Safety of and Immune Response to Recombinant Live-Attenuated Parainfluenza Type 1 Virus Vaccine

Summary

Human Parainfluenza Virus Type 1 (HPIV1) is a leading cause of viral respiratory infections in children, the elderly, and those with compromised immune systems. HPIV1 is also the leading cause of viral croup in children under 6 years old. The purpose of this study is to determine the safety of and immune response to a HPIV1 vaccine, rHPIVI1 84/del170/942A, in 2 groups of adults and then in children who have been previously exposed to HPIV1. Once the safety of this vaccine has been established in these groups, an additional 2 groups of infants and children who have not been previously exposed to HPIV1 will be vaccinated. Naïve infants and children are the most vulnerable to naturally circulating HPIV1 and are the target population of this vaccine.

Timeline

Start

2008-03

Primary completion

2012-07

Completion

2012-07

Publications

• Background Bartlett EJ, Amaro-Carambot E, Surman SR, Collins PL, Murphy BR, Skiadopoulos MH. Introducing point and deletion mutations into the P/C gene of human parainfluenza virus type 1 (HPIV1) by reverse genetics generates attenuated and efficacious vaccine candidates. Vaccine. 2006 Mar 24;24(14):2674-84. doi: 10.1016/j.vaccine.2005.10.047. Epub 2005 Nov 15.
• Background Bartlett EJ, Castano A, Surman SR, Collins PL, Skiadopoulos MH, Murphy BR. Attenuation and efficacy of human parainfluenza virus type 1 (HPIV1) vaccine candidates containing stabilized mutations in the P/C and L genes. Virol J. 2007 Jul 2;4:67. doi: 10.1186/1743-422X-4-67.
• Karron RA, San Mateo J, Thumar B, Schaap-Nutt A, Buchholz UJ, Schmidt AC, Bartlett EJ, Murphy BR, Collins PL. Evaluation of a Live-Attenuated Human Parainfluenza Type 1 Vaccine in Adults and Children. J Pediatric Infect Dis Soc. 2015 Dec;4(4):e143-6. doi: 10.1093/jpids/piu104. Epub 2014 Nov 12.

Drugs

Indications