Clinical trials: Controlled Human Infection
Influenza
Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults
The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Indonesia/05/2005 (H5N1) administered at 4 dose levels in adjuvanted (GLA-SE) rHA…
- Trial name
- NCT01147068
- Testing
- 0.5mL Intramuscular Injection
- Where
- 4 sites in United States
- Volunteers
- 392 people, healthy volunteers welcome
- Sponsor
- Protein Sciences Corporation
Influenza
Study of CD388 for the Prevention of Influenza in Subjects Not at Risk for Influenza Complications
The purpose of this study is to evaluate the effectiveness of CD388 in preventing symptomatic laboratory-confirmed influenza infections, as compared to placebo, and to select a dose of CD388 that is effective in preventing the…
- Trial name
- NAVIGATE (NCT06609460)
- Testing
- CD388 Injection
- Where
- 57 sites in United States, United Kingdom
- Volunteers
- 5,071 people, healthy volunteers welcome
- Sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Hepatitis B
Clinical Study to Evaluate the Efficacy and Safety of DA-2803 in Chronic Hepatitis B Patients
This study is a multi-center, double-blind, active-controlled, randomized, parallel clinical study to evaluate the efficacy and safety of DA-2803 in chronic hepatitis B subjects
- Trial name
- NCT05957380
- Testing
- DA-2803, DA-2803-R
- Where
- South Korea
- Volunteers
- 120 people
- Sponsor
- Dong-A ST Co., Ltd.
Diphtheria, Tetanus
Study to Evaluate the Immunogenicity of LR20062 Compared to Control When Administered Intramuscularly in Healthy Infants At 2, 4, 6 Months of Age
This is a phase II, randomized, double-blind, active-controlled, parallel-group, multicenter study to evaluate the immunogenicity and safety of DTaP-HepB-IPV-Hib hexavalent vaccine LR20062 in healthy infants as primary series at…
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT06618196
- Testing
- LR20062, DTaP-HepB-IPV-Hib vaccine
- Volunteers
- 336 people, healthy volunteers welcome
- Sponsor
- LG Chem
Hepatitis B
Phase I Safety and Immunogenicity of FP-02.2 in Chronic Hepatitis B
This study evaluates the safety and immunogenicity of FP-02.2, a new therapeutic Hepatitis B vaccine, administered as an add-on therapy to entecavir or tenofovir.
- Trial name
- NCT02496897
- Testing
- FP-02.2 Vaccine, IC31® Adjuvant
- Where
- 21 sites in South Korea, United Kingdom
- Volunteers
- 61 people
- Sponsor
- Altimmune, Inc.
Human Immunodeficiency Virus Infection
A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects.
This is a double-blind Phase 2a study to test the safety and efficacy of an investigational HIV drug, amdoxovir (300 mg or 500 mg twice daily) compared with tenofovir DF 300 mg once daily in HIV-1 infected antiretroviral…
- Trial name
- NCT01737359
- Testing
- amdoxovir 300 mg bid, amdoxovir 500 mg bid, tenofovir DF 300 mg qd
- Where
- 6 sites in Argentina
- Volunteers
- 2 people
- Sponsor
- RFS Pharma, LLC
Cervical Cancer, Vulvar Cancer
Evaluate the Immunogenicity and Safety of 4-valent and 9-valent HPV Recombinant Vaccine in Chinese Healthy Females
The study will evaluate the immunogenicity and safety of 4-valent and 9-valent HPV recombinant vaccine in Chinese healthy females 20 to 45 years of age.
- Conditions
- Cervical Cancer, Vulvar Cancer, Vaginal Cancer, CIN1
- Trial name
- NCT04425291
- Testing
- 4-valent HPV Vaccine, 9-valent HPV Vaccine, GARDASIL®
- Where
- China
- Volunteers
- 1,680 people, healthy volunteers welcome
- Sponsor
- Shanghai Bovax Biotechnology Co., Ltd.
Influenza
Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA Vaccine Candidate Variations in Healthy Adults
The main purpose of the study is to evaluate the safety, reactogenicity, and the immunogenicity of mRNA-1010 vaccine candidate variations.
- Trial name
- NCT05868382
- Testing
- mRNA-1010, mRNA-1010.4, mRNA-1010.6
- Where
- 10 sites in United States
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Post Polio Syndrome, PPS
Efficacy and Safety of Xepol (Human Immunoglobulin) in Subjects With Post-Polio Syndrome (PPS)
The primary objective was to assess the effect of Xepol compared to placebo on physical health and on muscle strength in subjects with post-polio syndrome.The secondary objective was to assess the effect of Xepol compared to…
- Trial name
- NCT00160082
- Testing
- Xepol
- Where
- 4 sites in Sweden
- Volunteers
- 124 people
- Sponsor
- Calliditas Therapeutics AB
Influenza
The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults
The purpose of this study is to evaluate the preventative antiviral activity of CD388, as compared to saline placebo, when administered as a single dose to healthy adult participants in a human viral challenge model of influenza.
- Trial name
- NCT05523089
- Testing
- CD388
- Where
- United Kingdom
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Hepatitis C
A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C
Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules.
- Trial name
- NCT01591668
- Testing
- Single Ascending Dose Cohorts GS-9620, Multiple Ascending Dose Cohorts GS-9620
- Where
- 11 sites in United States, Puerto Rico
- Volunteers
- 51 people
- Sponsor
- Gilead Sciences
SARS-CoV-2 (COVID-19) Infection
Safety, Tolerability, and Systemic Exposure of Apo-Si- K170A-C76 in Healthy Volunteers
The goal of this First in Human Phase 1 clinical trial is to to assess the safety, tolerability, and systemic exposure of single, twice daily (BID) doses and repeated BID doses of ascending dosing by intranasal administration of…
- Trial name
- BID (NCT07095049)
- Testing
- Apo-Si-K170A-C76
- Where
- Israel
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Interna Therapeutics Ltd.
Shigellosis
Safety and Efficacy of the Bacteriophage Preparation, ShigActive™, in a Human Experimental Model of Shigellosis
The study is a first-in-human Phase 1/2a randomized, double-blind, placebo-controlled trial to assess the clinical safety and efficacy of ShigActive in healthy adults with experimental Shigella challenge.
- Trial name
- NCT05182749
- Testing
- bacteriophage
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Intralytix, Inc.
COVID-19
SCB-2019 as COVID-19 Vaccine
This is a randomized, double blind, placebo controlled, first-in-human (FIH) study to assess safety, reactogenicity, and immunogenicity of SCB-2019 at multiple dose levels, administered as 2 injections IM in healthy subjects.
- Trial name
- NCT04405908
- Testing
- SCB-2019, SCB-2019 with AS03 adjuvant, SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant
- Where
- Australia
- Volunteers
- 166 people, healthy volunteers welcome
- Sponsor
- Clover Biopharmaceuticals AUS Pty
Hepatitis C Virus
TMC649128HPC1002 - a Trial inGenotype 1 Hepatitis C Virus (HCV) - Infected Participants to Determine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of TMC649128, Alone and Combined With Pegylated Interferon + Ribavirin
The purpose of this study is to determine in genotype 1 Hepatitis C Virus (HCV)-infected participants, the safety, tolerability, pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and…
- Trial name
- NCT01391117
- Testing
- TMC649128., TMC649128
- Where
- 3 sites in Netherlands, Poland
- Volunteers
- 14 people
- Sponsor
- Tibotec BVBA
HIV
Safety and Immunogenicity Study of DNA.HTI, MVA.HTI and ChAdOx1.HTI in HIV-1-positive Patients (AELIX-002)
The AELIX-002 study aims to evaluate the safety and the immunogenicity of an heterologous prime-boost regimen with DNA.HTI, MVA.HTI and ChAdOx1.HTI in early diagnosed and treated HIV-1 positive individuals, males and…
- Trial name
- NCT03204617
- Testing
- DNA.HTI 0.5mL at weeks 0, 4 and 8 + MVA.HTI 0.5mL at weeks 12 and 20 (DDDMM), At least 24 weeks since DDDMM, ChAdOx1.HTI 0.5mL at weeks 0 and 12 + MVA.HTI 0.5mL at week 24 (CCM)
- Where
- Spain
- Volunteers
- 45 people
- Sponsor
- Aelix Therapeutics
Infection, Human Immunodeficiency Virus
Single Dose Escalation Study of GSK2838232 in Healthy Subjects
GSK2838232 is a novel human immune virus (HIV) maturation inhibitor being developed for the treatment of chronic HIV infection. This study is the first administration of GSK2838232 in humans to establish the initial safety…
- Trial name
- NCT01802918
- Testing
- GSK2838232, Ritonavir
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteer
Study of TRX-100 Evaluating the Safety, Pharmacokinetics, and Food Effect in Healthy Volunteers
This is a Phase 1b, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and food effect of single oral doses of TRX-100 tablets and capsules in healthy adult volunteers.
- Trial name
- NCT07526506
- Testing
- TRX-100
- Where
- Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Traws Pharma, Inc.
Influenza
A Phase 2a to Evaluate the Safety of MEDI8852 in Adults With Uncomplicated Influenza
The purpose of this study is to evaluate safety and tolerability of a single dose of MEDI8852 when given with oseltamivir, the safety and tolerability of oseltamivir alone, and the safety and tolerability of a single dose of…
- Trial name
- MEDI8852 (NCT02603952)
- Testing
- Oseltamivir, MEDI8852
- Where
- 31 sites in United States, South Africa
- Volunteers
- 126 people
- Sponsor
- MedImmune LLC
RSV Infection
Human Challenge Study to Evaluate the Efficacy of MV-012-968 Vaccine
The purpose of this research study is to evaluate whether the investigational, live attenuated, intranasally delivered vaccine MV-012-968 ('study vaccine') may have prophylactic efficacy against symptomatic RSV infection when…
- Trial name
- NCT04690335
- Testing
- MV-012-968
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Meissa Vaccines, Inc.