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 |
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Authors: | Bernstein David I Falloon Judith Yi Tingting |
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Affiliation: | a Cincinnati Children's Hospital Medical Center, University of Cincinnati, 3333 Burnet Avenue, Cincinnati, OH 45229, USA b MedImmune, LLC, One MedImmune Way, Gaithersburg, MD 20878, USA |
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Abstract: | ObjectiveTo 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.MethodsIn this double-blind, multicenter study, subjects were randomized 2:1 to receive a 105 TCID50 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.ResultsVaccine 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.ConclusionThe safety, shedding, and immunogenicity profiles of rHPIV3cp45 in HPIV3-seronegative infants 6 to <12 months of age support further development of this vaccine.ClinicalTrials.gov Identifier: NCT00508651. |
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Keywords: | AE, Adverse event CI, Confidence interval ELISA, Enzyme-linked immunosorbent assay FFU, Fluorescent focus units GMFR, Geometric mean fold rise from baseline GMT, Geometric mean titer HAI, Hemagglutination inhibition HPIV3cp45, Live, attenuated human parainfluenza virus type 3 vaccine PIV3, Parainfluenza virus type 3 rHPIV3cp45, Recombinant, live, attenuated human parainfluenza virus type 3 vaccine SD, Standard deviation SE, Solicited adverse event TCID50, Median tissue culture infectious dose ts, Temperature sensitive |
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