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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Poliomyelitis
• Intervention / Treatment: Biological: Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio); Biological: Inactivated poliomyelitis vaccine (IPOL); Biological: VLP-Polio; Biological: IPOL

Detailed Description

Currently, there is no cure for poliomyelitis but only treatments to relieve the symptoms. The most effective way to prevent poliomyelitis is vaccination. There are two existing polio vaccines, inactivated poliovirus vaccine (IPV) and oral poliovirus vaccine (OPV), and global immunizations now include IPV-only and IPV/OPV sequential doses starting from 6 weeks (2 months) of age.

The development of improved, safer and less-expensive vaccines is still being demanded for a long-term Polio-eradication strategy, especially regarding those low-income countries who constitute the majority of world population. Therefore, it is important to develop a more effective poliomyelitis vaccine to construct a more comprehensive protection.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yujia Chen; Phone Number: 022-58213600-6051; Email: yujia.chen@cansinotech.com

Study Locations

• Australia
  • Victoria
    • Geelong, Victoria, Australia
      • Nucleus Network Pty Ltd
    • Melbourne, Victoria, Australia
      • Nucleus Network Pty Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental vaccine group A, Low dose, Intramuscular injection (IM); 1 dose of Low-adjuvant dose VLP-Polio vaccine on Visit 1	Biological: Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio); 1 dose of VLP-Polio vaccine (0.5ml) on Visit 1
Active Comparator: Control vaccine group A, IM; 1 dose of IPOL vaccine on Visit 1	Biological: Inactivated poliomyelitis vaccine (IPOL); 1 dose of IPOL vaccine (0.5ml) on Visit 1
Experimental: Experimental vaccine group B, Medium dose, Intramuscular injection (IM); 1 dose of Medium dose VLP-Polio vaccine on Visit 1	Biological: VLP-Polio; 1 dose of VLP-Polio vaccine (0.5ml) on Visit 1
Active Comparator: Control vaccine group B, IM; 1 dose of IPOL vaccine on Visit 1	Biological: IPOL; 1 dose of IPOL vaccine (0.5ml) on Visit 1
Experimental: Experimental vaccine group C, High dose, Intramuscular injection (IM); 1 dose of High dose VLP-Polio vaccine on Visit 1	Biological: VLP-Polio; 1 dose of VLP-Polio vaccine (0.5ml) on Visit 1
Active Comparator: Control vaccine group C, IM; 1 dose of IPOL vaccine on Visit 1	Biological: IPOL; 1 dose of IPOL vaccine (0.5ml) on Visit 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of solicited adverse reactions (AEs) within 7 days post vaccination.	Within 7 days post vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurrence of unsolicited AEs within 28 days post-vaccination.	Within 28 days post-vaccination
Occurrence of solicited AEs within 30 mins post-vaccination.	Within 30 mins post-vaccination
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
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
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
Occurrence of abnormal safety laboratory parameters on Day 3, Day 8.	Day 3, Day 8 post-vaccination
Occurrence of serious adverse events (SAEs) during the study period.	Through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: CanSino Biologics Inc.
• Collaborators: Novotech (Australia) Pty Limited
• Investigators: Principal Investigator: Christina Chang, Dr, Nucleus Network Pty Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): September 3, 2024
• Study Completion (Estimated): September 3, 2024

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Safety; Vaccine; Immunogenicity; Trivalent; ≥18 years
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Neuromuscular Diseases; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Myelitis; Neuroinflammatory Diseases; Poliomyelitis; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: CTP-VLP-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No