Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Virus or component thereof
Reexamination Certificate
2001-01-26
2008-10-07
Campell, Bruce (Department: 1648)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Virus or component thereof
C424S204100, C424S205100
Reexamination Certificate
active
07431931
ABSTRACT:
The present invention provides compositions for making a medicament and methods for the administration of a vaccine compositions for protection against human rotaviral disease without significant reactogenicity. Human x rhesus reassortant rotavirus compositions were made which when administered during the first 7 to about 10 days of life, provided a composition which was non-reactogenic followed by booster immunizations at 16 to 18 weeks or 14 to 20 weeks, up to 1 year of age. The immune response induced by the initial neonatal administration of the live rotavirus vaccine composition protects the infant from the reactogenicity of the composition when administered as a second vaccine dose at or after 2 months of age. Administration of the immunogenic composition also is expected to ablate or significantly diminish the increase in the excess of intussusception observed 3 to 7 days following administration of the initial dose of rotavirus vaccine at about 2 to 4 months.
REFERENCES:
patent: 4571385 (1986-02-01), Greenberg et al.
Midthun and Kapikian, Rotavirus Vaccines: an Overview, Clinical Microbiology Reviews, Jul. 1996, vol. 9, No. 3 pp. 423-434.
Clements-Mann et al., Safety and Immunogenicity of live attenuated human-bovine reassortant rotavirus vaccines with VP7-specificity for serotypes 1, 2, 3 or 4 in adults, children and infants, Vaccine, 1999, vol. 17, Issues 20-21, pp. 2715-2725.
Bernstein et al., “Evaluation of WC3 rotavirus vaccine and correlates of protection in healthy infants,”J. Infect. Dis. 162:1055-1062 (1990).
Bernstein et al., “Evaluation of rhesus rotavirus monovalent and tetravalent reassortant vaccines in US children. US Rotavirus Vaccine Efficacy Group,”JAMA273:1191-1196 (1995).
Christy et al., “Evaluation of a bovine-human rotavirus reassortant vaccine in infants,”J. Infect. Dis. 168:1598-1599 (1993).
Clark et al., “Immune response of infants and children to low-passage bovine rotavirus (strain WC3),”Am. J. Dis. Child. 140:350-356 (1986).
Clark et al., “Immune protection of infants against rotavirus gastroenteritis by a serotype 1 reassortant of bovine rotavirus WC3,”J. Infect. Dis. 161:1099-1104 (1990).
Clark et al., “Serotype 1 reassortant of bovine rotavirus WC3, strain WI79-9, induces a polytypic antibody response in infants,”Vaccine8:327-332 (1990).
Clements-Mann et al., “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,”Vaccine17:20-21 (1999).
Dagan et al., “Safety and immunogenicity of oral tetravalent human-rhesus reassortant vaccine in neonates,”Pediatr. Infect. Dis. J11:991-996 (1992).
Flores et al., “Reactions to and antigenicity of two human-rhesus rotavirus reassortant vaccine candidates of serotypes 1 and 2 in Venezuelan inflants,”J. Clin. Microbiol. 27:512-518 (1989).
Flores et al., “Comparison of reactogenicity and antigenicity of M37 rotavirus vaccine and rhesus-rotavirus-based quadrivalent vaccine,”Lancet336:330-3374 (1990).
Flores et al., “Reactogenicity and immunogenicity of a high-titer rhesus rotavirus-based quadrivalent rotavirus vaccine,”J. Clin. Microbiol. 31:2439-2445 (1993).
Gay et al., “Rotavirus vaccination and intussusception,”Lancet354:956 (1999).
Green et al., “Comparison of the amino acid sequences of the major neutralization protein of four human rotavirus serotypes,”Virology161:153-159 (1987).
Green et al., “Prediction of human rotavirus serotype by nucleotide sequence analysis of the VP7 protein gene,”J. Virol. 62:1819-1823 (1988).
Green et al., “Sequence analysis of the gene encoding the serotype-specific glycoprotein (VP7) of two new human rotavirus serotypes,”Virology168:429-433 (1989).
Green et al., “Homotypic and heterotypic epitope-specific antibody responses in adult and infant rotavirus vaccinees: implications for vaccine development,”J. Infect. Dis. 161:667-679 (1990).
Halsey et al., “Human-rhesus reassortant rotavirus vaccines: safety and immunogenicity in adults, infants, and children,”J. Infect Dis. 158:1261-1267 (1988).
Hoshino et al., “Serotypic characterization of rotaviruses derived from asymptomatic human neonatal infections,”J. Clin. Microbiol. 21:425-430 (1985).
Joensuu et al., “Randomised placebo-controlled trial of rhesus-human reassortant rotavirus vaccine for prevention of severe rotavirus gastroenteritis,”Lancet350:1205-1209 (1997).
Kapikian et al., “Rhesus rhotavirus: A candidate vaccine for prevention of human rotavirus disease,”Vaccines85, Chanock et al., eds., Cold Spring Harbor Laboratory Press, Cold Spring Harbor, New York, pp. 357-367 (1985).
Kapikian et al., “Development of a rotavirus vaccine by a ‘Jennerian’ and a modified ‘Jennerian’ approach,”Vaccines88, Chanock et al., eds., Cold Spring Harbor Laboratory Press, Cold Spring Harbor, New York, pp. 151-159 (1988).
Kapikian et al., “An update on the ‘Jennerian’ and modified ‘Jennerian’ approach to vaccination of infants and young children against rotavirus diarrhea,”Adv. Exp. Med. Biol. 327:59-69 (1992).
Kapikian et al., “Jennerian and modified Jennerian approach to vaccination against rotavirus diarrhea using a quadrivalent rhesus rotavirus (RRV) and human-RRV reassortant vaccine,”Arch. Virol. 12:163-175 (1996).
Kapikian et al., “Efficacy of a quadrivalent rhesus rotavirus-based human rotavirus vaccine aimed at preventing severe rotavirus diarrhea in infants and young children,”J. Infect. Diseases174:S65-72 (1996).
Madore et al., “Field trial of rhesus rotavirus or human-rhesus rotavirus reassortant vaccine of VP7 serotype 3 or 1 specificity in infants,”J. Infect. Dis. 166:235-243 (1992).
Midthun and Kapikian, “Rotavirus Vaccines: An Overview,”Clinical Microbiology Reviews, US, Wa, DC, 9(3):432-434 (1996).
Midthun et al., “Reassortant rotaviruses as potential live rotavirus vaccine candidates,”J. Virol. 53:949-954 (1985).
Midthun et al., “Single gene substitution rotavirus reassortants containing the major neutralization protein (VP7) of human rotavirus serotype 4,”J. Clin. Microbiol. 24:822-826 (1986).
Midthun et al., “Comparison of immunoglobulin A (IgA), IgG, and IgM enzyme-linked immunosorbent assays, plaque reduction neutralization assay, and complement fixation in detecting seroresponses to rotavirus vaccine candidates,”J. Clin. Microbiol. 27:2799-2804 (1989).
Nakagomi et al., “Isolation and molecular characterization of a serotype 9 human rotavirus strain,”Microbiol. Immunol. 34:77-82 (1990).
Perez-Schael et al., “Clinical studies of a quadrivalent rotavirus vaccine in Venezuelan infants,”J. Clin. Microbiol. 28:553-558 (1990).
Ramin Shadman, “The withdrawl of the rotashield rotavirus vaccination due to an association with intussusception: fact or fiction?”,Vaccine Revolution Papers, Stanford University, pp. 1-5 (2000).
Rennels et al., “Lack of an apparent association between intussusception and wild or vaccine rotavirus infection,”Ped Infant10:924-925 (1998).
Simasathien et al., “Vaccination of Thai infants with rhesus-human reassortant tetravalent oral rotavirus vaccine,”Pediatr. Infect. Dis. J. 13:590-596 (1994).
Taniguichi et al., “Antibody response to serotype-specific and cross-reactive neutralization epitopes on VP4 and VP7 after rotavirus infection or vaccination,”J. Clin. Microbiol. 29:483-487 (1991).
Timenetsky et al., “A novel human rotavirus serotype with dual G5-G11 specificity,”J. Gen. Virol. 78:1373-1378 (1997).
Treanor et al., “Evaluation of the protective efficacy of a serotype 1 bovine-human rotavirus reassortant vaccine in infants,&#
Chanock Robert
Kapikian Albert Z.
Vesikari Timo
Campell Bruce
Hurt Sharon
The United States of America as represented by the Department of
Townsend and Townsend / and Crew LLP
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