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Vaccine Studies Trials

Preventive vaccine research, including COVID, Lyme, and pediatric studies. 518 recruiting now nationwide.

Recruiting

Safety, Tolerability, and Preliminary Antitumor Activity of Cationic Peptide-IL22BP mRNA in Advanced Solid Tumors

mRNA Vaccine Β· Solid Tumor Cancer Β· Peptides

The goal of this phase 1 clinical trial is to evaluate the safety, tolerability, and preliminary antitumor activity of a peptide-delivered IL-22BP biotherapy in patients with advanced solid tumors. The main questions it aims to answer are: Is the IL-22BP formulation safe and tolerable? Does the IL-22BP formulation show preliminary antitumor activity?

Chengdu18–70 yrsAll genders
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NGS-MRD Assessment of Combination Immunotherapies Targeting B-ALL

B-Cell Acute Lymphoblastic Leukemia

The purpose of this study is to determine the feasibility, safety, and efficacy of a combination therapy in the treatment of B-cell acute lymphoblastic leukemia (B-ALL) based on multi-antigen-targeted chimeric antigen receptor T cells (CAR-T) followed by engineered immune effector cytotoxic T lymphocytes (CTLs) and immune-modified dendritic cell vaccine (DCvac). This approach is aimed to achieve NGS MRD negative in B-ALL patients, which can identify a very low risk of relapse and define patients with possible long-term remission without further treatment.

Shenzhen0.5–65 yrsAll genders
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Safety and Immunogenicity of a Sub-unit Protein CD40.RBDv Bivalent COVID-19 Vaccine, Adjuvanted or Not, as a Booster in Volunteers.

COVID-19

The goal of this clinical trial, on healthy volunteers, is to learn more about safety and reactogenicity of the CD40.RBDv vaccine. The main questions that will be studied are : * Is the CD40.RBDv (adjuvanted or not) safe ? * Does the CD40.RBDv (adjuvanted or not) imply an immunologic response ? Participants will receive, depending on their randomization arm, 1 or 2 injections of the CD40.RBDv vaccine or a single injection of approved mRNA vaccine

Multiple locations18–84 yrsAll genders
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Sleep and Adolescent Vaccine Immunogenicity Pilot/Observational Study

Vaccination

The main reason for this research study is to understand whether the sleep habits of 11-12 years-olds impact their response to a vaccine. The vaccine is called MCV4. It protects against meningococcal illness, which is rare but can be severe. The American Academy of Pediatrics recommends that the vaccine be given at age 11 or 12. The vaccine has been approved for youth in this age range for over 20 years and is one of the vaccines that primary care doctors typically give around this age. However, nobody has studied how sleep affects children's response to it. This could be important because research on adults suggests that sleep affects the immune system. We want to look at that issue in a younger age range. Participating families will be asked to have their child keep their regular sleep schedule during the 5-week study, without much variation. During that time, they will wear a special wristwatch at night to track their sleep. Each day they will fill out a short online form. They and a parent/guardian will come to Cincinnati Children's twice. Each visit will last 1 - 1 Β½ hours. The first visit will happen at the end of the 1st week. The second is at the end of the 5th week. During visits, they will fill out forms and we will get data from the wristwatch. During the first visit, the participating child would get the vaccine. During the second, they will have a blood test.

Cincinnati, OH11–12 yrsAll genders
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Butantan-DV Vaccine in Elderly Populations (DEN-04-IB)

Dengue

This is a randomized, double-blind (60 -79 years) and open-label (40-59 years), three-arm parallel Phase 3b, multicenter study to evaluate the safety and non-inferiority of the humoral immune response of the Butantan Dengue vaccine (Dengue 1,2,3,4 (attenuated)) in participants aged 60 -79 years (elderly) compared to participants aged 40 to 59 years (adults), with or without previous dengue and healthy based on clinical examination.

Curitiba40–79 yrsAll genders
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Safety and Serum Virus Neutralizing Antibody Responses of VYD2311, a COVID-19 Vaccine, and Coadministered VYD2311 With a COVID-19 Vaccine

COVID-19

The main purposes of this research study are to measure the safety (whether it causes any side effects), tolerability (if it does cause any side effects, how well your body is able to handle them), and reactions, both local at the injection site and systemic, that may occur in the body after receiving VYD2311, or a COVID-19 vaccine, or a combination of VYD2311 and a COVID-19 vaccine in healthy participants. This research study will measure the amount of serum virus neutralizing antibodies produced in the blood (antibodies that block a virus from infecting cells) and pharmacokinetics of VYD2311 compared to a COVID-19 vaccine, when each is administered alone or concurrently. Pharmacokinetics is the study of how a drug moves through the body, including how it is absorbed (taken into the body), distributed (spread throughout the body), metabolized (broken down in the body), and eliminated (removed from the body), and how the body affects the drug.

Overland Park, KS18–49 yrsAll genders
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Personalized Tumor Vaccines and Pabolizumab in Patients With Advanced Pancreatic Cancer

Advanced Pancreatic Cancer

The main objective of this study was to observe and evaluate the safety and tolerability of mRNA-0217/S001 vaccine encoding personalized tumor neoantigens alone/in combination with Pembrolizumab injection for the treatment of Advanced Pancreatic Cancer. The secondary objective was to observe the preliminary efficacy of mRNA-0217/S001 personalized tumor vaccine in the treatment of advanced solid tumors with neoantigen-specific CD4+ and CD8+ T lymphocyte responses, objective tumor response rate (ORR) and disease control rate (DCR), progression-free survival (PFS) and overall survival (OS) caused by mRNA-0217/S001 personalized tumor vaccine.

Qionghai18+ yrsAll genders
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Safety and Tolerability of AI-Designed Pan-Cancer Neoantigen mRNA Vaccine (PAN-NeoVax) in Advanced Solid Tumors

Cancer

This is a phase I, open-label, single-arm, single-center, dose-escalation study to evaluate the safety, tolerability, and preliminary anti-tumor efficacy of PAN-NeoVax, an artificial intelligence (AI)-designed pan-cancer neoantigen mRNA vaccine delivered via lipid nanoparticles (LNP), administered by intratumoral injection in patients with advanced or metastatic solid tumors who have failed second-line therapy. The study employs a classical "3+3" dose-escalation design with three dose levels (25 ΞΌg, 50 ΞΌg, and 100 ΞΌg mRNA). Each subject will receive 5 doses of basic immunization (first 4 doses at weekly intervals, fifth dose at 1 month after the fourth dose).

Chengdu18–70 yrsAll genders
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Improving Vaccine Protection for Adults

Immune System Responses and Trained Immunity After AS01 Administration Β· Healthy Adult

As people grow older, their immune system - the body's natural defence against diseases - becomes weaker, making them more vulnerable to infections and less responsive to vaccines. This was clearly seen during the COVID-19 pandemic, where older adults were more likely to develop severe illness. Researchers have made an interesting discovery about AS01, an ingredient already used in successful vaccines like the shingles vaccine. They found clues that AS01 might work like a general fitness trainer for the immune system, potentially making it stronger and better at fighting off various types of infections, not just specific ones. To confirm this possibility, we are conducting this research study with adults aged 21-59 to test whether AS01 by itself can boost and train the immune system, how long this boost lasts, and if it actually helps you fight off other infections more effectively.

Multiple locations21–59 yrsAll genders
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Laboratory Evaluation of Pregnancy Malaria Vaccine Candidates/In-vitro Testing of Pregnancy Malaria Vaccine Candidates

Malaria

Background: \- Malaria is a disease that affects many people in African countries. It is caused by germs that are spread by mosquito bites. It can be fatal if not diagnosed and treated right away. Children younger than 5 and pregnant women are most at risk to get malaria. Researchers want to create a vaccine that will prevent malaria infection during pregnancy. Objectives: \- To create a vaccine that will prevent malaria infection during pregnancy. To assess possible vaccines using in-vitro tests with parasites taken from pregnant women. Eligibility: \- Pregnant women ages 15-25 Design: * The study site is an area in Mali, West Africa. * Participants: * Will have blood drawn. * Will give consent for the blood sample to be used for future research. * May have a physical exam. * Participants who have malaria or anemia will get treatment.

Multiple locations15–25 yrsWomen
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A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negative Breast Cancer

Anatomic Stage IV Breast Cancer AJCC v8 Β· Metastatic Triple-Negative Breast Carcinoma

This phase II trial studies how well a cancer vaccine called STEMVAC works in combination with chemotherapy in treating patients with PD-L1 negative, triple-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). STEMVAC is designed to target proteins that are expressed on breast cancer stem cells, and it is believed to work by boosting the immune system to recognize and destroy the invader tumor cells that are causing the disease. Chemotherapy drugs 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. Giving STEMVAC in combination with chemotherapy may be an effective treatment for PD-L1 negative metastatic triple-negative breast cancer.

Seattle, WA18+ yrsAll genders
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A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series

Diphtheria Β· Tetanus Β· Pertussis

The purpose of this study is to evaluate immunogenicity, safety and lot-to-lot consistency of LBVD in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants

DasmariΓ±as0–0 yrsAll genders
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A Study on the Immune Response and Safety of the Second Dose of an Investigational Chickenpox Vaccine When Given to Healthy Children 3 Months After a First Dose at 12 to 15 Months of Age

Chickenpox

The purpose of this study is to evaluate the immune response and safety of GSKs investigational varicella vaccine (VNS Vaccine) compared to an already approved varicella vaccine, Varivax (VV), when administered as second dose to healthy children. 3 months after first dose at 12 to 15 months. The study will be conducted in children who have not previously contracted varicella or received a varicella vaccination.

SalvaleΓ³n de HigΓΌey1–1.3 yrsAll genders
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Screening of Healthy Volunteers for Investigational Antimalarial Drugs, Malaria Vaccines, and Controlled Human Malaria Challenge

Malaria

Background: Malaria is a serious infection caused by a parasite. People get malaria when an infected mosquito bites them. Malaria can cause major health and social problems in places were malaria is common, such as Africa but can also affect travelers who have never been exposed to malaria. Researchers at the NIH want to find a safe and effective malaria vaccine, antimalarial drugs, or prevention regimen. To do this, healthy volunteers are recruited under a general screening study in order to see if are qualified to join a future malaria study. Objective: To screen healthy volunteers to see if they are eligible to join investigational malaria studies. The studies will be trials of investigational antimalarial drugs, malaria vaccines, or prevention regimens. They may also involve controlled human malaria infection trials. Eligibility: Healthy people ages 18 50 Design: Participants will first be prescreened by phone. Participants will be screened with: Medical history Physical exam Blood and urine tests Participants may go more than 1 year without joining a clinical trial. If this happens, they may be re-contacted to see if they still want to be part of this screening protocol. Those who still want to participate and have had relevant medical changes will be rescreened. ...

Bethesda, MD18–50 yrsAll genders
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