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
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
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
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
Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the US
Completed
This study used 3 different formulations of tetravalent CYD dengue vaccine. The primary objective of the study was to evaluate the neutralizing antibody response after 2 doses of two different formulations of tetravalent dengue vaccine administered at Month 0 and Month 6. The secondary objectives were: * To evaluate the safety of the 3 formulations of tetravalent CYD dengue vaccine. * To describe the neutralizing antibody responses to each of the 3 vaccine formulations. * To describe vaccine... Read More
Gender:
ALL
Ages:
Between 18 years and 45 years
Trial Updated:
05/21/2019
Locations: Investigational Site 001, New Orleans, Louisiana
Conditions: Dengue Fever, Dengue Hemorrhagic Fever, Dengue Virus
HerpeVac Trial for Young Women
Completed
The primary purpose of this study is to see if a herpes vaccine may prevent genital herpes disease in women who are not infected. The study will enroll approximately 7550 healthy women. These women will be randomly assigned to 1 of 2 possible study groups: herpes vaccine (experimental group) or hepatitis A vaccine (control group). Participants will receive their assigned vaccine at 0, 1, and 6 months. Participants will have 9 scheduled study visits and additional unscheduled visits for an evalua... Read More
Gender:
FEMALE
Ages:
Between 18 years and 30 years
Trial Updated:
07/26/2018
Locations: GSK Investigational Site, Baton Rouge, Louisiana +1 locations
Conditions: Herpes Simplex Infection
Docetaxel and Prednisone With or Without Vaccine Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
Terminated
This randomized phase II trial studies how well docetaxel and prednisone with or without vaccine therapy works in treating patients with hormone-resistant prostate cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Vaccines made from an antigen may help the body build an effective i... Read More
Gender:
MALE
Ages:
18 years and above
Trial Updated:
08/21/2017
Locations: Ochsner Medical Center Jefferson, New Orleans, Louisiana
Conditions: Hormone-Resistant Prostate Cancer, Prostate Adenocarcinoma, Recurrent Prostate Carcinoma, Stage IV Prostate Cancer