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New antiviral shot could boost flu protection when given with vaccine

NCT ID NCT07300085

Prevention Sponsor: Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This early-stage trial is testing whether a new long-acting antiviral medicine called CD388 can be safely given at the same time as the high-dose flu vaccine. About 100 healthy adults aged 18 to 49 will receive either the vaccine plus CD388 or the vaccine plus a placebo. Researchers will check if CD388 interferes with the body's immune response to the vaccine and monitor for any side effects.

What this could mean

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

Active substance
Fluzone High-Dose influenza vaccine and CD388 (a long-acting antiviral)
What this could lead to
If successful, this could show that combining a long-acting antiviral with the flu vaccine is safe and doesn't reduce vaccine effectiveness, potentially offering better flu prevention.
What could go wrong
This is a very early (phase 1) and small trial (100 healthy adults), so results may not apply to older or sicker people. The main goal is safety and immune response, not proof of preventing flu.

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 710 people

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

Started

Nov 2025

Expected to finish

Dec 2026

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 49 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.

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Be ≥18 to ≤49 years of age * Be deemed healthy by the Investigator * Have not received any seasonal influenza vaccine and have not had a diagnosed or suspected influenza infection within 12 months prior to Day 1 of the trial Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Had an active malignancy within 5 years prior to screening, except basal cell or squamous cell skin cancer. Any history of breast cancer or melanoma is exclusionary. * Has previously been diagnosed with Guillain-Barre Syndrome following a previous influenza vaccination.

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Conditions

The condition(s) this trial relates to.

influenza prevention target

As listed by the trial registrant

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

Healthy participants

Contacts and locations

Locations

  • California Clinical Trials Medical Group (CCTMG) managed by Parexel

    Glendale, California, 91206, United States

  • Parexel ( Site 0001)

    Glendale, California, 91206, United States

  • Parexel ( Site 0002)

    Baltimore, Maryland, 21225, United States

  • Parexel International - EPCU Baltimore

    Baltimore, Maryland, 21225, United States

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