Nasal Flu Vaccine for COPD
Recruiting in Palo Alto (17 mi)
MB
Overseen byMichael B Drummond, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: University of North Carolina, Chapel Hill
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
This study will determine the functional status of the nasal immune environment with LAIV exposure in COPD persons with frequent exacerbations (defined as individuals with two or more episodes of worsening in COPD symptoms requiring treatment with antibiotics and/or steroids in the prior 12 months) and COPD persons without frequent exacerbations to determine acute exacerbation of COPD (AECOPD)-associated dysfunction in a) cytokines and immune effector cells of the nasal mucosa and b) viral replication. The investigators hypothesize that: 1) COPD frequent exacerbators, compared to COPD infrequent exacerbators, will demonstrate altered mucosal immune responses to LAIV exposure, and 2) COPD frequent exacerbators, compared to COPD infrequent exacerbators, will demonstrate increased markers of influenza viral replication after LAIV exposure.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop using certain medications. You cannot participate if you use regular suppressive antibiotics, daily oral prednisone, intranasal corticosteroids within 30 days prior to screening, or chronic immunosuppression within 30 days prior to screening. Additionally, you cannot use blood thinners beyond full dose aspirin.
What data supports the idea that Nasal Flu Vaccine for COPD is an effective treatment?
The available research shows that influenza vaccination can help prevent influenza in people with COPD. One study found that the current-season flu vaccine reduced the chance of getting the flu by 40% in COPD patients. Another study highlighted that flu vaccines are recommended for people with COPD to prevent hospitalizations. While the data is mostly about flu vaccines in general, it suggests that getting vaccinated can help reduce flu-related problems in people with COPD.12345
What safety data exists for the nasal flu vaccine in COPD patients?
The nasal flu vaccine, known as FluMist or LAIV, has been studied for safety in various populations. It is generally well tolerated in healthy individuals aged 5-49, with common side effects including abdominal pain, chills, cough, diarrhea, headache, and sore throat. In patients with chronic lung diseases like COPD, studies have assessed adverse reactions and their impact on lung function and respiratory symptoms. However, specific safety data for COPD patients is limited, and further research is needed to fully understand the safety profile in this group.678910
Is the nasal flu vaccine a promising treatment for COPD?
The nasal flu vaccine, known as LAIV or FluMist, is a promising treatment for preventing the flu. It is easy to use because it is given through the nose instead of a shot. This makes it less painful and more convenient. While most studies focus on other types of flu vaccines for COPD patients, the nasal flu vaccine has shown to be effective in preventing the flu in healthy people, which suggests it could be beneficial for those with COPD as well.610111213
Research Team
MB
Michael B Drummond, MD
Principal Investigator
University of North Carolina, Chapel Hill
Eligibility Criteria
This trial is for adults over 40 with COPD, who've had two or more flare-ups in the past year requiring treatment. They must have stable blood pressure and oxygen levels, no recent tobacco use, and not be on certain medications like nasal steroids or immunosuppressants. People with asthma, recent respiratory infections, or those who can't avoid contact with immunocompromised individuals after vaccination are excluded.Inclusion Criteria
If you are in the healthy control group, your blood pressure should be between 90/55 and 160/90.
I do not have any nasal symptoms according to a questionnaire.
Individual in the healthy control group must complete informed consent
See 12 more
Exclusion Criteria
I was hospitalized due to COVID-19.
You have had severe allergic reactions to certain things in the past.
I have not used any chronic immunosuppression medication in the last 30 days.
See 22 more
Treatment Details
Interventions
- LAIV (Virus Therapy)
Trial OverviewThe study tests how a live attenuated influenza vaccine (LAIV) affects the nasal immune response in people with COPD. It compares those who frequently have exacerbations to those who don't by measuring cytokines, immune cells in the nose, and viral replication markers following LAIV exposure.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Healthy ControlExperimental Treatment1 Intervention
Individuals with spirometry-confirmed normal lung function and no asthma history
Group II: COPD Infrequent ExacerbatorsExperimental Treatment1 Intervention
Individuals with less than two episodes of worsening in COPD symptoms requiring treatment with antibiotics and/or steroids in the prior 12 months
Group III: COPD Frequent ExacerbatorsExperimental Treatment1 Intervention
Individuals with two or more episodes of worsening in COPD symptoms requiring treatment with antibiotics and/or steroids in the prior 12 months
LAIV is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as FluMist for:
- Prevention of influenza A and B in individuals 2 through 49 years of age
🇪🇺 Approved in European Union as Fluenz for:
- Prevention of influenza A and B in children and adolescents from 24 months to less than 18 years of age
🇨🇦 Approved in Canada as FluMist for:
- Prevention of influenza A and B in individuals 2 through 59 years of age
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Eastowne Medical Office BuildingChapel Hill, NC
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Who Is Running the Clinical Trial?
University of North Carolina, Chapel Hill
Lead Sponsor
Trials
1588
Patients Recruited
4,364,000+
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Trials
3987
Patients Recruited
47,860,000+
References
Influenza Vaccine Effectiveness in Preventing Hospitalizations in Older Patients With Chronic Obstructive Pulmonary Disease. [2021]Annual influenza immunization is recommended for people with chronic obstructive pulmonary disease (COPD) by all major COPD clinical practice guidelines. We sought to determine the seasonal influenza vaccine effectiveness (VE) against laboratory-confirmed influenza-associated hospitalizations among older adults with COPD.
Influenza vaccine for chronic obstructive pulmonary disease (COPD). [2022]Influenza vaccinations are currently recommended in the care of people with COPD, but these recommendations are based largely on evidence from observational studies, with very few randomised controlled trials (RCTs) reported. Influenza infection causes excess morbidity and mortality in people with COPD, but there is also the potential for influenza vaccination to cause adverse effects, or not to be cost effective.
Acute respiratory illness in patients with COPD and the effectiveness of influenza vaccination: a randomized controlled study. [2019]To determine the effectiveness of influenza vaccination on influenza-related acute respiratory illness (ARI) and overall ARI in patients with COPD, and its relationship to the degree of airflow obstruction.
Chronic obstructive pulmonary disease and influenza vaccination effect in preventing outpatient and inpatient influenza cases. [2022]Evidence of influenza vaccine effectiveness in preventing confirmed influenza among persons diagnosed with chronic obstructive pulmonary disease (COPD) is scarce. We assessed the average effect of influenza vaccination in the current and prior seasons in preventing laboratory-confirmed influenza in COPD patients. We carried out a pooled test-negative case-control design in COPD patients hospitalized or presented to primary healthcare centres with influenza-like illness who were tested for influenza in 2015/2016 to 2019/2020 seasons in Navarre, Spain. Influenza vaccination status in the current and 5 prior seasons was compared between confirmed-influenza cases and test-negative controls. Vaccination effect was compared between target patients for vaccination with and without COPD. Out of 1761 COPD patients tested, 542 (31%) were confirmed for influenza and 1219 were test-negative controls. Average effect for current-season vaccination in preventing influenza was 40% (95% CI 20-54%), and for vaccination in prior seasons only was 24% (95% CI -10 to 47%). Point estimates seemed higher in preventing outpatient cases (60% and 58%, respectively) than inpatient cases (37% and 19%, respectively), but differences were no statistically significant. Influenza vaccination effect was similar in target population with and without COPD (p = 0.339). Influenza vaccination coverage in control patients with COPD was 68.3%. A 13.7% of the influenza cases in patients with COPD could be prevented by extending the influenza vaccine coverage. Average effect of current-season influenza vaccination was moderate to prevent influenza in COPD persons. The increase of influenza vaccination coverage can still prevent COPD exacerbations.
[Analysis of the effectiveness of joint or sequential vaccination with pneumococcal and influenza vaccines in patients with chronic obstructive pulmonary disease]. [2020]One of the extremely important problems of managing patients with chronic obstructive pulmonary disease (COPD) is to prevent exacerbations. The article presents data on the clinical and economic efficiency of joint vaccine prevention of conjugate pneumococcal vaccine Prevenar 13 (PCV13) and SOVIGRIPP flu vaccine in patients with COPD.
Influenza vaccination for the pediatric patient: a focus on the new intranasal, cold-adapted, live attenuated vaccine. [2021]FluMist is the first live attenuated, cold-adapted intranasal influenza vaccine (LAIV) approved for the prevention of influenza A and B. Clinical trials have shown that annual vaccination with LAIV is effective for the prevention of influenza. LAIV appears well tolerated in healthy patients 5-49 years of age. The most common adverse events are abdominal pain, chills, cough, diarrhea, headache, irritability, lethargy, muscle aches, otitis media, rhinitis, sinusitis, sore throat, and vomiting. FluMist has a novel intranasal route of administration that allows for influenza prevention without a painful intramuscular injection. Barriers preventing acceptance of LAIV include defining the appropriate patient population, cost, and insurance coverage.
Adverse events following live-attenuated intranasal influenza vaccination of children with cystic fibrosis: Results from two influenza seasons. [2018]Despite the approved use of live-attenuated intranasal influenza vaccine (LAIV) for seasonal immunization of patients with cystic fibrosis (CF), many questions remain unanswered regarding the timing, duration, and types of adverse events that occur following administration of this vaccine.
Adverse effects associated with influenza vaccination in patients with COPD: a randomized controlled study. [2006]The aim of this study was to assess the frequency and type of adverse reactions following influenza vaccination and its effects on lung function, dyspnoeic symptoms, exercise capacity, and clinical acute respiratory illness (ARI) in patients with COPD, and the relationship of these adverse effects to the degree of airflow obstruction.
Genetic stability of live, cold-adapted influenza virus components of the FluMist/CAIV-T vaccine throughout the manufacturing process. [2008]FluMist is a live-attenuated, trivalent influenza vaccine (LAIV) recently approved for intranasal administration. To demonstrate genetic stability during manufacture of the vaccine viruses in LAIV and a similar vaccine in development (CAIV-T), full genome consensus sequences were determined at multiple manufacturing stages for four influenza type A and five type B strains. The critical cold-adapted (ca), temperature-sensitive (ts) and attenuated (att) mutations were preserved in the virus manufacturing intermediates. Moreover, sequence identity was observed for all vaccine intermediates of the same strain. Minor sequence differences were noted in the shared gene segments of the vaccine viruses and their common progenitor master donor virus (MDV) and several of the hemagglutinin (HA) and neuraminidase (NA) genes contained nucleotide differences when compared to the wild-type parent. Nonetheless, all vaccine viruses retained the ca, ts, and att phenotypes. Thus, genetic and phenotypic stability of the vaccine viruses is maintained during the manufacture of LAIV/CAIV-T vaccines.
Influenza virus vaccination of patients with chronic lung disease. [2019]To evaluate the safety of, and mucosal and systemic immune responses induced by two influenza virus vaccine regimens in subjects with COPD.
Influenza: the virus and prophylaxis with inactivated influenza vaccine in "at risk" groups, including COPD patients. [2021]Influenza is a major respiratory pathogen, which exerts a huge human and economic toll on society. Influenza is a vaccine preventable disease, however, the vaccine strains must be annually updated due to the continuous antigenic changes in the virus. Inactivated influenza vaccines have been used for over 50 years and have an excellent safety record. Annual vaccination is therefore recommended for all individuals with serious medical conditions, like COPD, and protects the vaccinee against influenza illness and also against hospitalization and death. In COPD patients, influenza infection can lead to exacerbations resulting in reduced quality of life, hospitalization and death in the most severe cases. Although there is only limited literature on the use of influenza vaccination solely in COPD patients, there is clearly enough evidence to recommend annual vaccination in this group. This review will focus on influenza virus and prophylaxis with inactivated influenza vaccines in COPD patients and other "at risk" groups to reduce morbidity, save lives, and reduce health care costs.
Immunogenicity of trivalent seasonal influenza vaccine in patients with chronic obstructive pulmonary disease. [2023]Objective: Current evidence on the immunogenicity of influenza vaccination in patients with chronic obstructive pulmonary disease (COPD) is limited. To address this need for additional knowledge, we conducted a study on the immunogenicity of trivalent seasonal influenza vaccine (TIV) in COPD patients.Methods: We recruited patients from respiratory outpatient clinics of three hospitals in Tangshan, Hebei province who had stable confirmed COPD, were less than 80 y old, and reported not having had influenza or receiving TIV during the study season prior to enrollment. Patients who had a history of allergy to any TIV component or were classified as having very severe COPD were excluded from the study. Eligible and consenting participants were given one dose of TIV after obtaining a baseline blood sample. A second blood sample was obtained 5 weeks later. We used hemagglutination inhibition (HI) assays to measure antibody responses. We considered seropositive to be an HI titer ≥1:10. We considered seroprotection to be an HI titer ≥1:40 and seroconversion to be either a change from seronegative to a post-vaccination titer of ≥1:40 or a fourfold rise in antibody titer among baseline seropositive subjects. Each subject was followed for 1 month to assess the frequency and type of adverse events.Results: Eighty-eight subjects completed our study; the median age was 64 y; most (62.5%) had moderately severe COPD; 48.9% of the subjects had comorbid conditions in addition to COPD. Post-vaccination seropositive rates for influenza H1N1, H3N2, and B were all 100%; corresponding seroprotection rates were 96.6%, 93.2%, and 98.9%; seroconversion rates were 81.8%, 87.5%, and 75.0%. There were no statistical differences in seroconversion (P = .10) and seroprotection (P = .30) among the three types of influenza virus. Geometric mean titers (1:) of HI antibodies to H1N1, H3N2, and B were 18.8 (95% CI: 14.0-25.1), 12.2 (95% CI: 9.6-15.4), and 31.8 (95% CI: 26.1-38.8) at baseline, and 267.0 (95% CI: 213.8-333.4), 190.3 (95% CI: 151.7-238.6), and 201.1 (95% CI: 166.5-242.8) after vaccination.Conclusion: The immunogenicity of one dose of influenza vaccine was excellent in COPD patients. Our study supports recommending influenza vaccination for COPD patients to provide protection from influenza and its complications.
Effects of influenza vaccination on clinical outcomes of chronic obstructive pulmonary disease: A systematic review and meta-analysis. [2021]Influenza is a threat to patients with chronic obstructive pulmonary disease (COPD), influenza vaccination help to reduce incidence of influenza infection, however, whether it is beneficial to COPD patients in clinical outcomes lacks for evidence due to limited studies and participations.