CD388 + Flu Vaccine for Flu
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of a new antiviral medicine, CD388, used with the Fluzone® High-Dose flu vaccine. Some participants will receive both the vaccine and CD388, while others will receive the vaccine and a placebo (an inactive substance). The researchers aim to determine if CD388 affects the immune response, which is how the body builds protection against the flu. Individuals who haven't had a flu shot or flu infection in the past year and consider themselves healthy might be suitable for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new antiviral medicine.
Will I have to stop taking my current medications?
You may need to stop taking certain medications, especially those with known or suspected effects on the immune system, at least 14 days before the trial starts. However, if you are on stable medications for non-immune-related conditions, like blood pressure or thyroid medications, you might be able to continue them with approval from the trial's medical team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that CD388, an antiviral medicine, is safe for humans. In earlier studies, participants tolerated CD388 well, and researchers found no serious safety issues. Those taking CD388 did not experience more unwanted effects than those taking a placebo, indicating that CD388 is generally safe.
This study examines whether CD388 can be safely used with the Fluzone High-Dose flu vaccine. Previous results are encouraging, but individual experiences may vary. Researchers will closely monitor participants for any side effects.12345Why do researchers think this study treatment might be promising?
Most treatments for the flu, like antiviral medications, focus on reducing symptoms and shortening the duration of the illness. But CD388 works differently, targeting the virus directly by enhancing the immune response when combined with the Fluzone HD influenza vaccine. Researchers are excited about CD388 because it offers a novel mechanism of action that could potentially provide stronger and longer-lasting protection against the flu compared to current options. Additionally, its use alongside a flu vaccine could be a game-changer in preventing severe flu cases, making it an innovative addition to current preventative strategies.
What evidence suggests that this trial's treatments could be effective for the flu?
Research has shown that CD388, which participants in this trial may receive, offers promising protection against the flu. In earlier studies, a single 450mg dose of CD388 provided 76% protection from flu symptoms for 24 weeks, significantly outperforming a placebo, which contains no active medicine. CD388 was also well-tolerated, indicating safety for most people. These findings suggest that CD388 could effectively enhance flu prevention methods.36789
Who Is on the Research Team?
Nicole Davarpanah, MD, JD
Principal Investigator
Cidara Therapeutics Inc.
Are You a Good Fit for This Trial?
Healthy individuals aged 18-49 with a BMI of 18-32 kg/m^2 and weight over 50 kg, who haven't had the flu or flu vaccine in the past year. They must have normal blood pressure, heart rate, and ECG readings, understand trial risks, provide consent, and be able to attend follow-up visits.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Fluzone HD influenza vaccine and either CD388 or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CD388
Trial Overview
The study tests if CD388 injection affects immune response when given with Fluzone HD influenza vaccine compared to a placebo. It measures antibody levels post-vaccination to ensure CD388 doesn't weaken vaccine effectiveness while monitoring safety.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will be randomized to receive open-label Fluzone HD influenza vaccine by intramuscular (IM) injection plus CD388 450 milligrams (mg) by subcutaneous (SQ) injection. Participants will be randomized at a 1:1 ratio between the 2 arms.
Participants will be randomized to receive open-label Fluzone HD influenza vaccine by IM injection plus placebo by SQ injection. Participants will be randomized at a 1:1 ratio between the 2 arms.
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Who Is Running the Clinical Trial?
Cidara Therapeutics Inc.
Lead Sponsor
Citations
Cidara Therapeutics Announces Positive Topline Results ...
Single doses of 450mg, 300mg and 150mg of CD388 conferred 76%, 61% and 58% protection, respectively, from symptomatic influenza over 24 weeks compared to ...
2.
vaccineadvisor.com
vaccineadvisor.com/news/novel-antiviral-gets-breakthrough-tx-status-for-universal-flu-protection/Novel Antiviral Gets Breakthrough Tx Status for Universal ...
Over 24 weeks, statistically significant prevention efficacy (PE) was observed for all 3 doses of CD388 compared with placebo (PE: 150mg: 57.7% ...
Prophylactic Efficacy of CD388, a Novel Drug–Fc Conjugate ...
CD388 was well-tolerated and demonstrated prophylactic activity against RT-qPCR–confirmed influenza infection in a human challenge study. The ...
NCT05523089 | The Effectiveness of CD388 to Prevent Flu ...
The purpose of this study is to evaluate the preventative antiviral activity of CD388, as compared to saline placebo, when administered as a single dose to ...
5.
cidrap.umn.edu
cidrap.umn.edu/influenza-general/experimental-flu-drug-may-protect-better-flu-vaccines-company-data-showExperimental flu drug may protect better than flu vaccines, ...
Highest dose provided 76% protection All results for the 4,726 participants assessed for the primary end point were statistically significant. ...
Cidara Therapeutics Announces Late-Breaking Phase 2b ...
CD388 was well tolerated with no apparent safety issues. The results suggested that a single dose of CD388 could have the potential to provide ...
Study of CD388 for the Prevention of Influenza in Subjects ...
The purpose of this study is to evaluate the effectiveness of CD388 in preventing symptomatic laboratory-confirmed influenza infections, as compared to placebo.
8.
contagionlive.com
contagionlive.com/view/cidara-s-cd388-demonstrates-up-to-76-protection-against-influenza-in-phase-2b-navigate-trialCidara's CD388 Demonstrates Up to 76% Protection ...
CD388 demonstrated up to 76% efficacy in preventing laboratory-confirmed influenza following a single seasonal dose in healthy adults. The ...
Phase III trial of flu preventative CD388 accelerated
The planned Phase III study will be a global, multicentre, randomised, double-blind, placebo-controlled study to evaluate the safety and ...
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