Safety and Immunogenicity of Q Fever Vaccine
Withdrawn
The purpose of this study is to evaluate the safety of Q Fever Vaccine, Phase I, Inactivated, Dried, NDBR 105 and collect data on incidence of occupational Q fever infection in vaccinated personnel.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
12/30/2019
Locations: Special Immunizations Program, Division of Medicine, USAMRIID, Fort Deterick, Maryland
Conditions: Q Fever
IM Recombinant Ricin Toxin Vaccine (RVEc) - 3-Dose Primary Series With Boost
Withdrawn
This study seeks to determine the safety and immunogenicity of a series of 3 primary vaccinations and a booster vaccination of Recombinant ricin toxin A-chain 1-33/44-198 (rRTA 1-33/44-198) vaccine (RVEc) at 10, 50, or 75 μg IM. This study is evaluating if RVEc will display an acceptable safety profile as determined by adverse event (AE) data and if RVEc will elicit anti-ricin antibody titers and ricin toxin-neutralizing antibodies in vaccine recipients.
Gender:
ALL
Ages:
Between 18 years and 50 years
Trial Updated:
12/30/2019
Locations: Department of Clinical Research, USAMRIID, Fort Deterick, Maryland
Conditions: Ricin Poisoning
ID Recombinant Ricin Toxin A-Chain Vaccine RVEc™ - 3-Dose Primary Series With Boost
Withdrawn
This study seeks to determine the safety and immunogenicity of a series of 3 primary vaccinations and a booster vaccination of Recombinant ricin toxin A-chain 1-33/44-198 (rRTA 1-33/44-198) vaccine (RVEc) at 10 or 20 μg intradermally (ID). This study is evaluating if RVEc will display an acceptable safety profile as determined by adverse event (AE) data and if RVEc will elicit anti-ricin antibody titers and ricin toxin-neutralizing antibodies in vaccine recipients.
Gender:
ALL
Ages:
Between 18 years and 50 years
Trial Updated:
12/30/2019
Locations: Department of Clinical Research, USAMRIID, Fort Deterick, Maryland
Conditions: Ricin Poisoning
Booster Dose (50 µg) of Recombinant Ricin Toxin Vaccine (RVEc™) in Previously Vaccinated Healthy Adults
Completed
The purpose of this study is to evaluate the safety and immunogenicity of a single 50-μg booster dose of RVEc. Subjects will be recruited from the cohort that received three 50-μg doses of RVEc in a Phase 1 trial (NCT01317667).
Gender:
ALL
Ages:
Between 18 years and 50 years
Trial Updated:
12/17/2019
Locations: Department of Clinical Research, USAMRIID, Frederick, Maryland
Conditions: Ricin Poisoning
Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine
Completed
The purpose of the present study is to assess and compare in healthy non-pregnant women 18 to 40 years of age the safety and immunogenicity of a liquid formulation of Group B Streptococcus (GBS) Trivalent Vaccine (not requiring reconstitution prior to administration), and of the lyophilized formulation of GBS Trivalent Vaccine, administered in non-pregnant and pregnant women in the clinical development program to date.
Gender:
FEMALE
Ages:
Between 18 years and 40 years
Trial Updated:
11/19/2019
Locations: GSK Investigational Site, Baltimore, Maryland
Conditions: Infections, Streptococcal, Streptococcal Infections
Phase 1/2a Trial of Pf GAP p52-/p36- Sporozoite Malaria Vaccine
Terminated
The purpose of this study is to assess safety and tolerability of escalating doses of a genetically attenuated parasite malaria vaccine (p52-/p36- GAP vaccine) in healthy malaria-naive adults. The study will also assess preliminary efficacy of p52-/p36- GAP vaccine following primary experimental challenge with P. falciparum sporozoites. Lastly, the study will assess immunogenicity of p52-/p36- GAP in malaria-naïve healthy adults and preliminary efficacy of p52-/p36- GAP vaccine following primary... Read More
Gender:
ALL
Ages:
Between 18 years and 50 years
Trial Updated:
10/04/2019
Locations: Walter Reed Army Institute of Research, Silver Spring, Maryland
Conditions: Malaria
Safety, Immunogenicity and Efficacy Against of a Combined Malaria Vaccine in Healthy Malaria-naïve Adults
Completed
This study will evaluate whether administration of two investigational malaria vaccines (257049 and Ad35.CS.01 vaccines) combined in one immunization schedule increases protection against malaria infection as compared to protection induced by the 257049 vaccine alone. The study will also evaluate the safety and the immune response to the new combination of the two experimental malaria vaccines.
Gender:
ALL
Ages:
Between 18 years and 50 years
Trial Updated:
06/04/2019
Locations: GSK Investigational Site, Silver Spring, Maryland
Conditions: Malaria
Patient-donor Vaccination in the Context of Allogeneic Bone Marrow Transplant With Post-transplant Cyclophosphamide
Terminated
This research is being done to understand the effects of certain types of bone marrow transplant (BMT) on the immune system. Your doctors are planning a BMT, using one of your family members as the bone marrow donor, for your cancer. Part of that BMT involves a chemotherapy drug, called Cyclophosphamide (Cytoxan), given after the transplant. This research is being done to understand the effects of Cyclophosphamide on the immune system.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
05/08/2019
Locations: Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland
Conditions: Transplant-Related Cancer
Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine
Completed
The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age
Gender:
ALL
Ages:
Between 40 years and 70 years
Trial Updated:
03/18/2019
Locations: Not set, Rockville, Maryland
Conditions: Healthy
Evaluation of a Single Vaccination With One of Three Ascending Dose Levels of a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) in Healthy Adults Aged 18 to <65 Years
Completed
This is a first-in-human (Phase 1) and Phase 2 study of a single vaccination with one of three dose levels of an investigational vaccine against Staphylococcus aureus (SA4Ag). The main goal of the study is to determine how safe and well tolerated the vaccine is as well as to describe the immune response elicited by the vaccine in healthy adults aged 18 to \<65 years. In addition, the study aims to assess the effect of the SA4Ag vaccine on the presence of the Staphylococcus aureus on the skin and... Read More
Gender:
ALL
Ages:
Between 18 years and 64 years
Trial Updated:
02/28/2019
Locations: SNBL Clinical Pharmacology Center, Inc., Baltimore, Maryland
Conditions: Staphylococcal Infections
Immune Responses to H5N1 Vaccine With and Without AS03 Adjuvant
Completed
Background: - Adjuvants are substances included in vaccines that stimulate the immune system and increase the body's response to the vaccine. The AS03 adjuvant is used in seasonal flu vaccines in Europe. However, it has not been fully tested in the United States. Researchers want to test the immune responses of people who receive a bird flu vaccine with or without AS03 to better understand how the adjuvant works. This information may help develop better flu vaccines. Objectives: - To compare... Read More
Gender:
ALL
Ages:
Between 18 years and 45 years
Trial Updated:
02/22/2019
Locations: National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland
Conditions: Influenza
CS DNA MVA Trial in Mampong, Ghana
Withdrawn
The purpose of this study is to evaluate the safety, tolerability, and effectiveness of 2 doses of a malaria vaccine (DNA) followed by a dose of another type of malaria vaccine (MVA) given as a "booster." Forty-eight adults in Ghana, ages 18-50 years, will participate for 17 months. They will be randomly assigned to 1 of 4 treatment groups. Group 1 will receive the DNA malaria vaccine at months 0 and 1, and the booster at month 7. Group 2 will receive a rabies vaccine at months 0 and 1, and an i... Read More
Gender:
ALL
Ages:
Between 18 years and 50 years
Trial Updated:
01/18/2019
Locations: Naval Medical Research Center, Silver Spring, Maryland
Conditions: Plasmodium Falciparum Malaria