생후 6-12주 영아를 대상으로 진행된 연구에서, 로타텍은 로타바이러스 G1-G4로 인한 위장관염 입원/응급실 방문에 94.5%(95% CI 91.2-96.6)의 감소1,a를 보였으며, 접종 차수 사이의 효과는 1차 접종 14일 후부터 2차 접종까지 100%(95% CI 72-100), 2차 접종 14일부터 3차 접종까지 91%(95% CI 63-99) 감소를 나타냈습니다.2,b
로타텍은 반드시 3차까지 접종을 하여야 합니다.
이 백신은 매 회차에 1튜브(2ml) 전량을 경구투여하고, 3차에 걸쳐 투여합니다.
다른 백신과 마찬가지로, 이 백신이 모든 투여자에서 완전한 예방효과를 보이지 않을 수도 있습니다. *로타텍은 대조군 대비 장중첩증의 발생 증가가 관찰 되지 않았습니다.1, a (로타텍은 장중첩증의 병력을 가진 영아에게 투여 금기입니다.3)
Vesikari T, Matson DO, Dennehy P, et al; Rotavirus Efficacy and Safety Trial (REST) Study Team. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med. 2006;354(1):23–33.
Dennehy PH, et al. Efficacy of the pentavalent rotavirus vaccine, RotaTeq® (RV5), between doses of a 3-dose series and with less than 3 doses (incomplete regimen). Hum Vaccin 2011;7(5):563-8.
로타텍 허가사항. 식품의약품안전처
REST was a double-blind, placebo-controlled, randomized, multinational trial conducted from 2001 to 2004. Healthy infants 6 to 12 weeks of age were randomized to receive 3 oral doses of RotaTeq or placebo at 4- to 10-week intervals. The primary end point was safety with regard to intussusception, with nested adverse event and clinical efficacy substudies. Protective efficacy was measured approximately 14 days after the third dose.
REST was a large-scale, placebo-controlled, multicenter, randomized clinical trial that enrolled nearly 70,000 infants year round. Healthy infants between 6 and 12 weeks of age at dose 1 were randomized 1:1 to receive 3 oral doses of RV5 or placebo. Post-hoc analyses. Efficacy between doses of RV5, as measured by a reduction in the rate of RVGE-related health care encounters, including hospitalizations and ED visits, among infants who received all 3 doses of RV5 or placebo was evaluated to examine whether the vaccine confers early protection before completion of the 3-dose regimen. The efficacy of RV5 for infants who received only 1 dose or only 2 doses of vaccine or placebo was also evaluated. Among infants who completed the 3-dose vaccination series and were not protocol violators (i.e., per-protocol population), vaccine efficacy between doses was measured using 2 analyses that differed with regard to the time interval used: (1) Analysis A, defined as ≥14 days PD1 up to dose 2 and ≥ 14 days PD2 up to dose 3; and (2) Analysis B, defined as ≥14 days PD1 through 13 days PD2 and from ≥14 days PD2 through 13 days PD3
사람 –소 균주 백신이라던데..?
2007년 8월, 우리나라에 가장 먼저 출시된 로타바이러스 백신 로타텍®은,1 사람과 소에서 분리된 로타바이러스 주를
배열하여 만든 5개의 재배열 로타바이러스 주(G1, G2, G3, G4, P1A)가 포함되어 있습니다.2