Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
Recruiting
This phase II trial studies how well nab-paclitaxel, durvalumab, and tremelimumab with or without personalized synthetic long peptide vaccine (neoantigen vaccine) works in treating patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopp... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
07/25/2025
Locations: Wake Forest University at Clemmons, Clemmons, North Carolina +1 locations
Conditions: Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma, Invasive Breast Carcinoma
A Study to Evaluate the Safety and Immunogenicity of Two Doses of a Novel H5 Central Antigen mRNA-LNP in Healthy Adults
Recruiting
This is a phase 1, multicenter, randomized, double-blind trial of two influenza A/H5 mRNA-based vaccines on healthy adult participants, 18-49 years of age. Stage 1 will serve as the open-label, dose finding stage. The first 10 participants will receive 12.5 mcg of H5 AC-Anhui RNA vaccine (Group 1), and the second 10 participants will receive 25 mcg of H5 AC-Anhui RNA vaccine (Group 2). After Protocol Safety Review Team (PSRT) review of reactogenicity and safety data through Day 8 for both Groups... Read More
Gender:
ALL
Ages:
Between 18 years and 49 years
Trial Updated:
07/24/2025
Locations: Duke Vaccine and Trials Unit, Durham, North Carolina
Conditions: Avian Influenza
VGX-3100 and Electroporation in Treating Patients With HIV-Positive High-Grade Anal Lesions
Completed
This phase II trial studies the use of human papillomavirus (HPV) deoxyribonucleic acid (DNA) plasmids therapeutic vaccine VGX-3100 (VGX-3100) and electroporation in treating patients with human immunodeficiency virus (HIV)-positive high-grade anal lesions. Vaccines made from DNA may help the body build an effective immune response to kill tumor cells. Electroporation helps pores in your body's cells take in the drug to strengthen your immune system's response. Giving VGX-3100 and electroporatio... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
07/15/2025
Locations: Wake Forest Baptist health Sciences, Winston-Salem, North Carolina
Conditions: Anal Intraepithelial Neoplasia, High Grade Squamous Intraepithelial Neoplasia, HIV Positivity, Human Papillomavirus-16 Positive, Human Papillomavirus-18 Positive
Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women
Completed
This is a pilot, prospective, randomized, open-label clinical trial. During the study, pregnant women will be randomized (1:1) to receive co-administration of a single intramuscular (IM) 0.5 mL dose of US-licensed inactivated influenza vaccine (IIV) and a single intramuscular (IM) 0.5 mL dose of US-licensed Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap) or sequential administration of the vaccines (IIV followed by Tdap \~ 21 days later). Vaccines will b... Read More
Gender:
FEMALE
Ages:
Between 18 years and 45 years
Trial Updated:
07/08/2025
Locations: Duke University, Durham, North Carolina
Conditions: Pregnancy
Safety, Tolerability, and Immunogenicity of V110 or V114 Co-administered With a Booster Dose of mRNA-1273 in Healthy Adults (V110-911)
Completed
The purpose of this study is to evaluate the concomitant and non-concomitant use of messenger ribonucleic acid (mRNA) mRNA-1273, the nucleoside-modified mRNA vaccine for active immunization to prevent coronavirus disease (COVID-19) caused by severe acute respiratory syndrome coronavirus (SARS-CoV-2), with a 23-valent pneumococcal polysaccharide vaccine (V110) for the prevention of pneumococcal disease, or a 15-valent pneumococcal conjugate vaccine (V114) indicated for the prevention of invasive... Read More
Gender:
ALL
Ages:
50 years and above
Trial Updated:
07/08/2025
Locations: Accellacare - Winston-Salem ( Site 0049), Winston-Salem, North Carolina
Conditions: Pneumococcal Infection
Simultaneous mRNA COVID-19 and IIV Vaccination in Pregnancy Study
Active Not Recruiting
This study is a prospective, randomized clinical trial. During this study, pregnant women will be randomly assigned to receive IIV and mRNA COVID-19 vaccine either simultaneously or sequentially (7-14 days apart). All participants will receive an mRNA COVID-19 vaccine at Visit 1 (Day 1). Solicited local and systemic symptoms of reactogenicity will be assessed on day of visit for Visits 1 and 2 and daily during the 6 days following each visit using either electronic or paper symptoms diaries, de... Read More
Gender:
FEMALE
Ages:
18 years and above
Trial Updated:
07/08/2025
Locations: Duke University, Durham, North Carolina +1 locations
Conditions: Birth Outcomes, Safety, Adverse Event Following Immunization
PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma
Active Not Recruiting
The primary goal of this prospective clinical trial is to evaluate the safety of PEP-CMV in patients with recurrent medulloblastoma and malignant glioma. Patients with histologically-proven medulloblastoma or malignant glioma who had received prior therapy for their initial diagnosis and subsequently had tumor recurrence/progression may be enrolled any time after recurrence/progression regardless of prior adjuvant therapy. PEP-CMV is a vaccine comprised of Component A, a synthetic long peptide (... Read More
Gender:
ALL
Ages:
Between 3 years and 35 years
Trial Updated:
07/04/2025
Locations: Duke University Medical Center, Durham, North Carolina
Conditions: Recurrent Medulloblastoma, Recurrent Brain Tumor, Childhood, Malignant Glioma
Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS
Active Not Recruiting
The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study. Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS). COVID-19 sub-study: The purpose of... Read More
Gender:
ALL
Ages:
Between 18 years and 100 years
Trial Updated:
07/04/2025
Locations: Asheville Neurology Specialists PA, Asheville, North Carolina +4 locations
Conditions: Relapsing Multiple Sclerosis
Study to Evaluate Immunogenicity and Safety of a High-Dose Influenza Vaccine in Adults 50 Through 64 Years of Age
Completed
The purpose of this study is to evaluate Immunogenicity and Safety of a High-Dose (HD) Influenza Vaccine (IV) in Adults 50 through 64 Years of Age.
Gender:
ALL
Ages:
Between 50 years and 64 years
Trial Updated:
06/30/2025
Locations: Centricity Morehead- Site Number : 8400014, Morehead City, North Carolina +1 locations
Conditions: Influenza
Safety and Immunogenicity of 9-valent Human Papillomavirus (9vHPV) Vaccine Coadministered With Messenger Ribonucleic Acid (mRNA)-1273 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (COVID-19) Vaccine (V503-076)
Completed
The purpose of this study to evaluate the safety and immunogenicity of a 2-dose regimen of 9vHPV vaccine, where the first dose is administered concomitantly with a first dose of a 2-dose regimen of mRNA-1273 vaccine versus nonconcomitant administration of 9vHPV and mRNA-1273 vaccines in boys and girls 9 to 11 years of age.
Gender:
ALL
Ages:
Between 9 years and 11 years
Trial Updated:
06/30/2025
Locations: Carolina Institute for Clinical Research, LLC ( Site 0042), Fayetteville, North Carolina +1 locations
Conditions: Papillomavirus Infections, Coronavirus Disease (COVID-19)
A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo
Active Not Recruiting
This is a Phase 2, multicenter, randomized, double-blind placebo controlled, 2-arm study to evaluate the effect of amlitelimab on vaccine antibody responses, and the safety of amlitelimab concurrently administered with non-live vaccines in adult participants with moderate-to-severe atopic dermatitis (AD). The purpose of this study is to compare the immune responses to concomitantly administered Boostrix (tetanus, diphtheria, and acellular pertussis \[Tdap\]) and Pneumovax 23 (PPSV) vaccines in... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
06/26/2025
Locations: Velocity Clinical Research - Durham- Site Number : 8401175, Durham, North Carolina
Conditions: Dermatitis Atopic
Study of mRNA-1010 Seasonal Influenza Vaccine in Adults
Completed
This study includes 3 parts: Parts A, B, and C. The purpose of this study is to evaluate the immunogenicity and safety of mRNA-1010 seasonal influenza vaccine in adults.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
06/23/2025
Locations: Javara Inc., Charlotte, North Carolina +2 locations
Conditions: Seasonal Influenza