Clinical Trial: Safety of and Immune Response to a Human Parainfluenza Virus Vaccine (rHPIV3cp45) in Healthy Infants

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase 1 Study to Determine the Safety, Infectivity, and Tolerability of Two Doses of Live Attenuated Recombinant Cold Passaged (cp) 45 Parainfluenza Type 3 Virus Vaccine, rHPIV3cp45, Lot PIV3 102A, De

Brief Summary: Human parainfluenza viruses (HPIVs) are a major health concern in infants and young children under 5 years of age, causing serious respiratory tract disease. The purpose of this study is to test the safety of and immune response to a new HPIV vaccine in healthy infants and children.

Detailed Summary:

HPIV type 3 (HPIV3) ranks second only to respiratory syncytial virus as the most important cause of bronchiolitis and pneumonia in infants less than 6 months of age. HPIV3 can cause severe disease in the first 2 years of life and is responsible for 11% of hospitalizations for respiratory diseases in children. This study will evaluate the safety and immunogenicity of a live recombinant attenuated intranasal HPIV3 vaccine, rHPIV3cp45.

This study will last for a maximum of 180 days. Infants will be enrolled into one of two study groups, Group 1 or Group 2. Depending on the study location, groups will enroll either sequentially or concurrently. Within each group, infants will be randomly assigned to receive 2 immunizations of rHPIV3cp45 or placebo. Immunizations will be given as nose drops. Immunizations will be given at study entry and approximately 4 to 10 weeks after study entry.

On the day of immunization, a physical exam, vital signs measurement, blood collection, and medical history will occur. Infants will be observed for 15 minutes after immunization for any immediate adverse effects. Parents or guardians will be given a thermometer to take with them and will be instructed on how to take their infant's temperature. They will be given the study schedule and will need to provide contact phone numbers so study personnel can contact them by phone during the days after immunization. Parents and guardians will be contacted by telephone on days without study visits, from Day 1 to Day 19 and on Day 180 after immunization, and asked about any illnesses or adverse effects they have observed in their immunized infants.

Parents or guardians will need to record their infant's temperature daily for at least the 17 days immediately following immunization. During this 17-day period, th
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Current Primary Outcome:

  • Frequency of vaccine-related reactogenicity events (REs) that occur during the acute monitoring phase of the study [ Time Frame: For 17 days after each dose ]
  • Proportion of infants that develop fourfold or greater rises in hemagglutination-inhibition (HAI) antibody titer following two doses of vaccine [ Time Frame: Throughout study ]


Original Primary Outcome:

  • Frequency of vaccine-related reactogenicity events (REs) that occur during the acute monitoring phase of the study (Days 0 to 17 for each dose)
  • Proportion of infants that develop fourfold or greater rises in hemagglutination-inhibition (HAI) antibody titer following two doses of vaccine


Current Secondary Outcome:

  • For the subset of infants enrolled in group 1 of the study (n=24), quantifying the amount of vaccine virus shed by each recipient [ Time Frame: Throughout study ]
  • Assessment of the immunogenicity of a second dose of vaccine and the protection of the first dose against reinfection with the second dose [ Time Frame: Throughout study ]
  • Determination of the number of vaccinated infants infected with rHPIV3cp45 [ Time Frame: Throughout study ]
  • Determination of the number of vaccinated subjects infected with a second dose of rHPIV3cp45 vaccine [ Time Frame: Throughout study ]
  • Determination of the phenotypic stability of vaccine virus shed [ Time Frame: Throughout study ]


Original Secondary Outcome:

Information By: National Institute of Allergy and Infectious Diseases (NIAID)

Dates:
Date Received: March 28, 2006
Date Started: June 2006
Date Completion:
Last Updated: July 15, 2010
Last Verified: July 2010