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24 recruiting in VA
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Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 Alone and in Combination in Patients With Selected Solid Tumors

Selected Types of Solid Tumor

Brief Summary: The purpose of this clinical trial is to evaluate the safety, tolerability, preliminary efficacy, and immunogenicity of EVM14 administered intramuscularly (IM) alone and in combination with pembrolizumab in patients with selected solid tumors.

Fairfax, VA18+ yrsAll genders
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A Clinical Study of Novel Pneumococcal Vaccine V118C in Children (V118C-002)

Pneumococcal Infection

Researchers are looking for new vaccines to prevent pneumococcal disease, which is any infection in the lungs or other parts of the body that is caused by a type of bacteria called Streptococcus pneumoniae. V118C is a new vaccine designed to help prevent disease from Streptococcus pneumoniae bacteria. This study will look at V118C in toddlers and infants. The goal of the study is to learn how safe V118C is for children and how well they tolerate it.

Charlottesville, VA0.2โ€“1.3 yrsAll genders
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A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration of Protection of a Single Dose

RSV Infection

This study aims to check how safe and well-tolerated a second dose of RSVpreF is when given during later pregnancies, and to see how long the immunity lasts from a single dose given during a previous pregnancy by examining the blood of nonpregnant participants who had the vaccine before.

Norfolk, North Chesterfield +more, VA0+ yrsAll genders
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BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies

Healthy

BEATRIX (group B strEptococcus mATeRnal and Infant VaX study) The purpose of this study is to learn about the safety and how the group B streptococcus (GBS) vaccine works in pregnant women and their babies. This study is seeking healthy pregnant participants: * aged 49 or younger who can join. * between 24 and 36 weeks of gestation ("Gestational age" is a medical term used to describe how far along your pregnancy is) * had a fetal ultrasound examination performed with no major fetal abnormalities observed * documented negative for HIV, syphilis and Hepatitis B All participants in this study will receive only 1 shot in an arm. This could either be a group B streptococcus 6-valent polysaccharide conjugate vaccine (GBS6) or placebo. Placebo is an inactive substance used in the study for comparison purposes; in this study, the placebo injection will be saline (saltwater). The pregnant participants may take part in this study for a maximum of 14 months (6 months after delivery) , and their babies for about 12 months after they are born. The pregnant participants will need to visit the research site at least 3 to 4 times with some visits permitted to occur over the telephone. A subset of infants will be asked to take part in the study for up to 19 months. The subset will receive diphtheria toxoid-containing vaccine and/or pneumococcal vaccine following each country's standard immunization plan and have blood drawn 1 month after completion of the primary and/or toddler (booster) doses.

Falls Church, Norfolk +more, VA0โ€“49 yrsAll genders
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A Study to Learn About mRNA Vaccines Against Influenza in Adults

Healthy Adults

The purpose of this study is to learn about safety in participants taking the study vaccine (mRNA-based vaccine) and the ability of the study vaccine to trigger the body's immune response, targeting the flu virus (influenza virus). This study is seeking healthy participants 18 years of age or older. All participants in this study will receive only 1 dose in their arm, to deliver one of the experimental flu vaccines or one of the approved flu vaccines used for comparison. Participants will take part in this study for about 6 months, and participants will need to visit the study site at least 3 times. A blood sample will be taken at each of the 3 planned study visits and a swab from inside the nose will be taken at the first study visit.

Charlottesville, VA18+ yrsAll genders
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A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants

Pneumococcal Disease

The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs that can cause pneumonia (lung infections), meningitis (brain infections), and otitis media (ear infections) in infants when compared to the pneumococcal vaccine that is currently in use, 20vPnC (Prevnar 20ยฎ). This study will test if the new pneumococcal vaccine is as safe as the one that is currently in use. This new vaccine can possibly provide additional protection against germs that cause pneumococcal disease that are not included in the vaccines that are currently given to infants. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae. There are two groups in this study. All participants will be assigned to one of the two groups. This study is seeking participants who are: \- infants who are about 2 months of age About 2400 infants will be assigned by chance to one of the two groups to receive either PG4 (new vaccine) or 20vPnC (currently in use) into the left thigh muscle at 2, 4, 6, and 12 to 15 months of age. Infants will take part in this study for about 16 to 19 months (about 1 and a half years). During this time, infants will have 6 study clinic visits and 1 phone call. At these study clinic visits, parent(s)/legal guardian(s) will be asked if the infant experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine.

Gordonsville, VA0โ€“0 yrsAll genders
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Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer

Anatomic Stage IV Breast Cancer AJCC v8 ยท Invasive Breast Carcinoma ยท Metastatic Triple-Negative Breast Carcinoma

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 stopping them from spreading. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known whether giving nab-paclitaxel, durvalumab, and tremelimumab with or without neoantigen vaccine will work better in treating patients with triple negative breast cancer.

Richmond, VA18+ yrsAll genders
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A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age

Chickenpox

The purpose of this study is to assess the consistency of immune response to three different lots of GSK's investigational varicella vaccine (VNS Vaccine), and to compare the safety and immune response of VNS vaccine to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted in healthy children aged 12 to 15 months, who have neither contracted varicella nor received a varicella vaccination.

Richmond, VA1โ€“1.3 yrsAll genders
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Recruiting

Study to Assess Safety and Immunogenicity of an Egg-based H5N8 Influenza Vaccine at Multiple Dose Levels Adjuvanted With Matrix-M in Healthy Participants 18 Years of Age and Above.

Healthy Volunteers ยท Influenza

The study aims to evaluate an egg-based H5N8 influenza vaccine up to 3 dose levels (low, medium, and high dose) given with or without adjuvant to see if the adjuvant improves vaccine effectiveness. The study will enroll healthy adults aged 18 years and over. Participants will receive 2 injections in their arm of either one of the 3 dose levels of the study vaccine (low, medium, or high dose) with the adjuvant or the unadjuvanted vaccine (high dose). Study duration per participant: approximately 14 months (including screening visit).

Charlottesville, VA18+ yrsAll genders
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A Study on the Immune Response and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine, When Administered as Intramuscular Injection to Healthy Children 15 Months to 6 Years of Age

Measles ยท Measles-Mumps-Rubella+Chickenpox Vaccine

This study is evaluating the immunogenicity and safety of intramuscular administration of the investigational MMRVNS vaccine compared to intramuscular administration of the MMRV (Merck's measles, mumps, rubella and varicella) vaccine (ProQuad) that is already licensed for this route, when administered as a second dose in children 15 months to 6 years of age who were previously primed with a first dose of any combination of measles, mumps, rubella and varicella-containing vaccine(s).

Richmond, VA1.3โ€“6 yrsAll genders
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Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne

Acne

The purpose of the trial is to evaluate the safety, efficacy and immunogenicity of up to 3 intramuscular injections of the Acne mRNA vaccine candidate at up to four dose levels in adult participants aged 18 to 45 years with moderate to severe acne. This trial will consist of a Core Study followed by an optional Long-Term Extension (LTE). The Core Study will consist of: * Two cohorts evaluating the 2-administration regimen (Cohorts A): Sentinel Cohort A and Main Cohort A. * Two cohorts evaluating the 3-administration regimen (Cohorts B): Sentinel Cohort B and Main Cohort B. Participants from Sentinel Cohorts A and B and from Main Cohort A will be invited to an additional 30-month follow up after completing their last planned Core Study visit to assess the long-term effects of the vaccine. Participants from Main Cohort B will be invited to another LTE study managed through a separate protocol.

Lynchburg, VA18โ€“45 yrsAll genders
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Recruiting

A Study to Learn About How a New Pneumococcal Vaccine Works in Infants.

Pneumococcal Disease

The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs that can cause pneumonia (lung infections), meningitis (brain infections), and otitis media (ear infections) in infants when compared to the pneumococcal vaccine that is currently in use, 20vPnC (Prevnar 20ยฎ). This study will test if the new pneumococcal vaccine is as safe as the one that is currently in use. It will also assess how the new vaccine works in comparison to the one that is currently in use when given with other childhood vaccines. To measure how the new pneumococcal vaccine compares to the current one, blood samples will be used to measure the body's ability to create proteins to fight those germs. This new vaccine can possibly provide additional protection against germs that cause pneumococcal disease that are not included in the vaccines that are currently given to infants. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae. There are three groups in this study. All participants will be assigned to one of the three groups. This study is seeking participants who are: * infants who are 2 months of age in Group 1; * infants who are 2 to 6 months of age in Groups 2 and 3; and * said to be healthy by the study doctor About 3000 infants will be assigned to Group 1. The infants in this group will have a 1 in 2 chance (50%) of receiving either PG4 (new vaccine) or 20vPnC (currently in use) into the left thigh muscle at 2, 4, 6, and 12 to 15 months of age. About 140 infants from outside the United States will be assigned to Group 2. The infants in this group will have a 1 in 2 chance (50%) of receiving either PG4 or 20vPnC into the left thigh muscle at 2 to 6, 3 to 8, 4 to 10, and 12 to 15 months of age. About 90 infants from outside the United States will be assigned to Group 3. The infants in Group 3 will have a 1 in 3 chance (33%) of receiving either PG4 into the left thigh muscle, PG4 under the skin of the left thigh, or 20vPnC into the left thigh muscle at 2 to 6, 3 to 8, 4 to 10, and 12 to 15 months of age. Infants in Group 1 will take part in this study for about 16 to 19 months (about 1 and a half years). Infants in Groups 2 and 3 will take part in this study for 12 to 21 months (about 1 to 1 and a half years). During this time, infants will have 6 study clinic visits and 1 phone call. At these study clinic visits, parent(s)/legal guardian(s) will be asked if the infant experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine. Infants will have 3 blood samples collected.

Richmond, VA0โ€“0 yrsAll genders
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Recruiting

A Study on the Efficacy of a Vaccine Against Influenza in Adults โ‰ฅ65 Years of Age

Influenza, Human

This study will compare an investigational mRNA flu vaccine with a licensed flu vaccine in adults 65 years of age and older. Participants will receive one injection and will be followed during the flu season. The study will measure prevention of laboratory-confirmed flu illness, side effects, and immune responses.

Charlottesville, Newport News +more, VA65+ yrsAll genders
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Recruiting

Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer

Non-Small Cell Lung Cancer

This first-in-human (FIH) study for BNT116 aims to establish the safety profile and a safe dose for BNT116 monotherapy as well as for BNT116 in combination with approved medicinal products and/or in combination with investigational medicinal products (IMPs) including, but not limited to, cemiplimab, docetaxel, carboplatin, paclitaxel, osimertinib, anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs), rearranged during transfection (RET) TKIs, BNT316 (an anti-cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\] antibody), an anti-B7-H3 antibody conjugated to a topoisomerase I inhibitor, an anti-human epidermal growth factor receptor 3 (HER3) antibody conjugated to a topoisomerase I inhibitor or a bispecific antibody for programmed death ligand 1 (PD-L1) and vascular endothelial growth factor A (VEGF-A) in participants with non-small cell lung cancer (NSCLC). The study will comprise several cohorts for dose confirmation in monotherapy as well as in combinations of BNT116 as mentioned above. The study will enroll participants with NSCLC in advanced or metastatic stage in Cohorts 1 to 4 and Cohorts 7 to 10, unresectable NSCLC Stage III in Cohorts 5 and 11, resectable NSCLC of Stage II and III in Cohort 6, advanced/metastatic epidermal growth factor receptor (EGFR)-mutant NSCLC in Cohort EGFR, and advanced/metastatic ALK rearranged or RET rearranged NSCLC in Cohort ALK/RET. Cohort EGFR and Cohort ALK/RET will enroll only at selected sites in the US.

Fairfax, VA18+ yrsAll genders
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A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine and a Marketed Measles, Mumps and Rubella Vaccine When Administered as Intramuscular Injection to Healthy Children 12 to 15 Months of Age

Chickenpox

This study aims to assess the immune response and safety of GSK's candidate chickenpox and marketed MMR vaccines when given to children 12 to 15 months of age via a muscle injection. It compares the GSK vaccines to Merck's chickenpox vaccine, administered just under the skin. Additionally, the study will evaluate the immune response and safety of giving the GSK vaccines along with other childhood vaccines through a muscle injection.

Richmond, VA1โ€“1.3 yrsAll genders
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A Study to Learn About a Clostridioides Difficile Vaccine in People 65 Years of Age and Older

Clostridoides Difficile Associated Disease

The purpose of the study is to learn about how effective, safe, and tolerable the Clostridioides difficile (C. difficile) vaccine is in decreasing the number of C. difficile infections (pCDI) in adults 65 years of age or older. The participants will receive either the C. difficile vaccine or placebo (saline). A placebo does not contain any active ingredients. The vaccines will be given as a shot into the upper arm muscle. This study looks at the number of diarrhea (loose stools) events related to a C. difficile infection, so the length of the study can change. If these events happen quickly, the study may finish sooner; if they happen slowly, it could take longer. Sometimes, the study might stop early if the vaccine clearly does not work. Participants will stay in the study until enough events have occurred to answer the main question. On average, each person is expected to take part for up to about three and a half years. During this time, participants will have 3 planned clinic visits and 3 planned phone visits. After these visits, more scheduled clinic visits will happen every year until the end of study. Besides the scheduled study visits, if at any time during the study a participant has 3 or more loose stools in 24 hours, they will be asked to save the next one (the fourth or later) and contact the study site. The study site will check to see if it could be a C. difficile infection. This check may happen at the clinic or through a phone or video call.

Richmond, VA65+ yrsAll genders
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A Study on the Safety of an Investigational Chickenpox Vaccine, When Given to Healthy Children, 12 to 15 Months of Age

Chickenpox

The purpose of this study is to assess how well-tolerated GSK's investigational varicella vaccine (VNS Vaccine) is, in comparison to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted on healthy children aged 12 to 15 months, and who have neither contracted varicella nor received a varicella vaccination.

Richmond, Vienna, VA1โ€“1.3 yrsAll genders
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Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents

Pneumococcal Disease

The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs that can cause pneumonia (lung infections), meningitis (brain infections), and otitis media (ear infections) in children when compared to the pneumococcal vaccine that is currently in use, 20vPnC (Prevnar 20ยฎ). This study will test if the new pneumococcal vaccine is as safe as the one that is currently in use. It will also assess how the new vaccine works in comparison to the one that is currently in use. To measure how the new pneumococcal vaccine compares to the current one, blood samples will be used to measure the body's ability to create proteins to fight those germs. This new vaccine can possibly provide additional protection against germs that cause pneumococcal disease that are not included in the vaccines that are currently given to children. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae This study is seeking participants who: * Are children aged 15 months to 18 years. * May or may not have received any doses of pneumococcal conjugate vaccine (PCV) in the past. The study will be conducted in the United States, Puerto Rico, and other countries. Participants will be assigned to 1 of 3 groups based on age: Group 1: 15 months to less than 2 years (about 300 participants) Group 2: 2 years to less than 5 years (about 300 participants) Group 3: 5 years to less than 18 years (about 600 participants) Within each group, participants will be assigned by chance in a 2:1 ratio to receive 1 vaccine injection (shot) with either PG4 (new vaccine) or 20vPnC, given in the arm or thigh. This means that for every 3 participants, about 2 will receive PG4 and about 1 will receive 20vPnC. Each participant will take part in the study for approximately 6 months. During this time, each participant will visit a clinic 2 times (visit 1 for vaccination and visit 2 to follow up) and will be contacted via telephone once (for a 6 month follow up). At the study clinic visits, participants will have their blood drawn and be asked if they have experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine. During the 6-month follow-up contact, participants will be asked about any further side effects.

Charlottesville, Richmond, VA1.3โ€“17 yrsAll genders
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