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

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ClinicalTrials.gov Identifier: NCT06101173
Recruitment Status : Active, not recruiting
First Posted : October 26, 2023
Last Update Posted : March 13, 2024
Sponsor:
Collaborator:
Novotech (Australia) Pty Limited
Information provided by (Responsible Party):
CanSino Biologics Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Poliomyelitis Biological: Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio) Biological: Inactivated poliomyelitis vaccine (IPOL) Biological: VLP-Polio Biological: IPOL Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : January 15, 2024
Estimated Primary Completion Date : September 3, 2024
Estimated Study Completion Date : September 3, 2024

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of solicited adverse reactions (AEs) within 7 days post vaccination. [ Time Frame: Within 7 days post vaccination ]

Secondary Outcome Measures :
  1. Occurrence of unsolicited AEs within 28 days post-vaccination. [ Time Frame: Within 28 days post-vaccination ]
  2. Occurrence of solicited AEs within 30 mins post-vaccination. [ Time Frame: Within 30 mins post-vaccination ]
  3. Occurrence of abnormal safety laboratory parameters on Day 3, Day 8. [ Time Frame: Day 3, Day 8 post-vaccination ]
  4. Occurrence of serious adverse events (SAEs) during the study period. [ Time Frame: Through study completion, an average of 6 months ]
  5. 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. [ Time Frame: Day 1 before vaccination and Day 29 and Day 180 after the vaccination ]
  6. 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. [ Time Frame: Day 1 before vaccination and Day 29 and Day 180 after the vaccination ]
  7. 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. [ Time Frame: Day 1 before vaccination and Day 29 and Day 180 after the vaccination ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 54 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06101173


Locations
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Australia, Victoria
Nucleus Network Pty Ltd
Geelong, Victoria, Australia
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia
Sponsors and Collaborators
CanSino Biologics Inc.
Novotech (Australia) Pty Limited
Investigators
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Principal Investigator: Christina Chang, Dr Nucleus Network Pty Ltd.
More Information
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Responsible Party: CanSino Biologics Inc.
ClinicalTrials.gov Identifier: NCT06101173    
Other Study ID Numbers: CTP-VLP-001
First Posted: October 26, 2023    Key Record Dates
Last Update Posted: March 13, 2024
Last Verified: October 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CanSino Biologics Inc.:
Vaccine
Trivalent
Immunogenicity
Safety
≥18 years
Additional relevant MeSH terms:
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Poliomyelitis
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
Vaccines
Immunologic Factors
Physiological Effects of Drugs