Vaccines Treatment Options in Georgia

This study is a Phase 3, randomized, modified double-blind study which aims to document the safety profile of the PCV21 vaccine (investigational pneumococcal vaccine) compared to a licensed 20-valent pneumococcal conjugate vaccine in infants aged from approximately 2 months (42 to 89 days). The study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 to 15 months of age. Routine pediatric vaccines will be given as per local recommendations. There will be 6 study visits: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age until 15 months of age, V06 separated from V05 by 30 days. Read Less

This study aims to answer the question: does 1-dose HPV vaccination generate the same immune responses compared to 2- or 3-dose HPV vaccination? This will be done by studying the immune response in blood, lymph nodes, and bone marrow. Human papillomaviruses (HPV) cause cancers (cervical, anal, oropharyngeal, vulvar, vaginal, and penile), and the current HPV vaccine is highly effective at preventing disease by HPV types that cause 90% of cancer cases. While this vaccine generates high levels of antibodies that last for \> 10 years, understanding of how this occurs is limited, and studying this immune response will help design new and better vaccines. The study population consists of healthy adult (age 18-45) participants who have not previously received an HPV vaccine, do not have antibodies against certain types of HPV, do not have a history of HPV infection or disease (such as genital warts, abnormal pap test, or HPV DNA test), and do not have contraindications to study procedures. Populations of increased concern are not being enrolled. Read Less

This phase Ib trial tests the safety, side effects and best dose of tumor membrane vesicle (TMV) vaccine therapy alone and in combination with pembrolizumab and evaluates how well it works in treating patients with head and neck squamous cell cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Vaccines made from a person's tumor cells, such as TMV vaccines, may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving TMV vaccine therapy alone or with pembrolizumab may be safe, tolerable and/or effective in treating patients with recurrent and/or metastatic head and neck squamous cell cancer. Read Less

This is a study of CDC-9 inactivated rotavirus vaccine (IRV) microneedle patch (MNP) for intradermal administration in healthy adults aged 18 to 45 years at two dose levels in a 3-dose series. The purpose is to determine if it is safe and if the recipient's immune system responds to the vaccine. Read Less

The ability of the vaccines today to generate a long-lasting protection against infections varies greatly from one vaccine to another. The yellow fever vaccine (YF-17D) is one of the most successful vaccines ever developed, having been administered to over 600 million people globally. A single vaccination is known to induce durable protection over several decades. In contrast, the quadrivalent influenza vaccine (QIV) generates an immunity that wanes quickly with no long-lasting protection. Currently, the duration of immune protection for new vaccines is difficult to predict during vaccine product development and can only be ascertained by a "wait and see" approach. This is due, in part, to the fact that some of the signals that activate a durable immune system protection remain unknown. This study aims to provide a better understanding of this problem by vaccinating willing participants with either the FDA-approved yellow fever vaccine or the quadrivalent influenza vaccine and collecting baseline and follow-up biologic samples to compare how the immune system reacts. Read Less

The purpose of this study is to learn about how the flu and COVID vaccines act when given alone or when mixed together. This study is seeking healthy participants aged 18 or older. All participants in this study will receive only 1 shot to their arm, either a flu or COVID vaccine, alone or mixed. Participants will take part in this study for about 6 months, and participants will need to visit the clinical study site at least 4 times. Read Less

The primary objective of the study is to determine the relative efficacy of the investigational oral severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine tablet VXA-CoV2-3.3 compared to a currently recommended vaccine for the prevention of symptomatic Coronavirus Disease 2019 (COVID-19). In order to represent a more recently circulating SARS-CoV-2 variant, the main study endpoints will now evaluate the VXA-CoV2-3.3 (KP.2 strain) vaccine, and not the VXA-CoV2-3.1 (XBB.1.5 strain) vaccine. Read Less

Influenza virus is a significant pathogen in pediatric solid organ transplant (SOT) recipients. However, these individuals respond poorly to standard-dose (SD) inactivated influenza vaccine (IIV). Recent studies have investigated two strategies to overcome poor immune responses in SOT recipients: (1) administration of high-dose (HD)-IIV compared to SD-IIV and (2) two doses of SD-IIV compared to one dose of SD-IIV in the same influenza season. One study compared HD-IIV vs. SD-IIV in adult SOT recipients and noted that HD-IIV was safe and more immunogenic; however, the median post-transplant period was 38 months. A phase I pediatric study comparing a single dose of HD-IIV vs. SD-IIV was safe with higher immunogenicity, but the study was limited by small sample size and median post-transplant vaccine administration was 26 months. In another phase II trial of adult SOT recipients, two doses of SD-IIV one month apart compared to one-dose of SD-IIV revealed modestly increased immunogenicity when given at a median of 18 months post-transplant. Therefore, these studies lack both evaluation in the early post-transplant period and substantive pediatric populations. Additionally, the administration of two-doses of HD-IIV in the same influenza season has not been evaluated in pediatric SOT recipients. Thus, the optimal immunization strategy for pediatric SOT recipients less than 24 months post-transplant is unknown. In addition, immunologic predictors and correlates of influenza vaccine immunogenicity in pediatric SOT recipients have not been well-defined. The central hypothesis of our proposal is that pediatric SOT recipients 1-23 months post-transplant who receive two doses of HD-quadrivalent inactivated influenza vaccine (QIV) will have similar safety but higher Hemagglutination Inhibition (HAI) geometric mean titers (GMTs) to influenza antigens compared to pediatric SOT recipients receiving two doses of SD-QIV. Read Less

The purpose of this study is to evaluate the immunogenicity, reactogenicity, and safety, of mRNA-1083 multicomponent influenza and COVID-19 vaccine in adults ≥18 to \<65 years of age. Read Less

This phase II clinical trial tests how well the cytomegalovirus-modified vaccinica Ankara (CMV-MVA) Triplex vaccine given to human leukocyte antigens (HLA) matched related stem cell donors works to prevent cytomegalovirus (CMV) infection in patients undergoing hematopoietic stem cell transplant. The CMV-MVA Triplex vaccine works by causing an immune response in the donors body to the CMV virus, creating immunity to it. The donor then passes that immunity on to the patient upon receiving the stem cell transplant. Giving the CMV-MVA triplex vaccine to donors may help prevent CMV infection of patients undergoing stem cell transplantation. Read Less

This clinical trial evaluates the influenza virus vaccination in evaluating human immune response in patients with lymphoma. Evaluating immune response may increase the understanding of how the immune system changes when patients receive treatment for lymphomas by looking at the antibody levels and the level of the different cells that make up the immune system over time compared to those without lymphoma. Read Less

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 increases the number of white blood cells in the body following chemotherapy for certain types of cancer and is used to alert the immune system. It is not yet known if TPIV100 and sargramostim will work better in treating patients with HER2 positive, stage II-III breast cancer. Read Less