Safety and Efficacy of BARS13 in the Elderly

  • STATUS
    Recruiting
  • End date
    Jun 1, 2023
  • participants needed
    120
  • sponsor
    Advaccine (Suzhou) Biopharmaceuticals Co., Ltd.
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Updated on 8 June 2021
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Summary

Advaccine Clinical Research are developing a vaccine called BARS13 for the active immunisation of infants (aged 6 months to 5 years old) and the elderly (aged 60-80 years old) for the seasonal prevention of Respiratory Syncytial Virus (RSV) infection. A total of 120 volunteers aged 60 - 80 years (inclusive) will be enrolled in this study, and will be divided into 3 groups (or 'cohorts') of 40 people per cohort. The aim of the study is to evaluate the safety and tolerability of BARS13 in this age group.

Description

Advaccine Clinical Research is developing a recombinant Respiratory Syncytial Virus (rRSV) vaccine - BARS13 for the protection of children (6 months to 5 years old) and the elderly from RSV infection.

This is a two centre, randomised, double-blind, placebo-controlled study in healthy adults aged 60-80 years old to evaluate the safety and immunogenicity of the rRSV investigational vaccine, BARS13.

This study will be conducted in two centres in Australia with CMAX as the coordinating site.

Vaccinations for all participants will occur before local Australian RSV peak season (winter/early spring). A total of up to 120 eligible participants will be enrolled administered by IM injection to the deltoid region of the arm. Cohort 1 (low repeat dose) includes one dose of 10micrograms of the vaccine on one arm and one dose of placebo on the other arm given sequentially on Day 1 and 29. Cohort 2 (high repeat dose) includes one dose of 10micrograms of the vaccine on each arm given sequentially on Day 1 and 29. Cohort 3 (high repeat multiple dose) includes one dose of 10microgarms of vaccine to each arm sequentially on Day 1, 29 and 57.

Details
Condition rsv infection, Respiratory syncytial virus infection
Treatment Placebo, Recombinant Respiratory Syncytial Virus Vaccine (BARS13) /placebo, Recombinant Respiratory Syncytial Virus Vaccine (BARS13)
Clinical Study IdentifierNCT04681833
SponsorAdvaccine (Suzhou) Biopharmaceuticals Co., Ltd.
Last Modified on8 June 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Participants who meet all of the following criteria at screening are eligible to participate in the study
Healthy male or female adults, or adults with stable chronic disease aged 60 to 80 years old, inclusive
Body mass index (BMI) 40 kg/m2
Screening 12-lead ECG must be within normal range (QT interval corrected using Fridericia's formula [QTcF] males 450 msec; females 470 msec) or with abnormalities, which are not hazardous to the patient according to the opinion of the Investigator at the screening visit
Haematology, serum chemistry, coagulation and urinalysis test results not deviating from the normal reference range by age and gender to a clinically relevant extent at screening
Systolic blood pressure in the range of 90 to 160 mmHg (inclusive) and diastolic blood pressure in the range of 50 to 95 mmHg (inclusive) after 5 minutes in supine position at the screening visit
Willing and able (on both a physical and cognitive basis) to give informed consent prior to study enrolment
Able to comply with study requirements; including access to transportation for study visits
Access to inbound and outbound telephone communication with caregivers and study staff
The participant and his partner must use an acceptable, highly effective, contraceptive method from screening and for a period of at least 3 months after the last dose of study drug

Exclusion Criteria

Participants who meet any of the following criteria are not eligible to participate in the study
Participation in research involving investigational product (IP) (drug / biologic / device) within 45 days before the planned date of the Day 1 vaccination
History of a serious reaction to any prior vaccination
Received any vaccine other than an inactivated or live attenuated influenza vaccine in the 4 weeks preceding the study vaccination; or any RSV vaccine at any time
Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination
Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine
Positive testing for active human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, Quantiferon (Tuberculosis [TB] infection)
Positive urine drug screen at screening, or pre-vaccination for any drug of abuse unless there is an explanation acceptable to the PI
A positive alcohol breathalyser test at screening or pre-vaccination
Testing result for RSV IgG(GP) above the cut-off value defined in the RSV IgG(GP) ELISA assay protocol
Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study
Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or a tympanic temperature 38.0C on the planned day of vaccine administration)
Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse
Birthmarks, tattoos, wound or other skin conditions over the deltoid region of both arms
Subject with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention
History of any chronic respiratory illness, including current diagnosis of asthma within 2 years, COPD Stage 2 exercise induced wheezing, reactive airway disease, emphysema, chronic bronchitis or cystic fibrosis
Any respiratory illness within 14 days prior to receiving the first dose of study vaccination
Any active pulmonary infection or other inflammatory conditions, even in the absence of febrile episodes, within 14 days prior to the first study vaccination
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