drugset / Trial / NCT00366782
Safety of and Immune Response to a Cow/Human Parainfluenza Virus Vaccine (rB/HPIV3) in Healthy Infants, Children, and Adults
Phase 1
Completed
51 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Johns Hopkins Bloomberg School of Public Health · collab
RandomizedParallel-groupTriple-blindPrevention
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.
Timeline
- Start
- 2007-03
- Primary completion
- 2011-02
- Completion
- 2011-06
Publications
- Background Durbin AP, Karron RA. Progress in the development of respiratory syncytial virus and parainfluenza virus vaccines. Clin Infect Dis. 2003 Dec 15;37(12):1668-77. doi: 10.1086/379775. Epub 2003 Nov 20.
- Background Greenberg DP, Walker RE, Lee MS, Reisinger KS, Ward JI, Yogev R, Blatter MM, Yeh SH, Karron RA, Sangli C, Eubank L, Coelingh KL, Cordova JM, August MJ, Mehta HB, Chen W, Mendelman PM. A bovine parainfluenza virus type 3 vaccine is safe and immunogenic in early infancy. J Infect Dis. 2005 Apr 1;191(7):1116-22. doi: 10.1086/428092. Epub 2005 Feb 22.
- Background Lee MS, Greenberg DP, Yeh SH, Yogev R, Reisinger KS, Ward JI, Blatter MM, Cho I, Holmes SJ, Cordova JM, August MJ, Chen W, Mehta HB, Coelingh KL, Mendelman PM. Antibody responses to bovine parainfluenza virus type 3 (PIV3) vaccination and human PIV3 infection in young infants. J Infect Dis. 2001 Oct 1;184(7):909-13. doi: 10.1086/323150. Epub 2001 Aug 15.
- Background 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.
- Results Karron RA, Thumar B, Schappell E, Surman S, Murphy BR, Collins PL, Schmidt AC. Evaluation of two chimeric bovine-human parainfluenza virus type 3 vaccines in infants and young children. Vaccine. 2012 Jun 6;30(26):3975-81. doi: 10.1016/j.vaccine.2011.12.022. Epub 2011 Dec 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rB/HPIV3 | Vaccine | 100000 unknown | Intranasal |
| Subject | rB/HPIV3 | Vaccine | 1e+06 unknown | Intranasal |