Pfizer C4781004 mRNA Influenza
A Phase 3, randomized, observer-blinded study to evaluate the efficacy, safety, tolerability, and immunogenicity of a modified RNA vaccine against influenza compared to licensed inactivated influenza vaccine in healthy adults 18 years of age or older. Currently enrolling ages 65+.
Pfizer C3671013 RSV
A Phase 3 study to evaluate the efficacy, immunogenicity, and safety of Respiratory syncytial virus (RSV) prefusion F subunit vaccine in adults.
Novavax 2019nCoV-301 COVID-19
A Phase 3, randomized, observer-blinded, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine with Matrix-M1TM adjuvant in adult participants 18 years or older.
Pfizer C4591031 COVID-19 Booster
A Phase 3 master protocol to evaluate additional dose(s) of BNT162b2 in healthy individuals previously vaccinated with BNT162b2.
Pfizer C4591001 COVID-19
A Phase 2/3, placebo-controlled, randomized, observer-blind, dose-finding study to evaluate the safety, tolerability, immunogenicity, and efficacy of a SARS-CoV-2 RNA vaccine candidate (BNT162b2) against COVID-19 in healthy individuals.
Bavarian Nordic A/S POX-MVA-031 Smallpox
The main purpose of this clinical trial is to show that three lots, or batches, of an investigational vaccine called MVA-BN, produced at different times, have the same quality. In addition, blood will be drawn for basic lab tests and health will be monitored for any side effects. Blood will also be collected and analyzed for the amount of antibodies produced, which is how protection against smallpox is measured.
Smallpox was an infectious disease caused by a virus called variola. In 1980, after years of vaccination campaigns throughout the 19th and 20th centuries, the world was considered free of smallpox and mass vaccinations against smallpox stopped. Routine vaccinations for smallpox in the US were stopped in 1971. Today, the majority of the world’s population does not have existing protection against smallpox.
There is recent concern over the use of the smallpox virus as a biological weapon for terrorism. In response to this concern, the United States government is making efforts to improve its ability to protect its citizens in the event of a bioterrorist attack.
Smallpox vaccine supplies worldwide are no longer sufficient, and the currently approved US smallpox vaccine can sometimes cause severe side effects. Also, the vaccine cannot be used by people with weakened immune systems such as HIV-positive and transplant patients. Therefore, efforts are being made to develop new and safer smallpox vaccines.
DMID 16-0077 Pharmacokinetics of Antibacterials in Critically Ill Adults
This study is evaluating patients in the intensive care unit (ICU) that are on an antibiotic (cefepime, meropenem and/or piperacillin-tazobactam) as part of their care.
The overall goal of this study is to evaluate how the body absorbs these antibiotics when people are very ill and being cared for in an intensive care setting. We will also try to understand how different factors such as weight, kidney function, severe infection and other medical conditions affect these antibiotics.
DMID 17-0078 H7N9 Flu
The main purpose of this study is to find ways to improve immune responses to H7N9 vaccines.
This study is evaluating two different H7N9 vaccines that do and do not contain an adjuvant called AS03. This study will compare immune responses of the two different H7N9 vaccines given with or without the AS03 adjuvant including the timing of the second study vaccination. This study will also look at the safety of the H7N9 vaccines and AS03 adjuvant.
DMID 17-0090 H7N9 Flu
The purpose of this research study is to find ways to improve the immune responses to H7N9 flu vaccines, because previous studies have found that H7 influenza strains generally do not lead to strong immune responses in people. H7N9 influenza is a type of “bird flu” that can infect humans and frequently causes death or severe disease. One way to improve the response to vaccines or to allow for the use of smaller amounts of vaccine is to include a substance that can stimulate the immune system. This type of substance is called an adjuvant. An adjuvant may cause the body to produce more antibodies when it is given with a vaccine.
This study will look at an A/H7N9 Inactivated Influenza Vaccine (IIV) that does or does not contain an adjuvant called AS03. The trial will compare the study vaccine with or without AS03 as a boost in volunteers who received an H7N9 flu vaccine in a previous study and in volunteers who have never received an H7N9 flu vaccine. The study will also look at the safety of the study vaccine and AS03 adjuvant.
DMID 18-0011 Quadrivalent Flu
The purpose of this research study is to assess the safety, reactogenicity (reactions at the injection site and overall side effects) and effectiveness of the 2018-2019 seasonal Fluzone or Flublok given without or with one of two adjuvant formulations. An adjuvant is a substance that may cause the body to produce more antibodies when it is given with a vaccine. The two adjuvants being evaluated in this study are AF03 and Advax-CpG55.2. The adjuvants are investigational and have not been approved or licensed by the US Food and Drug Administration (FDA). Fluzone and Flublok are quadrivalent influenza vaccines (QIV) for the 2018-2019 season and are licensed and approved by the FDA.
DMID 16-0078 Pharmacokinetics of Beta-Lactams in Cystic Fibrosis
This study is evaluating hospitalized patients with cystic fibrosis on one of the following antibiotics: cefepime, meropenem, or piperacillin-tazobactam. Each of these antibiotics is approved by the Food and Drug Administration (FDA) to treat bacterial infections and are commonly used in children and adults with cystic fibrosis.
It is known how these antibiotics move around the body and how they are removed from the body in healthy volunteers. Patients with CF usually have less fat in their bodies, have other health problems, and take other medicines, which may affect how these antibiotics work and move in the body in ways we do not yet know.
This study is being done to help understand how these 3 antibiotics move around the body and how they are removed from the body in children and adults with CF. We want to understand whether we need to give more or less of the drug, or potentially give it more frequently for CF patients than we do for other patients.
DMID 02-009 Smallpox
The purpose of this study was to determine the ability of one of the smallpox vaccines to cause a sore that typically lasts up to 4 weeks at the site of vaccination, and the ability of the vaccine to cause proteins, called antibodies, to appear in your blood as part of the body’s defense system.
DMID 02-054 Smallpox
The purpose of this study was to find out if the smallpox vaccines are safe and to see if it will cause a sore where the shot was given. The sore usually indicated a successful vaccination. This sore can last up to 4 weeks. We also wanted to know if the vaccine can cause proteins, called antibodies, to appear in your blood as part of the body’s defense system.
DMID 04-022 H. influenzae Flu
The purpose of this research study was to learn more about how a germ called Haemophilus influenzae is able to live in the nose and throat. This process is called “colonization.” These germs live in the nose and throat of up to 80% of normal, healthy adults. In almost all cases, this germ causes no symptoms. However, in some people these germs can lead to ear, sinus or lung infections. If we can better understand how this germ lives for long periods of time in the nose and throat, we may be able to develop new treatments that would help prevent ear, sinus and lung infections. Also, if we can develop colonization in healthy individuals, we can use this model to study new treatments for Haemophilus influenzae.
DMID 04-100 Flu
The purpose of this research study was to compare reactions (side-effects) and immune system responses in subjects who are vaccinated with either a single dose of a standard flu vaccine or an experimental high dose vaccine. The experimental vaccine included approximately four times the amount of each of three influenza virus proteins that are in the standard vaccine. Both the standard vaccine and the high dose vaccine contained the three influenza virus proteins that were recommended by the U.S. FDA for the 2004-2005 influenza season.
DMID 05-0075 Flu II
Another method for giving flu vaccine has been developed. Instead of a shot in the arm, vaccine is given just under the skin of the arm. A much smaller amount of vaccine is needed when given this way. The purpose of this research study was to find out if giving the smaller dose of flu vaccine under the skin helps prevent the flu compared to giving the vaccine the usual way, as a shot in the arm. If the other method is effective, people may be more likely to get the flu vaccine and the current supply of vaccine could be used to make more doses to give to more people.
DMID 05-0141 Avian Flu
The purpose of this research study was to compare how the body reacts to different strengths of the new A/H5N1 flu vaccine when given with or without the addition of aluminum hydroxide adjuvant. We also looked at how antibodies are made after receiving the A/H5N1 flu vaccine. The study vaccine is given as an injection or shot in the arm. There are 8 different dosage/adjuvant groups of the new A/H5N1 vaccine that were tested in this study.
DMID 06-0012 Smallpox
The purpose of this research study was to study the ability of a new investigational smallpox vaccine called INVAMUNE® to produce a strong immune response (the body’s defense system) against smallpox disease. Another purpose of this study was to see how quickly someone can be protected against smallpox after a release of smallpox into the environment.
DMID 06-0016 CSL Flu
The purpose of this study was to provide information needed to get a flu vaccine made by CSL Limited and currently being used in Australia, Britain and other European countries licensed and available in the United States. If approved, this vaccine could help increase the amount of flu vaccine for use in the United States. This is very important because the United States has faced a flu vaccine shortage for the last couple of years (in 2006).
DMID 07-0022 Clade II H5 Flu Re-vaccination
The purpose of this study was to study the safety and immune responses in people who had previously received 2 doses of an inactivated (or killed) H5N1 avian (bird) influenza vaccine derived from one type of H5N1 avian influenza virus after being given a single dose of a similar vaccine derived from a different type of H5N1 avian influenza virus. A second reason for this study was to compare responses in people who had received two different but similar types of A/H5N1 vaccine (the type from the previous study vaccine and the type used in this study vaccine) to the responses in subjects like you who receive two doses of only the H5N1 vaccine used in this study. Information obtained from the results may provide important information into the usefulness of giving individuals H5N1 vaccine prior to the start of an influenza pandemic.
DMID 08-0006 Tularemia
There is currently no licensed vaccine to prevent infection and disease from tularemia in people. The availability of a vaccine may protect from the disease or may result in a milder disease and fewer complications. The main purpose of this study is to assess the ability of the two tularemia vaccines (USAMRIID-LVS and DVC-LVS) to cause the body to develop an immune response and to obtain more information on side effects of the vaccines.
Tularemia or “rabbit fever" is a disease of animals and humans. It is caused by a bacterium called Francisella tularensis (F. tularensis) found in rodents, rabbits and hares. In the United States, about 200 people are reported to have tularemia each year, usually after exposure to a sick animal. It can also be spread through being bitten by an infected tick, deerfly or other insect, by drinking contaminated water, by eating contaminated food, or by breathing in the dust from soil or animal pelts that are infected. Tularemia is not spread through person to person contact.
Exposure to the bacteria through the skin can result in skin sores and swollen lymph nodes. Exposure through the eyes can cause redness, swelling, and drainage from the eyes. Exposure by eating food containing the bacteria can cause a sore throat. Exposure by breathing in the bacteria or through blood containing the bacteria can cause pneumonia. All forms of tularemia can cause fever and general body symptoms, such as headache, fatigue, muscle and joint pains. Although tularemia can be life-threatening, most infections can be treated successfully with antibiotics.
DMID 08-0013 Avian Anhui Flu
This study tested an "H5" bird flu vaccine (influenza A/H5N1 subvirion vaccine). The vaccine, A/Ahnui/05, was produced for the US Department of Health and Human Services by Novartis. This research studied the vaccine’s safety and the body’s immune responses, including anti-H5 flu antibodies (the body’s protective proteins found in the blood) for this inactivated influenza A/H5N1 virus vaccine.
DMID 08-0015 Photodynamic
The purpose of this research study was to find out whether a combination of a liquid called methylene blue and light treatment called photodynamic therapy (PDT) is safe when given into a breathing tube, and if it could destroy bacteria that commonly grows on the inside of the tube.
DMID 08-0017 Rotavirus
The purpose of this research study was to determine if two rotavirus vaccines approved by the United States Food and Drug Administration (FDA) can be given in different combinations and still provide good protection from rotavirus infections in children. The two approved vaccines are called RotaTeq® and Rotarix®.
Rotavirus is the most common cause of severe diarrhea in children. Before common rotavirus vaccine use in 2006, each year in the United States, rotavirus was responsible for more than 410,000 doctor visits, more than 205,000 emergency room visits, between 55,000 to 70,000 hospitalizations, and 20 to 60 deaths in children younger than 5 years of age. Although rotavirus disease can occur at any age, it most commonly causes significant vomiting and diarrhea in young children. It is sometimes called the "stomach flu." The first infection is generally the most severe, with vomiting and diarrhea with dehydration seen in children aged three to 35 months. The virus often causing this vomiting and diarrhea is called "rotavirus."
DMID 08-0040 High Dose Smallpox
The purpose of this research was to compare the ability of a new investigational smallpox vaccine called IMVAMUNE® to produce a strong immune response against smallpox disease if given as one single, higher dose compared with two lower doses given one month apart. Another purpose of the study was to see how quickly someone might be protected against smallpox.
DMID 09-0002 Smallpox
The purpose of this research was to compare the immune responses of an investigational smallpox vaccine called IMVAMUNE® prepared for injection in two different ways and given in different ways. Both vaccine preparations had the same name but one came as a liquid and one came as a powder that has liquid added just before giving the shot. The vaccine that came as a liquid was given two different ways 1) as a shot just under the skin called “subcutaneously” or SQ or 2) as a shot between the layers of the skin called “intradermal” or ID. ID vaccine had a lower vaccine dose than the SQ vaccine.
DMID 09-0016 Zostavax
The purpose of this study was to see if it is safe to give patients who have chronic kidney disease the shingles vaccine (ZOSTAVAX®) before they have a kidney transplant.
ZOSTAVAX® is a vaccine that is approved to prevent shingles in normal, generally healthy older people who are 50 years old or older. It works by boosting the immune response to the virus. ZOSTAVAX® is not approved for people who are taking immunosuppressants because it is a live virus vaccine that could cause illness in people with weakened immune systems. In this study, patients were immunized with ZOSTAVAX® at least 4 weeks before they had their transplant. Their immune system will not be weakened by the medicines at the time they get their vaccine. Four weeks may allow time for the vaccine to boost the immune response before taking the immunosuppressant medicines.
DMID 09-0018 Flu for Infants
This study is being conducted to evaluate the possibility of improved protection against influenza in children 6 through 35 months of age. The proposal is that this will happen by giving an increased dose of flu vaccine with the child having no increase in side effects.
Influenza can be prevented by receiving a flu vaccine. The routine immunization schedule recommends that a 0.25mL dose of flu vaccine be given to all children 6 through 35 months of age. This is half of the full 0.5 mL dose given to older children and adults. The half-dose was chosen in the past, due to the concerns about the original flu vaccine’s side effects. However, the flu vaccine has been modified over the years. Health scientists believe children 6 through 35 months might build up more infection-fighting proteins in their blood (antibody protection) if given the full dose size, with no increase in side effects expected.
DMID 09-0033 Flu for Pregnant Women
The purpose of this research study was to see how much antibody the body makes after getting a flu vaccine. We also looked at how the body reacted to the flu vaccine and how it affected the pregnant woman’s baby. The information from this study helped guide scientists in developing flu vaccines for pregnant women.
DMID 09-0043 H1N1 Flu for Adults
The purpose of this study was to see how the body reacted to different strengths of the H1N1 flu shot. This study also compared how age affected the body’s response to the H1N1 flu shot.
In this study, 2 strengths of the H1N1 flu shot were tested (given about 3 weeks apart). The results of this study helped researchers find out if the different strengths of the H1N1 flu shot make the body produce H1N1 antibodies that are better at fighting H1N1 flu.
DMID 09-0047 H1N1 Flu for Children
This research study tested a vaccine against the 2009 H1N1 virus. In this study, 2 H1N1 flu shots were given with and without the “regular” seasonal flu shot in different combinations at 3 different time points. The results of this study helped researchers determine if it is safe for the H1N1 flu shot to be given with the “regular” seasonal flu shot. It also helped researchers determine if getting the “regular” seasonal flu shot improved the body’s ability to makeH1N1 antibodies that are better at fighting H1N1 flu. This study also compared how age affected the body’s response to the H1N1 flu shot.
DMID 09-0058 H1N1 Flu + MF59 Adjuvant
The purpose of this study was to see how the body reacted to different strengths of the H1N1 flu shot when it was given with or without an "adjuvant." In this study, 3 strengths of the H1N1 flu shot were tested (3.75 micrograms, 7.5 micrograms, and 15 micrograms) combined with an adjuvant. In addition, two strengths of the H1N1 flu shot (7.5 microgram and 15 microgram) were tested without adjuvant.
The results of this study helped researchers determine if the different strengths of the H1N1 flu shot with or without adjuvant make your body produce H1N1 antibodies that are better at fighting H1N1 flu. This study also compared how age affected the body’s response to the H1N1 flu shot.
DMID 09-0073 H1N1 Flu for HIV Patients
The purpose of this study was to see how the body reacted to different strengths of the H1N1 flu shot in persons infected with HIV. This study also compared how CD4 count (also known as T cell count) affected the body’s response to the H1N1 flu shot.
In this study, 2 strengths of the H1N1 flu shot were given twice, about 3 weeks apart. The results of this study helped researchers determine if the different strengths of the H1N1 flu shot make the body produce H1N1 antibodies that are better at fighting H1N1 flu.
DMID 10-0016 Avian Mix & Match Flu
The purpose of this study was to make sure the H5N1 flu shot with and without adjuvant was safe without causing many side effects, and to see how the body reacted to lower strengths of the H5N1 flu shot when it was given with and without the MF59 adjuvant. The results of this study helped researchers determine if the lower strengths of the H5N1 flu shot with and without the MF59 adjuvant helps the body make antibodies that are better at fighting the A/H5N1 “bird flu” virus. This information was used to find ways to cause more antibodies to form so that more people can be better protected and lower strengths of the H5N1 flu shot can be used.
DMID 10-0076 High Dose Flu for RA Patients
Participants in this research study had rheumatoid arthritis (RA) and were receiving tumor necrosis factor inhibitor (TNFi) therapy, or were a healthy volunteer who served as a control subject. The purpose of this research study was to determine if people with rheumatoid arthritis on TNFi therapy had an improved immune response to the high dose influenza vaccine compared with those receiving the standard dose of influenza vaccine.
Tumor Necrosis Factor (TNF) is a substance that is increased in rheumatoid arthritis (RA), and it increases inflammation. Therapy to inhibit TNF reduces inflammation, and is beneficial for many people with RA. Although Fluzone® High Dose is a licensed product for those over 65; it had not been studied extensively in people with RA or approved for use in younger people. The high dose vaccine includes four times the amount of each of three influenza virus proteins that are in the standard vaccine. Influenza vaccine is recommended for people with rheumatoid arthritis; however, the response to the standard influenza vaccine is not as strong in people with RA, particularly those receiving TNFi therapy. Similarly, influenza vaccine is not as potent in elderly people (> 65 years of age), and previous studies found that using a higher dose of influenza vaccine in elderly subjects improves the vaccine response. Because of this, there is a licensed high dose influenza vaccine product recommended for people 65 years of age and older. We tested the higher dose influenza vaccine in people under age 65 with RA on TNFi therapy and healthy volunteers to see if the high dose vaccine improved the immune response.
DMID 11-0021 INMAVMUNE® Smallpox
This study evaluated a smallpox vaccine that contained a weakened vaccinia virus, called IMVAMUNE®. IMVAMUNE® vaccine is usually given as a two dose series, with the second dose given 28 days after the first dose, and the vaccinations are given by needle and syringe.
One purpose of this study was to see whether the two doses could be given closer together. In this study some people got two doses given 28 days apart, some got two doses given 21 days apart, and some got two doses given 14 days apart. Giving the doses closer together may allow people to be protected from smallpox infection sooner. Another purpose of this study was to evaluate giving the vaccine by a jet injector device instead of by the traditional needle and syringe method. Jet injectors propel the liquid vaccine through a very small hole that creates a “liquid needle” that can penetrate the skin. In this study, some people got the IMVAMUNE® vaccine given by the Stratis® jet injector and some people got the vaccine delivered by a needle. For everyone, the vaccine will be given subcutaneously (or SQ), which means just under the skin.
DMID 11-0031 Leishmaniasis
This research study evaluated a study vaccine that has been designed to target an infectious disease called leishmaniasis. This disease is caused by a parasite that is present in many developing countries. About 500,000 new cases of the most severe form of leishmaniasis, visceral leishmaniasis, occur each year. Visceral leishmaniasis can cause severe swelling of the liver and spleen, fever, weight loss and a weakened immune system. If left untreated almost all will die from the disease. It is a significant infection for people who live in many developing countries, but also has caused disease in our troops in Afghanistan and Iraq and in travelers who visit countries where this parasite lives. The current medications that treat leishmaniasis are toxic, difficult to administer and expensive. More importantly, these medications often fail to cure people who are infected with leishmania parasites. A vaccine could prove to be the most effective method to control leishmaniasis.
In this study, we evaluated a vaccine that contains LEISH-F3, a protein from the leishmania organism, along with one of three adjuvants. The three adjuvants in the study are called GLA- SE, MPL-SE or SE alone.
DMID 11-0034 Pneumococcal for Elderly Adults
The purpose of this study was to see whether giving two injections of PCV13 to adults who had been previously vaccinated with PPV23 improved the antibody response to the pneumococcal strains in PCV13. A group of adults 55 through 74 years of age who previously received PPV23 between three and seven years earlier (the previously vaccinated group) were enrolled. Half received an injection of PCV13 in one arm, and half received an injection of PCV13 in each arm (for a total of two injections of PCV13). Another group of adults 55 through 74 years of age who had never received PPV23 (the never vaccinated group) were enrolled and all were given one injection of PCV13.
There were two main comparisons. First, among the previously vaccinated group, the antibody responses in those given two injections of PCV13 were compared to the antibody responses in those given one injection of PCV13, to see if two doses were better than one. Second, the antibody responses in the previously vaccinated group given two injections of PCV13 were compared with the responses to the single injection of PCV13 in the never vaccinated group, to see if the antibody responses to two injections of PCV13 in adults who were previously vaccinated with PPV23 was similar to the antibody response to one injection of PCV13 in adults who never received PPV23.
The pneumococcus is a bacterium (germ) that is a common cause of serious infections, including bloodstream infections and pneumonia. Infants and persons over 65 years of age are at highest risk of these infections.
DMID 12-0011 H3N2 Flu for Adults
The purpose of this research study was to test a vaccine against the H3N2v virus. It had never been tested in humans. This vaccine was designed to protect people against H3N2v and was not expected to protect participants against the common “seasonal flu” that occurs each year. In this study the H3N2v flu was given at two different time points about 3 weeks apart. The results of this study helped researchers determine if the H3N2v flu shot is safe and how many H3N2v flu shots should be given to make the body produce antibodies that are better at fighting H3N2v flu. This study also compared how age affected the body’s response to the H3N2v flu shot.
DMID 12-0021 GML in Bacterial Vaginosis
The purpose of this research study was to find out if 5% Monolaurin (GML) Vaginal Gel compared to placebo (contains no medicine) gel was safe, bearable, and worked well in the treatment of (Bacteria Vaginosis) BV. The study product was applied in the vagina with a pre-filled applicator. The GML vaginal gel is a jelly-like product that is similar to KY gel. The placebo only had the jelly and no GML.
BV is a disease of the vagina caused by bacteria. The most common symptom of BV is an abnormal off-white vaginal discharge with an unpleasant smell. However, up to 50% of women with BV do not have symptoms. At the time, current treatment of BV included taking an oral antibiotic or using an antibiotic gel in the vagina for 5 to 7 days. However, about 30% of women would have another episode of BV within 3 months of therapy. New therapies for BV were needed.
DMID 12-0053 Oxfendazole
The purpose of this research study was to evaluate, in humans, the safety of the drug, oxfendazole, and how the body gets rid of it. The reason we tested this drug is because we were searching for treatments for a disease caused by a parasite affecting the central nervous system (CNS), cerebral cysticercosis. Individuals were given a single dose of the drug and we tested blood and urine to see how much of the drug got into the blood stream and how long it lasted in the body. We also followed to see how individuals tolerated the medication.
In humans, cerebral cysticercosis is the most common disease caused by a parasite affecting the central nervous system (CNS). On a worldwide basis, approximately 50,000 people die each year because of neurocysticercosis, and it is estimated that 1000 cases occur annually in the United States (US). The current treatment for neurocysticercosis is far from ideal: complete cure is achieved in approximately 50% of cases, with regimens that require multiple doses of drug over several weeks. Oxfendazole is currently marketed for use against parasitic infections in beef livestock. In preliminary studies in pigs, single oral doses of oxfendazole appear to have substantial activity against cysticercosis. These data suggest that oxfendazole has the potential to be useful as a single dose oral treatment for neurocysticercosis.
DMID 12-0109 Tuberculosis
In this study, we evaluated the safety, tolerability and immunogenicity of a TB (Tuberculosis) vaccine. This study tested ID93 alone or in combination with two different adjuvants (GLA-SE or AP10-602). ID93 is a protein that contains some pieces of the TB bacterium that are thought to be important for TB infections. By developing a vaccine that allows you to develop antibodies to these pieces, we may be able to prevent or lessen TB infections.
TB is an infectious disease caused by a bacterium. TB is one of the leading causes of illness and death around the world with an estimated 8 million cases of active TB each year and 1.3 million deaths annually. Current treatment requires people to take multiple antibiotics for many months (often for 6 months or more), which makes it difficult for people to tolerate these medications and to finish the required length of therapy. Given the widespread occurrence of TB, the high rates of illness and death and the complexities of treatment, effective TB vaccines could have great impacts on global health. The current licensed BCG vaccine doesn’t prevent TB infections in adults and has only limited effectiveness in children, so there is a great need for a more effective vaccine.
DMID 13-0032 H7N9 Flu + MF59 Adjuvant
This study tested vaccine (H7N9 flu shot) and adjuvant (MF59) combinations against the influenza A/H7N9 virus. The purpose of this study was to assess whether the H7N9 flu shot with and without the MF59 adjuvant was safe and did not cause unacceptable or intolerable side effects, and to see how the body reacted to different strengths of the H7N9 flu shot when it was given with and without the MF59 adjuvant. The results of this study helped researchers determine which strengths of the H7N9 flu shot with and without the MF59 adjuvant cause more antibodies and cells to form so that more people can be better protected and lower strengths of the H7N9 flu shot can be used.
In this study participants were given two doses of the H7N9 flu shot with or without the MF59 adjuvant about 3 weeks apart.
DMID 13-0034 H7N9 Flu + MF59 Adjuvant for Elderly Adults
This study tested vaccine (H7N9 flu shot) and adjuvant (MF59) combinations against the influenza A/H7N9 virus. The purposes of this study were to assess whether the H7N9 flu shot administered with the MF59 adjuvant was safe and did not cause unacceptable or intolerable side effects, to see how the body reacted to different strengths of the H7N9 flu shot when administered with the MF59 adjuvant using two different study vaccination schedules, and to assess the effect of a third dose of the H7N9 flu shot administered with the MF59 adjuvant on the immune system. The results of this study helped researchers determine which strengths of the H7N9 flu shot administered with the MF59 adjuvant caused more antibodies to form so that more people can be better protected and lower strengths of the H7N9 flu shot can be used.
In this study, participants were given three doses of the H7N9 flu shot administered with the MF59 adjuvant over about 24 weeks. The first two study vaccinations were given either about 4 or 8 weeks apart, while the third study vaccination was given about 24 weeks after receipt of the first study vaccination, depending on which of the two study vaccination schedules the participants were randomly assigned to.
14-0107 Yellow Fever
This study tested the safety and immune responses induced by an MVA-BN vectored YF (Yellow Fever) vaccine, given with or without adjuvant (ISA 720), in comparison with YF-VAX and MVA-BN alone.
YF is an illness that is caused by the YF virus. There are about 200,000 cases and 30,000 deaths from YF in transmission risk areas of Africa and South America each year. YF does not occur in the United States at this time, though it has in past centuries. YF is spread by the bite of infected mosquitoes, and people who are infected can have fever, back pain, headache, nausea, vomiting, fatigue, and weakness. Most people recover but approximately 15% develop severe disease with yellowing of the skin, bleeding, and shock. The risk of death with severe disease is 20-50%.
One way to provide protection against YF is to use a vaccine vector. A vaccine vector is a non-YF virus that has been weakened (attenuated). The vector contains YF virus proteins, but the vector cannot make more copies of itself in human cells. It is used to deliver the YF virus proteins to the body’s cells to induce immunity (cause the body to make antibodies) to YF. The vaccine vector being tested in this clinical trial (called MVA-BN) is modified vaccinia (virus in the same family as smallpox), into which YF virus proteins have been inserted. Other vaccinia-based vaccines have been tested and found to be safe and effective (inducing immunity) in people.
DMID 14-0112 Universal Flu
This study is evaluated whether the immune system could be primed (or prepared in advance) in persons by a protein vaccine called M-001 that contains several pieces of protein made by the flu virus. Priming means that the immune response to a second vaccine is improved by making more cells and antibodies after the second vaccine is given. In this case, we evaluated whether 2 doses of M-001 improved the immune responses to a later dose of the 2018-2019 seasonal flu vaccine.
DMID 15-0038 Chikungunya
The purpose of this research study was to see whether MV-CHIK, a vaccine for chikungunya virus, was safe, tolerable and if it stimulated a good immune response. This study also evaluated the best dose and immunization schedule for the vaccine.
Chikungunya virus is transmitted by mosquitos to humans. The typical signs and symptoms of chikungunya infection include fever, rash, and severe, debilitating joint pains. The infection rarely results in death, but over 50% of those infected suffer from prolonged joint aches and sometimes joint redness and swelling that can persist for weeks and, in some, can last for years.
The virus originally was mostly seen in the more tropical regions of Africa and Asia with scattered cases seen in other parts of the world. However, over the past 10 years, chikungunya has spread to more temperate climates and now is present on five continents including Europe, South America and North America. Since 2013, there have been large numbers of cases in Central and South America, the Caribbean and even a few locally transmitted cases in Florida. There are no licensed vaccines or treatments for this infection. A vaccine for this virus could be particularly useful for travelers, and for those who live in regions of the world that are prone to this infection.
The vaccine we studied (MV-CHIK) was created from a measles vaccine approved in Europe that had genes from chikungunya virus inserted into it. As the virus grows it makes chikungunya proteins, which may activate your body to make antibodies and other immune cells that could help protect against chikungunya infection. The goal of this study was to further understand the best dose and the best dosing schedule for receiving two doses of the vaccine and to continue to evaluate the safety of the vaccine.
The participants in this study received 2 injections and were randomized to one of the 3 vaccination schedules. Some of the participants received a lower dose of vaccine, some a higher dose of vaccine and some received a placebo (an inactive substance).
DMID 15-0045 Complicated Urinary Tract Infection
A urinary tract infection (UTI) is an infection of the kidneys, ureters, bladder and urethra. It is usually caused by bacteria. If a patient has an abnormal urinary tract or an underlying medical condition it is called a complicated UTI or cUTI. The cUTI is usually harder to treat than a simple UTI. The purpose of this research study was to evaluate whether two different oral antibiotics are safe and effective in the treatment of cUTI. These oral antibiotics are either given as an initial or “step down” therapy (after receiving IV antibiotics prescribed by a doctor) to treat the cUTI. The findings from this study may provide evidence that fosfomycin can be used as an alternative oral treatment for cUTI, especially if the infection is resistant to commonly used oral antibiotics.
DMID 15-0064 H5N8 Flu + AS03 or MF59 Adjuvant
This study tested vaccine (H5N8 flu shot) and two different adjuvant (AS03 or MF59) combinations against the A/H5N8 “bird flu” virus. The purpose of this study was to assess whether this H5N8 flu shot with or without the M59 or AS03 adjuvants was safe and did not cause unacceptable or intolerable side effects, and to see how the body reacted to different strengths of this H5N8 flu shot when it was given with or without the AS03 or MF59 adjuvants. The results of this study helped researchers find out which strengths of this H5N8 flu shot with or without the AS03 or MF59 adjuvants caused more antibodies to form so that more people can be better protected and lower strengths of this H5N8 flu shot can be used.
In this study, participants were given two doses of the study vaccine (H5N8 flu shot with or without the AS03 or MF59 adjuvants) administered intramuscularly about 3 weeks apart.
DMID 15-0095 Staphylococcus aureus
The purpose of this study was to test a new method to look for bacteria in your blood. This method is called a Micrococcal Nuclease (MN) Assay. This test takes less than 3 hours and may allow for earlier treatment if an infection is found. We had two versions of this new assay that we tested. We compared the MN assay results to the results from standard blood culture testing that care teams are already using to care for patients.
Bloodstream infections can occur when there is an infection in the body. Staphylococcus aureus (S.aureus) is a bacteria (or germ) that can cause infection in the bloodstream. S. aureus is the most common cause for infections that occur during a hospital stay.
DMID 16-0005 Oxfendazole II
The purpose of this research study was to assess the safety of the drug, oxfendazole, and how the body absorbs, distributes, and gets rid of it when given daily for five days. Oxfendazole is a medication that is currently used to treat parasite infections in beef livestock as well as many other animals. Another important unanswered question was the effect of food on the absorption of oxfendazole. Therefore, this study also assessed the absorption of oxfendazole given as a single dose with or without food.
Many people who live in developing countries suffer from worm infections. There are three major soil transmitted parasitic worms (roundworm, hookworm and whipworm) with over one billion cases reported worldwide. Nearly half of these cases result in significant illness especially in young children. The current treatment requires multiple doses of drug over a period of time. In humans there are two drugs albendazole and mebendazole that have been used for many of these worm infections. However, some of the worm infections are not cured with these drugs. Oxfendazole successfully treats a large variety of parasite infections in animals. Studies show that it can stay longer in both the blood and intestinal tract and these characteristics might make it a very effective drug in humans especially for infections that are not well treated with the current drugs that are approved for humans.
DMID 16-0018 S. aureus in Prosthetic Joint Infection
Our aim was to conduct a retrospective study to investigate the association between CAS (computer-assisted surgery) and clinical outcomes in patients with S. aureus PJI (prosthetic joint infection).
Our long-term research goal is to improve the quality of life among patients with S. aureus PJI by understanding variation in the use of CAS and its impact on clinical outcomes. PJI is one of the most challenging complications after a total joint replacement. The proportion of joint replacement patients who develop a PJI is relatively low (0.5%-2%), however, the overall incidence of PJI is predicted to increase given the growth in the population who would be eligible to receive prosthesis. In addition, management of PJI patients often results in long hospital stays, repeated surgical procedures, and months of physical therapy resulting in further loss of mobility and increased healthcare costs.
DMID 16-0027 Pharmacokinetics of Beta-lactam Antibacterials in Adults
The purpose of this research study was to learn more about how Beta-lactam antibiotics (a broad class of antibiotics that includes the penicillins and carbapenems) are used by the body. These antibiotics include meropenem and piperacillin-tazobactam. To study how the body handles Beta-lactam antibiotics, we measured Beta-lactam antibiotic levels in the blood. The results of this study will help doctors have better understanding of how the body uses these antibiotics and guide how much and how often they should give them to patients in the future.
DMID 16-0037 Pulmonary Non-Tuberculous Mycobacterial Infections
This was a multi-centered retrospective observational study. The results from these epidemiological studies could be used to plan clinical trials to evaluate new therapeutics.
Nontuberculous mycobacteria (NTM) include all mycobacteria except Mycobacterium tuberculosis (Mtb) and M. leprae. There are more than 160 NTM species, and although most are nonpathogenic, some cause serious disease. In the US, M. avium-intracellulare complex (MAC), M. kansasii and M. abscessus are the most common, clinically relevant NTM. The mechanism of NTM transmission is not clearly known, but it is believed that NTM are generally acquired from the environment. Patients with underlying pulmonary disease including chronic obstructive lung disease (COPD) and bronchiectasis, thoracic skeletal abnormalities, rheumatoid arthritis, or immune deficiency either acquired or due to use of immunosuppressive drugs including steroids and anti-TNF are at increased risk of developing pulmonary NTM.
Treatment of pulmonary NTM is difficult for two reasons. First, some of the drugs particularly rifampin and clarithromycin used for the treatment of NTM may interact with other drugs. The risk of drug interaction is a serious issue in pulmonary NTM because patients could be on multiple drugs for other chronic diseases. In one study from South Korea on patients with pulmonary M. abscessus, the default rate (defined as interruption of treatment for more than 2 consecutive months) was about 7%. Second, despite long term treatment (at least 18 months), limited studies indicate that 10% - 50% of cases fail to respond, with the highest failure rates for M. abscessus and MAC. New drugs and treatment regimens are essential to shorten the duration of treatment, increase cure rate, eliminate the possibility of serious drug interactions, and manage treatment failures.
DMID 17-0075 H7N9 Flu
The purpose of this study was to find out more about ways to improve the immune responses to H7N9 influenza vaccines because previous studies have found that H7 influenza strains generally do not lead to strong immune responses in people. This study evaluated three different dose amounts of an investigational H7N9 vaccine that contains an adjuvant called AS03, and two different dose amounts of the vaccine without any adjuvant. In this study, we compared the immune response to H7N9 vaccine that includes an adjuvant to the immune response to the vaccine given without an adjuvant. The study also looked at the safety of the vaccines and adjuvants.