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Next-Generation polio vaccine enters human testing

NCT ID NCT07688369

Vaccine Sponsor: Serum Institute of India Pvt. Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This trial tests a new recombinant polio vaccine (rPV) against the current standard IPOL vaccine in healthy adults aged 18 to 60. The goal is to see if the new vaccine is safe and triggers a strong immune response. It is a small, early-stage study to gather initial data.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Recombinant Poliomyelitis Vaccine (rPV)
What this could lead to
If successful, this could lead to a more modern, potentially easier-to-produce polio vaccine to help maintain global polio immunity.
What could go wrong
This is an early phase 1 trial with only 36 healthy adults, so safety and immune response are still being tested. The vaccine may not work as well as the current one or could have unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Healthy Volunteers aged between 18 to 60 years inclusive. * Good physical and mental health based on medical history, physical examination, clinical laboratory,electrocardiogram (ECG), and vital signs, as judged by the Investigator. * Participants must refrain from strenuous exercise within 96 hours (4 days) prior to Screening, Day 1, Day 8,and Day 30.. * Willing and able to comply with restrictions of nicotine (i.e., tobacco and nicotine products) usethroughout the study is not permitted from within 48 hours (2 days) prior to Screening, from Day 1 until Day8, and within 48 hours (2 days) prior to the end of study visit. * Participants must agree to use highly effective contraception from Day 1 until 90 days after the last studyvisit. Key Exclusion Criteria: * History of Polio * Any vaccination received 30 days before Screening and Day 30 * Pregnant or lactating females * BMI \>35.0kg/m2 * History of alcohol abuse or drug addiction * Have received any polio vaccines within 6 months prior to screening. * History of major surgeries * History of receipt of a blood transfusion, other blood products, or immunoglobulins in 3 months prior tostudy vaccination * any confirmed or suspected congenital or acquired immunosuppressive or immunodeficient condition.

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Conditions

The condition(s) this trial relates to.

poliomyelitis prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Polio immunity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Doherty Clinical Trials Limited

    East Melbourne, Victoria, 3002, Australia