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

NCT06101173 | Completed Phase 1

• 1 other identifier: CTP-VLP-001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Poliomyelitis

Keywords

Vaccine; Trivalent; Immunogenicity; Safety; ≥18 years

Outcome Measures

Primary Outcomes (1)

• Occurrence of solicited adverse reactions (AEs) within 7 days post vaccination.

  Within 7 days post vaccination

Secondary Outcomes (7)

• 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

• 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

• 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

Study Arms (6)

Experimental vaccine group A, Low dose, Intramuscular injection (IM)

EXPERIMENTAL

1 dose of Low-adjuvant dose VLP-Polio vaccine on Visit 1

Biological: Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio)

Control vaccine group A, IM

ACTIVE COMPARATOR

1 dose of IPOL vaccine on Visit 1

Biological: Inactivated poliomyelitis vaccine (IPOL)

Experimental vaccine group B, Medium dose, Intramuscular injection (IM)

EXPERIMENTAL

1 dose of Medium dose VLP-Polio vaccine on Visit 1

Biological: VLP-Polio

Control vaccine group B, IM

ACTIVE COMPARATOR

1 dose of IPOL vaccine on Visit 1

Biological: IPOL

Experimental vaccine group C, High dose, Intramuscular injection (IM)

EXPERIMENTAL

1 dose of High dose VLP-Polio vaccine on Visit 1

Biological: VLP-Polio

Control vaccine group C, IM

ACTIVE COMPARATOR

1 dose of IPOL vaccine on Visit 1

Biological: IPOL

Interventions

Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio) BIOLOGICAL

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

Experimental vaccine group A, Low dose, Intramuscular injection (IM)

Inactivated poliomyelitis vaccine (IPOL) BIOLOGICAL

1 dose of IPOL vaccine (0.5ml) on Visit 1

Control vaccine group A, IM

VLP-Polio BIOLOGICAL

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

Experimental vaccine group B, Medium dose, Intramuscular injection (IM)

IPOL BIOLOGICAL

1 dose of IPOL vaccine (0.5ml) on Visit 1

Control vaccine group B, IM

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CanSino Biologics Inc.: lead
• Novotech (Australia) Pty Limited: collaborator

Study Sites (2)

Nucleus Network Pty Ltd

Geelong, Victoria, Australia

Location

Nucleus Network Pty Ltd

Melbourne, Victoria, Australia

Location

MeSH Terms

Conditions

Poliomyelitis

Interventions

Poliovirus Vaccine, Inactivated

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Vaccines, Inactivated; Vaccines; Biological Products; Complex Mixtures; Poliovirus Vaccines; Viral Vaccines

Study Officials

• Christina Chang, Dr

  Nucleus Network Pty Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 26, 2023
• Study Start: January 15, 2024
• Primary Completion: March 15, 2024
• Study Completion: September 11, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

AU (2)