drugset / Trial / NCT00308412
Safety of and Immune Response to a Human Parainfluenza Virus Vaccine (rHPIV3cp45) in Healthy Infants
Phase 1
Completed
45 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 and children.
Timeline
- Start
- 2006-06
- Primary completion
- 2010-04
- Completion
- 2010-04
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 HB, Piedra PA. Immunization against viral respiratory disease: a review. Pediatr Infect Dis J. 2004 Nov;23(11 Suppl):S254-61. doi: 10.1097/01.inf.0000144756.69887.f8.
- Background Karron RA, Belshe RB, Wright PF, Thumar B, Burns B, Newman F, Cannon JC, Thompson J, Tsai T, Paschalis M, Wu SL, Mitcho Y, Hackell J, Murphy BR, Tatem JM. A live human parainfluenza type 3 virus vaccine is attenuated and immunogenic in young infants. Pediatr Infect Dis J. 2003 May;22(5):394-405. doi: 10.1097/01.inf.0000066244.31769.83.
- 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rHPIV3cp45 | Vaccine | 100000 unknown | Intranasal |