiratory Syncytial Virus Prophylaxis
What is being tested?: Motavizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 31 participants
Where: No sites listed yet
Study dates: Mar 2004to Jan 2005
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 Up to 24 months
All sexes
No healthy volunteers
Child

Who may be able to join

Previously healthy
Age 24 months and younger at the time of randomization
Gestational age of 36 weeks gestation and older
Randomization within 24 hours after hospitalization
Hospitalized for lower respiratory tract illness (ie, respiratory syncytial virus (RSV) bronchiolitis and/or pneumonia) documented by positive RSV antigen detection or culture in respiratory secretions within 72 hours before randomization

Who cannot join

Already received or would receive ribavirin or other anti-viral treatment for the current episode of RSV infection prior to randomization
Required intubation for ventilatory support
Any medically significant underlying ongoing chronic illness or organ system dysfunction or other known acute illness, other than RSV infection
Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency
Requirement for supplemental oxygen at any time prior to the current RSV infection (brief use of oxygen in the immediate postnatal period to treat a transient condition was allowed)
Mechanical ventilation at any time prior to the onset of the current RSV infection

Show all 11Show fewer

Congenital heart disease (children with medically or surgically corrected patent ductus arteriosus [PDA], small atrial septal defect [ASD] or ventricular septal defect [VSD] were allowed)
Previous reaction to intravneous immunoglobulin (IVIG), blood products, or other foreign proteins
Prior use of IVIG, RSV-IGIV (RespiGam), palivizumab (Synagis), or other immunoglobulin products within the past 2 months
Currently receiving other investigational agents or have received any other investigational agents within the last 3 months
Prior or current participation in any investigational study with a therapeutic agent or vaccine for RSV

About this study

Official title: A Phase 1, Randomized, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a Single Intravenous Dose of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody to Respiratory Syncytial Virus (RSV), in Otherwise Healthy Children Hospitalized With RSV Infection

The purpose of this study is to determine the safety of motavizumab (MEDI-524) following a single intravenous dose in children hospitalized with respiratory syncytial virus (RSV).

Read the detailed description

This study was designed as a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation, multicenter clinical study to evaluate the safety, tolerability, serum concentrations, and immunogenicity of a single intravenous dose of motavizumab (MEDI-524) and the effect on the amount of respirtory syncytial virus (RSV) in the respiratory tract (nasopharynx) of otherwise healthy children hospitalized with RSV infection.

Conditions: Respiratory Syncytial Virus Prophylaxis
Being tested: Motavizumab, Placebo
Keywords: MEDI-524, Motavizumab, respiratory syncytial virus, children, intravenous, Rezield

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MotavizumabBiological
Also called MEDI-524
Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0
MotavizumabBiological
Also called MEDI-524
Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0
MotavizumabBiological
Also called MEDI-524
Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0
PlaceboOther
Single dose of placebo administered intravenously (in the vein) on Day 0

Study groups in NCT00192504
Study group	Role	What they receive
Motavizumab, 3 mg/kg as a single intravenous dose	Experimental	Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0 Receives: Biological: Motavizumab
Motavizumab, 15 mg/kg as a single intravenous dose	Experimental	Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0 Receives: Biological: Motavizumab
Motavizumab, 30 mg/kg as a single intravenous dose	Experimental	Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0 Receives: Biological: Motavizumab
Placebo, as a single intravenous dose	Placebo comparator	Placebo, as a single intravenous dose administered on Day 0 Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects Reporting Adverse Events Through 30 Days After Dosing
Safety and tolerability of motavizumab (MEDI-524) was measured by adverse events through 30 days after dosing
Measured: From the start of treatment to 30 days after dosing
Number of Subjects Reporting Serious Adverse Events Through 30 Days After Dosing
Safety and tolerability of motavizumab (MEDI-524) was measured by serious adverse events through 30 days after dosing
Measured: From the start of treatment to 30 days after dosing
The Occurrence of Increased Toxixity Grade From Baseline as Determined by Laboratory Evaluations
Safety and tolerability of motavizumab (MEDI-524) was measured by the occurrence of increased toxicity grade from baseline as determined by laboratory evaluations (complete blood count, aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), creatinine, and urinalysis) at baseline and at each study collection time point following dosing
Measured: From the start of treatment to 30 days after dosing
To Describe the Mean Trough Serum Concentrations of Motavizumab (MEDI-524) Administered as a Single Intravenous Dose at Day 2 and Day 30
Mean trough serum concentrations of motavizumab (MEDI-524) were collected on Day 2 and on Day 30. Serum concentrations of MEDI-524 were analysed using a qualified enzyme-linked immunosorbent assay (ELISA).
Measured: Day 2 and Day 30

Secondary outcomes (2)

To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 0
The serum anti-motavizumab antibody titers were measured in subjects on Day 0 (before dosing). Anti-motavizumab antibody assays were performed at MedImmune using a qualified assay.
Measured: Immediately before dosing on Day 0
To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 30
The serum anti-motavizumab antibody titers were measured in subjects on Day 30. Anti-motavizumab antibody assays were performed at MedImmune using a qualified assay.
Measured: Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2004Jan 2005

First posted19 Sep 2005 (estimated)
Study startMar 2004
Primary completionJan 2005
Study completionJan 2005

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.
Other trials for Respiratory Syncytial Virus ProphylaxisStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00192504
Sponsor's protocol ID: MI-CP106
Status last verified: Oct 2006
First submitted: 13 Sep 2005
Last updated: 8 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingObservational study
Severe Pediatric Respiratory Syncytial Virus Infections Occurring in the Era of Antiviral Prophylaxis
Children <24 Months Hospitalized for RSV-related Lower Respiratory Tract Infection
RecruitingPhase 2
rBCG-N-RSV Vaccine in Adults Aged 60 Years and Older
Respiratory Syncytial Virus Infection Prevention, Tuberculosis Prevention
Active, not recruitingObservational study
Stakeholder-Informed RSV Prevention Economic Model in Botswana
RSV
RecruitingPhase 3
Prevention of RSV Infection in Infants by Administering Nirsevimab to Infants, With or Without Maternal RSV Vaccination
RSV Immunization
Active, not recruitingPhase 1
A Study of RSV-HMPV Bivalent Vaccine VXB-241 in Older Adults
Healthy Volunteers

All Respiratory Syncytial Virus Prophylaxis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a Single Intravenous Dose of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody to Respiratory Syncytial Virus (RSV), in Otherwise Healthy Children Hospitalized With RSV Infection
ClinicalTrials.gov ID: NCT00192504
Acronym / sponsor ID: MI-CP106
Conditions: Respiratory Syncytial Virus Prophylaxis
Keywords: MEDI-524, Motavizumab, respiratory syncytial virus, children, intravenous, Rezield
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: MedImmune LLCIndustry (pharma, biotech, devices)
Study start: Mar 2004
Primary completion: Jan 2005 (actual)
Study completion: Jan 2005 (actual)
First posted: 19 Sep 2005 (estimated)
Results: Posted 8 Oct 2021

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 the safety of motavizumab (MEDI-524) following a single intravenous dose in children hospitalized with respiratory syncytial virus (RSV).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Motavizumab, 3 mg/kg as a single intravenous dose	Experimental	Biological: MotavizumabMotavizumab, 3 mg/kg as a single intravenous dose administered on Day 0
Motavizumab, 15 mg/kg as a single intravenous dose	Experimental	Biological: MotavizumabMotavizumab, 15 mg/kg as a single intravenous dose administered on Day 0
Motavizumab, 30 mg/kg as a single intravenous dose	Experimental	Biological: MotavizumabMotavizumab, 30 mg/kg as a single intravenous dose administered on Day 0
Placebo, as a single intravenous dose	Placebo comparator	Other: PlaceboPlacebo, as a single intravenous dose administered on Day 0

Who may qualify

Ages: Up to 24 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Previously healthy
Age 24 months and younger at the time of randomization
Gestational age of 36 weeks gestation and older
Randomization within 24 hours after hospitalization
Hospitalized for lower respiratory tract illness (ie, respiratory syncytial virus (RSV) bronchiolitis and/or pneumonia) documented by positive RSV antigen detection or culture in respiratory secretions within 72 hours before randomization

Key exclusion criteria (11 listed)

Already received or would receive ribavirin or other anti-viral treatment for the current episode of RSV infection prior to randomization
Required intubation for ventilatory support
Any medically significant underlying ongoing chronic illness or organ system dysfunction or other known acute illness, other than RSV infection
Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency
Requirement for supplemental oxygen at any time prior to the current RSV infection (brief use of oxygen in the immediate postnatal period to treat a transient condition was allowed)

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
MotavizumabAlso: MEDI-524Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0	Biological	Motavizumab, 3 mg/kg as a single intravenous dose
MotavizumabAlso: MEDI-524Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0	Biological	Motavizumab, 15 mg/kg as a single intravenous dose
MotavizumabAlso: MEDI-524Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0	Biological	Motavizumab, 30 mg/kg as a single intravenous dose
PlaceboSingle dose of placebo administered intravenously (in the vein) on Day 0	Other	Placebo, as a single intravenous dose

Primary outcome

Number of Subjects Reporting Adverse Events Through 30 Days After Dosing
Time frame: From the start of treatment to 30 days after dosing
Safety and tolerability of motavizumab (MEDI-524) was measured by adverse events through 30 days after dosing
Number of Subjects Reporting Serious Adverse Events Through 30 Days After Dosing
Time frame: From the start of treatment to 30 days after dosing
Safety and tolerability of motavizumab (MEDI-524) was measured by serious adverse events through 30 days after dosing
The Occurrence of Increased Toxixity Grade From Baseline as Determined by Laboratory Evaluations
Time frame: From the start of treatment to 30 days after dosing
Safety and tolerability of motavizumab (MEDI-524) was measured by the occurrence of increased toxicity grade from baseline as determined by laboratory evaluations (complete blood count, aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), creatinine, and urinalysis) at baseline and at each study collection time point following dosing
To Describe the Mean Trough Serum Concentrations of Motavizumab (MEDI-524) Administered as a Single Intravenous Dose at Day 2 and Day 30
Time frame: Day 2 and Day 30
Mean trough serum concentrations of motavizumab (MEDI-524) were collected on Day 2 and on Day 30. Serum concentrations of MEDI-524 were analysed using a qualified enzyme-linked immunosorbent assay (ELISA).

2 secondary outcomes

To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 0
Time frame: Immediately before dosing on Day 0
To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 30
Time frame: Day 30

Results and safety

Results posted to the registry on 8 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Motavizumab (MEDI-524), 3 mg/kg	5	4
Motavizumab (MEDI-524), 15 mg/kg	5	5
Motavizumab (MEDI-524), 30 mg/kg	6	5
Placebo	15	15

Primary outcome: Number of Subjects Reporting Adverse Events Through 30 Days After Dosing

Time frame: From the start of treatment to 30 days after dosing. Number. Unit: Participants

Measure	Motavizumab (MEDI-524), 3 mg/kg n = 5	Motavizumab (MEDI-524), 15 mg/kg n = 5	Motavizumab (MEDI-524), 30 mg/kg n = 5	Placebo n = 15
Value	3	5	3	6

Population analysed: All patients who recieved study drug were included in the analysis of safety.

Primary outcome: Number of Subjects Reporting Serious Adverse Events Through 30 Days After Dosing

Time frame: From the start of treatment to 30 days after dosing. Number. Unit: participants

Measure	Motavizumab (MEDI-524), 3 mg/kg n = 4	Motavizumab (MEDI-524), 15 mg/kg n = 5	Motavizumab (MEDI-524), 30 mg/kg n = 5	Placebo n = 15
Value	0	0	1	1

Primary outcome: The Occurrence of Increased Toxixity Grade From Baseline as Determined by Laboratory Evaluations

Time frame: From the start of treatment to 30 days after dosing. Number. Unit: Participants

Measure	Motavizumab (MEDI-524), 3 mg/kg n = 5	Motavizumab (MEDI-524), 15 mg/kg n = 5	Motavizumab (MEDI-524), 30 mg/kg n = 5	Placebo n = 15
Value	0	1	1	1

Population analysed: All patients who recieved study drug were included in the analysis of safety.

Primary outcome: To Describe the Mean Trough Serum Concentrations of Motavizumab (MEDI-524) Administered as a Single Intravenous Dose at Day 2 and Day 30

Time frame: Day 2 and Day 30. Mean (Standard Deviation). Unit: Micrograms per mililiter

Measure	Motavizumab (MEDI-524), 3 mg/kg n = 4	Motavizumab (MEDI-524), 15 mg/kg n = 5	Motavizumab (MEDI-524), 30 mg/kg n = 5	Placebo n = 15
Trough Serum Concentration at Day 2	61.78 (20.09)	170.8 (38.43)	333.2 (99.86)	0 (0)
Trough Serum Concentration at Day 30	16.63 (13.08)	59.18 (12.72)	80.28 (27.34)	0 (0)

Population analysed: All patients who recieved a full dose of study drug were included in the analysis of trough serum concentrations. One patient in the 3 mg/kg group was not assessed for serum trough levels at either Day 2 or Day 30.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Motavizumab (MEDI-524), 3 mg/kg	0 of 5 (0%)	3 of 5 (60%)	Not reported
Motavizumab (MEDI-524), 15 mg/kg	0 of 5 (0%)	5 of 5 (100%)	Not reported
Motavizumab (MEDI-524), 30 mg/kg	1 of 5 (20%)	3 of 5 (60%)	Not reported
Placebo	1 of 15 (6.7%)	6 of 15 (40%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Respiratory Syncytial Virus Prophylaxis

Not yet recruitingObservational study
Severe Pediatric Respiratory Syncytial Virus Infections Occurring in the Era of Antiviral Prophylaxis
Children <24 Months Hospitalized for RSV-related Lower Respiratory Tract Infection
RecruitingPhase 2
rBCG-N-RSV Vaccine in Adults Aged 60 Years and Older
Respiratory Syncytial Virus Infection Prevention, Tuberculosis Prevention
Active, not recruitingObservational study
Stakeholder-Informed RSV Prevention Economic Model in Botswana
RSV
RecruitingPhase 3
Prevention of RSV Infection in Infants by Administering Nirsevimab to Infants, With or Without Maternal RSV Vaccination
RSV Immunization
Active, not recruitingPhase 1
A Study of RSV-HMPV Bivalent Vaccine VXB-241 in Older Adults
Healthy Volunteers

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.

Genevieve A Losonsky, MD study director

MedImmune LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Motavizumab in people with Respiratory Syncytial Virus Prophylaxis, run by MedImmune LLC.

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 11 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 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

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 8 Oct 2021). 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 Subjects Reporting Adverse Events Through 30 Days After Dosing (time frame: From the start of treatment to 30 days after dosing). The study lists 4 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 NCT00192504.

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 8 Oct 2021.