Safety, efficacy, and immunogenicity of a live, quadrivalent human-bovine reassortant rotavirus vaccine in healthy infants

详细信息    查看全文

• 作者：H. Fred Clark ; David I. Bernstein ; Penelope H. Dennehy ; Paul Offit ; Michael Pichichero ; John Treanor ; Richard L. Ward ; David L. Krah ; Alan Shaw ; Michael J. Dallas ; Laura Digilio ; Joseph J. Eiden ; Nathalie Ivanoff ; Karen M. Kaplan ; Penny Heaton
• 刊名：The Journal of Pediatrics
• 出版年：2004
• 出版时间：February 2004
• 年：2004
• 卷：144
• 期：2
• 页码：184-190
• 全文大小：149 K

文摘

Objectives

To investigate safety, efficacy, and immunogenicity of live quadrivalent rotavirus vaccine (QRV) containing human-bovine (WC3) reassortant rotavirus serotypes G1, G2, G3, and P1a.

Study design

This was a randomized, double-blinded, placebo-controlled trial. During 1993 to 1994, at 10 US study sites, 439 healthy infants 2 to 6 months of age, were enrolled to receive 3 doses of oral QRV or placebo at approximately 8-week intervals.

Results

The vaccine was generally well tolerated; no serious vaccine-related adverse experiences were reported. Risk differences and 95 % confidence intervals suggested no differences between vaccine and placebo recipients in the incidences of fever, irritability, vomiting, or diarrhea during the 14 days after any dose. QRV was 74.6 % efficacious (95 % CI: 49.5 % , 88.3 % ) in preventing rotavirus acute gastroenteritis (AGE), regardless of severity and 100 % efficacious (95 % CI: 43.5 % , 100 % ) in preventing severe rotavirus AGE through one rotavirus season. Serotype G1 was identified in most infants with rotavirus AGE. A ≥3-fold rise in serum neutralizing antibody to G1 was observed in 57 % (45/79) of vaccinees. A ≥3-fold rise in serum anti-rotavirus IgA and fecal anti-rotavirus IgA was observed in 88 % (162/185) and 65 % (104/159) of vaccinees, respectively.

Conclusions

QRV was generally well tolerated, immungenic, and highly effective against rotavirus gastroenteritis.