A Study to Evaluate the Safety and Immunogenicity of Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) in Healthy Adults

Poliomyelitis Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06101173
• Other study ID #: CTP-VLP-001
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 15, 2024
• Est. completion date: September 3, 2024

Study information

• Verified date: October 2023
• Source: CanSino Biologics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: September 3, 2024
• Est. primary completion date: September 3, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 54 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Poliomyelitis

Intervention

Biological:
• Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio)
1 dose of VLP-Polio vaccine (0.5ml) on Visit 1
• Inactivated poliomyelitis vaccine (IPOL)
1 dose of IPOL vaccine (0.5ml) on Visit 1
• VLP-Polio
1 dose of VLP-Polio vaccine (0.5ml) on Visit 1
• IPOL
1 dose of IPOL vaccine (0.5ml) on Visit 1
• VLP-Polio
1 dose of VLP-Polio vaccine (0.5ml) on Visit 1
• IPOL
1 dose of IPOL vaccine (0.5ml) on Visit 1

Locations

Country	Name	City	State
Australia	Nucleus Network Pty Ltd	Geelong	Victoria
Australia	Nucleus Network Pty Ltd	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
CanSino Biologics Inc.	Novotech (Australia) Pty Limited

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of solicited adverse reactions (AEs) within 7 days post vaccination.		Within 7 days post vaccination
Secondary	Occurrence of unsolicited AEs within 28 days post-vaccination.		Within 28 days post-vaccination
Secondary	Occurrence of solicited AEs within 30 mins post-vaccination.		Within 30 mins post-vaccination
Secondary	Occurrence of abnormal safety laboratory parameters on Day 3, Day 8.		Day 3, Day 8 post-vaccination
Secondary	Occurrence of serious adverse events (SAEs) during the study period.		Through study completion, an average of 6 months
Secondary	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.		Day 1 before vaccination and Day 29 and Day 180 after the vaccination
Secondary	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.		Day 1 before vaccination and Day 29 and Day 180 after the vaccination
Secondary	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.		Day 1 before vaccination and Day 29 and Day 180 after the vaccination