PMID- 21782874
OWN - NLM
STAT- MEDLINE
DCOM- 20120307
LR  - 20211020
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 29
IP  - 40
DP  - 2011 Sep 16
TI  - 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.
PG  - 7042-8
LID - 10.1016/j.vaccine.2011.07.031 [doi]
AB  - OBJECTIVE: To evaluate the safety, tolerability, immunogenicity, and viral 
      shedding profiles of a recombinant, live, attenuated human parainfluenza virus 
      type 3 (HPIV3) vaccine, rHPIV3cp45, in healthy HPIV3-seronegative infants 6 to 
      <12 months of age. METHODS: In this double-blind, multicenter study, subjects 
      were randomized 2:1 to receive a 10(5)TCID(50) dose of rHPIV3cp45 (n=20) or 
      placebo (n=10) at enrollment and at 2 and 4 months after the first dose. Blood 
      for evaluation of antibody to HPIV3 was collected at baseline and approximately 1 
      month after each dose. Solicited adverse events (SEs) and unsolicited adverse 
      events (AEs) were collected on days 0-28 after each dose. Nasal wash samples for 
      vaccine virus shedding were collected 3 times after each dose (7-10, 12-18, and 
      28-34 days post dose) and at unscheduled illness visits. Subjects were followed 
      for 180 days after the last dose. RESULTS: Vaccine virus was shed by 85% of 
      vaccine recipients after dose 1, by 1 subject after dose 2, and was not shed by 
      any subject after dose 3. The highest titer of shed virus was detected on day 7 
      after dose 1. The attenuation phenotype and the genotype of the vaccine virus 
      were stable in shed virus. Seroresponse (>/= 4-fold rise in HPIV3 antibody from 
      baseline) occurred in 61% of subjects after dose 1 and in 77% after dose 3. 
      Either seroresponse or shedding occurred in 95% of vaccine subjects. Adverse 
      events were similar in vaccine and placebo recipients. CONCLUSION: The safety, 
      shedding, and immunogenicity profiles of rHPIV3cp45 in HPIV3-seronegative infants 
      6 to <12 months of age support further development of this vaccine.
CI  - Copyright (c) 2011 Elsevier Ltd. All rights reserved.
FAU - Bernstein, David I
AU  - Bernstein DI
AD  - Cincinnati Children's Hospital Medical Center, University of Cincinnati, 3333 
      Burnet Avenue, Cincinnati, OH 45229, USA. david.bernstein@cchmc.org
FAU - Falloon, Judith
AU  - Falloon J
FAU - Yi, Tingting
AU  - Yi T
LA  - eng
GR  - UL1 TR000077/TR/NCATS NIH HHS/United States
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20110722
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Antibodies, Viral)
RN  - 0 (Parainfluenza Vaccines)
RN  - 0 (Placebos)
RN  - 0 (Vaccines, Attenuated)
SB  - IM
MH  - Antibodies, Viral/immunology
MH  - Double-Blind Method
MH  - Female
MH  - Genotype
MH  - Humans
MH  - Immune Tolerance/*immunology
MH  - Infant
MH  - Male
MH  - Parainfluenza Vaccines/*administration & dosage/adverse effects/immunology
MH  - Parainfluenza Virus 3, Human/*immunology
MH  - Phenotype
MH  - Placebos
MH  - Vaccines, Attenuated/administration & dosage/adverse effects/immunology
MH  - Virus Shedding/immunology
EDAT- 2011/07/26 06:00
MHDA- 2012/03/08 06:00
CRDT- 2011/07/26 06:00
PHST- 2011/04/13 00:00 [received]
PHST- 2011/07/01 00:00 [revised]
PHST- 2011/07/08 00:00 [accepted]
PHST- 2011/07/26 06:00 [entrez]
PHST- 2011/07/26 06:00 [pubmed]
PHST- 2012/03/08 06:00 [medline]
AID - S0264-410X(11)01052-8 [pii]
AID - 10.1016/j.vaccine.2011.07.031 [doi]
PST - ppublish
SO  - Vaccine. 2011 Sep 16;29(40):7042-8. doi: 10.1016/j.vaccine.2011.07.031. Epub 2011 
      Jul 22.