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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/NCT06101173




Registration number
NCT06101173
Ethics application status
Date submitted
20/10/2023
Date registered
26/10/2023
Date last updated
13/03/2024

Titles & IDs
Public title
A Study to Evaluate the Safety and Immunogenicity of Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) in Healthy Adults
Scientific title
A Randomized, Observer-Blind, Positive-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) in Healthy Adults Aged 18-54 Years
Secondary ID [1] 0 0
CTP-VLP-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poliomyelitis 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio)
Other interventions - Inactivated poliomyelitis vaccine (IPOL)
Other interventions - VLP-Polio
Other interventions - IPOL
Other interventions - VLP-Polio
Other interventions - IPOL

Experimental: Experimental vaccine group A, Low dose, Intramuscular injection (IM) - 1 dose of Low-adjuvant dose VLP-Polio vaccine on Visit 1

Active Comparator: Control vaccine group A, IM - 1 dose of IPOL vaccine on Visit 1

Experimental: Experimental vaccine group B, Medium dose, Intramuscular injection (IM) - 1 dose of Medium dose VLP-Polio vaccine on Visit 1

Active Comparator: Control vaccine group B, IM - 1 dose of IPOL vaccine on Visit 1

Experimental: Experimental vaccine group C, High dose, Intramuscular injection (IM) - 1 dose of High dose VLP-Polio vaccine on Visit 1

Active Comparator: Control vaccine group C, IM - 1 dose of IPOL vaccine on Visit 1


Other interventions: Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio)
1 dose of VLP-Polio vaccine (0.5ml) on Visit 1

Other interventions: Inactivated poliomyelitis vaccine (IPOL)
1 dose of IPOL vaccine (0.5ml) on Visit 1

Other interventions: VLP-Polio
1 dose of VLP-Polio vaccine (0.5ml) on Visit 1

Other interventions: IPOL
1 dose of IPOL vaccine (0.5ml) on Visit 1

Other interventions: VLP-Polio
1 dose of VLP-Polio vaccine (0.5ml) on Visit 1

Other interventions: IPOL
1 dose of IPOL vaccine (0.5ml) on Visit 1
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Occurrence of solicited adverse reactions (AEs) within 7 days post vaccination.
Timepoint [1] 0 0
Within 7 days post vaccination
Secondary outcome [1] 0 0
Occurrence of unsolicited AEs within 28 days post-vaccination.
Timepoint [1] 0 0
Within 28 days post-vaccination
Secondary outcome [2] 0 0
Occurrence of solicited AEs within 30 mins post-vaccination.
Timepoint [2] 0 0
Within 30 mins post-vaccination
Secondary outcome [3] 0 0
Occurrence of abnormal safety laboratory parameters on Day 3, Day 8.
Timepoint [3] 0 0
Day 3, Day 8 post-vaccination
Secondary outcome [4] 0 0
Occurrence of serious adverse events (SAEs) during the study period.
Timepoint [4] 0 0
Through study completion, an average of 6 months
Secondary outcome [5] 0 0
Geometric mean titer (GMT) of neutralizing antibodies against poliovirus type 1, 2, and 3 on Day 1 before vaccination and Day 29 and Day 180 after the vaccination.
Timepoint [5] 0 0
Day 1 before vaccination and Day 29 and Day 180 after the vaccination
Secondary outcome [6] 0 0
Geometric mean fold increase (GMI) of neutralizing antibodies against poliovirus type 1, 2, and 3 on Day 1 before vaccination and Day 29 and Day 180 after the vaccination.
Timepoint [6] 0 0
Day 1 before vaccination and Day 29 and Day 180 after the vaccination
Secondary outcome [7] 0 0
Seroconversion rate of neutralizing antibodies against poliovirus type 1, 2, and 3 on Day 1 before vaccination and Day 29 and Day 180 after the vaccination.
Timepoint [7] 0 0
Day 1 before vaccination and Day 29 and Day 180 after the vaccination

Eligibility
Key inclusion criteria
- Male and female volunteers aged 18 to 54 years at time of screening.

- Participants who can understand and comply with the study procedures, understand the
risks involved in the study, and provide written informed consent.

- Healthy or in stable health participants with pre-existing, stable, well-controlled
disease, defined as mild disease or medical condition not requiring medical therapy or
not requiring a change in medical therapy due to worsening of disease during the 6
months before enrollment may be enrolled at the discretion of the investigator.

- Female participants of childbearing potential must have a negative pregnancy test at
screening and before the administration of investigational vaccine and have been
using/ agree to use an adequate form of contraception 30 days prior to screening until
180 days post administration.

- Male participants must agree to use adequate contraception 30 days prior to screening
until 180 days after the vaccination.
Minimum age
18 Years
Maximum age
54 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Tympanic temperature >37.4°C.

- Evidence of excessive alcohol or drug abuse.

- Have received any polio vaccines within 6 months prior to screening.

- History of severe allergic reaction (e.g., anaphylaxis) to any component of the
vaccine.

- Pregnant or lactating at screening or planning to become pregnant (self or partner) at
any time during the study, including the follow-up period.

- History of epilepsy or convulsions.

- Have developmental cognitive disability, dementia, or intellectual disabilities.

- Immune deficiency or immune suppressive treatment or auto-immune disease. For
corticosteroids, a prednisone dose of <20 mg/day or equivalent is allowed. Inhaled and
topical corticosteroids are allowed.

- Current diagnosis of polio or history of polio infection.

- Positive for HIV, Hepatitis B or Hepatitis C.

- Positive for COVID-19 test.

- Bleeding disorders or the usage of anticoagulants.

- Have received any other immunizations within 14 days prior to screening.

- Suffering from serious chronic disease or the disease is in progress and cannot be
controlled, such as thyroid diseases (excluding thyroid nodules).

- Have received blood products within the past 3 months or plan to receive during the
study period.

- Participate in other studies within 30 days (<30 days) before and/or during the study
period.

- Abnormal safety laboratory parameters during the screening window that are clinically
significant as per the judgement of the investigator.

- Any other factors that might interfere with the participant's participation for the
full duration of the study, or is not in the best interest of the participants to
participate, in the opinion of the treating investigator.

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 administering the treatment/s
The people assessing the outcomes
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
3/09/2024
Actual
Sample size
Target
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Geelong
Recruitment hospital [2] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
- Geelong
Recruitment postcode(s) [2] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
CanSino Biologics Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized, observer-blind, positive-controlled study. There will be 3 treatment
groups, in each treatment group, participants will be randomly assigned to receive either
investigational vaccine (Low-adjuvant dose VLP-Polio, Medium dose VLP-Polio, or High dose
VLP-Polio that are defined as Dose A, Dose M, and Dose H, respectively) or control vaccine in
a ratio of 3:1 in each group. Distribution of participant's gender should be balanced in each
group.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06101173
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christina Chang, Dr
Address 0 0
Nucleus Network 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/NCT06101173