Chandola Temsunaro Rongsen, Taneja Sunita, Goyal Nidhi, Antony Kalpana, Bhatia Kiran, More Deepak, Bhandari Nita, Cho Iksung, Mohan Krishna, Prasad Sai, Harshavardhan Gvja, Rao Tataji Surender, Vrati Sudhanshu, Bhan Maharaj Kishan
Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.
Population Science Partnership Centre, Translational Health Science and Technology Institute, Faridabad, Haryana, India.
Heliyon. 2017 May 16;3(5):e00302. doi: 10.1016/j.heliyon.2017.e00302. eCollection 2017 May.
A phase III randomized double-blind placebo-controlled trial was conducted in the urban neighborhoods of Delhi to assess whether Oral Rotavirus Vaccine ROTAVAC interferes with the immune response to childhood vaccines when coadministered. Infants aged 6 weeks were randomized to receive three doses of either ROTAVAC or placebo along with childhood vaccines: Oral Polio Vaccine and vaccines against Diphtheria, Pertussis, Tetanus, Hepatitis B and type b given as Pentavalent at 6, 10, 14 weeks of age. Blood specimens were collected from all infants at baseline and 4 weeks post dose 3 to assess the immune response to antigens in Oral Polio Vaccine, Pentavalent and ROTAVAC vaccines. Non-inferiority of immune response to all vaccine components of the childhood vaccines when ROTAVAC was administered concurrently was demonstrated. Non-inferior immune responses to childhood vaccines were evaluated based on the seroprotective levels of antibodies against polio types 1, 2, and 3, Diphtheria toxoid, Tetanus toxoid, type b anti- polyribosyl ribitol phosphate antibodies and Hepatitis B antibodies; and the Geometric Mean Concentration for Pertussis. The proportion of infants who seroconverted (≥4 fold rise) was 38.6% in the ROTAVAC group and 12.2% in the placebo group. The frequency and severity of immediate adverse events, adverse events and serious adverse events were similar in both groups. None of the five reported deaths were considered to be related to the ROTAVAC and no case of intussusception meeting Brighton Diagnostic Certainty Level I criteria was reported. This study demonstrated that ROTAVAC can be safely administered with childhood vaccines without interfering with the immune response to the antigens contained in these vaccines.
在德里的城市社区进行了一项III期随机双盲安慰剂对照试验，以评估口服轮状病毒疫苗ROTAVAC与儿童疫苗同时接种时是否会干扰免疫反应。6周龄的婴儿被随机分为接受三剂ROTAVAC或安慰剂，同时接种儿童疫苗：口服脊髓灰质炎疫苗以及针对白喉、百日咳、破伤风、乙型肝炎和b型流感嗜血杆菌的疫苗（以五联疫苗形式在6、10、14周龄时接种）。在基线时以及第三剂接种后4周从所有婴儿采集血样，以评估对口服脊髓灰质炎疫苗、五联疫苗和ROTAVAC疫苗中抗原的免疫反应。结果表明，同时接种ROTAVAC时，对儿童疫苗所有成分的免疫反应无劣效性。基于针对脊髓灰质炎1型、2型和3型、白喉类毒素、破伤风类毒素、b型流感嗜血杆菌抗多聚核糖基核糖醇磷酸抗体和乙型肝炎抗体的血清保护水平，以及百日咳的几何平均浓度，评估了对儿童疫苗的非劣效免疫反应。血清转化（≥4倍升高）的婴儿比例在ROTAVAC组为38.6%，在安慰剂组为12.2%。两组中即时不良事件、不良事件和严重不良事件的频率和严重程度相似。报告的五例死亡均被认为与ROTAVAC无关，且未报告符合布莱顿诊断确定性I级标准的肠套叠病例。这项研究表明，ROTAVAC可以与儿童疫苗安全同时接种，而不会干扰对这些疫苗中所含抗原的免疫反应。
