Background

In response to the detection of porcine circovirus type 1 (PCV-1) in the human rotavirus vaccine (HRV), a PCV-free HRV (no detection of PCV-1 and PCV-2 according to the detection limit of tests used) was developed. Liquid (Liq) PCV-free HRV previously showed immunogenicity and safety profiles comparable to lyophilized (Lyo) HRV.

Methods

This was a phase 3a, randomized, single-blind study (NCT03207750) conducted in the United States. Healthy infants aged 6–12 weeks received 2 doses (0, 2 months) of either Liq PCV-free HRV or Lyo HRV with routine vaccines (0, 2, 4 months): diphtheria-tetanus-acellular pertussis, hepatitis B and inactivated poliovirus combination vaccine (DTaP-HBV-IPV), monovalent tetanus toxoid-conjugated vaccine against Haemophilus influenzae type b (Hib-TT), and 13-valent pneumococcal conjugate vaccine. Co-primary objectives were: (i) to assess non-inferiority of immune responses to routine vaccine antigens 1 month post-dose 3 following co-administration with Liq PCV-free HRV compared to Lyo HRV; (ii) to rule out a 10% decrease in seroresponse to pertussis antigens after dose 3. Other objectives were to evaluate immunogenicity and safety of HRV vaccines.

Results

Of 1272 vaccinated infants, 990 (489 in Liq PCV-free HRV and 501 in Lyo HRV group) were included in the per-protocol set. All statistical criteria were met, thus co-primary objectives were demonstrated. Seroprotection/seropositivity rates in both groups were high: 100% for diphtheria/tetanus, ≥99.3% for HBV, ≥99.8% for polio, ≥99.8% for each pertussis antigen, ≥90.8% for all pneumococcal serotypes except serotype 3 (≥69.1%), and ≥ 97.4% for Hib. Most infants seroconverted for anti-RV antibodies (76.3% of Liq PCV-free HRV and 78.9% of Lyo HRV recipients). Geometric mean concentrations/titers were comparable between groups. Incidences of adverse events and serious adverse events were similar between groups.

Conclusion

Routine pediatric vaccines co-administered with Liq PCV-free HRV showed non-inferior immune responses and similar safety profiles to those following co-administration with Lyo HRV.

中文翻译：

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在美国婴儿中同时使用人类轮状病毒疫苗（无猪圆环病毒）的液体制剂和常规儿童期疫苗：一项3期随机试验的结果

背景

响应于在人轮状病毒疫苗（HRV）中检测到猪圆环病毒1型（PCV-1），采用不含PCV的HRV（根据所用测试的检测限，未检测到PCV-1和PCV-2）。发达。不含PCV的液态（Liq）HRV先前显示出与冻干（Lyo）HRV相当的免疫原性和安全性。

方法

这是在美国进行的3a期随机单盲研究（NCT03207750）。6–12周龄的健康婴儿接受了2剂（0、2个月）无Liq PCV的HRV或Lyo HRV的常规疫苗（0、2、4个月）：白喉-破伤风-无细胞百日咳，乙型肝炎和脊髓灰质炎病毒灭活联合疫苗（DTaP-HBV-IPV），针对流感嗜血杆菌的单价破伤风类毒素结合疫苗b型（Hib-TT）和13价肺炎球菌结合疫苗。共同主要目标是：（i）与不含Leq HRV的Liq PCV HRV共同给药后，评估3剂后1个月后对常规疫苗抗原的免疫反应的非劣性；（ii）排除第3剂对百日咳抗原的血清反应降低10％。其他目标是评估HRV疫苗的免疫原性和安全性。

结果

在每个协议集中，包括了1272名接种疫苗的婴儿，其中990名（无Liq PCV的HRV组为489名，Lyo HRV组为501名）。满足所有统计标准，因此证明了共同主要目标。两组的血清保护/血清阳性率均很高：白喉/破伤风为100％，HBV≥99.3％，脊髓灰质炎≥99.8％，每种百日咳抗原≥99.8％，所有肺炎球菌血清型均为3型（≥69.1≥90.8％） ％），Hib≥97.4％。大多数婴儿血清转化为抗RV抗体（不含Liq PCV的HRV为76.3％，接受Lyo HRV的为78.9％）。两组之间的几何平均浓度/滴度可比。两组之间不良事件和严重不良事件的发生率相似。

结论

与不含Liq PCV的HRV共同使用的常规儿科疫苗显示出与Lyo HRV共同使用后的免疫反应相似且安全性低的免疫反应。