Safety and immunogenicity of inactivated hepatitis-A vaccine developed by Human Biologicals Institute in two age groups of healthy subjects: A phase I open label study. Issue 15 (8th April 2021)

• Record Type: Journal Article
• Authors: Susarla, Sai Krishna; Palkar, Sonali; SV, Pardha Saradhi; Diwan, Arundhati; Barsode, Supriya; Satish, M.; Rajashakar, BC; Sandhya, G.; Lingala, Rajendra; Sahoo, Devi Prasad
• Is Part Of: Vaccine. Volume 39:Issue 15(2021)
• Page Start: 2088
• Page End: 2093
• Publication Date: 2021-04-08
• Subjects: Hepatitis A -- Vaccine -- Inactivated -- Phase I -- Healthy subjects -- Immunogenicity -- Safety; HAV Hepatitis-A virus -- AE Adverse Event -- CI Confidence Interval -- GMT Geometric Mean Titre -- LAR Legally Acceptable Representative -- q.s quantum satis -- DCGI Drugs Controller General, India -- CTCAE Common Terminology Criteria for Adverse Events -- CRF Case Report Form -- ELISA Enzyme Linked Immunosorbent Assay -- SD Standard Deviation -- PP Per Protocol -- ITT Intention to Treat -- MedDRA Medical Dictionary for Regulatory Activities -- SOC System Organ Class -- WHO World Health Organization; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2021.03.012
• Languages: English
• ISSNs: 0264-410X

Abstract

Abstract: Background: Hepatitis-A is an acute viral infection of the liver. Hepatitis-A virus has worldwide spread and is endemic in India. Though the disease is self-limiting in most cases, outbreaks are reported frequently from both developing and developed countries of the world. Severity and fatality occur more among infected symptomatic adults. The infection can be prevented with proper and timely immunization. This phase I, single arm, open label, multicenter trial was designed to assess the safety and immunogenicity of the inactivated hepatitis-A vaccine developed by Human Biologicals Institute when administered in a single dose in two age groups of healthy subjects. Methods: This study was carried out in 55 subjects in two healthy age groups at two centers in India. Group A included subjects of 19–49 years and group B subjects of 12–18 years of age. Enrolled subjects received a single dose of inactivated hepatitis A vaccine. Blood samples were collected at baseline and 4–6 weeks after vaccination. Safety was assessed by collection and analysis of data on solicited and unsolicited adverse events and immunogenicity was assessed by estimating the seroconversion rate, seroprotection rate and the geometric mean titres of antibodies. Results: Among the 55 subjects enrolled, 15 reported adverse events. No serious adverse event was reported. Pain at the injection site was the lone local adverse event. Systemic adverse events reported in Group A were: fatigue, headache, diarrhoea, fever, anorexia, nausea and upper respiratory tract infection, whereas there was no systemic event reported in Group B. There was 100% seroconversion and seroprotection and significant rise in antibody titre levels were observed in both the groups post vaccination. Conclusions: This study found HBI inactivated hepatitis-A vaccine to be safe and highly immunogenic when administered as a single dose in adolescent and adult subjects.