TY - JOUR
T1 - A bovine parainfluenza virus type 3 vaccine is safe and immunogenic in early infancy
AU - Greenberg, David P.
AU - Walker, Robert E.
AU - Lee, Min Shi
AU - Reisinger, Keith S.
AU - Ward, Joel I.
AU - Yogev, Ram
AU - Blatter, Mark M.
AU - Yeh, Sylvia H.
AU - Karron, Ruth A.
AU - Sangli, Chithra
AU - Eubank, Lane
AU - Coelingh, Kathleen L.
AU - Cordova, Julie M.
AU - August, Marilyn J.
AU - Mehta, Harshvardhan B.
AU - Chen, Wendy
AU - Mendelman, Paul M.
N1 - Funding Information:
Potential conflicts of interest: D.P.G., K.S.R., J.I.W., R.Y., M.M.B., and S.H.Y. were investigators in this clinical study; R.A.K. was a consultant to MedImmune Vaccines, Inc., during the study; R.E.W., M.-S.L., C.S., L.E., K.L.C., J.M.C., M.J.A., H.B.M., W.C., and P.M.M. were employees of MedImmune Vaccines, Inc., during the study; MedImmune Vaccines, Inc. is developing a PIV3 vaccine. Financial support: MedImmune Vaccines, Inc.
PY - 2005/4/1
Y1 - 2005/4/1
N2 - Background. A phase 2 trial was conducted to assess in young infants the safety, tolerability, infectivity, and immunogenicity of multiple doses of an intranasal vaccine using bovine parainfluenza virus type 3 (bPIV3). Methods. One hundred ninety-two healthy 2-month-old infants were randomized 1:1:1 to receive 1 × 105 median tissue culture infective dose (TCID 50) bPIV3 vaccine, 1 × 106 TCID50 bPIV3 vaccine, or placebo at 2, 4, 6, and 12-15 months of age. Safety information was collected by use of diary sheets and telephone interviews. Nasal wash and serum specimens were collected for assessment of infectivity and immunogenicity. Results. The safety profiles of both dosages of bPIV3 were similar to that of placebo, with the exception of fever with temperature of ≥38.1°C after dose 2 only, occurring in 34% of the 1 × 105 TCID50 group, 35% of the 1 × 106 TCID50 group, and 12% of the placebo group (P<.01). No vaccine-related serious adverse events were reported. The cumulative vaccine infectivity (isolation of bPIV3 and/or bPIV3 seroconversion) after dose 3 was similar in the 2 vaccine groups (87% in the 1 × 105 TCID50 group and 77% in the 1 × 10 6 TCID50 group) (P = .46). Seroconversion rates after dose 3, assessed by means of hemagglutination inhibition assay, after adjustment for decrease in maternal antibody titers, were 67% in the 1 × 105 TCID50 group, 57% in the 1 × 106 TCID50 group, and 12% in the placebo group (P<.01). Isolation of bPIV3 was common after dose 1, dose 2, or dose 3, but only 1 of 51 participants in the vaccine groups had bPIV3 isolated after dose 4. Conclusions. Multiple doses of bPIV3 vaccine were well tolerated and immunogenic in young infants.
AB - Background. A phase 2 trial was conducted to assess in young infants the safety, tolerability, infectivity, and immunogenicity of multiple doses of an intranasal vaccine using bovine parainfluenza virus type 3 (bPIV3). Methods. One hundred ninety-two healthy 2-month-old infants were randomized 1:1:1 to receive 1 × 105 median tissue culture infective dose (TCID 50) bPIV3 vaccine, 1 × 106 TCID50 bPIV3 vaccine, or placebo at 2, 4, 6, and 12-15 months of age. Safety information was collected by use of diary sheets and telephone interviews. Nasal wash and serum specimens were collected for assessment of infectivity and immunogenicity. Results. The safety profiles of both dosages of bPIV3 were similar to that of placebo, with the exception of fever with temperature of ≥38.1°C after dose 2 only, occurring in 34% of the 1 × 105 TCID50 group, 35% of the 1 × 106 TCID50 group, and 12% of the placebo group (P<.01). No vaccine-related serious adverse events were reported. The cumulative vaccine infectivity (isolation of bPIV3 and/or bPIV3 seroconversion) after dose 3 was similar in the 2 vaccine groups (87% in the 1 × 105 TCID50 group and 77% in the 1 × 10 6 TCID50 group) (P = .46). Seroconversion rates after dose 3, assessed by means of hemagglutination inhibition assay, after adjustment for decrease in maternal antibody titers, were 67% in the 1 × 105 TCID50 group, 57% in the 1 × 106 TCID50 group, and 12% in the placebo group (P<.01). Isolation of bPIV3 was common after dose 1, dose 2, or dose 3, but only 1 of 51 participants in the vaccine groups had bPIV3 isolated after dose 4. Conclusions. Multiple doses of bPIV3 vaccine were well tolerated and immunogenic in young infants.
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U2 - 10.1086/428092
DO - 10.1086/428092
M3 - Article
C2 - 15747247
AN - SCOPUS:20144384490
SN - 0022-1899
VL - 191
SP - 1116
EP - 1122
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 7
ER -