AN OPEN-LABEL, SINGLE-TREATMENT, SINGLE-PERIOD, SINGLE DOSE, CLINICAL PHASE 1 STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF TETANUS VACCINE IN HEALTHY, ADULT SUBJECTS IN INDIA
Journal Title: Journal of Evidence Based Medicine and Healthcare - Year 2019, Vol 6, Issue 4
Abstract
BACKGROUND Tetanus toxoid vaccine has always been an indelible constituent of the Universal Immunization Programme in India. Besides being given to pregnant women in two doses, it used to be given in children at the ages of ten and sixteen. Gradually with the coming down of the burden of communicable diseases, the vaccine is now even recommended in five years age besides as a prophylactic vaccine for any injury of moderate to severe degree in the tropical situations. With India achieving Neonatal Tetanus Elimination in 2015, the pressures to ensure the availability of cost-effective vaccine has gone up. To cope with the increased demand of this vaccine in India, a bio similar tetanus vaccine vial for the Indian market is proposed and hence the Phase 1 study to validate the dose and the safety of the interventional product was planned at Kalinga Institute of Medical Sciences, Bhubaneswar in the eastern part of India under stringent regulatory guidelines of Central Drug Standards Control Organization (CDSCO), and adhering to the good clinical practice guidelines. MATERIALS AND METHODS 24 recruits (healthy adults aged 18-45 years) were taken up for the study with lab screening for blood parameters both preand seven days post vaccination. 23 subjects completed the study as per the protocol and were included in the Efficacy Analysis. Only solicited local adverse events were reported in the trial. Total number of solicited adverse events reported in the trial was 15 (62.5%) The maximal incidence of any local reaction after immunizations within 7 days of vaccination was 58.3% (Pain/Tenderness) followed by swelling/induration in 1 (4.2) subject. RESULTS IgG antibody response after single dose of vaccine was optimal in study population. There is a statistically significant difference between pre-vaccination and post-vaccination values for IgG response against Tetanus antibodies, after single dose. Prevaccination GMT of study changed from 2.24 IU/ml to 12.81 IU/ml, indicating significant results. CONCLUSION In our study, in a mixed age and gender group, the seroconversion was nearly 76% and the AEs were 62.5% all of which subsided on their own without medication, which suggests that the vaccine is effective and can proceed onto Phase 2 and 3 trials for further in-depth assessments of the safety and primarily immunogenicity of the vaccine.
Authors and Affiliations
Sonali Kar, Ajit Pal Singh, Pramod Chandra Samantaray, Shubhransu Patro, Bhaskar Thakur, Angeleena Esther, Amrita Burma, Bhagawati Charan Das
Keywords
Related Articles
- EP ID EP610091
- DOI 10.18410/jebmh/2019/43
- Views 82
- Downloads 0
LEVONORGESTREL-RELEASING INTRAUTERINE SYSTEM AS AN ALTERNATIVE THERAPY IN ABNORMAL UTERINE BLEEDING
BACKGROUND Abnormal uterine bleeding is one of the most frequent reasons for gynaecological consultation, occurring in approximately 30% of women of reproductive age. Menorrhagia by definition implies a menstrual blood l...
EARLY RESULTS OF UNSTABLE DISTAL RADIUS FRACTURES- ORIF WITH LOCKING COMPRESSION PLATE VERSUS LIGAMENTOTAXIS WITH EXTERNAL FIXATORS
BACKGROUND External Fixation (EF) and Open Reduction and Internal Fixation (ORIF) have been the traditional surgical modalities for unstable distal radius fractures. The Locking Compression Plates (LCP) acting as “intern...
STUDY OF PREVALENCE OF OBSTRUCTIVE LUNG DISEASE
BACKGROUND The aim of the study is to study the prevalence of obstructive lung diseases like COPD, Bronchitis and Bronchial Asthma in Community Health Center, Haliyal. MATERIALS AND METHODS This study was undertaken in C...
EPIDEMIOLOGICAL AND CLINICOPATHOLOGICAL MORPHOLOGY OF PATIENTS WITH HAEMOLYTIC ANAEMIA IN A TERTIARY CARE CENTER OF NORTH KERALA
BACKGROUND Haemolytic anaemia’s are characterised by increased RBC destruction and evidence of accelerated erythropoiesis. Haemolysis due to intrinsic RBC disorders, i.e. the inherited haemolytic anaemias are more common...
CLINICAL PROFILE OF ACUTE LOWER RESPIRATORY TRACT INFECTIONS IN CHILDREN BETWEEN 2MONTHS TO 5 YEARS
Acute respiratory infections are a leading cause of morbidity and mortality in under-five children in developing countries. Hence, the present study was undertaken to study the various risk factors, clinical profile and...