BACKGROUND: Mumps, a communicable, acute and previously well-controlled disease, has had recent and occasional resurgences in some areas. METHODS: A randomized, double-blind, controlled and multistep phase I study of an F-genotype attenuated mumps vaccine produced in human diploid cells was conducted. A total of 300 subjects were enrolled and divided into 4 age groups: 16-60 years, 5-16 years, 2-5 years and 8-24 months. The groups were immunized with one injection per subject. Three different doses of the F-genotype attenuated mumps vaccine, A (3.5 ± 0.25 logCCID50), B (4.25 ± 0.25 logCCID50) and C (5.0 ± 0.25 logCCID50), as well as a placebo control and a positive control of a licensed A-genotype vaccine (S79 strain) were used. The safety and immunogenicity of this vaccine were compared with those of the controls. RESULTS: The safety evaluation suggested that mild adverse reactions were observed in all groups. No serious adverse event (SAE) was reported throughout the trial. The immunogenicity test showed a similar seroconversion rate of the neutralizing and ELISA antibody in the 2- to 5-year-old and 8- to 24-month-old groups compared with the seroconversion rate in the positive control. The GMT of the neutralizing anti-F-genotype virus antibodies in the vaccine groups was slightly higher than that in the positive control group. CONCLUSIONS: The F-genotype attenuated mumps vaccine evaluated in this clinical trial was demonstrated to be safe and have effective immunogenicity vs. control.
RCT Entities:
BACKGROUND: Mumps, a communicable, acute and previously well-controlled disease, has had recent and occasional resurgences in some areas. METHODS: A randomized, double-blind, controlled and multistep phase I study of an F-genotype attenuated mumps vaccine produced in human diploid cells was conducted. A total of 300 subjects were enrolled and divided into 4 age groups: 16-60 years, 5-16 years, 2-5 years and 8-24 months. The groups were immunized with one injection per subject. Three different doses of the F-genotype attenuated mumps vaccine, A (3.5 ± 0.25 logCCID50), B (4.25 ± 0.25 logCCID50) and C (5.0 ± 0.25 logCCID50), as well as a placebo control and a positive control of a licensed A-genotype vaccine (S79 strain) were used. The safety and immunogenicity of this vaccine were compared with those of the controls. RESULTS: The safety evaluation suggested that mild adverse reactions were observed in all groups. No serious adverse event (SAE) was reported throughout the trial. The immunogenicity test showed a similar seroconversion rate of the neutralizing and ELISA antibody in the 2- to 5-year-old and 8- to 24-month-old groups compared with the seroconversion rate in the positive control. The GMT of the neutralizing anti-F-genotype virus antibodies in the vaccine groups was slightly higher than that in the positive control group. CONCLUSIONS: The F-genotype attenuated mumps vaccine evaluated in this clinical trial was demonstrated to be safe and have effective immunogenicity vs. control.
Entities:
Keywords:
F genotype attenuated mumps vaccine; Phase I clinical trial; immunogenicity; safety
Authors: Ruth Ann Jajosky; Patsy A Hall; Deborah A Adams; Felicia J Dawkins; Pearl Sharp; Willie J Anderson; J Javier Aponte; Gerald F Jones; David A Nitschke; Carol A Worsham; Nelson Adekoya; Timothy Doyle Journal: MMWR Morb Mortal Wkly Rep Date: 2006-06-16 Impact factor: 17.586
Authors: C L S Santos; M A Ishida; P G Foster; M A M Sallum; M A Benega; D B Borges; K O Corrêa; C R O Constantino; M A Afzal; T M Paiva Journal: J Med Virol Date: 2008-02 Impact factor: 2.327
Authors: S Schwarzer; S Reibel; A B Lang; M M Struck; B Finkel; E Gerike; A Tischer; M Gassner; R Glück; B Stück; S J Cryz Journal: Vaccine Date: 1998 Jan-Feb Impact factor: 3.641
Authors: Gustavo H Dayan; M Patricia Quinlisk; Amy A Parker; Albert E Barskey; Meghan L Harris; Jennifer M Hill Schwartz; Kae Hunt; Carol G Finley; Dennis P Leschinsky; Anne L O'Keefe; Joshua Clayton; Lon K Kightlinger; Eden G Dietle; Jeffrey Berg; Cynthia L Kenyon; Susan T Goldstein; Shannon K Stokley; Susan B Redd; Paul A Rota; Jennifer Rota; Daoling Bi; Sandra W Roush; Carolyn B Bridges; Tammy A Santibanez; Umesh Parashar; William J Bellini; Jane F Seward Journal: N Engl J Med Date: 2008-04-10 Impact factor: 91.245