Clinical Trials | The GW Vaccine Research Unit

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Current Clinical Trials

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of a COVID-19 Vaccine and an Influenza Vaccine Given as a Single Injection in Healthy Adults This is a phase 1/2 study that will evaluate combining a COVID vaccine and a flu vaccine into one single injection. This study is looking to enroll a total of 640 participants who are healthy adults ages 50 years and older who have NOT had a flu vaccine or a COVID vaccine within the last six months. For phase 1, 80 subjects will be enrolled and randomized into one of four groups to evaluate safety and immunogenicity data. For phase 2, 560 subjects will be enrolled and randomized to evaluate the safety, tolerability, and immunogenicity of a single injection. ClinicalTrials.gov Identifier: N/A Study Site: George Washington Medical Faculty Associates; Washington, D.C."
A Phase 3 Master protocol to evaluate the safety, tolerability, and immunogenicity of Respiratory Syncytial Virus (RSV) Prefusion F subunit vaccine in adults at high risk of severe RSV disease Substudy A (SSA): This study is an extension of the efficacy study and was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 2 years: At a dose of 120µg (as studied in the Phase 3 Efficacy Study) Blood samples will be collected for antibody testing. The duration of the study for each participant will be up to approximately 18 months. The study will be conducted in the United States. Substudy B (SSB): This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 1 year: At a dose of 120µg (as studied in the Phase 3 Efficacy Study) Blood samples will be collected for antibody testing. The duration of the study for each participant will be up to approximately 18 months. The study will be conducted in Argentina and the United States. ENROLLMENT COMPLETE ClinicalTrials.gov Identifier: NCT05035212 Study Site: George Washington Medical Faculty Associates; Washington, D.C.
A Phase 1/2 Study to Assess the Safety and Immunogenicity of JCXH-221, an mRNA-based Broadly Protective COVID-19 Vaccine This is a phase 1/2 study looking to enroll a total of 262 patients. For phase 1, two cohorts will be explored (18-64 age group and 65+ age group) for a total of 72 subjects. The subjects will be enrolled and randomized to either placebo or JCXH-221. A low dose of JCXH-221 will be explored vs placebo for each age group first. A high dose for those 2 cohorts will be explored once all safety data is reviewed. Once all of Phase 1 data has been reviewed, Phase 2 enrollment will open. In this portion of the trial, subjects will be enrolled and randomized to either JCXH-221 or a FDA approved Active comparator (Pfizer, Moderna, etc.). A total of 190 patients will be enrolled. ENROLLMENT COMPLETE ClinicalTrials.gov Identifier: NCT05743335 Study Site: George Washington Medical Faculty Associates; Washington, D.C.
A Phase 1/2 Randomized, Observer-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Modified RNA Vaccine Against Varicella Zoster Virus in Healthy Individuals Learn more about this study
Hookworm Vaccine Trial - Experimental Infection of Hookworm-naïve Adults With Dermally-applied Infectious Necator Americanus Hookworm Larvae Experimental infection of hookworm-naïve adults with dermally applied infectious Necator americanus hookworm larvae. An experimental hookworm infection model is being developed to provide early proof-of-concept that a hookworm vaccine targeting the blood-feeding pathway of adult hookworms is feasible and efficacious. The proposed model consists of vaccinating healthy, hookworm-naïve adults with a candidate hookworm vaccine, followed by challenging them with the investigational product, Necator americanus Larval Inoculum to assess the effect of vaccination on infection. The first proposed study will be a feasibility study that will consist of administering different doses of the Necator americanus Larval Inoculum to healthy adult volunteers to determine the optimal dose (i.e., number of infectious larvae) that is safe, well-tolerated and results in consistent infection. ENROLLMENT OPEN ClinicalTrials.gov Identifier: NCT01940757 Study Site: George Washington Medical Faculty Associates, Washington, D.C.
A Phase 2 Randomized Multisite Trial to Inform Public Health Strategies Involving the Use of MVA-BN Vaccine for Mpox This study is a Phase 2 randomized, open-label, non-placebo controlled, multi-site clinical trial that will evaluate two ID regimens for MVA-BN vaccine compared to the standard SC regimen in healthy, vaccinia-naïve adults 18 to 50 years of age, inclusive, (Stage 1). In Stage 2 of the study, the standard SC regimen will be evaluated in adolescents ages 12 through 17 years, inclusive, and compared to the standard SC regimen in adults ages 18 to 50, inclusive. ENROLLEMENT COMPLETE ClinicalTrials.gov Identifier: NCT05740982 Study Site: George Washington Medical Faculty Associates; Washington, D.C.
COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial) - Phase 2 Clinical Trial to Optimize Immune Coverage of SARS-CoV-2 Existing and Emerging Variants This phase 2 clinical trial will evaluate the safety and immunogenicity of additional doses of prototype and variant (alone or in combination) vaccine candidates in previously vaccinated participants with or without prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and will evaluate innate, cellular, and humoral immune responses to inform on how to shift the immune response to cover new variants as they emerge. ENROLLMENT COMPLETE ClinicalTrials.gov Identifier: NCT05289037 Study Site: George Washington Medical Faculty Associates; Washington, D.C.
Monkeypox Vaccine Trial - A Phase 2 Randomized, Open-Label, Multisite Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Vaccine (DMID 22-0020) This phase 2 multisite clinical trial will evaluate two intradermal (ID) regimens for Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine compared to the standard subcutaneous (SC) regimen in healthy, vaccinia-naïve adults 18 to 50 years of age. ENROLLMENT COMPLETE ClinicalTrials.gov Identifier: NCT05512949 Study Site: George Washington Medical Faculty Associates; Washington, D.C.
Schistosomiasis Vaccine Trial - Sm-TSP-2 Schistosomiasis Vaccine in Healthy Ugandan Adults Two-part clinical trial of a vaccine to protect against schistosomiasis caused by infection with S. mansoni. Two formulations of the Sm-TSP-2 vaccine will be tested; one using Alhydrogel® plus AP 10-702, each at 3 different doses of antigen: 10mcg, 30mcg, and 100mcg. The first part of the study will be a Phase 1 dose-escalation safety and immunogenicity study followed by a Phase IIb trial in which a large number of adults will be enrolled to assess the impact of the vaccine on infection with S. mansoni. The impact of the vaccine on infection with S. haematobium will also be assessed although this will be exploratory given that potential cross-protection against this species is only hypothetical at this point. ENROLLMENT COMPLETE ClinicalTrials.gov Identifier: NCT03910972 Study Site: Makerere University Walter Reed Project; Kampala, Uganda

Completed Clinical Trials

	1) Safety and Immunogenicity of Na-APR-1 Vaccine Co-administered With Na-GST-1 Vaccine in Brazilian Adults Phase 1 Study of the Safety and Immunogenicity of Na-APR-1 (M74)/Alhydrogel® Co-administered With Na-GST-1/Alhydrogel® in Brazilian Adults ClinicalTrials.gov Identifier: NCT02476773 Study Site: Americaninhas Vaccine Center, Americaninhas, Minas Gerais, Brazil. Please see the following article on SciDevNet.
	2) Safety and Immunogenicity of the Human Hookworm Candidate Vaccine Na-GST-1 With or Without CPG Phase 1 Study of the Safety and Immunogenicity of Na-GST-1/Alhydrogel, with or without a CpG ODN Adjuvant, in Healthy Adults living in the Washington DC area who have not been infected with or exposed to hookworms. ClinicalTrials.gov Identifier: NCT02143518 Study Site: George Washington Medical Faculty Associates; Washington, D.C.
	3) Safety and Immunogenicity of the Human Hookworm Candidate Vaccine Na-GST-1 With Different Doses of a Novel Adjuvant Phase I Study of the Safety and Immunogenicity of Na-GST-1/Alhydrogel® With Different Doses of the Novel Immunostimulant GLA-AF in Healthy Adults living in the Washington DC area who have not been infected with or exposed to hookworms. ClinicalTrials.gov Identifier: NCT01385189 Study Site: Children’s National Health System; Washington, D.C.
	4) Safety and Immunogenicity of the Na-APR-1 Hookworm Vaccine in Healthy Adults Phase 1 Study of the Safety and Immunogenicity of Na-APR-1 (M74)/Alhydrogel® when co-administered with different concentrations of the immunostimulant GLA-AF in Healthy Adults living in the Washington DC area who have not been infected with or exposed to hookworms. ClinicalTrials.gov Identifier: NCT01717950 Study Site: George Washington Medical Faculty Associates; Washington, D.C.
	5) Safety and Immunogenicity of Co-Administered Hookworm Vaccine Candidates Na-GST-1 and Na-APR-1 in Gabonese Adults This study will evaluate the safety and immunogenicity of co-administering Na-GST-1 and Na-APR-1 to healthy Gabonese adults living in an area of endemic hookworm infection. ClinicalTrials.gov Identifier: NCT02126462 Study Site: Centre de Recherches Médicales de Lambaréné, Gabon
	6) Safety and Immunogenicity of the Human Hookworm Candidate Vaccine Na-GST-1 With or Without Additional Adjuvant in Brazilian Adults Phase 1 Study of the Safety and Immunogenicity of Na-GST-1/Alhydrogel® with or without GLA-AF in Brazilian Adults. This two-part study evaluates the safety and immunogenicity of two formulations of Na-GST-1, first in hookworm-naïve individuals using an open-label design, and then in adults living in an area of endemic hookworm infection using a randomized, double-blind design. The two formulations to be evaluated are Na-GST-1 adsorbed to an adjuvant, Alhydrogel®, and Na-GST-1 adsorbed to Alhydrogel® and administered with GLA-AF. ClinicalTrials.gov Identifier: NCT01261130 Study Site: Belo Horizonte, Brazil (urban area, non-endemic) Americaninhas, Minas Gerais, Brazil (rural area, endemic)
	7) Safety and Immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted Phase 1 first-in-human clinical trial to assess the safety, tolerability, and immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted in healthy adult HIV-negative volunteers. ClinicalTrials.gov Identifier: NCT03547245 Study Site: George Washington Medical Faculty Associates; Washington, D.C.
	8 ) Regeneron COVID-19 Trial - Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult and Pediatric Patients With COVID-19 A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Patients With COVID-19. ClinicalTrials.gov Identifier: NCT04425629 Study Site: George Washington Medical Faculty Associates; Washington, D.C.
	9) Hookworm Vaccine Trial - Proof-of-efficacy trial of the Na-GST-1 hookworm vaccine using a Controlled Human Hookworm Infection model Phase 2 clinical trial to assess the efficacy of different formulations of the Na-GST-1 Hookworm Vaccine in healthy adult volunteers. ClinicalTrials.gov Identifier: NCT03172975 Study Site: George Washington Medical Faculty Associates; Washington, D.C.
	10) Sanofi COVID-19 Vaccine Trial - Study of Recombinant Protein Vaccines With Adjuvant as a Primary Series and as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older (VAT00002) Phase 2/3 clinical trial of recombinant protein vaccine with adjuvant against COVID-19 in adults 18 years af age and older. ClinicalTrials.gov Identifier: NCT04762680 Study Site: George Washington Medical Faculty Associates; Washington, D.C.
	11) Moderna COVID-19 Vaccine Trial - A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older Phase 3 clinical trial to evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent COVID-19 for up to 2 years after the second dose of mRNA-1273. ClinicalTrials.gov Identifier: NCT04470427 Study Site: George Washington Medical Faculty Associates; Washington, D.C.
	12) Lassa Fever Vaccine Trial - A Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Health A Phase 1 randomized, double-blinded, placebo-controlled, dose-escalation clinical trial to evaluate the safety and immunogenicity of rVSV∆G-LASV-GPC vaccine in adults in good general health. ENROLLMENT COMPLETE ClinicalTrials.gov Identifier: NCT04794218 Study Site: George Washington Medical Faculty Associates; Washington, D.C.
	13) HIV Vaccine Trial - Safety and Immunogenicity of recombinant HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted in healthy, HIV-uninfected adults Phase 1 first-in-human clinical trial to assess the safety, tolerability, and immunogenicity of BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted in healthy adult HIV-negative volunteers. ENROLLMENT COMPLETE ClinicalTrials.gov Identifier: NCT04224701 Study Site: George Washington Medical Faculty Associates; Washington, D.C.
	14) HIV Vaccine Trial - A Phase 1 Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and Core-g28v2 60mer mRNA Vaccine (mRNA-1644v2-Core) A Phase 1, Randomized, First-in-human, Open-label Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and Core-g28v2 60mer mRNA Vaccine (mRNA-1644v2-Core) in HIV-1 Uninfected Adults in Good General Health. ENROLLMENT COMPLETE ClinicalTrials.gov Identifier: NCT05001373 Study Site: George Washington Medical Faculty Associates; Washington, D.C. 15) An Open-Label Study to Evaluate the Safety and Immunogenicity of 2 Doses of 100μg BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, given to a Population of Adults in Good General Health Who have Received 3 doses of 300μg BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted This research study tests an experimental vaccine against human immunodeficiency virus (HIV). The purpose of this study is to find out if the study vaccine, BG505 SOSIP.GT1.1 gp140, is safe and how your immune system responds to it. BG505 SOSIP.664 gp140 is a protein that is man-made. It was created to look and behave like the envelope protein, the protein that sits on top of the outer surface of HIV, the virus that causes AIDS. In testing, BG505 SOSIP.664 gp140 has been shown to be safe and able to make antibodies against HIV. Participation in the study will last for about 15.25 months after the first vaccination. The study as a whole will last about 29 months. ClinicalTrials.gov Identifier: NCT05863585 Study Site: George Washington Medical Faculty Associates; Washington, D.C. 16) A Phase 1/2 Study to Assess the Safety and Immunogenicity of JCXH-221, an mRNA-based Broadly Protective COVID-19 Vaccine This is a phase 1/2 study looking to enroll a total of 262 patients. For phase 1, two cohorts will be explored (18-64 age group and 65+ age group) for a total of 72 subjects. The subjects will be enrolled and randomized to either placebo or JCXH-221. A low dose of JCXH-221 will be explored vs placebo for each age group first. A high dose for those 2 cohorts will be explored once all safety data is reviewed. Once all of Phase 1 data has been reviewed, Phase 2 enrollment will open. In this portion of the trial, subjects will be enrolled and randomized to either JCXH-221 or a FDA approved Active comparator (Pfizer, Moderna, etc.). A total of 190 patients will be enrolled. ENROLLMENT COMPLETE ClinicalTrials.gov Identifier: NCT05743335 Study Site: George Washington Medical Faculty Associates; Washington, D.C.