A/Texas for Flu

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Daniel Hoft, MD, PhD

Must not be taking: Antivirals, NSAIDs, Antihistamines, others

Disqualifiers: Asthma, Cardiovascular disease, Diabetes, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the body's response to a flu infection, specifically the H3N2 strain. Participants will be intentionally exposed to the flu to study symptom development and the immune response. Researchers will monitor blood and nasal swab samples before and after infection to determine if antibodies affect illness severity. This trial may suit healthy non-smokers without recent respiratory issues or significant medical conditions. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to contribute to groundbreaking insights.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking certain medications, including specific flu treatments, aspirin, intranasal steroids, decongestants, antihistamines, and NSAIDs, at least 7 days before and during your stay in the inpatient unit, unless approved by the investigator.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that the flu strain A/Texas/71/2017 (H3N2) is generally safe. In earlier studies, a single dose of this strain successfully caused an infection in over 70% of participants, indicating it worked as expected. Importantly, participants found the side effects manageable and not severe.

This study is in an early phase, focusing on checking safety in people. While detailed information on side effects is not yet available, its current testing phase indicates it has passed some initial safety checks. Participants will be closely monitored to ensure any reactions are quickly addressed. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard flu vaccines that are typically derived from inactivated or attenuated virus strains, the A/Texas treatment uses a specific strain of the influenza virus, RG-A/Texas/71/2017. Researchers are excited about this treatment because it targets a newer variant of the flu virus, potentially offering more effective protection against recent strains. Additionally, by focusing on a single dose administration, it may simplify the vaccination process and improve patient compliance. This innovative approach could lead to better prevention strategies during flu season, especially in rapidly changing flu landscapes.

What evidence suggests that this treatment might be an effective treatment for flu?

Research has shown that flu vaccines, including those similar to A/Texas, have mixed effectiveness. Some studies indicate that these vaccines can prevent millions of flu cases and hospitalizations each year. For example, estimates suggest that flu shots have prevented about 7.1 million flu cases and 3.7 million hospitalizations in the U.S. However, vaccine effectiveness can vary by age group and flu season. Reports have noted reduced effectiveness in certain years, such as the 2017–18 season, particularly for older adults. While A/Texas is being tested in this trial, past vaccines have demonstrated their ability to reduce the severity and spread of the flu. ^{6 7 8 9 10}

Who Is on the Research Team?

Daniel F. Hoft, MD, PhD

Principal Investigator

Saint Louis University Center for Vaccine Development

Are You a Good Fit for This Trial?

This study is for healthy individuals who will be intentionally infected with the flu to observe how their bodies respond. Participants must stay in a medical facility for at least 10 days and complete daily health diaries. They'll have blood tests and nasal swabs taken before and after infection to monitor immune responses.

Inclusion Criteria

Provide written informed consent prior to initiation of any study procedure

Understand and comply with planned study procedures and be available for all study visits

Non-habitual smoker of tobacco, or marijuana

Exclusion Criteria

Known allergy or intolerance to treatments for influenza

Known allergy to two or more classes of antibiotics

I have a weakened immune system or take medication that affects it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 or more visits (in-person)

Inpatient Challenge

Participants are admitted to the inpatient unit and receive the influenza challenge

10 days or longer

Daily monitoring (inpatient)

Post-Challenge Monitoring

Participants are monitored for symptoms and viral shedding, with daily assessments and potential treatment if still shedding virus

7 days minimum

Daily monitoring (inpatient)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with scheduled visits and a final phone call

90 days

3 visits (in-person), 1 call (phone)

What Are the Treatments Tested in This Trial?

Interventions

• A/Texas

Trial Overview The trial involves infecting participants with an H3N2 flu strain, known as A/Texas, to study symptom patterns and immune response timing. Researchers aim to determine if pre-existing antibodies affect the severity of illness or provide protection against infection.

How Is the Trial Designed?

Group I: Single Arm Experimental Treatment 1 Intervention

One dose of RG-A/Texas/71/2017 Influenza Virus

Who Is Running the Clinical Trial?

Daniel Hoft, MD, PhD

Lead Sponsor

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39052725/

Influenza Vaccine Effectiveness Against ... Results: The analysis included 85 389 ED/UC ARI encounters (17.0% influenza A positive; 37.8% vaccinated overall) and 19 751 hospitalizations ( ...

2. cdc.gov cdc.gov/flu-vaccines-work/php/effectiveness-studies/index.html

CDC Seasonal Flu Vaccine Effectiveness Studies CDC conducts studies each flu season to help determine how well flu vaccines are working. These vaccine effectiveness (VE) studies help regularly assess the ...

3. academic.oup.com academic.oup.com/cid/advance-article/doi/10.1093/cid/ciae658/7943530

Influenza Vaccine Effectiveness Against Medically Attended ... Statistically significant protection against any influenza was found for all age groups except adults aged 50–64 years. Lack of protection in ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7188082/

Effects of Influenza Vaccination in the United States During ... We estimated that influenza vaccination prevented 7.1 million (95% CrI, 5.4 million–9.3 million) illnesses and 3.7 million (95% CrI, 2.8 million–4.9 million) ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1600613522095107

Interim estimates of 2017–18 seasonal influenza vaccine ... This report documents the low effectiveness of this year's influenza vaccine, both in normal and immunosuppressed individuals.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06476275

Single Dose Texas 2017 (H3N2) Challenge Study Recombinant H3N2 (A/Texas/71/2017 (H3N2), clade 3C3a) influenza virus at 106 TCID50 dose. This dose has an attack rate of >70%, and a good safety profile ...

7. withpower.com withpower.com/trial/phase-1-influenza-human-7-2021-ac4d5

Influenza Challenge Study to Determine the Optimal ... Influenza Challenge Study to Determine the Optimal Infection Dose and Safety of a Recombinant H3N2 (A/Texas/71/2017 (H3N2, Clade 3C3a) Influenza Strain.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6595494/

Evaluation of correlates of protection against influenza A ... On average, influenza vaccines have been only approximately 30% effective in preventing influenza A(H3N2) infection, and were ineffective in preventing ...

9. ctv.veeva.com ctv.veeva.com/study/influenza-challenge-study-to-determine-the-optimal-infection-dose-and-safety-of-a-recombinant-h3n2

Influenza Challenge Study to Determine the Optimal Infection ... The primary objectives are: 1) To determine the optimal infectious dose of a recombinant influenza virus (A/Texas/71/2017 (H3N2), clade 3C3a) to ...

10. dshs.texas.gov dshs.texas.gov/sites/default/files/IDCU/disease/influenza/conference/docs/2017-docs/2a_Hoffman_Influenza-Vaccination-2017.pdf

Flu rates/ordering Influenza Vaccine Safety. 1.Good safety record. 2.Side effects. 3.Vaccine Adverse Event Reporting. System (VAERS). 4.Vaccine Safety Data Link (VSD). Page 20 ...