Enhancing Rabies Immunity: A Comparative Study of Antibody Responses Post-3rd Vaccine Dose with Different Immunoglobulin Approaches.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Antibody titres via RFFIT on day 14 i.e 7 days after 3rd dose of anti rabies vaccine.
研究概览
简要总结
Rabies is a 100% fatal yet 100% vaccine preventable disease of central nervous system.Globally and especially in India cases of animal bite are on the rise with an estimated 55000 deaths globally and 20000 alone in India.The high number of deaths can be attributed to lack of awareness about management and seriousness of disease amongst people and also due to non adherence to post exposure prophylaxis which involves 4 dose of anti rabies vaccine with or without RIG over a period of 1 month.
National immunization technical advisory group are advised to review their policies for post exposure prophylaxis and consider adopting intradermal vaccination of shorter duration of 0,3 and 7 as recommended by pasteur institute of cambodia reducing time of schedule from 1 month to 1 week by eliminating 4th dose which is also the most commonly missed dose by patients as advocated by many studies.Also Who in its position paer on Rabies in April 2018 has again advocated for wound only infiltration of RIG/RMAB which not only saves biologicals and patients but is also non inferior to giving any remaining RIG in site distant from site of bite which results in wastage of biologicals.
With above in mind we wish to evaluate -
-
Estimation of Antibody titre on day 14 by RFFIT with weight based RIG in one group and wound based RIG in another.
-
To know socio demographic profile and treatment seeking behaviour amongst these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All new cases of animal bites with no prior history of exposure to animal bite and willing to continue treatment from our Centre will be included in study.
排除标准
- •Those patients found reactive to equine immunoglobulin test dose.
- •Individuals with compromised immune systems.(HIV/TB/RA/DM/HCV/others) 3) Pregnant women.
- •Previous documented immunization against rabies.
- •Patients not adhering to ARV schedule as prescribed will be excluded.
- •Referred from other Centre for only RIG infiltration.
结局指标
主要结局
Antibody titres via RFFIT on day 14 i.e 7 days after 3rd dose of anti rabies vaccine.
时间窗: Antibody titres via RFFIT on day 14 i.e 7 days after 3rd dose of anti rabies vaccine.
次要结局
- Comparison of antibody titre amongst group receiving wound only RIG compared to group receiving weight based RIG.(After receiving antibody titre results)
研究者
AMANDEV SINGH
Government Medical College and Rajindra Hospital Patiala