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PoliomyelitisPhase 1NCT06101173

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

A Phase 1 study testing Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio), Inactivated poliomyelitis vaccine (IPOL) and VLP-Polio in people with Poliomyelitis, run by CanSino Biologics Inc. at 2 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 54 yearsHealthy volunteers can take part
Conditions the study is for
Poliomyelitis
What is being tested?
Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio), Inactivated poliomyelitis vaccine (IPOL) and VLP-Polio
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
2 sitesAustralia
Study dates
15 Jan 2024to 11 Sep 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 54 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

  • Nucleus Network Pty Ltd

    Geelong, Victoria

  • Nucleus Network Pty Ltd

    Melbourne, Victoria

Other trials in Australia

About this study

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

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
Being tested
Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio), Inactivated poliomyelitis vaccine (IPOL), VLP-Polio, IPOL
Keywords
Vaccine, Trivalent, Immunogenicity, Safety, ≥18 years
Medical subject headings
Poliomyelitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

  • Inactivated poliomyelitis vaccine (IPOL)Biological

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

  • VLP-PolioBiological

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

  • IPOLBiological

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

  • VLP-PolioBiological

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

  • IPOLBiological

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

Study groups in NCT06101173
Study groupRoleWhat they receive
Experimental vaccine group A, Low dose, Intramuscular injection (IM)Experimental1 dose of Low-adjuvant dose VLP-Polio vaccine on Visit 1
Receives: Biological: Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio)
Control vaccine group A, IMActive comparator1 dose of IPOL vaccine on Visit 1
Receives: Biological: Inactivated poliomyelitis vaccine (IPOL)
Experimental vaccine group B, Medium dose, Intramuscular injection (IM)Experimental1 dose of Medium dose VLP-Polio vaccine on Visit 1
Receives: Biological: VLP-Polio
Control vaccine group B, IMActive comparator1 dose of IPOL vaccine on Visit 1
Receives: Biological: IPOL
Experimental vaccine group C, High dose, Intramuscular injection (IM)Experimental1 dose of High dose VLP-Polio vaccine on Visit 1
Receives: Biological: VLP-Polio
Control vaccine group C, IMActive comparator1 dose of IPOL vaccine on Visit 1
Receives: Biological: IPOL

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Within 7 days post vaccination

Secondary outcomes (7)

  1. Occurrence of unsolicited AEs within 28 days post-vaccination.

    Measured: Within 28 days post-vaccination

  2. Occurrence of solicited AEs within 30 mins post-vaccination.

    Measured: Within 30 mins post-vaccination

  3. Occurrence of abnormal safety laboratory parameters on Day 3, Day 8.

    Measured: Day 3, Day 8 post-vaccination

  4. Occurrence of serious adverse events (SAEs) during the study period.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Day 1 before vaccination and Day 29 and Day 180 after the vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2023
  2. Study start15 Jan 2024
  3. Primary completion15 Mar 2024
  4. Study completion11 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06101173
Sponsor's protocol ID
CTP-VLP-001
Status last verified
Dec 2024
First submitted
20 Oct 2023
Last updated
4 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio), Inactivated poliomyelitis vaccine (IPOL) and VLP-Polio in people with Poliomyelitis, run by CanSino Biologics Inc. at 2 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of solicited adverse reactions (AEs) within 7 days post vaccination. (time frame: Within 7 days post vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06101173.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.

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