Safety of and Immune Response to Recombinant Live Attenuated Parainfluenza Type 3 Virus Vaccine in Healthy Infants and Children

This study has been completed.
Sponsor:
Collaborator:
Johns Hopkins Bloomberg School of Public Health
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01021397
First received: November 25, 2009
Last updated: December 31, 2012
Last verified: December 2012
  Purpose

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 primary purpose of this study is to test the safety of and immune response to a new HPIV vaccine in healthy infants and children.


Condition Intervention Phase
Paramyxoviridae Infections
Virus Diseases
Drug: rHPIV3cp45
Drug: rHPIV3cp45 placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Phase I Study to Determine the Safety, Infectivity, and Tolerability of 2 Doses of Live Attenuated Recombinant Cold-Passaged (cp) 45 Human Parainfluenza Type 3 Virus Vaccine, rHPIV3cp45, Lot PIV3#102A, Delivered as Nose Drops to HPIV3-Seronegative Infants and Children 6 to 36 Months of Age, at a 6 Month Interval

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Frequency of vaccine-related reactogenicity events and other adverse events [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Amount of serum antibody induced by vaccine in each recipient [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amount of vaccine virus shed by each recipient [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Immunogenicity of a second dose of vaccine and the protection of the first dose against re-infection with the second dose [ Time Frame: From Weeks 22 to 28 ] [ Designated as safety issue: No ]
  • Number of vaccinated infants infected with rHPIV3cp45 [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Number of vaccinated participants infected with a second dose of rHPIV3cp45 [ Time Frame: From Weeks 22 to 28 ] [ Designated as safety issue: Yes ]
  • Phenotypic stability of vaccine virus shed [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: November 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive one dose of vaccine virus at study entry and between Weeks 22 and 27
Drug: rHPIV3cp45
10^5 TCID50 nasal drops
Placebo Comparator: 2
Participants will receive one dose of vaccine virus placebo at study entry and between Weeks 22 and 27
Drug: rHPIV3cp45 placebo
1X-L15 nasal drops

Detailed Description:

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 approximately 28 weeks. Infants and children 6 months to 36 months of age will be randomly assigned to one of two groups. Group 1 participants will receive 2 immunizations of rHPIV3cp45. Group 2 participants will receive 2 doses of rHPIV3cp45 placebo. Immunizations will be given as nose drops and administered at study entry and approximately 22 to 27 weeks after study entry.

On the day of immunization, a physical exam and blood collection will occur. Participants 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 child'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 daily from Day 1 to Day 18 after each immunization.

Parents or guardians will need to record their child's temperature daily for at least 17 days immediately following immunization. During this 17-day period, study visits will occur on Days 3, 6, and 12 after each dose of vaccine or placebo. Participants will undergo a nasal wash for a viral culture at all study visits. There will be additional follow-up visits occurring sometime between 49 and 63 days after the first dose and 28 to 35 days after the second dose; blood collection will occur at the follow-up visits. Additional visits may be required on selected days during the month after immunization. Infants who experience illness or side effects may be asked to return to the clinic for examination.

  Eligibility

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Good general health
  • HPIV3-uninfected
  • Has received age-appropriate inactivated or subunit routine immunizations at least 2 weeks prior to study entry
  • Has received age-appropriate live routine immunizations at least 4 weeks prior to study entry and at least 2 weeks for rotavirus and inactivated vaccines
  • Available for the duration of the trial
  • Parent or guardian reachable by telephone for post-immunization contact
  • Parent or guardian willing to provide informed consent

Exclusion Criteria:

  • Known or suspected impairment of immunologic functions. Infants who are HIV-infected, who are bone marrow or solid organ transplant recipients, or who have received immunosuppressive therapy, including systemic corticosteroids within 30 days prior to study entry. Infants who are using topical steroids, topical antibiotic ointments and topical antifungal agents are not excluded.
  • Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
  • Previously received HPIV3 vaccine
  • Previous serious vaccine-associated adverse event or anaphylactic reaction
  • Known hypersensitivity to any vaccine component
  • Lung or heart disease, including reactive airway disease. Infants with clinically insignificant cardiac abnormalities are not excluded. Infants or children who wheezed once or received bronchodilator therapy once in the first year of life but who have not had any additional wheezing episodes or bronchodilator therapy for at least 12 months are not excluded.
  • Born prematurely before the 37th week of pregnancy if participant is currently less than 12 months of age
  • Member of a household containing immunocompromised individuals, pregnant caregivers, or infants less than 6 months of age
  • Attends day care with infants less than 6 months of age
  • Parent or guardian unable or unwilling to suspend daycare for 14 days following each immunization. More information on this criterion can be found in the protocol.
  • Enrolled in another investigational drug or vaccine study from 30 days prior to study entry until the final follow-up blood draw
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01021397

Locations
United States, Maryland
Center for Immunization Research (CIR), Johns Hopkins School of Public Health
Baltimore, Maryland, United States, 21205
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
Study Chair: Ruth A. Karron, MD Center for Immunization Research, Johns Hopkins University School of Public Health
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01021397     History of Changes
Other Study ID Numbers: CIR 255
Study First Received: November 25, 2009
Last Updated: December 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Respiratory Tract Infection

Additional relevant MeSH terms:
Paramyxoviridae Infections
Virus Diseases
Respirovirus Infections
Mononegavirales Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on August 21, 2014