Rhesus Rotavirus candidate vaccine. Clinical trial in children vaccinated between 2 and 5 months of age.

Live attenuated oral rhesus Rotavirus candidate vaccine (strain MMU 18006 [lot RRV-1]) was evaluated for immunogenicity, safety, and clinical protection in a double-blind, placebo-controlled trial involving 200 infants aged 2 to 5 months when vaccinated. Vaccine-induced fourfold or greater rise of Rotavirus antibodies was seen in 62% of the infants. Febrile reactions of short duration on days 3 and/or 4 after vaccination occurred in 26% of the vaccine recipients. The clinical follow-up covered two Rotavirus seasons, in which serotypes 1 and 4 were prevalent. There were 16 cases of confirmed Rotavirus diarrhea in the placebo-treated group and 10 in the vaccine-treated group; from this a vaccine protection rate of 38% was derived. Clinical severity of Rotavirus diarrhea was assessed by a score; 13 cases in the placebo-treated group and 5 in the vaccine-treated group were regarded as severe or moderately severe, giving a vaccine protection rate of 67%. The rhesus Rotavirus vaccine induces partial protection against heterotypic Rotavirus disease, but the level of protection achieved with the present vaccine dose in this age group appears to be insufficient for a general Rotavirus vaccination.

[1]  R. Glass,et al.  Rotavirus: the major etiologic agent of severe infantile diarrhea may be controllable by a "Jennerian" approach to vaccination. , 1986, The Journal of infectious diseases.

[2]  T. Vesikari,et al.  Neonatal rotavirus vaccination with RIT 4237 bovine rotavirus vaccine: a preliminary report , 1987, The Pediatric infectious disease journal.

[3]  G. Beards,et al.  Enzyme-linked immunosorbent assays based on polyclonal and monoclonal antibodies for rotavirus detection , 1984, Journal of clinical microbiology.

[4]  R. Yolken,et al.  Oral administration of human rotavirus to volunteers: induction of illness and correlates of resistance. , 1983, The Journal of infectious diseases.

[5]  T. Vesikari,et al.  Clinical trials of rotavirus vaccines. , 2007, Ciba Foundation symposium.

[6]  T. Flewett.  Rotavirus vaccines--achievements and prospects. , 1986, Archives of Disease in Childhood.

[7]  P. Byass,et al.  TRIAL OF AN ATTENUATED BOVINE ROTAVIRUS VACCINE (RIT 4237) IN GAMBIAN INFANTS , 1987, The Lancet.

[8]  M. Rennels,et al.  Safety, infectivity, transmissibility and immunogenicity of rhesus rotavirus vaccine (MMU 18006) in infants , 1986, Pediatric infectious disease.

[9]  M. Pichichero,et al.  Field trial of rhesus rotavirus vaccine in infants. , 1988, The Pediatric infectious disease journal.

[10]  A. Kapikian,et al.  PROTECTION AGAINST SEVERE ROTAVIRUS DIARRHOEA BY RHESUS ROTAVIRUS VACCINE IN VENEZUELAN INFANTS , 1987, The Lancet.

[11]  H. Greenberg,et al.  Serotypic similarity and diversity of rotaviruses of mammalian and avian origin as studied by plaque-reduction neutralization. , 1984, The Journal of infectious diseases.

[12]  A. Kapikian,et al.  Reactogenicity and antigenicity of the rhesus rotavirus vaccine in Venezuelan children. , 1987, The Journal of infectious diseases.

[13]  R. Edelman.  Perspective on the development and deployment of rotavirus vaccines. , 1987, The Pediatric infectious disease journal.

[14]  M. Rennels,et al.  Systemic and mucosal immune responses to rhesus rotavirus vaccine MMU 18006. , 1988, The Pediatric infectious disease journal.

[15]  G. Zissis,et al.  FAILURE OF LIVE, ATTENUATED ORAL ROTAVIRUS VACCINE , 1986, The Lancet.

[16]  G. Zissis,et al.  A comparative trial of rhesus monkey (RRV-1) and bovine (RIT 4237) oral rotavirus vaccines in young children. , 1986, The Journal of infectious diseases.

[17]  R. Glass,et al.  Prolonged efficacy of rhesus rotavirus vaccine in Swedish children. , 1989, The Journal of infectious diseases.

[18]  G. Beards.  Serotyping of rotavirus by NADP-enhanced enzyme-immunoassay. , 1987, Journal of virological methods.

[19]  M. Rennels,et al.  Immunogenicity and reactogenicity of lowered doses of rhesus rotavirus vaccine strain MMU 18006 in young children. , 1987, The Pediatric infectious disease journal.

[20]  G. Beards,et al.  Clinical efficacy of the RIT 4237 live attenuated bovine rotavirus vaccine in infants vaccinated before a rotavirus epidemic. , 1985, The Journal of pediatrics.