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Influenza clinical trials

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NCT ID: NCT03950986 Completed - Influenza Clinical Trials

Increasing Vaccine Uptake Among Veterans at the Atlanta VA Health Care System

Start date: October 15, 2018
Phase: N/A
Study type: Interventional

The Office of Evaluation Sciences is collaborating with Emory University and the Atlanta VA Health Care System to increase adult immunizations uptake among veterans. The intervention targets patients of primary care providers (physicians, physician assistants and nurse practitioners) through a modification of the existing reminders in the VA electronic health record system. The team will evaluate the intervention using a randomized controlled trial.

NCT ID: NCT03945825 Completed - Influenza Clinical Trials

Flublok or Fluzone With Advax-CpG55.2 or AF03

Start date: June 10, 2019
Phase: Phase 1
Study type: Interventional

This is a Phase I, randomized, double blinded, clinical trial in up to 240 males and non-pregnant females, 18-45 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of either the 2018/2019 seasonal Fluzone or Flublok Quadrivalent Influenza Vaccine (QIV) manufactured by Sanofi Pasteur (SP) given without adjuvant or with one of two adjuvant formulations, AF03 or Advax-CpG55.2. Eight Vaccine and Treatment Evaluation Unit (VTEU) sites will be included in the study. Study duration is approximately 18 months, and subject participation duration is 12 months. The primary objectives of this study are: 1) to assess the safety and reactogenicity of 2018/2019 Fluzone and Flublok with and without AF03 or Advax-CpG55.2 adjuvant; 2) to assess the serum hemagglutination inhibition (HAI) antibody responses against 2018/2019 QIV strains from baseline (Day 1) to approximately Day 29 after receipt of 2018/2019 Fluzone and Flublok with and without AF03 or Advax-CpG55.2 adjuvant; 3) to assess the serum neuraminidase inhibition antibody (NAI) responses by enzyme-linked lectin assay (ELLA) against NA antigens in the 2018/2019 QIV from baseline (Day 1) to approximately Day 29 after receipt of 2018/2019 Fluzone and Flublok with and without AF03 or Advax-CpG55.2 adjuvant; 4) to assess the influenza neutralizing (Neut) antibody titer responses against 2018/2019 QIV strains from baseline (Day 1) to approximately Day 29 after receipt of 2018/2019 Fluzone and Flublok with and without AF03 or Advax- CpG55.2 adjuvant.

NCT ID: NCT03930017 Completed - Influenza Clinical Trials

Pregnancy, Arsenic and Immune Response

PAIR
Start date: October 14, 2018
Phase:
Study type: Observational

As the global availability of vaccines increases, and reaches areas disproportionately affected by arsenic and malnutrition, resolving questions about potential environmental and biologic barriers to maternal immunization has become increasingly urgent. It is not known whether arsenic, a known developmental toxicant, can alter maternal immune responses to vaccination and whether exposure to arsenic during pregnancy can impair the transfer of maternal vaccine-induced antibody to the newborn. Moreover, factors known to affect arsenic metabolism and toxicity outcomes, particularly micronutrients critical in one-carbon metabolism, have not been evaluated in studies of arsenic immunotoxicity and vaccine-induced protection in mothers and their newborns. The objective in this study is to investigate whether maternal arsenic exposure and one-carbon metabolism micronutrient deficiencies alter maternal and newborn measures of vaccine-induced protection, respiratory morbidity, and systemic immune function following influenza vaccination during pregnancy.

NCT ID: NCT03926416 Completed - Influenza Clinical Trials

Safety Study of Live Attenuated Influenza Vaccine, CodaVax

Start date: February 21, 2017
Phase: Phase 1
Study type: Interventional

This study is being conducted to assess the safety, tolerability, and immunogenicity of the CodaVax-H1N1 influenza vaccine as compared to active and placebo controls when administered to healthy adults.

NCT ID: NCT03903718 Withdrawn - Influenza Clinical Trials

Evaluation of the Safety and Efficacy of a Monoclonal Antibody to Treat Influenza

Start date: April 3, 2020
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the efficacy and safety of MEDI8852 for the treatment of influenza caused by a wild type A/H1N1 challenge strain in healthy, influenza serosusceptible adults.

NCT ID: NCT03901001 Recruiting - Influenza Clinical Trials

Adjunctive Sirolimus and Oseltamivir Versus Oseltamivir Alone for Treatment of Influenza

Start date: May 8, 2023
Phase: Phase 3
Study type: Interventional

Seasonal influenza epidemics are important causes of mortality and morbidity. Cytokine dysregulation, with high levels of pro-inflammatory cytokines, occurs in patients with severe influenza A(H1N1)pdm09 virus infection, A(H5N1) infection, and A(H7N9) infection. We aim to investigate the effects of adjunctive sirolimus in adults hospitalized with influenza A or B infections involving the lower respiratory tract.

NCT ID: NCT03900988 Recruiting - Influenza Clinical Trials

Intravenous N-acetylcysteine and Oseltamivir Versus Oseltamivir in Adults Hospitalized With Influenza and Pneumonia

Start date: May 8, 2023
Phase: Phase 3
Study type: Interventional

Seasonal influenza epidemics are important causes of morbidity and mortality. Cytokine dysregulation, with high levels of pro-inflammatory cytokines, occurs in patients with severe influenza. Early therapy with a neuraminidase inhibitor (NAI) is associated with better outcome in patients hospitalized with influenza, but significant mortality occurs despite use of antivirals. N-acetylcysteine (NAC) is a modified form of the amino acid cysteine, with anti-oxidant properties. NAC was shown to inhibit the production of pro-inflammatory molecules in lung epithelial cells infected with influenza viruses. Previous case report showed that high dose NAC, administered as continuous intravenous infusion, was effective and safe in improving the clinical outcomes. We aim to perform a randomized controlled trial to evaluate the therapeutic role of adjunctive NAC in the clinical management of patients with influenza complicated by lower respiratory tract involvement and abnormal respiratory status. Such information when available may reveal the potential of NAC for optimization of management of severe influenza, and provide important insights into future adjunctive therapy research.

NCT ID: NCT03898986 Completed - Influenza Clinical Trials

The Effects of Attenuated Versus Inactivated Flu Vaccine in Twin Sets

FLU-TW
Start date: October 8, 2019
Phase: Phase 1
Study type: Interventional

This is one project of a larger ongoing study related to the immune system's response to the flu virus. This study is designed to investigate the immune response to the live attenuated influenza vaccine (LAIV) vs. the Inactivated Influenza Vaccine (IIV) in identical and fraternal twins.

NCT ID: NCT03898973 Withdrawn - Influenza Clinical Trials

Response to Inactivated Influenza Vaccine in Lymph Tissue and Blood

FLU-LN
Start date: April 11, 2019
Phase: Phase 4
Study type: Interventional

This is one project of a larger ongoing study related to the immune system's response to the flu virus. This study is designed to determine how immune memory develops at the actual site of exposure, and how immunization may alter this process.

NCT ID: NCT03888989 Completed - Influenza Clinical Trials

Response to Influenza Vaccine During Pregnancy

FLU-PG
Start date: September 30, 2019
Phase: Phase 1
Study type: Interventional

This is one project of a larger ongoing study related to the immune system's response to the flu virus. This study is designed to investigate the immune response to vaccination in pregnancy.