Clinical Trial: Evaluating the Safety and Immunogenicity of a Human Parainfluenza Type 3 (HPIV3) Virus Vaccine in Infants and Children

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

Official Title: Phase 1 Study to Determine the Safety, Infectivity, Immunogenicity and Tolerability of 2 Doses of Live Attenuated Recombinant Cold-passaged (cp) 45 Human Parainfluenza Type 3 Virus Vaccine, rHPIV3cp45

Brief Summary: Human parainfluenza virus type 3 (HPIV3) is a major cause of pneumonia and other respiratory diseases in infants and children. This study will evaluate the safety and immune response of an HPIV3 vaccine in infants and young children.

Detailed Summary:

Human parainfluenza viruses can cause serious respiratory tract disease in infants and children under 5 years of age, and approximately 25% of children under 5 years of age have experienced a clinically significant parainfluenza virus infection. HPIV3, one of the four types of the parainfluenza virus, can cause pneumonia, bronchiolitis, croup, and bronchitis, and virtually all children have experienced primary HPIV3 infections by the time they are 3 to 4 years of age. In the United States, HPIV3 is responsible for approximately 11% of hospitalizations for respiratory diseases in children. Because HPIV3-associated lower respiratory illness typically occurs in the first year of life, the need exists for an HPIV3 vaccine that is safe and effective in infants. The purpose of this study is to evaluate the safety and immunogenicity of two doses of a live attenuated HPIV3 vaccine in infants and young children.

This study will enroll healthy, HPIV3 seronegative infants and children 6 months to 36 months of age. Participants will be randomly assigned to receive either the HPIV3 vaccine or a placebo vaccine. At a baseline study visit, all participants will undergo a medical history review, physical examination, vital sign measurements, and a nasal wash procedure. They will then receive their assigned vaccine in the form of nose drops. Participants will remain in the study clinic for 30 minutes after the vaccination for monitoring. Participants' parents will receive a thermometer and will record participants' temperature for 18 days after the vaccination. Study staff will call participants' parents on Days 1-18, 84, 112, and 140 to monitor participants' temperature and medical status. Study visits will occur 3, 6, 12, and 56 days after the vaccination, and participants will undergo similar tests and procedures as at the vaccination visit; a blood collection will also occur at Day 56
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Current Primary Outcome:

  • Frequency of vaccine-related reactogenicity events that occur during the acute monitoring phase of the study [ Time Frame: Measured at Days 0-18 after each vaccination ]
  • Proportion of participants that develop 4-fold or greater rises in hemagglutination inhibition (HAI) antibody titer following 2 doses of vaccine [ Time Frame: Measured through 31 days after the second vaccination ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

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

Dates:
Date Received: December 2, 2010
Date Started: December 2010
Date Completion:
Last Updated: December 2, 2014
Last Verified: December 2014