Inpatient Challenge Study of rRSV A/Maryland/001/11, a Human Respiratory Syncytial Virus Challenge Strain, Administered to Healthy Adult Volunteers

NCT03624790 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CIR 320
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, infectivity and replication, and immunogenicity of a recombinant respiratory syncytial virus (rRSV A/Maryland/001/11) challenge virus administered intranasally to healthy adults.

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (9)

• Frequency of challenge virus-related solicited signs and symptoms

  Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017

  Measured through Day 56

• Severity of challenge virus-related solicited signs and symptoms

  Graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017

  Measured through Day 56

• Frequency of adverse events (AEs)

  Graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017

  Measured through Day 56

• Severity of AEs

  Graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017

  Measured through Day 56

• Number of participants infected with rRSV A/Maryland/001/11 challenge virus

  Defined as recovery of challenge virus from nasal wash, and/or detection of virus in nasal wash by real-time reverse transcription polymerase chain reaction (rRT-PCR), and/or a greater than or equal to 2.5-fold rise in serum neutralizing antibody titer to RSV

  Measured through Day 56

• Nasal wash virus titers of challenge virus shed

  Measured by plaque titration and rRT-PCR

  Measured through Day 56

• Number of days challenge virus was shed

  Measured by plaque titration and rRT-PCR

  Measured through Day 56

• Titer of serum immunoglobulin G (IgG) antibodies to the RSV F protein

  Measured by enzyme-linked immunosorbent assay (ELISA)

  Measured through Day 56

• Change in serum neutralizing antibody titer to RSV

  Measured by plaque reduction assay

  Measured through Day 56

Study Arms (2)

Cohort 1: rRSV A/Maryland/001/11

EXPERIMENTAL

Participants will receive a single dose of rRSV A/Maryland/001/11 at study entry (Day 0).

Biological: rRSV A/Maryland/001/11

Cohort 2: rRSV A/Maryland/001/11

EXPERIMENTAL

Participants will receive a single dose of rRSV A/Maryland/001/11 at study entry (Day 0).

Biological: rRSV A/Maryland/001/11

Interventions

rRSV A/Maryland/001/11 BIOLOGICAL

10\^5 PFU; delivered intranasally

Cohort 1: rRSV A/Maryland/001/11; Cohort 2: rRSV A/Maryland/001/11

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-pregnant adults between 18 years and 50 years of age, inclusive.
• General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator.
• Demonstrates comprehension of the protocol procedures and knowledge of RSV illness by passing a written comprehension examination (pass grade greater than or equal to 70%).
• Available for the duration of the trial.
• Willingness to participate in the study and stay confined to the inpatient unit for the required duration as evidenced by signing the informed consent document.
• Participants with childbearing potential must agree to have used effective birth control methods beginning at least one month prior to challenge, and continuing with 'per label/fully effective use' for the chosen method for the duration of the study, from amongst these:
• pharmacologic/hormonal contraceptives, including oral, parenteral, subcutaneous, and transcutaneous delivery;
• condoms or diaphragm with spermicide;
• intrauterine device;
• absolute abstinence from heterosexual intercourse as a matter of normal preferred lifestyle;
• or must be surgically sterile, or must be 50 years of age AND have had no menses at all for at least one full year.
• All participants of childbearing potential must provide samples for urine and serum pregnancy testing prior to enrollment, prior to challenge, as well as a statement of menstrual history, at each study contact throughout the study, and report if they may be pregnant immediately.
• Willingness to refrain from blood and plasma donation for 1 year after study enrollment.
• Willingness to refrain from receiving licensed or investigational vaccines or other investigational products from the day of enrollment until Study Day 56.
• Willingness to follow admission and isolation requirements for the indicated duration per protocol.

You may not qualify if:

• Subject who was previously challenged with RSV in any study, or previously participated in an RSV vaccine study.
• Any subject who is pregnant or lactating OR planning to become pregnant in the timeframe that begins 30 days prior to the inoculation and ends 30 days after inoculation. Pregnancy is determined by a positive test for human chorionic gonadotropin (β-HCG test).
• Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies.
• Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the study protocol.
• A history of asthma within the past 5 years, or a current diagnosis of asthma or reactive airway disease associated with exercise, seasonal hay fever or allergic rhinitis.
• Presence of any febrile illness or symptoms suggestive of a respiratory infection within 2 weeks prior to inoculation.
• Use of systemic or nasal steroid preparations or immunosuppressive drugs within 30 days prior to challenge. Topical steroid preparations are permitted.
• Inhaled bronchodilator or inhaled steroid use within the last year or use after upper respiratory tract infections within the last 5 years.
• Current or past (in the last 4 weeks) use of i.n. medications (including steroids, decongestants, or hormonal medications), or planning to use them within 28 days of study challenge
• Positive urine drug toxicology test for the presence of amphetamine, barbiturates, opiates, phencyclidine, benzodiazepines, methadone or cocaine metabolites.
• Evidence of current alcohol or illicit drug abuse or addiction.
• Other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol.
• History of anaphylaxis.
• Positive enzyme-linked immunosorbent assay (ELISA) and confirmatory tests for human immunodeficiency virus (HIV).
• Positive ELISA and confirmatory test (e.g., recombinant immunoblot assay) for hepatitis C virus (HCV).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Kawsar Talaat, MD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 10, 2018
• Study Start: July 31, 2018
• Primary Completion: October 24, 2024
• Study Completion: October 24, 2024
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

US (1)