Respiratory Syncytial Virus Human Challenge in Healthy Adult Volunteers

NCT02484417 | Completed Phase 1 FDA Drug

• 2 other identifiers: 15014815-I-0148
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Respiratory syncytial virus (RSV) can cause respiratory infections. Some of these can be life-threatening, especially in young children, the elderly, and people with weak immune systems. Researchers want to study RSV infection in a hospital setting in healthy adults. They want to use what they learn to test new treatments or vaccines in the future. Objectives: \- To study how the body responds to RSV. Eligibility: \- Healthy volunteers ages 18-50 Design:

• Participants will be screened under another protocol.
• Participants will have:
• Medical history
• Physical exams
• EKG. Heart rhythm is measured with small sticky patches on the chest, arms, and legs.
• Chest x-ray
• Pulmonary function tests. This measures how much air a person can move into and out of the lungs.
• Blood and urine tests
• Nasal washes and/or nasal swabs. For the wash, the nose will be rinsed with a sterile liquid. For the swab, the inside of the nostril will be rubbed with a cotton swab.
• Participants will have two, possibly three, follow-up outpatient visits, approximately 1, 2 and 6 months after receiving the dose of RSV.
• Participants will stay in the hospital under isolation for 7 or more days after getting the virus.
• The average stay is 10 days. Participants cannot leave the isolation unit. They cannot have visitors.
• The virus should cause a mild to medium cold.
• Participants will fill out a symptom card every day in the hospital and for 1 month after.
• Participants will have 2 follow-up visits, 28 and 56 days after leaving the hospital.
• Female participants who are sexually active must remain abstinent or use an effective form of birth control for 1 month before and after getting the virus.

Conditions

Upper Respiratory Tract Infection

Keywords

Neutralizing Antibody; Viral Shedding; Challenge; RSV; Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Collection and assessment of expected and unexpected AEs.

  Safety

  Safety will be assessed continuously during inpatient and outpatient phases of the study through Day 56

Secondary Outcomes (3)

• RSV challenge associated viral shedding from nasal secretions: viral titer onset, duration, peak, and AUC

  Viral shedding was assessed daily during the inpatient phase starting on day 2 following virus inoculation through day of discharge

• RSV challenge associated immune responses: neutralizing antibody and immune cell phenotyping

  Immune responses were assessed on days -1, 1, 7, and 10 during inpatient stay. Immune response were also examined during outpatient visits on day 28, day 56, and day 180.

• RSV challenge associated clinical disease: frequency of upper respiratory infection, symptom score, and mucous weights

  Clinical signs and symptoms were assessed daily during the inpatient phase. Interim history and physical was performed during outpatient visits.

Study Arms (3)

Cohort 1: RSV A2 10^5 PFU/dose

EXPERIMENTAL

Challenge 4 subjects with low dose and proceed to larger cohort after safety review.

Biological: RSV A2

Cohort 2: RSV A2 10^5 PFU/dose

EXPERIMENTAL

Challenge 12 subjects with the low dose and proceed to high dose after safety review.

Biological: RSV A2

Cohort 3: RSV A2 10^6.3 PFU/dose

EXPERIMENTAL

Challenge 12 subjects with the high dose

Biological: RSV A2

Interventions

RSV A2 BIOLOGICAL

Intranasal inoculation of healthy volunteers with 10\^5 or 10\^6.3 plaque forming units (PFU) of RSV A2.

Cohort 1: RSV A2 10^5 PFU/dose; Cohort 2: RSV A2 10^5 PFU/dose; Cohort 3: RSV A2 10^6.3 PFU/dose

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-50 years.
• General good health, without significant medical illness, physical exam findings, or significant laboratory abnormalities as determined by the investigator.
• Willingness to stay confined to the inpatient unit for required study duration.
• Willingness to have samples stored for future research.
• Subjects must be of non-childbearing potential (i.e., either surgically sterilized \[bilateral oophorectomy, bilateral tubal ligation, hysterectomy\] or, if of child-bearing potential and sexually active with a partner who can get them pregnant, then they must be have in place an effective method of contraception for at least 30 days prior to administration of the challenge virus and until 30 days after challenge virus administration:
• intrauterine device (IUD) or equivalent
• hormonal contraceptives (e.g., consistent, continuous use of contraceptive pill, patch, ring, implant or injection)
• if participant uses contraceptive pill, patch or ring, two methods of contraception are required; a barrier method is to be used at the time of potentially reproductive sexual activity (e.g. male/female condom, cap, or diaphragm plus spermicide)
• be in a monogamous relationship with a partner who has undergone a vasectomy at least 6 months prior to first dose of study agent.

You may not qualify if:

• The presence of any one of the following criteria is sufficient to exclude a prospective subject from enrolling in this study:
• Female subject 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.
• Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, hematologic, rheumatologic, endocrine, autoimmune, or renal disease.
• Complete blood count (CBC), AST, ALT, or creatinine values are both outside of the NIH Department of Laboratory Medicine normal reference range and deemed clinically significant by the PI.
• 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 medical, occupational, or family problem as a result of alcohol or illicit drug use during the past 12 months.
• Routine smoker of a tobacco product or marijuana currently or in the past year.
• Current alcohol abuse or addiction.
• Current illicit drug abuse or addiction.
• Presence of any febrile illness or symptoms suggestive of a viral respiratory infection within 2 weeks prior to inoculation accompanied by a positive multiplex FilmArray PCR performed on nasal wash.
• Use of corticosteroids (including nasal preparations) or immunosuppressive drugs within 30 days before inoculation.
• A history of asthma within the past 10 years, or a current diagnosis of asthma or reactive airway disease associated with exercise, seasonal hay fever or allergic rhinitis.
• Positive FDA-approved HIV test result prior to inoculation.
• Positive serology for hepatitis C virus within 6 months prior to inoculation.
• Presence of hepatitis B surface antigen within 6 months prior to inoculation.

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

• Lee FE, Walsh EE, Falsey AR, Betts RF, Treanor JJ. Experimental infection of humans with A2 respiratory syncytial virus. Antiviral Res. 2004 Sep;63(3):191-6. doi: 10.1016/j.antiviral.2004.04.005.

  PMID: 15451187 BACKGROUND

• DeVincenzo JP, Wilkinson T, Vaishnaw A, Cehelsky J, Meyers R, Nochur S, Harrison L, Meeking P, Mann A, Moane E, Oxford J, Pareek R, Moore R, Walsh E, Studholme R, Dorsett P, Alvarez R, Lambkin-Williams R. Viral load drives disease in humans experimentally infected with respiratory syncytial virus. Am J Respir Crit Care Med. 2010 Nov 15;182(10):1305-14. doi: 10.1164/rccm.201002-0221OC. Epub 2010 Jul 9.

  PMID: 20622030 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Jeffrey I Cohen, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: June 29, 2015
• Study Start: July 21, 2015
• Primary Completion: August 10, 2016
• Study Completion: August 10, 2016
• Last Updated: March 10, 2026

Record last verified: 2026-03-04

Locations

US (1)