A phase-I clinical study to assess the safety of Biological Es Hepatitis-A vaccine in 18-45 year old healthy adults.

Phase 1

Completed

• Conditions: Health Condition 1: Z23- Encounter for immunization

• Registration Number: CTRI/2021/12/038552
• Lead Sponsor: Biological E Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-11-10
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

1. Subject, in the opinion of the investigator, has ability to communicate and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits, with access to a consistent means of telephone contact, either residential landline or mobile).

2. Written or thumb printed informed consent (including audio-visual recording of consent process) obtained from the subject prior to performing any study specific procedure.

3. Hepatitis A vaccine-naïve male and the non-pregnant, non-lactating female human volunteers aged between 18 and 45 years of age (both inclusive) at the time of vaccination. [Note: Hepatitis-A vaccine-naïve is defined as subjects who have not been previously vaccinated with either a licensed or an investigational Hepatitis A vaccine based on personal verbal history and results of Anti-HAV IgG test].

4. Subjects considered of stable health as judged by the principal investigator based on personal medical history, protocol specific laboratory parameters and clinical examination findings before entering into the study.

5. Subjects that are negative at baseline for Human Immunodeficiency Virus (HIV), Hepatitis B and Hepatitis C infection based in laboratory tests.

Exclusion Criteria

1. Previous history of Hepatitis A vaccination;

2. Pregnant and nursing women;

3. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the administration of study vaccine (Day -29 to Day 0), or planned use during the study period;

4. Chronic administration (defined as more than 14 days in total) of immunosuppressants (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.) or other immune-modifying drugs (e.g. interferons) during the period starting six months prior to the first vaccine dose including use of any blood products. For corticosteroids, this will mean prednisone =0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed;

5.Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device);

6.Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required);

7.History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity likely to be exacerbated by any component of the study vaccine;

8.History or presence of significant alcoholism or drug abuse within the past one-year.

9.History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco product.

10.Subject is a direct descendant (child) of any person employed by the Sponsor or the Study Site (including the PI and study site personnel);

11.Acute disease and/or fever at the time or prior to vaccination defined as the endogenous elevation of at least one measured body temperature of =100.4°F (=38°C);

12.Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination;

13.Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Proportion of subjects with solicited adverse reactions <br/ ><br>2.Proportion of subjects with unsolicited local and systemic adverse events <br/ ><br>3.Serious adverse events (SAEs), if anyTimepoint: 1.during first 60 minutes of post-vaccination observation period and for 7 consecutive days <br/ ><br>2.during the total post-vaccination follow up period of 28 days. <br/ ><br>3.during the total post-vaccination follow up period of 28 days <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Geometric mean concentration (GMC)Timepoint: at baseline (prevac) and at Day 28 after single dose.;Proportion of subjects achieving fold increase in Anti-HAV IgG antibodiesTimepoint: at Day 28 post single dose, from baseline.;Proportion of subjects with anti-HAV IgG antibody concentrationsTimepoint: at day 28 will be calculated