A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.
Completed
This is a Phase 2/3 open-label study to evaluate the safety and immunogenicity of a booster dose of the XBB.1.5 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccine (SARS-CoV-2 rS) adjuvanted with Matrix-M™ in previously mRNA COVID-19 vaccinated adult participants ≥18 years of age and baseline SARS CoV-2 seropositive COVID-19 vaccine naïve participants ≥18 years of age.
Gender:
ALL
Ages:
Between 18 years and 54 years
Trial Updated:
05/29/2024
Locations: AMR New Orleans, New Orleans, Louisiana
Conditions: COVID-19
Study of an Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers
Completed
The primary objectives of the study were: * To assess the safety profile of each dose of the study product after each and any administration in all infants and toddlers regardless of baseline serostatus. * To characterize the Respiratory Syncytial Virus (RSV) A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV-naïve participants. The secondary objectives of the study were: * To quantify the amount of vaccine virus shed by each participan... Read More
Gender:
ALL
Ages:
Between 6 months and 18 months
Trial Updated:
05/20/2024
Locations: Benchmark Research-Site Number:8400006, Covington, Louisiana +1 locations
Conditions: Respiratory Syncytial Virus Infection
The COVID-19 VaccinE Response and Co-Administration in Rheumatology Patients (COVER-CoAd)
Active Not Recruiting
Based on the experience with influenza, pneumococcal, and shingles vaccinations in rheumatic disease populations, it is clear that some disease modifying anti-rheumatic drugs and the immunomodulatory therapies used to treat immune-mediated inflammatory diseases have the capacity to blunt immune responses to COVID-19 vaccines. Several studies have suggested that patients with autoimmune conditions may be at increased risk of poor COVID-19 outcomes. There is an urgent need to better clarify the i... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
02/12/2024
Locations: University Medical Center - New Orleans/LSU, New Orleans, Louisiana
Conditions: Rheumatic Diseases
A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children
Completed
This is a Phase 1/2/3 study in healthy children. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and immunogenicity of BNT162b2 in participants \<6 months of age may subsequently be evaluated.
Gender:
ALL
Ages:
Between 6 months and 15 years
Trial Updated:
12/18/2023
Locations: Ochsner Clinic Foundation, New Orleans, Louisiana +1 locations
Conditions: SARS-CoV-2 Infection, COVID-19
TPIV100 and Sargramostim for the Treatment of HER2 Positive, Stage II-III Breast Cancer in Patients With Residual Disease After Chemotherapy and Surgery
Recruiting
This phase II trial studies how well TPIV100 and sargramostim work in treating patients with HER2 positive, stage II-III breast cancer that has residual disease after chemotherapy prior to surgery. It also studies why some HER2 positive breast cancer patients respond better to chemotherapy in combination with trastuzumab and pertuzumab. TPIV100 is a type of vaccine made from HER2 peptide that may help the body build an effective immune response to kill tumor cells that express HER2. Sargramostim... Read More
Gender:
FEMALE
Ages:
18 years and above
Trial Updated:
12/15/2023
Locations: University Medical Center New Orleans, New Orleans, Louisiana
Conditions: Breast Adenocarcinoma, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7
Multi-epitope Folate Receptor Alpha Peptide Vaccine, GM-CSF, and Cyclophosphamide in Treating Patients With Triple Negative Breast Cancer
Active Not Recruiting
This randomized phase II trial studies how well multi-epitope folate receptor alpha peptide vaccine, sargramostim (GM-CSF), and cyclophosphamide work to prevent the recurrence of stage 1-3 triple negative breast cancer. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing th... Read More
Gender:
FEMALE
Ages:
18 years and above
Trial Updated:
01/12/2023
Locations: Ochsner Medical Center Jefferson, New Orleans, Louisiana
Conditions: Bilateral Breast Carcinoma, Stage IB Breast Cancer AJCC v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7, Triple-Negative Breast Carcinoma, Unilateral Breast Carcinoma, Breast Inflammatory Carcinoma, Stage II Breast Cancer AJCC v6 and v7
Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age
Completed
Study of the safety and immunogenicity of 20vPnC and influenza vaccine administered at the same visit or separately
Gender:
ALL
Ages:
65 years and above
Trial Updated:
06/15/2022
Locations: Alliance for Multispecialty Research, LLC, New Orleans, Louisiana
Conditions: Pneumococcal Disease
INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure
Completed
INVESTED will test the hypothesis that high dose trivalent influenza vaccine will reduce cardiopulmonary events to a greater extent than standard dose quadrivalent influenza vaccine in high-risk cardiovascular patients with a recent history of myocardial infarction or heart failure. The trial will enroll 9300 participants over one Vanguard (pilot) season and three additional influenza seasons. The primary endpoint will be a composite of all-cause mortality or cardiopulmonary hospitalization.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
12/22/2021
Locations: The Heart Clinic of Hamond, Hammond, Louisiana +2 locations
Conditions: Heart Failure, Myocardial Infarction
Immune System Function Following Vaccination in HIV Infected Children Taking Anti-HIV Drugs
Completed
The purpose of this study is to determine immune system function following vaccination in HIV-infected children currently taking anti-HIV drugs. To test the effectiveness of prior vaccination, patients in this study will receive booster shots of one of two pneumococcal vaccines, a hepatitis B vaccine, and a measles vaccine.
Gender:
ALL
Ages:
Between 6 years and 23 years
Trial Updated:
10/28/2021
Locations: Children's Hosp., New Orleans, Louisiana
Conditions: HIV Infections
Safety of and Immune Response to Two Influenza Vaccines in HIV Infected Children and Adolescents
Completed
The purpose of this study is to compare two flu vaccines to determine their safety and ability to stimulate an immune response in HIV infected children and adolescents. This study will also determine how often and how long people who receive a vaccine are able to spread flu vaccine virus to other people.
Gender:
ALL
Ages:
Between 5 years and 17 years
Trial Updated:
10/28/2021
Locations: Tulane/LSU Maternal/Child CRS, New Orleans, Louisiana
Conditions: HIV Infections, Influenza
A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants
Completed
To assess whether HIV-infected infants who receive a heptavalent pneumococcal conjugate vaccine have more local reactions at the site of injection and systemic reactions than placebo subjects. To assess whether this vaccine is more immunogenic than placebo following the third vaccination. Children with HIV infection are at increased risk for invasive pneumococcal infection, particularly bacteremia. A large proportion of pneumococcal disease is caused by a limited number of serotypes. The maximu... Read More
Gender:
ALL
Ages:
Between 2 months and 6 months
Trial Updated:
10/27/2021
Locations: Tulane/LSU Maternal/Child CRS, New Orleans, Louisiana
Conditions: HIV Infections, Pneumococcal Infections
Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation
Terminated
The purposes of the clinical trial are to determine whether the SA4Ag vaccine can prevent postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal fusion surgery, and to evaluate the safety of SA4Ag in patients who are undergoing elective spinal surgery.
Gender:
ALL
Ages:
Between 18 years and 85 years
Trial Updated:
12/11/2020
Locations: Ochsner Baptist Medical Center, New Orleans, Louisiana +2 locations
Conditions: Staphylococcal Vaccine