Actifed

Catarrh, Urticaria, Angioedema + 10 more

Treatment

14 FDA approvals

20 Active Studies for Actifed

What is Actifed

Triprolidine

The Generic name of this drug

Treatment Summary

Pseudoephedrine is a drug related to ephedrine, which is found in the ephedra plant. It has been used for centuries in Eastern medicine and first researched in the West in 1889. In 1927, it was discovered that pseudoephedrine has a decongestant effect, which is a weaker effect than that of ephedrine on the nervous system.

Silafed

is the brand name

image of different drug pills on a surface

Actifed Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Silafed

Triprolidine

1988

3

Approved as Treatment by the FDA

Triprolidine, also called Silafed, is approved by the FDA for 14 uses like Vasomotor Rhinitis and Seasonal Allergic Rhinitis .

Vasomotor Rhinitis

Seasonal Allergic Rhinitis

mild Angioedema

mild urticaria

Perennial Allergic Rhinitis (PAR)

Hay Fever

Catarrh

Used to treat Common Cold in combination with Codeine

upper respiratory discomfort

Used to treat upper respiratory discomfort in combination with Codeine

Rhinitis, Allergic

Rhinitis, Vasomotor

Urticaria

Allergic Conjunctivitis (AC)

Angioedema

Hypersensitivity

Effectiveness

How Actifed Affects Patients

Pseudoephedrine acts as a decongestant by narrowing the blood vessels in the nose and sinuses. Its effects can last for a short time unless it is taken as an extended release product. Taking this drug may cause side effects related to stimulation of the central nervous system, so people should be aware of this risk.

How Actifed works in the body

Pseudoephedrine works by activating certain receptors in the body and by inhibiting certain transporters. This triggers an increase in blood pressure, heart rate and muscle tension. It also affects the body's inflammatory response, making it useful in treating conditions involving inflammation. Pseudoephedrine also helps relieve congestion and treat priapism.

When to interrupt dosage

The suggested measure of Actifed is contingent upon the recognized condition, including Upper Respiratory Tract Infection, Airway secretion clearance therapy and Coughing. The dosage amount is contingent upon the delivery technique (e.g. Tablet, extended release or Oral), which is enumerated in the table beneath.

Condition

Dosage

Administration

Hay Fever

2.5 mg, , 2.5 mg/mL, 0.938 mg/mL, 1.25 mg/mL, 0.625 mg/mL, 1.25 mg, 4.0 mg, 0.313 mg/mL, 30.0 mg/mL, 0.025 mg/mg, 0.66 mg, 0.25 mg/mL, 12.5 mg/mL, 0.125 mg/mL, 2.0 mg/mL

, Oral, Tablet, coated - Oral, Tablet, coated, Tablet, film coated, Tablet, film coated - Oral, Syrup, Syrup - Oral, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Solution - Oral, Capsule - Oral, Solution, Suspension - Oral, Capsule

Urticaria

2.5 mg, , 2.5 mg/mL, 0.938 mg/mL, 1.25 mg/mL, 0.625 mg/mL, 1.25 mg, 4.0 mg, 0.313 mg/mL, 30.0 mg/mL, 0.025 mg/mg, 0.66 mg, 0.25 mg/mL, 12.5 mg/mL, 0.125 mg/mL, 2.0 mg/mL

, Oral, Tablet, coated - Oral, Tablet, coated, Tablet, film coated, Tablet, film coated - Oral, Syrup, Syrup - Oral, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Solution - Oral, Capsule - Oral, Solution, Suspension - Oral, Capsule

Influenza

2.5 mg, , 2.5 mg/mL, 0.938 mg/mL, 1.25 mg/mL, 0.625 mg/mL, 1.25 mg, 4.0 mg, 0.313 mg/mL, 30.0 mg/mL, 0.025 mg/mg, 0.66 mg, 0.25 mg/mL, 12.5 mg/mL, 0.125 mg/mL, 2.0 mg/mL

, Oral, Tablet, coated - Oral, Tablet, coated, Tablet, film coated, Tablet, film coated - Oral, Syrup, Syrup - Oral, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Solution - Oral, Capsule - Oral, Solution, Suspension - Oral, Capsule

Rhinitis, Vasomotor

2.5 mg, , 2.5 mg/mL, 0.938 mg/mL, 1.25 mg/mL, 0.625 mg/mL, 1.25 mg, 4.0 mg, 0.313 mg/mL, 30.0 mg/mL, 0.025 mg/mg, 0.66 mg, 0.25 mg/mL, 12.5 mg/mL, 0.125 mg/mL, 2.0 mg/mL

, Oral, Tablet, coated - Oral, Tablet, coated, Tablet, film coated, Tablet, film coated - Oral, Syrup, Syrup - Oral, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Solution - Oral, Capsule - Oral, Solution, Suspension - Oral, Capsule

Nasal Congestion

2.5 mg, , 2.5 mg/mL, 0.938 mg/mL, 1.25 mg/mL, 0.625 mg/mL, 1.25 mg, 4.0 mg, 0.313 mg/mL, 30.0 mg/mL, 0.025 mg/mg, 0.66 mg, 0.25 mg/mL, 12.5 mg/mL, 0.125 mg/mL, 2.0 mg/mL

, Oral, Tablet, coated - Oral, Tablet, coated, Tablet, film coated, Tablet, film coated - Oral, Syrup, Syrup - Oral, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Solution - Oral, Capsule - Oral, Solution, Suspension - Oral, Capsule

Hypersensitivity

2.5 mg, , 2.5 mg/mL, 0.938 mg/mL, 1.25 mg/mL, 0.625 mg/mL, 1.25 mg, 4.0 mg, 0.313 mg/mL, 30.0 mg/mL, 0.025 mg/mg, 0.66 mg, 0.25 mg/mL, 12.5 mg/mL, 0.125 mg/mL, 2.0 mg/mL

, Oral, Tablet, coated - Oral, Tablet, coated, Tablet, film coated, Tablet, film coated - Oral, Syrup, Syrup - Oral, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Solution - Oral, Capsule - Oral, Solution, Suspension - Oral, Capsule

Catarrh

2.5 mg, , 2.5 mg/mL, 0.938 mg/mL, 1.25 mg/mL, 0.625 mg/mL, 1.25 mg, 4.0 mg, 0.313 mg/mL, 30.0 mg/mL, 0.025 mg/mg, 0.66 mg, 0.25 mg/mL, 12.5 mg/mL, 0.125 mg/mL, 2.0 mg/mL

, Oral, Tablet, coated - Oral, Tablet, coated, Tablet, film coated, Tablet, film coated - Oral, Syrup, Syrup - Oral, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Solution - Oral, Capsule - Oral, Solution, Suspension - Oral, Capsule

Angioedema

2.5 mg, , 2.5 mg/mL, 0.938 mg/mL, 1.25 mg/mL, 0.625 mg/mL, 1.25 mg, 4.0 mg, 0.313 mg/mL, 30.0 mg/mL, 0.025 mg/mg, 0.66 mg, 0.25 mg/mL, 12.5 mg/mL, 0.125 mg/mL, 2.0 mg/mL

, Oral, Tablet, coated - Oral, Tablet, coated, Tablet, film coated, Tablet, film coated - Oral, Syrup, Syrup - Oral, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Solution - Oral, Capsule - Oral, Solution, Suspension - Oral, Capsule

Upper respiratory tract signs and symptoms

2.5 mg, , 2.5 mg/mL, 0.938 mg/mL, 1.25 mg/mL, 0.625 mg/mL, 1.25 mg, 4.0 mg, 0.313 mg/mL, 30.0 mg/mL, 0.025 mg/mg, 0.66 mg, 0.25 mg/mL, 12.5 mg/mL, 0.125 mg/mL, 2.0 mg/mL

, Oral, Tablet, coated - Oral, Tablet, coated, Tablet, film coated, Tablet, film coated - Oral, Syrup, Syrup - Oral, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Solution - Oral, Capsule - Oral, Solution, Suspension - Oral, Capsule

Rhinitis, Allergic

2.5 mg, , 2.5 mg/mL, 0.938 mg/mL, 1.25 mg/mL, 0.625 mg/mL, 1.25 mg, 4.0 mg, 0.313 mg/mL, 30.0 mg/mL, 0.025 mg/mg, 0.66 mg, 0.25 mg/mL, 12.5 mg/mL, 0.125 mg/mL, 2.0 mg/mL

, Oral, Tablet, coated - Oral, Tablet, coated, Tablet, film coated, Tablet, film coated - Oral, Syrup, Syrup - Oral, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Solution - Oral, Capsule - Oral, Solution, Suspension - Oral, Capsule

Allergic Conjunctivitis (AC)

2.5 mg, , 2.5 mg/mL, 0.938 mg/mL, 1.25 mg/mL, 0.625 mg/mL, 1.25 mg, 4.0 mg, 0.313 mg/mL, 30.0 mg/mL, 0.025 mg/mg, 0.66 mg, 0.25 mg/mL, 12.5 mg/mL, 0.125 mg/mL, 2.0 mg/mL

, Oral, Tablet, coated - Oral, Tablet, coated, Tablet, film coated, Tablet, film coated - Oral, Syrup, Syrup - Oral, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Solution - Oral, Capsule - Oral, Solution, Suspension - Oral, Capsule

Allergy to Tree Pollen

2.5 mg, , 2.5 mg/mL, 0.938 mg/mL, 1.25 mg/mL, 0.625 mg/mL, 1.25 mg, 4.0 mg, 0.313 mg/mL, 30.0 mg/mL, 0.025 mg/mg, 0.66 mg, 0.25 mg/mL, 12.5 mg/mL, 0.125 mg/mL, 2.0 mg/mL

, Oral, Tablet, coated - Oral, Tablet, coated, Tablet, film coated, Tablet, film coated - Oral, Syrup, Syrup - Oral, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Solution - Oral, Capsule - Oral, Solution, Suspension - Oral, Capsule

upper respiratory discomfort

2.5 mg, , 2.5 mg/mL, 0.938 mg/mL, 1.25 mg/mL, 0.625 mg/mL, 1.25 mg, 4.0 mg, 0.313 mg/mL, 30.0 mg/mL, 0.025 mg/mg, 0.66 mg, 0.25 mg/mL, 12.5 mg/mL, 0.125 mg/mL, 2.0 mg/mL

, Oral, Tablet, coated - Oral, Tablet, coated, Tablet, film coated, Tablet, film coated - Oral, Syrup, Syrup - Oral, Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Solution - Oral, Capsule - Oral, Solution, Suspension - Oral, Capsule

Warnings

Actifed has five counter-indications, and its use should be avoided when encountering any of the circumstances outlined in the following table.

There are 20 known major drug interactions with Actifed.

Common Actifed Drug Interactions

Drug Name

Risk Level

Description

Azelastine

Major

Triprolidine may increase the central nervous system depressant (CNS depressant) activities of Azelastine.

Ethanol

Major

Triprolidine may increase the central nervous system depressant (CNS depressant) activities of Ethanol.

Hydroxyzine

Major

The risk or severity of QTc prolongation can be increased when Triprolidine is combined with Hydroxyzine.

Mobocertinib

Major

The risk or severity of QTc prolongation can be increased when Triprolidine is combined with Mobocertinib.

Oliceridine

Major

The risk or severity of hypotension, sedation, death, somnolence, and respiratory depression can be increased when Triprolidine is combined with Oliceridine.

Actifed Toxicity & Overdose Risk

The lowest toxic dose of pseudoephedrine in rats has been found to be 2206mg/kg and 726mg/kg in mice. Symptoms of overdose include dizziness, headaches, nausea, vomiting, increased heart rate, chest pain, difficulty urinating, muscle weakness, anxiety, restlessness, insomnia, mental confusion, irregular heartbeat, fainting, seizures, loss of consciousness, and trouble breathing. Treatments for pseudoephedrine overdose include removing any unabsorbed drug and providing supportive care.

image of a doctor in a lab doing drug, clinical research

Actifed Novel Uses: Which Conditions Have a Clinical Trial Featuring Actifed?

270 active trials are underway to evaluate the potential of Actifed for alleviating Allergies, Migraines and Ocular ailments.

Condition

Clinical Trials

Trial Phases

Urticaria

0 Actively Recruiting

Angioedema

0 Actively Recruiting

Influenza

29 Actively Recruiting

Not Applicable, Phase 4, Phase 2, Phase 1, Phase 3

Allergic Conjunctivitis (AC)

1 Actively Recruiting

Phase 2

Hay Fever

0 Actively Recruiting

Nasal Congestion

0 Actively Recruiting

Catarrh

0 Actively Recruiting

upper respiratory discomfort

0 Actively Recruiting

Rhinitis, Vasomotor

0 Actively Recruiting

Rhinitis, Allergic

0 Actively Recruiting

Upper respiratory tract signs and symptoms

0 Actively Recruiting

Hypersensitivity

1 Actively Recruiting

Phase 4

Allergy to Tree Pollen

0 Actively Recruiting

Actifed Reviews: What are patients saying about Actifed?

5

Patient Review

7/15/2012

Actifed for Inflammation of the Nose due to an Allergy

Walact is an effective sinusitis medication that contains the active ingredient triplodene. You can find it at Walgreens.

5

Patient Review

10/4/2014

Actifed for Runny Nose

This treatment is effective and I would recommend it to others.

5

Patient Review

2/1/2019

Actifed for Cold Symptoms

This drug was recommended to me by a pharmacist when I had flu-like symptoms while traveling in France. It worked quickly and effectively.

3.7

Patient Review

2/1/2008

Actifed for Stuffy Nose

I unfortunately had to stop using this medication because it caused me to have severe anxiety attacks.

3.3

Patient Review

4/24/2010

Actifed for Cold Symptoms

I felt terrible the next day after taking this medication. I was extremely sleepy and depressed.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about actifed

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is Actifed called now?

"The active ingredients in Wal-Act D are the same as those in the old Actifed formula: Triprolidine HCL and Pseudoehedrine HL. I bought some today at Wallgreens; it's their house brand, and you have to ask the pharmacist for it."

Answered by AI

Does Actifed make you sleep?

"”

Actifed is an effective medication for cold symptoms that cause constant coughing, especially at night. It may cause drowsiness, but this is not a problem for use at night."

Answered by AI

What is the drug Actifed used for?

"Decongestants help to reduce swelling in the nose.

This medication is a combination of an antihistamine and a decongestant and is used to relieve the symptoms of the common cold, flu, allergies, or other breathing illnesses temporarily. The antihistamine component helps relieve watery eyes, itchy eyes, nose, and throat, as well as a runny nose and sneezing. The decongestant component helps to reduce swelling in the nose."

Answered by AI

Clinical Trials for Actifed

Image of Institute for Health Research in Aurora, United States.

Behavioral Nudge Texts for Flu Vaccination

Any Age
All Sexes
Aurora, CO

Influenza infection leads to significant morbidity and mortality each year. Influenza vaccines can reduce the risk of flu and the severity of flu illness, In addition, flu vaccinations can reduce flu complications such as pneumonia or worsening of chronic heart or lung disease. Each year, Kaiser Permanente of Colorado offers influenza vaccines to patients at no cost either at primary care clinic appointments or flu walk-in clinics in the fall prior to the upcoming flu season. In addition, as part of clinic appointment reminder text messages, there is a message to get the flu vaccine for patients who have not received the vaccine prior to the clinic visit. Building on these flu reminder text messages for patients who have not received a flu vaccine, this study will test different behavioral nudge text messages to improve influenza vaccination rates.

Waitlist Available
Has No Placebo

Institute for Health Research

Michael Ho, MD, PhD

Image of Andover Eye Associates in Andover, United States.

REGN5713 + REGN5715 for Allergic Eye

Any Age
All Sexes
Andover, MA

This study is researching 2 experimental drugs, REGN5713 and REGN5715. The study drugs will be either of these drugs given alone (either REGN5713 or REGN5715) or given together (REGN5713 and REGN5715) to reduce eye allergy signs and symptoms due to birch tree pollen allergy. The aim of the study is to see how safe and effective the study drugs are at lowering eye allergy signs and symptoms compared with placebo. The study will also evaluate whether the combination (REGN5713-5715) has different effectiveness than REGN5713 or REGN5715 alone. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs * How much of the study drugs is in the blood at different times * Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)

Phase 3
Recruiting

Andover Eye Associates

Clinical Trial Management

Regeneron Pharmaceuticals

Image of Cedars-Sinai Medical Center Otolaryngology Clinics in Los Angeles, United States.

Lavender Aromatherapy for Anxiety and Pain During Otolaryngologic Procedures

18+
All Sexes
Los Angeles, CA

The purpose of this study is to evaluate the efficacy of lavender aromatherapy in adult patients undergoing awake otolaryngologic procedures in the outpatient clinic setting. The main questions it aims to answer are: * Does lavender aromatherapy help reduce anxiety and/or pain, and improve patient comfort during awake otolaryngologic procedures in the clinic? * Do patients subjectively find aromatherapy relaxing and/or beneficial during the procedure? Researchers will compare lavender aromatherapy to placebo (an odorless liquid) to see if lavender aromatherapy helps improve patient comfort during their awake procedure Participants will: * Have their scheduled procedure performed with lavender aromatherapy or placebo during the duration of the procedure * Take a short, less than 1 minute questionnaire both before and after the procedure, describing their levels of anxiety, pain and subjective impressions of the aromatherapy

Recruiting
Paid Trial

Cedars-Sinai Medical Center Otolaryngology Clinics

Ankona Ghosh, MD

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Image of National Institutes of Health Clinical Center in Bethesda, United States.

BPL-1357 for Flu

18 - 55
All Sexes
Bethesda, MD

Background: Influenza (flu) infections are a serious global health threat. Each year, between 3 and 5 million people get the flu, and up to 500,000 die from it. Current vaccines protect against seasonal flus, but broader vaccines are needed to protect against potential flu pandemics. Objective: To test an experimental flu vaccine. Eligibility: Healthy people aged 18 to 55 years. Design: The study will last 5 to 8 months and has 2 phases, A and B. The study vaccine will be given either as a shot in the arm or as a nasal spray. Participants will receive 1 of 3 combinations: (1) study vaccine in the nose and placebo in the arm; (2) placebo in the nose and study vaccine in the arm; or (3) placebo in the nose and placebo in the arm. A placebo is just like the real vaccine but contains no active ingredients. Phase A: Participants will have 5 clinic visits over 56 days. They will receive a shot and a nasal spray at 2 of the visits, 28 days apart. At each visit, they will have a physical exam, with tests of their blood, urine, and nasal secretions. They will check their temperature at home and record any symptoms for 7 days after each vaccine. Phase B: Participants will stay in the hospital for at least 9 days. They will be infected with a flu virus. They will provide blood, urine, and nasal fluid samples. They will have tests of their heart function. They will remain in the hospital until they test negative for the flu 2 days in a row. They will have 2 follow-up visits, 4 and 8 weeks after leaving the hospital.

Phase 2
Waitlist Available

National Institutes of Health Clinical Center (+1 Sites)

Luca T Giurgea, M.D.

Image of Vanderbilt University Medical Center in Nashville, United States.

High vs. Standard Dose Influenza Vaccines for Flu

18+
All Sexes
Nashville, TN

This will be a follow-up study to the "Comparison of High Dose vs. Standard Dose Influenza Vaccine in Lung Allograft Recipient" study (DMID Protocol Number 22-0014) at Vanderbilt University Medical Center. Lung transplantation is a life-saving therapy for patients with advanced lung disease, and is also associated with an improvement in quality of life. However, due to the need for life-long immunosuppression to prevent acute cellular rejection and chronic lung allograft dysfunction ("chronic rejection"), lung transplant recipients are at risk for developing major infections. In fact, one-year survival is 85%, with infection being the leading cause of death within the first year post-transplant. We will conduct a follow-up phase II, randomized, double-blind trial to assess the impact of subsequent administration of two doses of HD-IIV compared to two doses of SD-IIV among lung recipients during the early post-transplant period. Demonstration of improved immunogenicity from two doses of HD-IIV over consecutive influenza seasons would provide potential broad benefit in reducing influenza disease and its associated complications in lung transplant recipients. Moreover, studying vaccine immunogenicity and safety in the same participants over consecutive years can provide insight into the influence of immunosuppression levels and allograft aging on vaccine-mediated immune modulation. This proposed study design will contribute significantly to influenza vaccination guidance and policy for the highly vulnerable lung transplant population. This proposed study is designed to address several key knowledge gaps in vaccine-mediated protection of lung transplant recipients against influenza: * Is there increased immunogenicity with administration of one or two doses of HD-IIV or SD-IIV in the subsequent season compared to two doses of HD-IIV or SD-IIV in the first season? * What is the durability of the humoral and cellular immune response between influenza seasons and does two doses of HD-IIV or SD-IIV sustain higher HAI titers compared to two doses of HD-IIV or SD-IIV in the first season? * What is the impact of maintenance immunosuppression levels on influenza vaccine immunogenicity within the same participant? * Will the optimal immunogenic vaccination strategy be associated with an acceptable long-term safety profile over successive influenza seasons, including injection-site and systemic reactions, allosensitization, and organ rejection?

Phase 2
Recruiting

Vanderbilt University Medical Center

Natahsa Halasa, MD, MPH

Image of University of Maryland, School of Medicine, Center for Vaccine Development and Global Health in Baltimore, United States.

pH1N1 Virus for Flu

18 - 55
All Sexes
Baltimore, MD

This protocol describes a clinical trial to develop and validate a Controlled Human Infection Model (CHIM) for influenza A/Arkansas/08/2020 (pH1N1). The study is designed to determine the optimal infectious dose of the pH1N1 challenge strain for use in future clinical trials evaluating influenza countermeasures. The study will enroll and challenge adult volunteers with the pH1N1 influenza virus challenge or sham inoculations. Given the adaptive design of this trial, the potential number of participants can vary. Depending on the pathway recommended by the PSRT and followed in the Trial Schema, the study population can range from around 30 to 120. However, it is anticipated that the final sample size will be around 60 participants receiving pH1N1 challenge product plus approximately 4 persons receiving a sham inoculation. Participants will be pre-screened for health and for serological HAI antibody titers of \</1:40 against the challenge strain. Eligible participants will be enrolled sequentially into challenge cohorts and will be randomly assigned to receive a single dose of either sham inoculation or the interventional study product at a dose between 10\^6 to 10\^7 TCID50 (or 10\^5 TCID50 if needed). Dose titration will be conducted under an adaptive escalation schedule whereby dosing will start at 10\^6 TCID50 and escalate to the next dose if a pre-determined symptomatic influenza attack rate and clinical symptom score thresholds are not met and if the dose is determined to be safe with no pre-defined halting criteria being met. The primary objectives of this study are to determine the optimal infectious dose of a pH1N1 viral challenge to cause laboratory-confirmed clinical influenza and to assess the safety profile of pH1N1 viral challenge.

Phase 1
Recruiting

University of Maryland, School of Medicine, Center for Vaccine Development and Global Health (+1 Sites)

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Influenza Virus for Influenza

18 - 49
All Sexes
Atlanta, GA

This study is designed to help us better understand how the immune system responds to the flu and how flu is transmitted in the environment. The ultimate goal is to develop better vaccines and drugs to protect against or fight the flu. This study will describe how the body's immune system responds to the flu virus during and after infection and how the flu virus is transmitted in the environment. The study will use a flu virus called A/Texas/71/2017 (H3N2), clade 3C3a produced specifically for clinical research in controlled conditions. The study will also assess the safety of the H3N2 influenza challenge in healthy participants. Mild to moderate symptoms are expected based on previous studies with this strain of influenza. Study volunteers will be recruited and screened from the general population of metro Atlanta through advertisements or identified from a database of research participants who have previously agreed to be contacted for future research studies. Participants will provide written consent before study participation. Up to 200 healthy adults, 18-49 years old, will be screened for participation. Eligible participants will take part in the study over 5 months. Enrolled participants will be admitted to Emory University Hospital during which time they will receive the influenza virus in the form of a spray in the nose or exposure to infected participants followed by an 8-12 day inpatient stay for observation. Follow-up outpatient visits will take place at the Hope Clinic of the Emory Vaccine Center. Participants will receive compensation (pro-rated for all visits completed) for their time and effort. There will be no costs to participants as a result of being in the study.

Phase 1
Recruiting

Emory University Hospital Clinical Research Network (+1 Sites)

Nadine Rouphael, MD

Image of Research Institute of McGill University Health Centre in Montréal, Canada.

COVID-19 Booster + Flu Vaccine for Immunocompromised People

18+
All Sexes
Montréal, Canada

The goal of this pragmatic embedded open-label, 2 x 2 factorial phase II randomized controlled trial is to evaluate strategies to improve COVID-19 booster and influenza vaccine immunogenicity in people living with immunocompromising conditions (PLIC). The main questions it aims to answer are: 1. Is co-administration of seasonal inactivated influenza vaccine (IIV) with the most up-to-date recommended COVID-19 booster dose non-inferior in inducing a 1-month peak protective humoral response against COVID-19, compared to a strategy of sequential administration of COVID-19 booster dose followed by seasonal IIV given one month later? 2. Is the administration of the most up-to-date recommended COVID-19 booster doses at 3-month intervals superior at maintaining a longer term protective humoral immune response, compared to booster doses administered at 6-month intervals? Researchers will compare (1) COVID-19 and Influenza vaccines administered at Day 0 + COVID-19 Booster at a 3-month interval, (2) COVID-19 vaccine administered at Day 0 and Influenza vaccine administered at Day 28 + COVID-19 Booster at a 3-month interval, (3) COVID-19 and Influenza vaccines administered at Day 0 + COVID-19 Booster at a 6-month interval, and (4) COVID-19 vaccine administered at Day 0 and Influenza vaccine administered at Day 28 + COVID-19 Booster at a 6-month interval to see if median neutralization capacity of patient sera is non-inferior in the co- vs. sequential administration arms at 1-month after the initial COVID-19 booster and superior in the 3-month interval arms vs. the 6-month interval arms at 12 months after the initial COVID-19 booster. These outcomes will also be compared at 2-months for question 1 and 6-months for question 2. People living with immunocompromising conditions who take part in the trial will have blood samples drawn to verify immune response, be monitored for changes in clinical events and therapies, and complete questionnaires to verify adverse effects, quality of life and economic impact.

Phase 2
Recruiting

Research Institute of McGill University Health Centre (+1 Sites)

Image of Rush University in Chicago, United States.

Science Communication Training for Vaccine Hesitancy

18 - 99
All Sexes
Chicago, IL

Dime La VerDAD is an innovative social media capacity-building program that empowers promotores de salud to debunk vaccine misinformation through the use of personal narratives on social media. The core of the implementation strategy consists of augmenting training and self-efficacy for natural community champions, "promotores de salud" from the Hispanic community as trusted messengers to debunk vaccination misinformation. The study will leverage existing community relationships in Chicago and a first of its kind misinformation curriculum to debunk misinformation in communities served by participating promotores de salud. Dime La VerDAD (Verify, Debunk, and Disseminate) is an innovative social media capacity-building program based on theoretical frameworks related to health communication that empowers promotores de salud to debunk vaccine misinformation through the use of personal narratives on social media. This mixed methods study will use a rigorous stepped wedge design to 1) deliver a scalable program of science communicators using an adapted curriculum grounded in infodemiology, 2) evaluate how debunking misinformation is perceived on social media, and 3) discern how use of personal narratives to enhance science communication can lead to changes in opinions and behavior (vaccination rates) about COVID and influenza vaccines among Chicago's predominantly Hispanic communities.

Recruiting
Has No Placebo

Rush University (+3 Sites)

Marina DelRios, MD

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