Sil Arijit, Ravi Mandyam D, Patnaik Badri N, Dhingra Mandeep S, Dupuy Martin, Gandhi Dulari J, Dhaded Sangappa M, Dubey Anand P, Kundu Ritabrata, Lalwani Sanjay K, Chhatwal Jugesh, Mathew Leni G, Gupta Madhu, Sharma Shiv D, Bavdekar Sandeep B, Rout Soumya P, Jayanth Midde V, D'Cor Naveena A, Mangarule Somnath A, Ravinuthala Suresh, Reddy E Jagadeesh
Shantha Biotechnics Private Limited - A Sanofi Company, Hyderabad, India.
Dept. of Pediatrics, JSS Medical College, Mysore, India.
Vaccine. 2017 May 19;35(22):2999-3006. doi: 10.1016/j.vaccine.2017.03.009. Epub 2017 Apr 24.
Vaccination is considered as the most cost effective method for preventing infectious diseases. Low grade fever is a known adverse effect of vaccination. In India, it is a common clinical practice to prescribe paracetamol either prophylactically or therapeutically to manage fever. Some studies have shown that paracetamol interferes with antibody responses following immunization. This manuscript reports the outcome of a post hoc analysis of data from a clinical trial of a pentavalent vaccine in Indian infants where paracetamol was not used or was used either as prophylaxis or for treatment of fever.
Pre and post vaccine antibody levels against Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus influenzae type B were assessed in no paracetamol and paracetamol groups. The paracetamol group was further divided into prophylactic and treatment groups.
Similar rates of seroprotection/seroresponse for anti-D, anti-T, anti-wP, anti-PT, anti-HBs and anti-PRP were observed in all the groups. There was no clear tendency for difference in percentage seroprotection/seroresponse and geometric mean (GM) titers in any of the groups.
The study found no evidence that paracetamol usage either as prophylactic or for treatment impact immunological responses to DTwP-HepB-Hib combination vaccine. [Clinical trial registry of India (study registration number CTRI/2012/08/002872)].
疫苗接种被认为是预防传染病最具成本效益的方法。低热是疫苗接种已知的不良反应。在印度，预防性或治疗性开具对乙酰氨基酚来处理发热是常见的临床做法。一些研究表明，对乙酰氨基酚会干扰免疫接种后的抗体反应。本手稿报告了一项针对印度婴儿五价疫苗临床试验数据的事后分析结果，该试验中未使用对乙酰氨基酚，或使用对乙酰氨基酚进行预防或治疗发热。
在未使用对乙酰氨基酚组和使用对乙酰氨基酚组中评估疫苗接种前后针对白喉、破伤风、百日咳、乙型肝炎、B型流感嗜血杆菌的抗体水平。使用对乙酰氨基酚组进一步分为预防组和治疗组。
在所有组中观察到抗D、抗T、抗wP、抗PT、抗HBs和抗PRP的血清保护/血清反应率相似。在任何组中，血清保护/血清反应百分比和几何平均（GM）滴度均无明显差异趋势。
该研究未发现证据表明预防性或治疗性使用对乙酰氨基酚会影响白百破-乙肝- Hib联合疫苗的免疫反应。[印度临床试验注册中心（研究注册号CTRI/2012/08/002872）]
