CompletedPhase 1

Respiratory Syncytial Virus Human Challenge in Healthy Adult Volunteers

United States32 participantsStarted 2015-07-21

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexALL

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Inclusion criteria

✓. 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:

Exclusion criteria

✕. 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.

What they're measuring

Collection and assessment of expected and unexpected AEs.

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

Trial details

NCT IDNCT02484417

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2016-08-10

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