PMID- 21926667
OWN - NLM
STAT- MEDLINE
DCOM- 20120511
LR  - 20131121
IS  - 1532-0987 (Electronic)
IS  - 0891-3668 (Linking)
VI  - 31
IP  - 2
DP  - 2012 Feb
TI  - Phase 1 study of the safety and immunogenicity of a live, attenuated respiratory 
      syncytial virus and parainfluenza virus type 3 vaccine in seronegative children.
PG  - 109-14
LID - 10.1097/INF.0b013e31823386f1 [doi]
AB  - BACKGROUND: Respiratory syncytial virus (RSV) and parainfluenza virus type 3 
      (PIV3) are important causes of lower respiratory tract illness and 
      hospitalization in young children. Currently, there is no licensed vaccine 
      against RSV or PIV3. METHODS: In this randomized, phase 1, double-blind, 
      placebo-controlled, dose-escalating study, 49 healthy RSV/PIV3-seronegative 
      children 6 to <24 months of age were randomized 2:1 to receive 3 doses (at 10, 
      10, or 10 median tissue culture infective dose [TCID50]) of MEDI-534 (a live, 
      attenuated RSV/PIV3 chimeric virus vaccine candidate) or placebo at 2-month 
      intervals. Solicited adverse events (SEs) and unsolicited adverse events (AEs) 
      were recorded during days 0 to 28 after each dose. Nasal wash samples were 
      collected 3 times (days 7-10, 12-18, and 28-34) after each dose and at 
      unscheduled illness visits. Blood for antibody response was collected at baseline 
      and 28 days after each dose. Subjects were followed for 180 days after the last 
      dose or to the end of the RSV season. RESULTS: Overall, there was no difference 
      in the incidence of SEs and AEs between the RSV/PIV3 vaccine and placebo arms. 
      Runny/stuffy nose was the most commonly reported SE. Medically attended lower 
      respiratory illness rates were balanced between treatment arms, and there was no 
      evidence of enhanced RSV disease or vaccine-related serious AEs. Vaccine virus 
      was detected in most vaccinees on days 7 to 10 after dose 1 in a dose-dependent 
      manner. Seroresponse to RSV and PIV3 was highest in subjects receiving the 10 
      dosage. CONCLUSIONS: The safety profile and vaccine take as measured by shedding 
      and/or seroresponse in this RSV/PIV3-seronegative pediatric population support 
      the continued development of this RSV/PIV3 pediatric vaccine candidate.
FAU - Bernstein, David I
AU  - Bernstein DI
AD  - Cincinnati Children's Hospital Medical Center, University of Cincinnati, 
      Cincinnati, OH, USA.
FAU - Malkin, Elissa
AU  - Malkin E
FAU - Abughali, Nazha
AU  - Abughali N
FAU - Falloon, Judith
AU  - Falloon J
FAU - Yi, Tingting
AU  - Yi T
FAU - Dubovsky, Filip
AU  - Dubovsky F
CN  - MI-CP149 Investigators
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Pediatr Infect Dis J
JT  - The Pediatric infectious disease journal
JID - 8701858
RN  - 0 (Antibodies, Viral)
RN  - 0 (Placebos)
RN  - 0 (Vaccines, Attenuated)
RN  - 0 (Viral Vaccines)
SB  - IM
MH  - Antibodies, Viral/blood
MH  - Double-Blind Method
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Humans
MH  - Incidence
MH  - Infant
MH  - Parainfluenza Virus 3, Human/*immunology
MH  - Placebos/administration & dosage
MH  - Respiratory Syncytial Virus, Human/*immunology
MH  - Vaccination/methods
MH  - Vaccines, Attenuated/administration & dosage/adverse effects/immunology
MH  - Viral Vaccines/administration & dosage/*adverse effects/*immunology
EDAT- 2011/09/20 06:00
MHDA- 2012/05/12 06:00
CRDT- 2011/09/20 06:00
PHST- 2011/09/20 06:00 [entrez]
PHST- 2011/09/20 06:00 [pubmed]
PHST- 2012/05/12 06:00 [medline]
AID - 10.1097/INF.0b013e31823386f1 [doi]
PST - ppublish
SO  - Pediatr Infect Dis J. 2012 Feb;31(2):109-14. doi: 10.1097/INF.0b013e31823386f1.