Clinical trials: Infection Prevention and Control
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
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
Influenza, Human Prevention, Respiratory Syncytial Viruses Prevention
A Study of an Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older
The purpose of this study is to evaluate the immunogenicity and safety of Ad26.RSV.preF-based vaccine and quadrivalent high-dose seasonal influenza vaccine when administered either concomitantly or separately.
- Trial name
- NCT05071313
- Testing
- Ad26.RSV.preF-based vaccine, Quadrivalent High-dose Influenza Vaccine
- Where
- 19 sites in United States
- Volunteers
- 777 people
- Sponsor
- Janssen Vaccines & Prevention B.V.
Adenovirus Infection, BK Virus Infection
Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
This is a Phase 3 study to evaluate posoleucel (ALVR105, Viralym-M); an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus…
- Conditions
- Adenovirus Infection, BK Virus Infection, Cytomegalovirus Infections, Epstein-Barr Virus Infections
- Trial name
- Prevent (NCT05305040)
- Testing
- Posoleucel (ALVR105)
- Where
- 88 sites in United States, Australia and 8 more
- Volunteers
- 451 people
- Sponsor
- AlloVir
Malaria
Safety, Tolerability, Pharmacokinetics and Protective Efficacy of MAM01 in Healthy Adults
This is a First-in-Human (FiH), randomized, two-part, dose-escalation trial of MAM01 monoclonal antibody (mAb) targeting the Plasmodium falciparum (Pf) Circumsporozoite Protein (CSP).
- Trial name
- NCT05891236
- Testing
- MAM01 1.5 mg/kg, MAM01 5 mg/kg, MAM01 10 mg/kg
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Gates Medical Research Institute
Respiratory Syncytial Virus Infection Prevention
A Study of an Ad26.RSV. preF-based Vaccine in Adults Aged 18 to 59 Years, Including Adults at High Risk for Severe RSV Infection
The purpose of the study is to investigate the safety and immunogenicity of the Ad26.RSV.preF based vaccine in adults 18 to 59 years of age who are healthy or at risk for severe Respiratory Syncytial Virus (RSV) disease, compared…
- Trial name
- NCT05070546
- Testing
- Ad26.RSV.preF-based Vaccine
- Where
- 23 sites in United States, Belgium and 3 more
- Volunteers
- 1,124 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
Preventive Medicine
Clinical Trial of Anaferon for Children Efficacy in Prevention of Influenza and Other ARVI
The objective of this study is to obtain additional data on the efficacy and safety of 12-week course of therapy with Anaferon for children for prevention of influenza and other acute respiratory viral infections in children…
- Trial name
- NCT03301155
- Testing
- Anaferon for children
- Where
- 33 sites in Russia, Uzbekistan
- Volunteers
- 1,036 people, healthy volunteers welcome
- Sponsor
- Materia Medica Holding
Hiv, Minority Stress
Developing an Online Mindfulness-based Intervention to Reduce Minority Stress and HIV Risk Among Young Adult MSM - Aim 3
The overall aim of the research study is to develop and test a mindfulness-based program for young adult gay, bisexual, and queer men at risk for HIV (Brown University IRB approved protocol #2004002698).
- Conditions
- Hiv, Minority Stress, Mental Health Wellness 1
- Trial name
- MBQR (NCT05855655)
- Testing
- Mindfulness-Based Queer Resilience (MBQR)
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Brown University
Prevention of CMV Infection or Disease
Letermovir (MK-8228) Versus Placebo in the Prevention of Clinically-Significant Cytomegalovirus (CMV) Infection in Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients (MK-8228-001)
The study evaluated the efficacy and safety of letermovir (MK-8228) for the prevention of clinically-significant CMV infection in adult, CMV-seropositive recipients of allogeneic hematopoietic stem cell transplant (HSCT).
- Trial name
- NCT02137772
- Testing
- Letermovir
- Volunteers
- 570 people
- Sponsor
- Merck Sharp & Dohme LLC
Respiratory Syncytial Virus Prophylaxis
Safety Study of a Monoclonal Antibody to Respiratory Syncytial Virus (RSV) in Children Hospitalized With RSV Infection
The purpose of this study is to determine the safety of motavizumab (MEDI-524) following a single intravenous dose in children hospitalized with respiratory syncytial virus (RSV).
- Trial name
- NCT00192504
- Testing
- Motavizumab
- Volunteers
- 31 people
- Sponsor
- MedImmune LLC
Herpes Zoster
A Study to Evaluate the Safety and Efficacy of Inactivated Varicella-zoster Vaccine (VZV) as a Preventative Treatment for Herpes Zoster (HZ) and HZ-related Complications in Adult Participants With Solid Tumor or Hematologic Malignancy (V212-011)
This is a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of V212 when administered to adults with solid tumor malignancy (STM) receiving chemotherapy and to assess the impact of V212 on…
- Trial name
- NCT01254630
- Testing
- V212
- Volunteers
- 5,305 people
- Sponsor
- Merck Sharp & Dohme LLC
Neonatal Infection
Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement
EcN has been registered as a medical drug under the brand name Mutaflor® SUSPENSION in Ukraine in 2010. Indications for its clinical use are acute diarrhea in infants and toddlers including those on tube feeding tube, diarrhea in…
- Trial name
- EMSUP (NCT01540162)
- Where
- Ukraine
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Odessa National Medical University
Haemophilus Influenzae Type b, Neisseria Meningitidis
Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age
The primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6…
- Trial name
- NCT00345579
- Testing
- GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014, ActHIB, Pediarix/Infanrix Penta
- Where
- 63 sites in United States, Mexico
- Volunteers
- 4,432 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Yellow Fever
Trial of Yellow Fever Inactivated Vaccine
The Phase 1 trial is a single-center, randomized, double blind, placebo-controlled, dose-ranging out-patient study designed to provide the first clinical data on the safety, tolerability and immunogenicity of XRX-001 inactivated…
- Trial name
- NCT00995865
- Testing
- XRX-001 Inactivated yellow fever vaccine
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
Serogroup B Meningococcal Meningitis
Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
The proposed study was aimed to assess the immunogenicity, safety, tolerability and lot to lot consistency of 3 lots of Novartis Meningococcal B vaccine when given concomitantly with routine infant vaccines.
- Trial name
- NCT00657709
- Testing
- Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1), Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2), Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)
- Where
- 66 sites in Austria, Czechia and 3 more
- Volunteers
- 3,630 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
HIV Infection, Tuberculosis
Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers With HIV
Tuberculosis (TB) is highly endemic in sub-Saharan Africa. The increased burden of TB in settings with high prevalence of the Human Immunodeficiency Virus (HIV) is associated with high rates of transmission of Mycobacterium…
- Conditions
- HIV Infection, Tuberculosis, Pneumocystis Jiroveci Pneumonia
- Trial name
- NCT00080119
- Testing
- Isoniazid (INH), Trimethoprim/Sulfamethoxazole (TMP/SMX)
- Where
- 6 sites in Botswana, South Africa
- Volunteers
- 1,354 people, healthy volunteers welcome
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
HIV/AIDS, Tuberculosis
Targeted Universal TB Testing With Simultaneous TPT Prescribing Among People Living With HIV in South Africa
Background: In 2023, the South African Department of Health introduced targeted universal TB testing (TUTT) at antiretroviral therapy (ART) initiation (irrespective of the presence of TB symptoms).
- Trial name
- TUTT-PT (NCT06739915)
- Testing
- TUTT-PT Intervention
- Where
- South Africa
- Volunteers
- 364 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection
GonoScreen: Efficacy of Screening STIs in MSM
A Multicentre, controlled, randomized trial of 3 site (urethra, pharynx and rectum) sampling performed every 3 months (3x3) for Neisseria gonorrhoea (Ng)/Chlamydia trachomatis (Ct) screening (comparator) vs.
- Trial name
- GonoScreen (NCT04269434)
- Testing
- No Screening
- Where
- 5 sites in Belgium
- Volunteers
- 1,014 people, healthy volunteers welcome
- Sponsor
- Institute of Tropical Medicine, Belgium
Prevention From Norovirus Infection
Norovirus Bivalent-Vaccine Efficacy Study
The purpose of this study is to determine whether the norovirus vaccine is effective in preventing acute gastroenteritis due to the experimental human Norovirus GII.4 challenge dose.
- Trial name
- NCT01609257
- Testing
- Norovirus Bivalent Vaccine, Saline Comparator
- Where
- 5 sites in United States
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Takeda
Increased Risk of SARS-CoV-2 Infection
Prevention of Infection and Incidence of COVID-19 in Medical Personnel Assisting Patients With New Coronavirus Disease
This is a randomized controlled trial of the efficacy and safety evaluation of oral administration of Bromhexine hydrochloride for the prevention of SARS-CoV-2 infection and COVID-19 disease in medical personnel assisting…
- Trial name
- NCT04405999
- Testing
- Bromhexine Hydrochloride
- Where
- Russia
- Volunteers
- 50 people
- Sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health