IMPAACT2013: Safety and Immune Response of a Single Dose of a Vaccine for Respiratory Syncytial Virus (RSV) in Healthy Infants 6 to 24 Months Old

Phase I Study of the Infectivity, Safety and Immunogenicity of a Single Dose of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, Delivered as Nose Drops to RSV-Seronegative Infants 6 to 24 Months Old

Categories:

Phase I/II

Healthy Volunteers

Infectious Diseases

Diseases Treated:

Respiratory Syncytial Virus (RSV)

Eligibility Overview:

  • 6 to 24 months old
  • In good health
  • Never been diagnosed with Respiratory Syncytial Virus (RSV)
  • Growing at normal rate for age
  • Received routine immunizations, appropriate for age
  1. Brief Summary

    Human respiratory syncytial virus (RSV) is the most common viral cause of serious acute lower respiratory illness in infants and children younger than 5 years old throughout the world. Currently, no licensed vaccine against RSV is available.

    Several live-attenuated RSV vaccines have been tested in adult and pediatric trials as part of an ongoing vaccine development program by the National Institute of Allergy and Infectious Diseases (NIAID). This study will evaluate the live attenuated recombinant D46/NS2/N/ΔM2-2-HindIII vaccine virus for the first time in humans. This vaccine is a derivative of the live attenuated recombinant RSV LID DM2-2 vaccine virus, which is genetically similar to RSV MEDI ΔM2-2. Both of these have been studied in RSV-seronegative children.

    Primary Objectives

    • To assess the frequency and severity of study product-related solicited and unsolicited adverse events (AE) for 28 days following inoculation in vaccinated participants
    • To assess study product-related SAE for 56 days following inoculation for vaccinated participants
    • To determine the peak titer of vaccine virus shed and duration of virus shedding by each participant
    • To assess the proportion of vaccinated infants infected with study vaccine
    • To characterize antibody responses (Day 56) to the study vaccine

    Eligibility Criteria

    Inclusion criteria include:

    • 6 to 24 months old
    • In good health
    • Seronegative for RSV antibody
    • Growing at normal velocity for age
    • Received routine immunizations, appropriate for age

    Exclusion Criteria include:

    • Known or suspected HIV infection or impairment of immunological functions
    • Received immunosuppressive therapy within 28 days of study enrollment
    • Bone marrow/solid organ transplant recipient
    • Previously received a licensed or investigational RSV vaccine or placebo or any anti-RSV product
    • Clinically significant heart disease
    • Lung disease
    • Born at less than 34 weeks gestation
    • Born at less than 37 weeks gestation and younger than 1 year old at enrollment
    • Household contains, or will contain, an infant less than 6 months of age at enrollment date through Day 28
    • Household contains an immunocompromised individual
    • Attends a daycare facility and shares a room with infants younger than 6 months old (May participate if parent/guardian suspends daycare for 28 days following inoculation)
    • Any of the following symptoms at time of enrollment:
      • Rectal temperature of 100.4oF (38oC) or more
      • Upper respiratory signs or symptoms or significant nasal congestion
      • Otitis media
    • Received any of the following prior to enrollment:
      • Any inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days prior, or
      • Any live vaccine, other than rotavirus vaccine, within 28 days prior, or
      • Another investigational vaccine or investigational drug within 28 days prior

    Study Sites

    St. Jude Children's Research Hospital
    Memphis, Tennessee

    Collaborating sites in the U.S.

  2. About this study

    Respiratory Syncytial Virus is a virus (germ) that can cause breathing problems in infants and children. It is commonly known as RSV. Symptoms of an RSV infection may include fever, runny nose, sore throat, ear infection, cough and croup. RSV can also cause serious lung infections such as pneumonia and wheezing. At this time, there is no FDA approved vaccine to prevent RSV illness.

    Doctors who develop vaccines at the National Institutes of Health (NIH) have made a live virus vaccine that may help prevent RSV illness in babies and children. A live virus vaccine contains a weakened, live virus. It is designed to create an immune response in your body. In other words, it helps your body respond in a way that will protect you from getting sick from the virus. 

    The RSV vaccine in this study contains a live, weakened form of RSV. It is an experimental vaccine. It has not been tested in humans and has not been approved by the U.S. Food and Drug Administration (FDA). However, other RSV vaccines very similar to this one have been tested in both adults and children. In those cases, patients experienced an immune response and did not have many side effects.

    This study will test the RSV vaccine in healthy infants who have never had RSV. Babies will receive either one dose of the vaccine or one dose of a placebo. A placebo does not contain any of the vaccine. This placebo is made of water, salt, vitamins and sugar.

    The vaccine or placebo will be given to babies as nose drops. Whether your baby receives the vaccine or placebo will be decided randomly by a computer, like flipping a coin. You will not know if your child receives the real vaccine or a placebo until the end of the study.

    Purpose of this clinical trial

    The main goal of this study is to find out how safe and effective a single dose of the vaccine is against RSV in infants. Researchers want to know what, if any, side effects may occur. They also want to see how well the babies’ immune systems respond to the vaccine.

    Eligibility overview

    • 6 to 24 months old
    • In good health
    • Never been diagnosed with Respiratory Syncytial Virus (RSV)
    • Growing at normal rate for age
    • Received routine immunizations, appropriate for age
  3. IMPAACT2013 Quick View
    Sponsors National Institute of Allergy and Infectious Diseases (NIAID)
    ClinicalTrials.gov identifier NCT03102034
    Trial Start Date March 2017
    Estimated Enrollment 33
    Study Type Interventional
    Study Phase Phase I
    Conditions RSV
    Ages 6 to 24 months old
    Principal investigator Nehali Patel, MD
    Study Sites St. Jude Children's Research Hospital and collaborating sites in the U.S.
    For a consultation or to discuss IMPAACT2013 St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

Contact

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.