A randomized, double-blind, placebo-controlled, phase 1/2a study of the safety and immunogenicity of a live, attenuated human parainfluenza virus type 3 vaccine in healthy infants

Vaccine

Volumn 29, Issue 40, 2011, Pages 7042-7048

  Bernstein, David I ^a   Falloon, Judith ^b   Yi, Tingting ^b  

^a UNIVERSITY OF CINCINNATI   (United States)

^b MEDIMMUNE   (United States)

Author keywords

Safety, Immunogenicity, Vaccine, Pediatrics, Parainfluenza, Parainfluenza virus type 3

Indexed keywords

HUMAN PARAINFLUENZA VIRUS 3 ANTIBODY; LIVE VACCINE; PARAINFLUENZA VACCINE; PLACEBO; RECOMBINANT VACCINE; RHPIV3C45 VACCINE; UNCLASSIFIED DRUG; VIRUS ANTIBODY;

ANTIBODY DETECTION; ANTIBODY RESPONSE; ANTIBODY TITER; ARTICLE; BLOOD SAMPLING; BRONCHIOLITIS; CONTROLLED STUDY; COUGHING; DOUBLE BLIND PROCEDURE; DROWSINESS; DRUG FEVER; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FOLLOW UP; HUMAN; HUMAN TISSUE; IMMUNOGENICITY; INFANT; IRRITABILITY; LOWER RESPIRATORY TRACT INFECTION; MALE; MULTICENTER STUDY; NORMAL HUMAN; NOSE SMEAR; OTITIS MEDIA; PARAINFLUENZA VIRUS 3; PARAINFLUENZA VIRUS INFECTION; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PNEUMOCOCCAL INFECTION; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINORRHEA; SIDE EFFECT; VACCINATION; VIRUS IMMUNITY; VIRUS SHEDDING; VIRUS STRAIN; WHEEZING;

ANTIBODIES, VIRAL; DOUBLE-BLIND METHOD; FEMALE; GENOTYPE; HUMANS; IMMUNE TOLERANCE; INFANT; MALE; PARAINFLUENZA VACCINES; PARAINFLUENZA VIRUS 3, HUMAN; PHENOTYPE; PLACEBOS; VACCINES, ATTENUATED; VIRUS SHEDDING;

EID: 80052316051     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2011.07.031     Document Type: Article

References (17)

1. Hall C.B. Respiratory syncytial virus and parainfluenza virus. N Engl J Med 2001, 344:1917-1928.
2. Lee M.S., Walker R.E., Mendelman P.M. Medical burden of respiratory syncytial virus and parainfluenza virus type 3 infection among US children. Implications for design of vaccine trials. Hum Vaccin 2005, 1(1):6-11.
3. Glezen W.P., Frank A.L., Taber L.H., Kasel J.A. Parainfluenza virus type 3: seasonality and risk of infection and reinfection in young children. J Infect Dis 1984, 150(6):851-857.
4. Weinberg G.A., Hall C.B., Iwane M.K., Poehling K.A., Edwards K.M., Griffin M.R., et al. Parainfluenza virus infection of young children: estimates of the population-based burden of hospitalization. J Pediatr 2009, 154(5):694-699.
5. Sato M., Wright P.F. Current status of vaccines for parainfluenza virus infections. Pediatr Infect Dis J 2008, 27(Suppl 10):S123-S125.
6. Belshe R.B., Hissom F.K. Cold adaptation of parainfluenza virus type 3: induction of three phenotypic markers. J Med Virol 1982, 10(4):235-242.
7. Clements M.L., Belshe R.B., King J., Newman F., Westblom T.U., Tierney E.L., et al. Evaluation of bovine, cold-adapted human, and wild-type human parainfluenza type 3 viruses in adult volunteers and in chimpanzees. J Clin Microbiol 1991, 29(6):1175-1182.
8. Belshe R.B., Karron R.A., Newman F.K., Anderson E.L., Nugent S.L., Steinhoff M., et al. Evaluation of a live attenuated, cold-adapted parainfluenza virus type 3 vaccine in children. J Clin Microbiol 1992, 30(8):2064-2070.
9. Karron R.A., Wright P.F., Newman F.K., Makhene M., Thompson J., Samorodin R., et al. A live human parainfluenza type 3 virus vaccine is attenuated and immunogenic in healthy infants and children. J Infect Dis 1995, 172(6):1445-1450.
10. Karron R.A., Belshe R.B., Wright P.F., Thumar B., Burns B., Newman F., et al. A live human parainfluenza type 3 virus vaccine is attenuated and immunogenic in young infants. Pediatr Infect Dis J 2003, 22(5):394-405.
11. Belshe R.B., Newman F.K., Tsai T.F., Karron R.A., Reisinger K., Roberton D., et al. Phase 2 evaluation of parainfluenza type 3 cold passage mutant 45 live attenuated vaccine in healthy children 6-18 months old. J Infect Dis 2004, 189(3):462-470.
12. Belshe R.B., Newman F.K., Anderson E.L., Wright P.F., Karron R.A., Tollefson S., et al. Evaluation of combined live, attenuated respiratory syncytial virus and parainfluenza 3 virus vaccines in infants and young children. J Infect Dis 2004, 190(12):2096-2103.
13. Madhi S.A., Cutland C., Zhu Y., Hackell J.G., Newman F., Blackburn N., et al. Transmissibility, infectivity and immunogenicity of a live human parainfluenza type 3 virus vaccine (HPIV3cp45) among susceptible infants and toddlers. Vaccine 2006, 24(13):2432-2439.
14. Skiadopoulos M.H., Surman S., Tatem J.M., Paschalis M., Wu S.L., Udem S.A., et al. Identification of mutations contributing to the temperature-sensitive, cold-adapted, and attenuation phenotypes of the live-attenuated cold-passage 45 (cp45) human parainfluenza virus 3 candidate vaccine. J Virol 1999, 73(2):1374-1381.
15. Durbin A.P., Karron R.A. Progress in the development of respiratory syncytial virus and parainfluenza virus vaccines. Clin Infect Dis 2003, 37(12):1668-1677.
16. Siegrist C.A., Cordova M., Brandt C., Barrios C., Berney M., Tougne C., et al. Determinants of infant responses to vaccines in presence of maternal antibodies. Vaccine 1998, 16(14-15):1409-1414.
17. Tang R.S., Schickli J.H., MacPhail M., Fernandes F., Bicha L., Spaete J., et al. Effects of human metapneumovirus and respiratory syncytial virus antigen insertion in two 3' proximal genome positions of bovine/human parainfluenza virus type 3 on virus replication and immunogenicity. J Virol 2003, 77(20):10819-10828.