Safety and Efficacy of BARS13 in the Elderly

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Advaccine (Suzhou) Biopharmaceuticals Co., Ltd.
• Treatments: Vaccines

Criteria

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 ≥38.0°C 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.