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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/NCT04851977




Registration number
NCT04851977
Ethics application status
Date submitted
13/04/2021
Date registered
21/04/2021
Date last updated
21/04/2021

Titles & IDs
Public title
A First in Human Study to Evaluate the Safety and Immune Response to a Vaccine for the Treatment of a Respiratory Virus, When Administered Into the Arm in Healthy Adult Participants
Scientific title
A Phase I, First in Human (FIH), Randomised, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate Safety, Reactogenicity and Immunogenicity of the Recombinant Respiratory Syncytial Virus Vaccines (BARS13) When Administered Intramuscularly (IM) to Healthy Adult Volunteers
Secondary ID [1] 0 0
ADVA-BARS13-001
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
Other interventions - Respiratory Syncytial Vaccine
Other interventions - Respiratory Syncytial Vaccine
Other interventions - Placebo

Experimental: Cohort 1: low dose - IM injection on Day 0 (12 active, 3 placebo); with follow up at 7 days ± 1 day post vaccination and at Day 30 ± 5 days and a final follow up/end of study (EOS) teleconference assessment at Day 60 ± 5 days.

Placebo Comparator: Cohort 2: low dose - IM injection on Day 0 and at Day 30 (12 active, 3 placebo) with follow up at 7 days post vaccination (Day 7 ± 1 day and Day 37 ± 1 day) and Day 60 ± 5 days and a final follow up/ EOS teleconference assessment at Day 90 ± 5 days.

Experimental: Cohort 3: high dose - IM injection on Day 0 (12 active, 3 placebo); with follow up at 7 days ± 1 day post vaccination and at Day 30 ± 5 days and a final follow up/end of study (EOS) teleconference assessment at Day 60 ± 5 days.

Placebo Comparator: Cohort 4: high dose - IM injection on Day 0 (12 active, 3 placebo); with follow up at 7 days ± 1 day post vaccination and at Day 30 ± 5 days and a final follow up/end of study (EOS) teleconference assessment at Day 60 ± 5 days.


Other interventions: Respiratory Syncytial Vaccine
BARS13 low dose (one dose of 10 µg rRSV-G protein/10 µg CsA by IM injection to the deltoid region of one arm, and one dose of placebo [saline/mannitol] by IM injection to the deltoid region of the other arm, given sequentially).

Other interventions: Respiratory Syncytial Vaccine
BARS13 high dose (IM injection of 10 µg rRSV-G protein/10 µg CsA administered to the deltoid region of each arm [one injection of 10 µg rRSV-G protein/10 µg CsA per arm], given sequentially). The high dose is twice the strength of the low dose.

Other interventions: Placebo
Placebo (IM injection of saline/mannitol administered to the deltoid region of each arm [one injection per arm], given sequentially).
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of systemic reactions
Timepoint [1] 0 0
7 days post vaccination
Primary outcome [2] 0 0
Incidence of local reactions
Timepoint [2] 0 0
7 days post vaccination
Primary outcome [3] 0 0
Occurrence of any AE during a 30-minute post-vaccination safety observation period
Timepoint [3] 0 0
30 minutes post vaccination on Day 0 and 30
Primary outcome [4] 0 0
Occurrence of any AE during a 30-day follow-up period after each vaccination
Timepoint [4] 0 0
30 days post vaccination
Primary outcome [5] 0 0
Occurrence of any Serious Adverse Event (SAE) form baseline (Day 0) to the last visit
Timepoint [5] 0 0
60 days post last vaccination
Primary outcome [6] 0 0
Occurrence of any clinical laboratory abnormalities (Toxicity grade > or = 1) form baseline (Day 0) to the last visit
Timepoint [6] 0 0
60 days post vaccination
Secondary outcome [1] 0 0
Humoral response to BARS13: IgG antibody titers (GMTs) measured by ELISA prior to vaccination (Day 0) and post vaccination at Day 30 (all cohorts) and at Day 60 (cohorts 2 and 4 only)
Timepoint [1] 0 0
Pre-vaccination
Secondary outcome [2] 0 0
Humoral response to BARS13: IgG antibody titers (GMTs) measured by ELISA prior to vaccination (Day 0) and post vaccination at Day 30 (all cohorts) and at Day 60 (cohorts 2 and 4 only)
Timepoint [2] 0 0
30 day post each vaccination
Secondary outcome [3] 0 0
Humoral response to BARS13: IgG antibody titers (GMFRs) measured by ELISA prior to vaccination (Day 0) and post vaccination at Day 30 (all cohorts) and at Day 60 (cohorts 2 and 4 only)
Timepoint [3] 0 0
Pre-vaccination
Secondary outcome [4] 0 0
Humoral response to BARS13: IgG antibody titers (GMFRs) measured by ELISA prior to vaccination (Day 0) and post vaccination at Day 30 (all cohorts) and at Day 60 (cohorts 2 and 4 only)
Timepoint [4] 0 0
30 day post each vaccination

Eligibility
Key inclusion criteria
- 1. A male or female aged 18-45 years (inclusive) at the time of the first vaccination.

2. Able to communicate effectively with study personnel and is considered reliable,
willing, and cooperative in terms of compliance with the protocol requirements.

3. Written informed consent signed prior to undertaking any protocol related
procedures.

4. Haematology, clinical chemistry and urinalysis test results not deviating from the
normal reference range by age and gender to a clinically relevant extent at screening.

5. 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 is to assess the adequacy of methods of
contraception on a case-by-case basis.

6. Women of child-bearing potential (WOCBP) must use highly effective contraceptive
measures (failure rate of < 1% per year when used consistently and correctly)
throughout the study and intend to continue use of contraception for at least 3 months
following the last vaccination. Highly effective contraceptive measures could include:
combined (oestrogen and progestogen containing) hormonal contraception associated with
inhibition of ovulation, progestogen-only hormonal contraception associated with
inhibition of ovulation, intrauterine device, intrauterine hormone releasing system,
bilateral tubal occlusion, vasectomised partner, and sexual abstinence. The PI is to
assess the adequacy of methods of contraception on a case-by-case basis.

7. Participant in otherwise general good health based on medical history and physical
examination, as determined by the PI.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 1. Presence of clinically significant medical history, unstable chronic or acute
disease, or physical, or laboratory findings that, in the opinion of the PI may
potentially increase the expected risk of exposure to the investigational vaccine,
compromise the safety of the participant, or interfere with any aspect of study
conduct or interpretation of results.

2. Body Mass Index (BMI) great than or equal to 40 at screening. 3. Significant
infection or other acute illness, including fever over 37.5°C/99.5°F on the day of
randomisation.

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

5. Inadequate venous access to allow collection of blood samples. 6. Breastfeeding or
pregnant as confirmed by a positive serum beta human chorionic gonadotropin (.-HCG)
pregnancy test at screening or positive urine pregnancy test at subsequent clinic
visits at time points as delineated in the study schedule.

7. Received any prophylactic or therapeutic vaccine, or investigational drug, within 3
months of first vaccination, or anticipated in the follow up period defined for this
study.

8. History of severe allergy (requiring hospital care), severe reaction to any drug or
prior vaccination, or any known or suspected allergies or sensitivities to any
component of the investigational vaccine or placebo.

9. Immunosuppression caused by disease (such as human immunodeficiency virus [HIV]) or
medications, immunosuppressive therapy (such as long-term systemic corticosteroids
therapy).

10. History of hepatitis B or hepatitis C infection. 11. History of autoimmune
disorder. 12. History of splenectomy or of condition affecting splenic function. 13.
History of malignancy of any organ system (other than localised basal cell carcinoma
of the skin), treated or untreated, within the past five years, regardless of whether
there is evidence of local recurrence or metastases.

14. History of any neurological disorders or seizures. 15. Thrombocytopenia or
bleeding disorder contraindicating intramuscular vaccination.

16. Receipt of immunoglobulins or blood products within 3 months of first vaccination.

17. Requirement for antipyretic or analgesic medication on a daily or every other day
basis from randomisation through 72 hours after vaccination.

18. History of alcohol or drug abuse or psychiatric disorder that in the opinion of
the PI could affect the participants' safety or compliance with study.

19. 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.

20. A positive alcohol breathalyser test at screening or pre-vaccination. 21.
Participant unwilling to abstain from blood donation during the course of the study,
and/or participation in any research study involving blood sampling (more than 450 mL
/unit of blood), or blood donation to the Australian Red Cross Blood Service (ARCBS)
or other blood bank during the 2 months prior to the screening visit.

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 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/08/2019
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Advanced Vaccine Laboratories Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne

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

Ethics approval
Ethics application status

Summary
Brief summary
Advanced Vaccine Laboratories Pty Ltd is developing a recombinant Respiratory Syncytial Virus
(rRSV) vaccine for the protection of children (6 months to 5 years old) and the elderly from
RSV infection. Human RSV infects nearly all children by the age of two years, and it is a
leading cause of severe lower respiratory tract (LRT) disease in both paediatric and elderly
populations as well as in individuals was immune system is profoundly compromised.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04851977
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ben Snyder, MBBS
Address 0 0
The Alfred
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/NCT04851977