Safety and Efficacy of a Pentavalent Human–Bovine (WC3) Reassortant Rotavirus Vaccine

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Journal Article 1 Mention

Timo Vesikari•2006

David O. MatsonPenelope H. Dennehy

Top 5% · 95th percentile

1,882 citations · Infectious Diseases

Open Access

TLDR

A new oral vaccine for babies can prevent most serious stomach illnesses caused by rotavirus, and it is just as safe as not getting the vaccine.

Summary

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1 Study Aim

The main goal of this study was to find out if a new oral vaccine, made from both human and cow rotavirus strains (called the pentavalent human–bovine WC3 reassortant rotavirus vaccine), is safe and works well to prevent rotavirus gastroenteritis (a stomach infection that causes diarrhea and vomiting) in young infants. Simply put: The study wanted to see if this new vaccine keeps babies safe from getting very sick from rotavirus.

2 Study Design

Researchers conducted a large, randomized, double-blind, placebo-controlled trial. They enrolled healthy infants aged 6 to 12 weeks. The infants were randomly assigned to receive either three doses of the live pentavalent human–bovine (WC3 strain) reassortant rotavirus vaccine or a placebo. The doses were given by mouth at intervals of 4 to 10 weeks. The study used active surveillance to track serious side effects and other health events in both groups. Over 68,000 infants participated, with about half in each group. Simply put: Babies were randomly given either the vaccine or a fake treatment, and doctors watched closely for any health problems.

3 Findings

The study reports that the vaccine did not increase the risk of intussusception (a rare type of bowel blockage), with similar numbers of cases in both the vaccine and placebo groups. The vaccine was highly effective, reducing hospital visits and emergency care for rotavirus gastroenteritis caused by the main virus types (G1-G4) by 94.5% after the third dose. In a smaller group within the study, the vaccine prevented 74% of all rotavirus gastroenteritis cases and 98% of severe cases during the first rotavirus season after vaccination. The vaccine also reduced clinic visits for rotavirus by 86%. The authors conclude that the vaccine is both safe and very effective at preventing serious rotavirus illness in infants. Simply put: The vaccine kept most babies from getting very sick from rotavirus and did not cause more serious side effects than not getting the vaccine.

Abstract

BACKGROUND: Rotavirus is a leading cause of childhood gastroenteritis and death worldwide. METHODS: We studied healthy infants approximately 6 to 12 weeks old who were randomly assigned to receive three oral doses of live pentavalent human-bovine (WC3 strain) reassortant rotavirus vaccine containing human serotypes G1, G2, G3, G4, and P[8] or placebo at 4-to-10-week intervals in a blinded fashion. Active surveillance was used to identify subjects with serious adverse and other events. RESULTS: The 34,035 infants in the vaccine group and 34,003 in the placebo group were monitored for serious adverse events. Intussusception occurred in 12 vaccine recipients and 15 placebo recipients within one year after the first dose including six vaccine recipients and five placebo recipients within 42 days after any dose (relative risk, 1.6; 95 percent confidence interval, 0.4 to 6.4). The vaccine reduced hospitalizations and emergency department visits related to G1-G4 rotavirus gastroenteritis occurring 14 or more days after the third dose by 94.5 percent (95 percent confidence interval, 91.2 to 96.6 percent). In a nested substudy, efficacy against any G1-G4 rotavirus gastroenteritis through the first full rotavirus season after vaccination was 74.0 percent (95 percent confidence interval, 66.8 to 79.9 percent); efficacy against severe gastroenteritis was 98.0 percent (95 percent confidence interval, 88.3 to 100 percent). The vaccine reduced clinic visits for G1-G4 rotavirus gastroenteritis by 86.0 percent (95 percent confidence interval, 73.9 to 92.5 percent). CONCLUSIONS: This vaccine was efficacious in preventing rotavirus gastroenteritis, decreasing severe disease and health care contacts. The risk of intussusception was similar in vaccine and placebo recipients. (ClinicalTrials.gov number, NCT00090233.)

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