Safety and immunogenicity of live attenuated human-bovine (UK) reassortant rotavirus vaccines with VP7-specificity for serotypes 1, 2, 3 or 4 in adults, children and infants.
Live rotavirus vaccine candidates representing VP7 serotypes 1, 2, 3 or 4 derived by reassortment between bovine UK rotavirus and human rotavirus strains D, DS-1, P or ST3 were evaluated for safety and immunogenicity in adults, children and infants. Infection was defined by evidence of rotavirus shed in stools or a 4-fold or greater increase in serum rotavirus-specific IgA or IgG ELISA or plaque reduction neutralization antibody. A single oral dose (10(5.3) or 10(5.8) pfu) of reassortant virus was well tolerated and infected most infants: 10/20 (50%) by D x UK; 9/11 (82%) by DS-1 x UK; 8/10 (80%) by P x UK and 13/14 (93%) by ST3 x UK. All 14 infants given two doses of D x UK were infected. These findings demonstrating satisfactory levels of attenuation, safety, infectivity and immunogenicity of each reassortant in infants warrant additional studies of a candidate vaccine containing these four strains.
Clements-Mann
M L
ML
Center for Immunization Research, Department of International Health, School of Public Health, Johns Hopkins University, Baltimore, MD 21205, USA.
Makhene
M K
MK
Mrukowicz
J
J
Wright
P F
PF
Hoshino
Y
Y
Midthun
K
K
Sperber
E
E
Karron
R
R
Kapikian
A Z
AZ
D000293:Adolescent; D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000818:Animals; D000914:Antibodies, Viral / Q000097:blood; D000956:Antigens, Viral; D002213:Capsid / Q000276:immunology*; D036022:Capsid Proteins; D002417:Cattle; D002675:Child, Preschool; D006801:Humans; D007117:Immunization, Secondary; D007223:Infant; D008875:Middle Aged; D012401:Rotavirus / Q000276:immunology*; D012703:Serotyping; D014611:Vaccination; D014613:Vaccines, Attenuated / Q000009:adverse effects / Q000276:immunology; D014614:Vaccines, Synthetic / Q000276:immunology*; D014765:Viral Vaccines / Q000009:adverse effects / Q000276:immunology*
D000914:Antibodies, Viral; D000956:Antigens, Viral; D036022:Capsid Proteins; C050779:VP7 protein, Rotavirus; D014613:Vaccines, Attenuated; D014614:Vaccines, Synthetic; D014765:Viral Vaccines; D000410:Alanine Transaminase