Clinical Trial: Safety of and Immune Response to a Cow/Human Parainfluenza Virus Vaccine (rB/HPIV3) in Healthy Infants, Children, and Adults

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

Official Title: A Phase 1 Study of the Safety and Immunogenicity of the Recombinant Live-Attenuated Chimeric Bovine/Human Parainfluenza Type 3 Virus Vaccine, rB/HPIV3, Lot PIV3 #101A, Del

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, children, and adults.

Detailed Summary:

HPIV type 3 (HPIV3) ranks second only to respiratory syncytial virus as the most common 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, chimeric bovine/human, attenuated intranasal HPIV3 vaccine, rB/HPIV3. This vaccine combines modified human HPIV3 with a related, modified cow virus, bovine parainfluenza type 3 virus (BPIV3). Vaccinations will be given as nose drops to healthy adults, children seropositive for HPIV3, and infants and children seronegative for HPIV3.

There are four groups in this study. Group 1 will consist of adults who will receive the higher dose of rB/HPIV3. Group 2 will consist of seropositive children who will be randomly assigned to receive the higher dose of rB/HPIV3 or placebo. Group 2 will not begin enrollment until the completion of Group 1 safety data review. Participants of both Groups 1 and 2 will be monitored for 10 days post vaccination for respiratory illness and for fever by self-reported temperature logs; these participants will be followed for a maximum of 28 days. Blood collection will occur at study entry and on Day 28; additional blood collection may occur up to 28 days prior to vaccination. Clinical assessments and nasal washes will occur at study entry and selected study visits. Group 1 participants will be contacted by phone on Day 180; Group 2 participants' parents or guardians will be contacted by phone on Days 1, 2, 8, 9, 11, and 180; study staff will ask about any illnesses or adverse events that may have occurred.

Groups 3 and 4 will consist of seronegative infants and children. Group 3 will not begin enrollment until the completion of Group 2
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 (Days 0 to 10 for adult and seropositive groups, Days 0 to 28 for seronegative groups) [ Time Frame: Throughout study ]
  • Quantifying the amount of vaccine virus shed by each recipient [ Time Frame: Throughout study ]
  • Determining the amount of serum antibody and mucosal antibody induced by the vaccine in each recipient [ 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 10 for adult and seropositive groups, Days 0 to 28 for seronegative groups)
  • proportion of subjects that develop fourfold or greater rises in hemagglutination-inhibition (HI) antibody titer following vaccination


Current Secondary Outcome:

  • Determining the phenotypic stability of vaccine virus shed [ Time Frame: Throughout study ]
  • Determining the number of vaccinated children and infants infected with rB/HPIV3 vaccine virus [ Time Frame: Throughout study ]


Original Secondary Outcome:

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

Dates:
Date Received: August 17, 2006
Date Started: March 2007
Date Completion:
Last Updated: February 29, 2012
Last Verified: February 2012