Intranasal Challenge of Healthy Adults With Respiratory Syncytial Virus (RSV)

NCT01475305 | Terminated Phase 1 Results

• 1 other identifier: CD-ID-MEDI-557-1090
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to evaluate the suitability of the challenge model in measuring the efficacy of MEDI-557 compared to placebo in healthy adult participants for the reduction in the incidence of RSV through 12 days post-RSV challenge with the RSV Memphis-37 strain.

Conditions

RSV Infection

Keywords

Respiratory Syncytial Virus (RSV); Healthy adults; MEDI-557; Intranasal challenge; Human model

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Plaque Assay Culture

  RSV infection is defined as positive plaque assay culture sample for greater than or equal to (\>=) 1 day through 12 days post-RSV challenge. A sample was determined positive if log10 plaque-forming units per milliliter \[pfu/mL\] greater than or equal lower limit of quantitation (LLOQ; 1.69 log10 pfu/mL) and 2 of the 3 replicates must have greater than (\>) 0 pfu/mL.

  From Day 4 to Day 15

Secondary Outcomes (23)

• Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Quantitative Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Direct Fluorescent Antibody (DFA), And by Any Method

  From Day 4 to Day 15

• Mean Viral Load AUC0-t by Plaque Assay Culture

  From Day 5 through Day 31

• Mean Viral Load AUC0-t by Realtime Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

  From Day 5 through Day 31

• Mean Nasal RSV Peak as Measured by Plaque Assay Culture

  From Day 5 through Day 31

• Mean Nasal RSV Peak as Measured by Quantitative Realtime Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

  From Day 5 through Day 31

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.

Drug: Placebo

MEDI-557

EXPERIMENTAL

Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.

Drug: MEDI-557

Interventions

Placebo DRUG

Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.

Placebo

MEDI-557 DRUG

Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.

MEDI-557

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy as determined by medical history and physical examination.
• Age 19 through 38 years at the time of screening.
• Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
• Weight less than or equal to (\<=) 10 kilogram (kg) with body mass index (BMI) less than (\<) 32 kilogram per meter square (kg/m\^2).
• Normotensive (systolic blood pressure \[BP\] \<150 millimeters of mercury (mmHg) and diastolic BP \< 90 mmHg).
• Females of childbearing age using contraception.
• Males who are sexually active with a female partner of childbearing potential, using contraception.
• Sero-suitable (that is, low serum RSV neutralizing antibody titre) for RSV infection.

You may not qualify if:

• Current medical conditions as follows:
• Clinical evidence of chronic pulmonary disease or any use of a bronchodilator or other asthma medication.
• Current smoker unwilling/unable to desist for the quarantine phase of the study.
• History or clinical evidence of recurrent lower respiratory tract infection.
• Evidence of infection with hepatitis A, B, or C virus or human immunodeficiency virus (HIV) by serology.
• Medical history as follows:
• History of immunodeficiency.
• History of chronic sinusitis.
• History of frequent epistaxis.
• History of or current diagnosis of diabetes.
• Prior/concomitant therapy including
• Receipt of any systemic chemotherapeutic agent at any time;
• Receipt of systemic glucocorticoids within 1 month, or any other immunosuppressive drug within 6 months prior to challenge.
• Receipt of any investigational drug within 6 months prior to dose or concurrent enrolment in another clinical study.
• Prior participation in a clinical trial of any experimental RSV viral challenge delivered directly to the respiratory tract at any time, or any other respiratory virus challenge within 1 year prior to dose.

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (1)

Research Site

London, E1 2AX, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Limitations and Caveats

The study was terminated before an adequate number of subjects were enrolled.

Results Point of Contact

• Title: Hasan Jafri, Medical Director
• Organization: Medimmune, LLC

jafrih@medimmune.com

301-398-4431

Study Officials

• Hasan Jafri, MD

  MedImmune LLC

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2011
• First Posted: November 21, 2011
• Study Start: October 20, 2011
• Primary Completion: December 3, 2011
• Study Completion: December 13, 2012
• Last Updated: July 21, 2017
• Results First Posted: July 21, 2017

Record last verified: 2017-07

Locations

GB (1)