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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04681833




Registration number
NCT04681833
Ethics application status
Date submitted
14/12/2020
Date registered
23/12/2020
Date last updated
2/11/2023

Titles & IDs
Public title
Safety and Efficacy of BARS13 in the Elderly
Scientific title
A Randomised, Double-blind, Placebo-controlled, Dose-ranging Phase II Study in 60 to 80-Year-Old Adults to Assess the Safety and Immunogenicity of BARS13
Secondary ID [1] 0 0
ADVA-BARS13-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Recombinant Respiratory Syncytial Virus Vaccine (BARS13) /placebo
Treatment: Drugs - Recombinant Respiratory Syncytial Virus Vaccine (BARS13)
Treatment: Drugs - Placebo

Experimental: Cohort 1: BARS13 low repeat dose - Active: One dose of 10 µg rRSV G protein/10 µg CsA administered by IM injection to the deltoid region of one arm, and one dose of placebo by IM injection to the deltoid region of the other arm, given sequentially (10 µg rRSV G protein/10 µg CsA in total for each vaccination) on Day 1 and 29.

Placebo Comparator: Cohort 1: BARS13 placebo low repeat dose - Placebo: One dose administered by IM injection to both arms, on Day 1 and 29.

Experimental: Cohort 2: BARS13 high repeat dose - Active: One dose of 10 µg rRSV G protein/10 µg CsA administered by IM injection to the deltoid region of each arm, given sequentially (20 µg rRSV G protein/20 µg CsA in total for each vaccination) on Day 1 and 29.

Placebo Comparator: Cohort 2: BARS13 placebo high repeat dose - Placebo: One dose administered by IM injection to both arms, on Day 1 and 29.

Experimental: Cohort 3: BARS13 high repeat multiple dose - Active: One dose of 10 µg rRSV G protein/10 µg CsA administered by IM injection to the deltoid region of each arm, given sequentially (20 µg rRSV G protein/20 µg CsA in total for each vaccination) on Day 1, Day 29 and Day 57.

Placebo Comparator: Cohort 3: BARS13 placebo high repeat multiple dose - Placebo: One dose administered by IM injection to both arms, on Day 1, Day 29 and Day 57.


Treatment: Drugs: Recombinant Respiratory Syncytial Virus Vaccine (BARS13) /placebo
Low Repeat Dose

Treatment: Drugs: Recombinant Respiratory Syncytial Virus Vaccine (BARS13)
High Repeat Dose/High Repeat Multiple Dose

Treatment: Drugs: Placebo
Liquid diluent/Lyophilised Powder
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of vaccine-related AEs, including the following solicited AEs
Timepoint [1] 0 0
From baseline (Day 1) to the end of Day 7.
Primary outcome [2] 0 0
Incidence and severity of vaccine-related AEs, including the following solicited AEs
Timepoint [2] 0 0
From Day 28 to the end of Day 35.
Primary outcome [3] 0 0
Incidence and severity of vaccine-related AEs, including the following solicited AEs
Timepoint [3] 0 0
From Day 57 to the end of Day 64 (only for multiple high repeat dose group).
Primary outcome [4] 0 0
Occurrence of AEs
Timepoint [4] 0 0
From baseline (Day 1) to the end of the 7-day, 28-day follow up period after each vaccination
Primary outcome [5] 0 0
Occurrence of any AE during a 60-minute post-vaccination safety observation period
Timepoint [5] 0 0
On Day 1 (all cohorts), Day 29 (all cohorts) and Day 57 (Cohort 3 only)
Primary outcome [6] 0 0
Occurrence of any AE leading to withdrawal
Timepoint [6] 0 0
During the 28-day follow up period after each vaccination
Primary outcome [7] 0 0
Occurrence of any serious adverse event (SAE)
Timepoint [7] 0 0
From baseline (Day 1) to the last visit, assessed up to 14 months
Primary outcome [8] 0 0
Occurrence of any clinically significant clinical laboratory abnormalities
Timepoint [8] 0 0
From baseline (Day 1) to the last visit, assessed up to 14 months
Primary outcome [9] 0 0
Treatment-emergent, clinically significant changes in vital signs and physical examinations.
Timepoint [9] 0 0
At specified intervals after each vaccination on Day 1 (all cohorts), Day 29 (all cohorts) and Day 57 (Cohort 3 only)
Secondary outcome [1] 0 0
Humoral response to BARS13
Timepoint [1] 0 0
Prior to each vaccination (Day 1 and Day 29 for all cohorts, and Day 57 for Cohort 3 only)
Secondary outcome [2] 0 0
Humoral response to BARS13
Timepoint [2] 0 0
At follow-up visits at 4, 8, 16, 24, 32, 40 and 52 weeks post last dose
Secondary outcome [3] 0 0
Humoral response to BARS13
Timepoint [3] 0 0
Prior to each vaccination (Day 1 and Day 29 for all cohorts, and Day 57 for Cohort 3 only)
Secondary outcome [4] 0 0
Humoral response to BARS13
Timepoint [4] 0 0
At follow-up visits at 4, 8, 16, 24, 32, 40 and 52 weeks post last dose

Eligibility
Key inclusion criteria
Inclusion:

Participants who meet all of the following criteria at screening are eligible to
participate in the study:

1. Healthy male or female adults, or adults with stable chronic disease aged 60 to 80
years old, inclusive. Stable disease includes adults with no new diagnosis,
hospitalization or changes in medication in the preceding 3 months. Adults with
stable, Stage 1 chronic obstructive pulmonary disease (COPD) are eligible for this
study provided they are not using inhaled or systemic corticosteroids.

2. Body mass index (BMI) =40 kg/m2.

3. Screening 12-lead electrocardiogram (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.

4. Hematology, 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.

5. 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. (May be repeated twice, if abnormal values were recorded in
the first instance, at the discretion of the PI).

6. Willing and able (on both a physical and cognitive basis) to give informed consent
prior to study enrolment.

7. Able to comply with study requirements, including access to transportation for study
visits.

8. Access to inbound and outbound telephone communication with caregivers and study
staff.

9. Males must be surgically sterile (>30 days since vasectomy with no viable sperm),
abstinent or, if engaged in sexual relations with a person of child-bearing potential,
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. Acceptable methods of contraception are the use of condoms
and an effective contraceptive for the female partner that could include surgical
sterilization (e.g., bilateral tubal ligation), hormonal contraception, or
intrauterine contraception/device. The PI or appropriate designee is to assess the
adequacy of methods of contraception on a case-by-case basis.

10. Females must be of nonchildbearing potential i.e., surgically sterilized
(hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before
screening) or postmenopausal (where postmenopausal is defined as no menses for 12
months without an alternative medical cause and a follicle-stimulating hormone level
=40 IU/L at the screening visit).
Minimum age
60 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion:

Participants who meet any of the following criteria are not eligible to participate in the
study:

1. Participation in research involving investigational product (IP) (drug / biologic /
device) within 45 days before the planned date of the Day 1 vaccination.

2. History of a serious reaction to any prior vaccination.

3. Received any vaccine other than an inactivated or live attenuated influenza vaccine or
coronavirus SARS-COV-2 (COVID-19) vaccine (not in a clinical trial setting) in the 4
weeks preceding the first study vaccination; or any RSV vaccine at any time or who
plan to receive any non-study vaccines within 28 days of the last dose of study
vaccine. Influenza vaccine and coronavirus SARS-COV-2 (COVID-19) vaccine should not be
given within 14 days of each dose of study vaccine.

4. Any known or suspected immunosuppressive condition, acquired or congenital, as
determined by history and/or physical examination.

5. 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. An immunosuppressant dose of glucocorticoid will be defined as a
systemic dose =10 mg of prednisone per day or equivalent. The use of topical and nasal
glucocorticoids will be permitted.

6. Positive testing for active HIV, HBsAg, HCV, Quantiferon (TB infection).

7. Positive urine drug screen at screening, or pre-vaccination for any drug of abuse
unless there is an explanation acceptable to the PI (e.g., the participant stated in
advance that they consumed a prescription or over the counter product which contained
the detected drug) and/or the participant had a negative urine drug screen on retest
by the pathology laboratory.

8. A positive alcohol breathalyzer test at screening or pre-vaccination.

9. Administration of immunoglobulins and/or any blood products within the 3 months
preceding the administration of the study vaccine or during the study.

10. Acute disease at the time of enrolment (defined as the presence of a moderate or
severe illness with or without fever, or an oral temperature =38.0°C on the planned
day of vaccine administration).

11. Suspicion or recent history (within one year of planned vaccination) of alcohol or
other substance abuse (regular consumption of > 10 units of alcohol/week [men and
women]; 1 unit = 237 mL of beer, 25 mL shot of 40% spirit or a 125 mL glass of wine. A
standard drink contains 10 g of alcohol).

12. Birthmarks, tattoos, wound or other skin conditions over the deltoid region of either
arm that, in the PI's opinion, could reasonably obscure and interfere with evaluation
of local injection site reactions.

13. Subject with a history of autoimmune disease or an active autoimmune disease requiring
therapeutic intervention including but not limited to: systemic or cutaneous lupus
erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré syndrome,
multiple sclerosis, Sjögren syndrome, idiopathic thrombocytopenic purpura, autoimmune
glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis),
psoriasis, and insulin-dependent diabetes mellitus (Type 1), Crohn's disease or
ulcerative colitis.

14. Any condition that in the opinion of the investigator would pose a health risk to the
subject if enrolled or could interfere with evaluation of the vaccine or
interpretation of study results (including neurologic, cognitive, or psychiatric
conditions deemed likely to impair the quality of study compliance or safety
reporting).

15. 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. Asthma diagnosed > 2 years ago is
allowed at PI discretion if the asthma is considered well controlled as per the Asthma
Australia Control Tool (score of =20 out of 25). Inhaled corticosteroids are allowed
provided dose is considered <10 mg prednisolone equivalent.

16. Any respiratory illness (e.g., cough, sore throat, dyspnea, wheezing or nocturnal
awakenings to respiratory symptoms) within 14 days prior to receiving the first dose
of study vaccination.

17. Any active pulmonary infection or other inflammatory conditions, even in the absence
of febrile episodes, within 14 days prior to the first study vaccination.

18. Any other condition or prior therapy that in the opinion of the PI would make the
volunteer unsuitable for this study, including inability to cooperate fully with the
requirements of the study protocol or likelihood of noncompliance with any study
requirements.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2024
Actual
Sample size
Target
Accrual to date
Final
125
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
Q-Pharm Pty Ltd - Herston
Recruitment hospital [2] 0 0
CMAX Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
4006 - Herston
Recruitment postcode(s) [2] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Advaccine (Suzhou) Biopharmaceuticals Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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 125
volunteers aged 60 - 80 years (inclusive) will be enrolled in this study, and will be divided
into 3 groups (or 'cohorts') of 40 people (cohort 1 and 2) and 45 people (cohort 3). The aim
of the study is to evaluate the safety and tolerability of BARS13 in this age group.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04681833
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Natasha Martin, MBBS
Address 0 0
CMAX Clinical Research Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04681833