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A Trial to Evaluate the Effect of CD388 on the Immunogenicity of Fluzone® HD Vaccine

NCT07300085 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-24

No results posted yet for this study

Summary

The goal of this clinical study is to investigate how safe and effective it is to receive both the Fluzone® High-Dose (HD) influenza vaccine and CD388, a long-acting antiviral medicine, at the same time. Some participants will receive the vaccine and CD388, while others will receive the vaccine and a placebo. The study aims to determine whether taking CD388 together with the flu vaccine affects the body's ability to build protection-called an immune response-against the flu, as compared to getting the vaccine with a placebo. The hypothesis is that giving both at the same time does not weaken the immune response to the vaccine. The study will measure the amount of antibodies (proteins produced by the immune system to fight flu viruses) generated by participants in both groups to check that CD388 does not interfere with how well the vaccine works. Participants will also be closely watched for any side effects or reactions to check that CD388 is safe to take alongside the vaccine. Expanded access to the study treatments (flu vaccine and CD388) will not be provided to participants after the study ends.

Conditions

  • Healthy Participants

Interventions

BIOLOGICAL

Fluzone HD influenza vaccine

Fluzone HD injectable suspension, 2025-2026 Formula

COMBINATION_PRODUCT

CD388 Injection

CD388 liquid for injection

COMBINATION_PRODUCT

Placebo

Placebo to match

Sponsors & Collaborators

  • Cidara Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Nicole Davarpanah, MD, JD · Cidara Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-08
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07300085 on ClinicalTrials.gov