Perez-Schael I, Blanco M, Garcia D, White L, Alfonzo E, Crespo I, Cunto W, Pittman A L, Kapikian A Z, Flores J
Instituto de Biomedicina, IBM de Venezuela, Centro Cientifico (W.C.), Caracas.
J Med Virol. 1994 Apr;42(4):330-7. doi: 10.1002/jmv.1890420403.
Three phase I trials of the rhesus rotavirus (RRV)-based quadrivalent vaccine [composed of serotype 3 (RRV), and serotypes 1 (D x RRV), 2 (DS1 x RRV), and 4 (ST3 x RRV) human rotavirus x RRV reassortants] and the M37 (nursery strain) rotavirus vaccine candidates were conducted in an attempt to find a safe and optimally antigenic formulation. Infants 10-20 weeks old received, in trial I, 1) the quadrivalent vaccine as two separate bivalent doses (1 x 10(4) PFU each of D x RRV and RRV, followed 4 weeks later by 1 x 10(4) PFU each of DS1 x RRV and ST3 x RRV) or 2) placebo; in trial II, 1) one dose of quadrivalent vaccine (10(4) PFU of each component), or 2) two doses of quadrivalent vaccine, or 3) a 10(4) PFU dose of M37 vaccine, or 4) M37 vaccine followed by the quadrivalent vaccine, or 5) placebo; in trial III, 1) a dose of a higher-titered quadrivalent vaccine (10(5) PFU of each component), or 2) two doses of higher titered quadrivalent vaccine, or 3) a dose of higher titered M37 vaccine (10(5) PFU) or 4) two doses of M37 vaccine (10(5) PFU), or 5) M37 vaccine (10(5) PFU) followed by the higher titered quadrivalent vaccine, or 6) placebo. A mild, transient fever during the first week postvaccination was associated with the bivalent or quadrivalent vaccines but not with the M37 vaccine. Fourfold or greater serum IgA ELISA responses to rotavirus were observed in 48-92% of the infants receiving quadrivalent vaccine and in 32-50% of those receiving M37 vaccine.(ABSTRACT TRUNCATED AT 250 WORDS)
开展了三项I期试验，研究基于恒河猴轮状病毒（RRV）的四价疫苗[由3型（RRV）以及1型（D x RRV）、2型（DS1 x RRV）和4型（ST3 x RRV）人轮状病毒x RRV重配株组成]和M37（托儿所毒株）轮状病毒候选疫苗，试图找到一种安全且抗原性最佳的制剂。10至20周龄的婴儿在试验I中接受：1）四价疫苗，分两次接种不同的二价剂量（每次接种1×10⁴ PFU的D x RRV和RRV，4周后再分别接种1×10⁴ PFU的DS1 x RRV和ST3 x RRV）；或2）安慰剂；在试验II中接受：1）一剂四价疫苗（每种成分10⁴ PFU）；或2）两剂四价疫苗；或3）10⁴ PFU剂量的M37疫苗；或4）先接种M37疫苗，再接种四价疫苗；或5）安慰剂；在试验III中接受：1）一剂更高滴度的四价疫苗（每种成分10⁵ PFU）；或2）两剂更高滴度的四价疫苗；或3）一剂更高滴度的M37疫苗（10⁵ PFU）；或4）两剂M37疫苗（10⁵ PFU）；或5）先接种M37疫苗（10⁵ PFU），再接种更高滴度的四价疫苗；或6）安慰剂。接种疫苗后第一周出现的轻度、短暂发热与二价或四价疫苗有关，但与M37疫苗无关。在接受四价疫苗的婴儿中，48%至92%的婴儿对轮状病毒的血清IgA ELISA反应呈四倍或更高倍数增加，在接受M37疫苗的婴儿中，这一比例为32%至50%。（摘要截选至250词）
