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
Sponsor study identifier
interventional
12
1 country
2
Study Start
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2011
Actual (reported)Study Completion
December 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
November 25, 2009
Actual (reported)November 30, 2009
Actual (reported)December 2011
Actual (reported)December 2011
Actual (reported)Frequency of vaccine-related reactogenicity events and other adverse events
Throughout study
Amount of serum antibody induced by vaccine in each recipient
Throughout study
Amount of vaccine virus shed by each recipient
Throughout study
Immunogenicity of a second dose of vaccine and the protection of the first dose against re-infection with the second dose
From Weeks 22 to 28
Number of vaccinated infants infected with rHPIV3cp45
Throughout study
Number of vaccinated participants infected with a second dose of rHPIV3cp45
From Weeks 22 to 28
Phenotypic stability of vaccine virus shed
Throughout study
Participants will receive one dose of vaccine virus at study entry and between Weeks 22 and 27
Participants will receive one dose of vaccine virus placebo at study entry and between Weeks 22 and 27
10\^5 TCID50 nasal drops
1X-L15 nasal drops
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Center for Immunization Research (CIR), Johns Hopkins School of Public Health
Baltimore, Maryland, 21205, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Madhi SA, Cutland C, Zhu Y, Hackell JG, Newman F, Blackburn N, Murphy BR, Belshe RB, Karron RA, Deatly AM, Gruber WC, Bernstein DI, Wright PF. Transmissibility, infectivity and immunogenicity of a live human parainfluenza type 3 virus vaccine (HPIV3cp45) among susceptible infants and toddlers. Vaccine. 2006 Mar 20;24(13):2432-9. doi: 10.1016/j.vaccine.2005.12.002. Epub 2005 Dec 20.
Skiadopoulos MH, Surman SR, Riggs JM, Orvell C, Collins PL, Murphy BR. Evaluation of the replication and immunogenicity of recombinant human parainfluenza virus type 3 vectors expressing up to three foreign glycoproteins. Virology. 2002 May 25;297(1):136-52. doi: 10.1006/viro.2002.1415.
Ruth A. Karron, MD
Center for Immunization Research, Johns Hopkins University School of Public Health
12 participants (actual enrollment reported by the registry).
First Submitted
November 25, 2009
First Posted
November 30, 2009
Study Start
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2011
Actual (reported)Study Completion
December 2011
Actual (reported)Last Updated
January 3, 2013
Record last verified: 2012-12
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Source: ClinicalTrials.gov.
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