Clinical trials: Controlled Human Infection
Chronic Hepatitis B
Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB)
The primary objectives of this study are to evaluate the safety and tolerability of the 12 week treatment regimens of inarigivir soproxil plus tenofovir alafenamide (TAF) or commercially available nucleoside/nucleotide (NUC) in…
- Trial name
- NCT03434353
- Testing
- Inarigivir Soproxil, TAF
- Where
- 13 sites in Hong Kong, South Korea
- Volunteers
- 123 people
- Sponsor
- Gilead Sciences
COVID, Corona Virus Infection
Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms
The study is a prospective, randomized, controlled investigation designed for comparison of two groups for the reduction of respiratory distress in a CoViD-19 population, using gammaCore Sapphire (nVNS) plus standard of care…
- Conditions
- COVID, Corona Virus Infection, Respiratory Failure, Respiratory Distress Syndrome, Adult
- Trial name
- SAVIORII (NCT04382391)
- Testing
- gammaCore® Sapphire (non-invasive vagus nerve stimulator), Standard of care therapies
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Influenza Type A, Influenza Type B
Safety, Tolerability, and Pharmacokinetics of SAB-176 in Healthy Participants
Influenza causes substantial morbidity and mortality worldwide despite available antivirals and vaccines. SAB Biotherapeutics, Inc.
- Conditions
- Influenza Type A, Influenza Type B, Influenza
- Trial name
- NCT04471038
- Testing
- SAB-176, Normal Saline
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- SAb Biotherapeutics, Inc.
Anogenital Human Papilloma Virus Infection, Condyloma Acuminata
Efficacy and Tolerability Study of V501 in Japanese Males (V501-122)
A study to evaluate the efficacy and tolerability of V501 (quadrivalent Human Papilloma Virus [HPV] [Type 6, 11, 16 and 18] L1 Virus-Like Particle vaccine, GARDASIL™) in healthy, 16- to 26-year old Japanese males.
- Trial name
- NCT01862874
- Testing
- V501
- Volunteers
- 1,124 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis B Virus
A Double-Blind Single-Ascending Dose (SAD) and Multiple-Ascending Dose (MAD) Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7049389 in Healthy Chinese Participants
This study will assess the safety and tolerability of RO7049389 compared to placebo in single- and multiple-ascending doses in healthy Chinese participants.
- Trial name
- NCT03570658
- Testing
- RO7049389
- Where
- China
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatitis C Virus Infection
Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis…
- Trial name
- ASTRAL-1 (NCT02201940)
- Testing
- SOF/VEL
- Where
- 80 sites in United States, Belgium and 7 more
- Volunteers
- 741 people
- Sponsor
- Gilead Sciences
Malaria,Falciparum, Plasmodium Falciparum
Safety and Protective Efficacy of Pb(PfCS@UIS4)
In the underlying study, a genetically modified P. berghei parasite is used. P. berghei is one of the four Plasmodium species that causes malaria in rodents. The hypothesis is that immunization of humans with P.
- Conditions
- Malaria,Falciparum, Plasmodium Falciparum, Plasmodium Berghei, Controlled Human Malaria Infection (CHMI)
- Trial name
- PbVac (NCT03138096)
- Testing
- Pb(PfCS@UIS4)-infected mosquitoes, Challenge infection P. falciparum
- Where
- 2 sites in Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Infections, Rotavirus
To Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK's Oral Human Rotavirus Vaccine in Pre-Term Infants
This study is planned to evaluate the safety (in terms of occurrence of any serious adverse events), reactogenicity (any side effects) and immunogenicity (ability of the vaccine to develop antibodies that fight infection) of the…
- Trial name
- NCT00420745
- Testing
- Rotarix™
- Where
- 31 sites in France, Poland and 2 more
- Volunteers
- 1,009 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV Infections, AIDS Virus
Treatment Simplification by Darunavir/Ritonavir 800/100 mg Once a Day Versus a Triple Combination Therapy With Darunavir/Ritonavir
The purpose of the study is to compare the efficacy, safety and tolerability of darunavir/ritonavir 800/100 mg once a day (O.D.) as a monotherapy versus a triple combination therapy containing 2 nucleosides and…
- Conditions
- HIV Infections, AIDS Virus, Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome Virus
- Trial name
- MONET (NCT00458302)
- Testing
- darunavir (DRV, TMC114)
- Where
- 27 sites in Austria, Belgium and 9 more
- Volunteers
- 256 people
- Sponsor
- Janssen-Cilag International NV
Healthy
Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactivated Split Influenza Vaccine in Healthy Korea Children
The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated Split Influenza Vaccine (IL-YANG FLU Vaccine Prefilled Syringe INJ.) administered as a single intramuscular injection.
- Trial name
- NCT02263131
- Testing
- IL-YANG FLU Vaccine Prefilled Syringe INJ., VAXIGRIP Prefilled Syringe INJ.
- Volunteers
- 416 people, healthy volunteers welcome
- Sponsor
- Il-Yang Pharm. Co., Ltd.
Influenza, Human
A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age
This Phase 3 study is a randomized, observer-blind immunogenicity and safety study of aQIV (an MF59-adjuvanted quadrivalent influenza vaccine) compared with a licensed quadrivalent influenza vaccine in adults 50 to 64 years of…
- Trial name
- NCT05044195
- Testing
- aQIV, Comparator QIV
- Where
- 29 sites in United States, Estonia and 1 more
- Volunteers
- 2,044 people, healthy volunteers welcome
- Sponsor
- Seqirus
Influenza
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults in the USA
The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults
- Trial name
- NCT00958126
- Testing
- CSL425
- Where
- 11 sites in United States
- Volunteers
- 1,313 people, healthy volunteers welcome
- Sponsor
- Seqirus
Condylomata Acuminata, Papillomavirus Infections
A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts
This is a Phase 2, double-blind, placebo-controlled study to determine the dose regimen, safety, tolerability, and efficacy of VP-102 in subjects with External Genital Warts (EGW).
- Conditions
- Condylomata Acuminata, Papillomavirus Infections, Skin Diseases, Viral, Skin Diseases, Infectious
- Trial name
- CARE-1 (NCT03981822)
- Testing
- VP-102 and applicator
- Where
- 4 sites in United States
- Volunteers
- 105 people
- Sponsor
- Verrica Pharmaceuticals Inc.
Human Immunodeficiency Virus (HIV), HIV Associated Neurocognitive Disorders (HAND)
A Study of the Neurological Effects of Adding Raltegravir to HAART Regimen in Patients With HIV
HIV related cognitive impairment still occurs despite highly active antiretroviral therapy (HAART). HIV disease affects the brain in 20-40% of patients with advancing HIV disease leading to varying degrees of cognitive…
- Trial name
- HANDral (NCT01448486)
- Testing
- Raltegravir
- Where
- 2 sites in Australia
- Volunteers
- 6 people
- Sponsor
- St Vincent's Hospital, Sydney
Influenza A
A Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza A
The purpose of this study is to evaluate the efficacy, safety, and tolerability of VIR-2482 compared to placebo in preventing influenza A illness in healthy adults 18 to <65 years of age without pre-existing risk factors for…
- Trial name
- NCT05567783
- Testing
- VIR-2482 (450 mg), VIR-2482 (1200 mg)
- Where
- 51 sites in United States
- Volunteers
- 2,977 people, healthy volunteers welcome
- Sponsor
- Vir Biotechnology, Inc.
Aspergillosis; Pulmonary, Invasive (Etiology)
Posaconazole for the Prevention of Influenza-associated Aspergillosis in Critically Ill Patients
The objective of this study is to deliver proof of concept that antifungal prophylaxis can reduce the incidence of Influenza Associated Aspergillosis (IAA) in ICU (intensive care unit) patients with severe influenza.
- Trial name
- POSA-FLU (NCT03378479)
- Testing
- SOC +Posaconazole 18 MG/ML (milligram/milliliter), standard of care (SOC)
- Where
- 12 sites in Belgium, France and 1 more
- Volunteers
- 88 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Hepatitis C, Treatment Naïve, Genotype 1 Patients
Study of Combination Treatment With IMO-2125 and Ribavirin in Naïve Hepatitis C-infected, Genotype 1 Patients
Phase 1, randomized, double-blind, placebo-controlled, dose-escalation study with 3 dose levels of IMO-2125 in combination with standard weight based ribavirin (investigational treatment arm) or placebo in combination with…
- Trial name
- NCT00990938
- Testing
- IMO-2125, Saline
- Where
- France
- Volunteers
- 63 people
- Sponsor
- Idera Pharmaceuticals, Inc.
Recurrent Hepatitis C
Efficacy of Everolimus as Inhibitor of Fibrosis Progression in Liver Transplant Patients With Recurrence of Hepatitis C Viral Infection
This study will assess the efficacy of everolimus as an inhibitor of fibrosis progression in liver transplant patients who have a recurrence of hepatitis C viral infection in the transplant
- Trial name
- REVERT (NCT00582738)
- Testing
- CsA-TAC (standard Treatment), Everolimus
- Where
- Argentina
- Volunteers
- 43 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Hepatitis C Infection
A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1b Infection
The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as…
- Trial name
- PEARL-III (NCT01767116)
- Testing
- ABT-450/r/ABT-267, ABT-333, Ribavirin
- Volunteers
- 419 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Malaria
A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria
This was a randomized, dose-escalation Phase I/IIa study to evaluate safety, tolerability, immunogenicity and efficacy of an investigational RNA-based vaccine (BNT165e) for prevention of P.
- Trial name
- NCT06069544
- Testing
- BNT165c, BNT165d
- Where
- 5 sites in United States
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- BioNTech SE