AV-1 for Dengue Fever

Not currently recruiting at 2 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: AbViro LLC

Must not be taking: Antidepressants, Immunosuppressants, NSAIDs, others

Disqualifiers: Alcoholism, Drug abuse, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AV-1 to determine its effectiveness in preventing or treating dengue fever, using a controlled infection model with the DENV-3 virus. Researchers aim to assess AV-1's ability to stop the virus before it starts (prophylaxis) and treat it once infection occurs (therapeutic effect). The trial includes different groups to evaluate both prevention and treatment strategies. Ideal participants are healthy adults who have not had dengue fever or related viruses and do not plan to travel to areas where these viruses are active. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it does mention that certain medications are prohibited. These include oral/systemic anti-neoplastic agents, medications that alter drug absorption, metabolism, or elimination, immunosuppressive drugs, aspirin products, and NSAIDs. It's best to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that AV-1 is likely to be safe for humans?

Research has shown that AV-1 is safe for humans based on earlier studies. A study supported by the National Institute of Allergy and Infectious Diseases (NIAID) found AV-1 to be safe for people. This study set the stage for more testing, demonstrating that participants handled the treatment well.

AV-1 is a monoclonal antibody, a lab-made protein that helps the immune system fight infections like dengue fever. Initial trials showed no serious side effects in those who received AV-1, indicating the treatment did not cause major problems and making it a promising option for further research.

Since this trial is in a later phase, AV-1 has already passed earlier safety tests. This phase will help confirm its safety and effectiveness. While more data will be collected, current evidence suggests that AV-1 is a safe treatment option for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for dengue fever?

Researchers are excited about AV-1 for dengue fever because it offers a potentially groundbreaking approach to both preventing and treating the disease. Unlike current treatments, which primarily focus on symptom relief, AV-1 is designed to target and neutralize the dengue virus itself. This could mean faster recovery times and better prevention of severe symptoms. Additionally, AV-1 could provide a more comprehensive solution by addressing multiple strains of the virus, which is a significant challenge in dengue fever management. This novel approach could significantly reduce the global burden of dengue fever by offering both prophylaxis and direct treatment options.

What evidence suggests that this trial's treatments could be effective for dengue fever?

Research has shown that AV-1 is a medicine being tested to help prevent or treat dengue fever, which mosquitoes spread. In this trial, participants will join different groups to receive AV-1 either as a preventive measure or as a treatment after infection. Early results suggest that AV-1 is safe for people. Previous studies have examined how AV-1 can aid the body's recovery from dengue after infection. This medicine works by directly targeting the dengue virus, potentially stopping it from spreading in the body. Although it's still early, researchers hope that AV-1 can reduce symptoms or even prevent the virus. ^{1 2 4 6 7}

Who Is on the Research Team?

Urban Ramstedt, PhD

Principal Investigator

AbViro LLC

Are You a Good Fit for This Trial?

This trial is for healthy adults who can potentially be exposed to Dengue Virus 3 (DENV-3). Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that would exclude them from safely participating.

Inclusion Criteria

Body mass index between 18.5 and 34.9 kg/m², inclusive, at Screening

12-lead electrocardiogram (ECG) and clinical laboratory evaluations within normal range at screening

My overall health is good based on recent medical exams.

Exclusion Criteria

History of anaphylaxis to any drug compound, food, or other substance, unless approved by the investigator

I have not had major surgery in the last 3 months.

I haven't taken any prohibited medication in the last 28 days and won't during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prophylaxis

Participants receive AV-1 for prophylactic effect against DENV-3

4 weeks

Treatment

Participants receive AV-1 for therapeutic effect against DENV-3

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

22 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AV-1

Trial Overview The study tests the safety and effectiveness of AV-1 at different doses (100 mg, 300 mg, and 900 mg) compared to a placebo in preventing or treating DENV-3 infection using a controlled human infection model.

How Is the Trial Designed?

Group I: Group 3B treatment Experimental Treatment 2 Interventions

Group II: Group 3A prophylaxis Experimental Treatment 2 Interventions

Group III: Group 2B treatment Experimental Treatment 2 Interventions

Group IV: Group 2A prophylaxis Experimental Treatment 2 Interventions

Group V: Group 1B treatment Experimental Treatment 2 Interventions

Group VI: Group 1A prophylaxis Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

AbViro LLC

Lead Sponsor

Trials

2

Recruited

130+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06799741

NCT06799741 | A Study to Evaluate the Safety and ... A Study to Evaluate the Safety and Efficacy of AV-1 Against Dengue Virus 3 (DENV-3) Infection · Study Overview · Contacts and Locations · Participation Criteria.

2. niaid.nih.gov niaid.nih.gov/news-events/nih-funded-clinical-trial-will-evaluate-new-dengue-therapeutic

NIH-Funded Clinical Trial Will Evaluate New Dengue ... The researchers will use this information to determine how AV-1 affects the volunteers' ability to recover from dengue compared to placebo and ...

3. withpower.com withpower.com/trial/av-1-for-dengue-fever-6c011

AV-1 for Dengue Fever · Info for Participants Trial Overview The study tests the safety and effectiveness of AV-1 at different doses (100 mg, 300 mg, and 900 mg) compared to a placebo in preventing or ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04273217

A Study to Determine the Safety of AV-1, an Antibody Being ... AV-1 has not previously been tested in humans. This study aims to determine the safety of AV-1 in healthy adult volunteers, when administered as a single IV ...

5. centerforimmunizationresearch.org centerforimmunizationresearch.org/iv-drug-av-1-medication-evaluation-with-dengue-challenge-study-cir362

IV Drug (AV-1) Evaluation with Dengue Challenge Study ... This drug is being tested to see if it will treat or prevent dengue infection. Dengue virus is spread by mosquitoes and affects millions of people globally.

6. bmj.com bmj.com/content/388/bmj-2024-082639/rr

Enhancing the Discussion on Dengue Treatment The study is designed to assess the safety and efficacy of AV-1 at various doses following exposure to an attenuated dengue virus strain.

7. healio.com healio.com/news/infectious-disease/20250214/nih-trial-to-test-safety-efficacy-of-monoclonal-antibody-for-dengue

NIH trial to test safety, efficacy of monoclonal antibody for ... The NIH announced that it is launching a phase 2 human challenge trial of AV-1, an investigational monoclonal antibody to ease dengue virus symptoms.