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Safety, efficacy, and immunogenicity of 2 doses of bovine-human (UK) and rhesus-rhesus-human rotavirus reassortant tetravalent vaccines in Finnish children.
J Infect Dis 2006; 194(3):370-6JI

Abstract

BACKGROUND

Live oral rhesus-rhesus-human rotavirus reassortant tetravalent (RRV-TV) vaccine was efficacious against rotavirus gastroenteritis but was withdrawn because of a rare association with intussusception. A corresponding tetravalent (types G1, G2, G3, and G4) reassortant vaccine based on bovine-human (UK) rotavirus reassortant tetravalent (BRV-TV) vaccine was developed concurrently.

METHODS

Before the withdrawal of RRV-TV vaccine, parallel placebo-controlled trials of BRV-TV vaccine (observer blinded) versus RRV-TV vaccine (double blinded) with a 2 : 1 ratio of vaccine : placebo were conducted in Finland in a total of 510 infants. Two doses of study vaccine or placebo were administered at ages 3 and 5 months.

RESULTS

The first dose of RRV-TV vaccine was followed by a significant excess rate of febrile reactions (36%), whereas the rate of fever after the administration of BRV-TV vaccine did not differ significantly from that in the placebo group. Neither vaccine induced diarrhea. A seroresponse was detected in 97% of BRV-TV vaccine recipients and 94% of RRV-TV vaccine recipients. Both vaccines were equally effective, with 68%-69% efficacy against any and 88%-100% efficacy against severe rotavirus gastroenteritis during the first epidemic season.

CONCLUSIONS

BRV-TV vaccine is a promising new candidate rotavirus vaccine, with low reactogenicity and high efficacy. Two doses of BRV-TV or RRV-TV vaccine are sufficient for the induction of protection against severe rotavirus disease.

Authors+Show Affiliations

Vaccine Research Center, University of Tampere Medical School, Tampere, Finland. timo.vesikari@uta.fiNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

16826486

Citation

Vesikari, Timo, et al. "Safety, Efficacy, and Immunogenicity of 2 Doses of Bovine-human (UK) and Rhesus-rhesus-human Rotavirus Reassortant Tetravalent Vaccines in Finnish Children." The Journal of Infectious Diseases, vol. 194, no. 3, 2006, pp. 370-6.
Vesikari T, Karvonen AV, Majuri J, et al. Safety, efficacy, and immunogenicity of 2 doses of bovine-human (UK) and rhesus-rhesus-human rotavirus reassortant tetravalent vaccines in Finnish children. J Infect Dis. 2006;194(3):370-6.
Vesikari, T., Karvonen, A. V., Majuri, J., Zeng, S. Q., Pang, X. L., Kohberger, R., ... Kapikian, A. Z. (2006). Safety, efficacy, and immunogenicity of 2 doses of bovine-human (UK) and rhesus-rhesus-human rotavirus reassortant tetravalent vaccines in Finnish children. The Journal of Infectious Diseases, 194(3), pp. 370-6.
Vesikari T, et al. Safety, Efficacy, and Immunogenicity of 2 Doses of Bovine-human (UK) and Rhesus-rhesus-human Rotavirus Reassortant Tetravalent Vaccines in Finnish Children. J Infect Dis. 2006 Aug 1;194(3):370-6. PubMed PMID: 16826486.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety, efficacy, and immunogenicity of 2 doses of bovine-human (UK) and rhesus-rhesus-human rotavirus reassortant tetravalent vaccines in Finnish children. AU - Vesikari,Timo, AU - Karvonen,Aino V, AU - Majuri,Jukka, AU - Zeng,Shang-Qin, AU - Pang,Xiao-Li, AU - Kohberger,Robert, AU - Forrest,Bruce D, AU - Hoshino,Yasutaka, AU - Chanock,Robert M, AU - Kapikian,Albert Z, Y1 - 2006/06/23/ PY - 2006/01/10/received PY - 2006/03/03/accepted PY - 2006/7/11/pubmed PY - 2007/12/6/medline PY - 2006/7/11/entrez SP - 370 EP - 6 JF - The Journal of infectious diseases JO - J. Infect. Dis. VL - 194 IS - 3 N2 - BACKGROUND: Live oral rhesus-rhesus-human rotavirus reassortant tetravalent (RRV-TV) vaccine was efficacious against rotavirus gastroenteritis but was withdrawn because of a rare association with intussusception. A corresponding tetravalent (types G1, G2, G3, and G4) reassortant vaccine based on bovine-human (UK) rotavirus reassortant tetravalent (BRV-TV) vaccine was developed concurrently. METHODS: Before the withdrawal of RRV-TV vaccine, parallel placebo-controlled trials of BRV-TV vaccine (observer blinded) versus RRV-TV vaccine (double blinded) with a 2 : 1 ratio of vaccine : placebo were conducted in Finland in a total of 510 infants. Two doses of study vaccine or placebo were administered at ages 3 and 5 months. RESULTS: The first dose of RRV-TV vaccine was followed by a significant excess rate of febrile reactions (36%), whereas the rate of fever after the administration of BRV-TV vaccine did not differ significantly from that in the placebo group. Neither vaccine induced diarrhea. A seroresponse was detected in 97% of BRV-TV vaccine recipients and 94% of RRV-TV vaccine recipients. Both vaccines were equally effective, with 68%-69% efficacy against any and 88%-100% efficacy against severe rotavirus gastroenteritis during the first epidemic season. CONCLUSIONS: BRV-TV vaccine is a promising new candidate rotavirus vaccine, with low reactogenicity and high efficacy. Two doses of BRV-TV or RRV-TV vaccine are sufficient for the induction of protection against severe rotavirus disease. SN - 1537-6613 UR - https://www.unboundmedicine.com/medline/citation/16826486/Safety_efficacy_and_immunogenicity_of_2_doses_of_bovine_human__UK__and_rhesus_rhesus_human_rotavirus_reassortant_tetravalent_vaccines_in_Finnish_children_ L2 - https://academic.oup.com/jid/article-lookup/doi/10.1086/505151 DB - PRIME DP - Unbound Medicine ER -