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

NCT ID: NCT06101173

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2024-09-11

Brief Summary

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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.

Detailed Description

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Conditions

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Poliomyelitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

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

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

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

Control vaccine group A, IM

1 dose of IPOL vaccine on Visit 1

Group Type ACTIVE_COMPARATOR

Inactivated poliomyelitis vaccine (IPOL)

Intervention Type BIOLOGICAL

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

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

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

Group Type EXPERIMENTAL

VLP-Polio

Intervention Type BIOLOGICAL

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

Control vaccine group B, IM

1 dose of IPOL vaccine on Visit 1

Group Type ACTIVE_COMPARATOR

IPOL

Intervention Type BIOLOGICAL

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

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

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

Group Type EXPERIMENTAL

VLP-Polio

Intervention Type BIOLOGICAL

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

Control vaccine group C, IM

1 dose of IPOL vaccine on Visit 1

Group Type ACTIVE_COMPARATOR

IPOL

Intervention Type BIOLOGICAL

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

Interventions

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

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

Intervention Type BIOLOGICAL

Inactivated poliomyelitis vaccine (IPOL)

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

Intervention Type BIOLOGICAL

VLP-Polio

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

Intervention Type BIOLOGICAL

IPOL

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

Intervention Type BIOLOGICAL

VLP-Polio

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

Intervention Type BIOLOGICAL

IPOL

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

54 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novotech (Australia) Pty Limited

INDUSTRY

Sponsor Role collaborator

CanSino Biologics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christina Chang, Dr

Role: PRINCIPAL_INVESTIGATOR

Nucleus Network Pty Ltd.

Locations

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Nucleus Network Pty Ltd

Geelong, Victoria, Australia

Site Status

Nucleus Network Pty Ltd

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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CTP-VLP-001

Identifier Type: -

Identifier Source: org_study_id