Clinical trials: Neutralizing Antibody
Hemophilia A
Non Neutralizing Antibodies: Prevalence and Characterization
Antibodies (Abs) directed against factorVIII (FVIII) remain the main iatrogenic complication in haemophilia A (HA) patients. Anti-FVIII Abs inhibiting pro-coagulant properties of the molecule are named inhibitors whereas Abs…
- Trial name
- NCT01541527
- Testing
- blood test
- Where
- France
- Sponsor
- University Hospital, Montpellier
Multiple Sclerosis
MATRIX: Measuring Neutralizing Antibodies in the Patients Treated With Interferon Beta 1a IM, in Mexico and Colombia
This is a cross sectional Phase 4, multicenter, study of AVONEX® and JUMTAB® to determine the frequency of IFN induced Neutralizing Antibodies (Nabs).
- Trial name
- MATRIX (NCT01556685)
- Testing
- clinical and neurological evaluation, Blood Sample
- Where
- 2 sites in Colombia, Mexico
- Volunteers
- 180 people
- Sponsor
- Biogen
COVID-19
Assessment of Incidence of SARS-CoV-2 Infection and COVID-19 in Brazil (AVISA)
This is an observational study, meaning that no interventions is tested, to determine incidence of SARS-CoV-2 infection and COVID-19 in different clinical sites in Brazil in several age groups.
- Trial name
- AVISA (NCT04355338)
- Where
- 11 sites in Brazil
- Volunteers
- 3,520 people, healthy volunteers welcome
- Sponsor
- Butantan Institute
Diabetes Mellitus, Type 1
Autoimmunity-blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes
Anti-CD3 monoclonal antibody (a.k.a. hOKT3gamma1 [Ala-Ala],teplizumab, MGA031) is a humanized antibody that is commonly used to prevent organ rejection.
- Trial name
- AbATE (NCT00129259)
- Testing
- Anti-CD3 mAb, Diabetes Standard of Care Treatment, Iron supplementation
- Where
- 7 sites in United States
- Volunteers
- 83 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Evaluating the Safety and Pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants
The purpose of this study was to assess the safety and pharmacokinetics (PK) of three monoclonal antibodies, VRC01, VRC01LS, and VRC07-523LS, in HIV-exposed infants who are at increased risk of mother-to-child HIV transmission.
- Trial name
- NCT02256631
- Testing
- VRC01, VRC01LS, VRC07-523LS
- Where
- 14 sites in United States, Puerto Rico and 2 more
- Volunteers
- 83 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
BK Polyomavirus, Kidney Transplant
Study of Anti-BKPyV Immune Responses in Kidney Transplant Patients With BKPyV Viremia
The human pathogen BK polyomavirus (BKPyV) is a ubiquitous, small, non-enveloped DNA virus that infects over 90% of people, typically in childhood with mild or no symptoms.
- Trial name
- NEPHRO-BK (NCT06988072)
- Testing
- blood sampling
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Fibrolamellar Hepatocellular Carcinoma (FLC)
DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Fibrolamellar Hepatocellular Carcinoma
The primary objective of the trial is the safety and tolerability of administering a vaccine targeting the DNAJB1-PRKACA fusion kinase, in combination with nivolumab and ipilimumab in patients with unresectable or metastatic FLC…
- Trial name
- NCT04248569
- Testing
- DNAJB1-PRKACA peptide vaccine, Nivolumab, Ipilimumab
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Human Papillomavirus Infection, Cervical Intraepithelial Neoplasia
Long-Term Immune Persistence After Bivalent HPV Vaccination in Females From Study 311-HPV-1005
This is a single-center, open-label, prospective observational extension of Study 311-HPV-1005 (NCT04965350). The study follows females who received at least one dose of a bivalent human papillomavirus vaccine containing HPV-16…
- Trial name
- NCT07833852
- Testing
- Recombinant Human Papillomavirus Bivalent (Types 16 and 18) Vaccine (Pichia pastoris)
- Where
- China
- Volunteers
- 486 people, healthy volunteers welcome
- Sponsor
- Shanghai Zerun Biotechnology Co.,Ltd
BK Virus Infection
Role of Neutralizing Antibodies in the Prediction and Treatment of BK Virus Infection in Hematopoietic Stem Cell Allograft Patients at the Pediatric Oncology-hematology Department of the HUS
The BK virus (BKV) belongs to the Polyomaviridae family. The primary infection, generally asymptomatic, occurs during childhood.
- Trial name
- BKV-Allograf (NCT05618275)
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Strasbourg, France
Japanese Encephalitis, Vaccine Preventable Disease
Seroprevalence of Neutralizing Antibodies Against Japanese Encephalitis Virus Among 6 Years Old Children With 5 Different Immunization Strategies in Zhejiang Province
This study is to evaluate the seroprevalence of neutralizing antibodies against Japanese encephalitis (JE) virus in children aged 6 years who were previously administered with 5 different immunization strategies by JE attenuated…
- Conditions
- Japanese Encephalitis, Vaccine Preventable Disease, Vaccine Reaction
- Trial name
- NCT04817917
- Testing
- Japanese Encephalitis Vaccine (Vero Cell), Inactivated;, No prospective interventions
- Where
- 3 sites in China
- Volunteers
- 712 people, healthy volunteers welcome
- Sponsor
- Zhejiang Provincial Center for Disease Control and Prevention
Human Papillomavirus Infection
Long-term Immune Persistence of a Bivalent HPV Vaccine in Females From Study 311-HPV-1004
This long-term extension study evaluates the persistence of neutralizing antibody responses to a bivalent human papillomavirus vaccine in females who previously participated in study 311-HPV-1004 (NCT02740777).
- Trial name
- NCT07820241
- Testing
- Bivalent Human Papillomavirus Vaccine (Types 16 and 18, Pichia pastoris)
- Where
- 2 sites in China
- Volunteers
- 348 people, healthy volunteers welcome
- Sponsor
- Shanghai Zerun Biotechnology Co.,Ltd
Rabies
Rabies Immunization Concomitant With JEV in Children
Background. The World Health Organization recommends pre-exposure vaccination (PreP) to protect children living in canine rabies endemic countries.
- Trial name
- NCT00703521
- Testing
- Rabies vaccine
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Mahidol University
Rabies
Randomized Phase II Trial on Safety and Neutralizing Activity of CL184 and Rabies Vaccine Versus Human Rabies Immune Globulin (HRIG) and Rabies Vaccine in Children and Adolescents
The aim of this study is to evaluate the safety of the monoclonal antibody cocktail CL184 in combination with rabies vaccine compared with human rabies immune globulin (HRIG) in combination with rabies vaccine in healthy children…
- Trial name
- NCT00708084
- Testing
- CL184, HRIG
- Where
- Philippines
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
Neuromuscular Deficits, Genetic Disorder
Multicenter Epidemiological Study for the Evaluation of the Seroprevalence of Total and Neutralizing Antibodies Against Adenoassociated Virus Serotypes Used in Gene Therapy in Patients With Neuromuscular Diseases of Genetic Origin.
This study aims to assess the overall seroprevalence of neutralizing antibodies against different AAVs potentially used in gene therapy in patients with genetic neuromuscular diseases.
- Trial name
- SeroDysMyo (NCT07633951)
- Testing
- Dosage of AAV neutralizing antibodies
- Where
- France
- Volunteers
- 450 people
- Sponsor
- Genethon
Mucopolysaccharidosis (MPS), Hunter Syndrome
A Study of ELAPRASE in Treatment-naïve Participants With Hunter Syndrome (Mucopolysaccharidosis [MPS] II)
The main aim of this study is to evaluate the ability of a prophylactic immune tolerizing regimen (ITR) to prevent or reduce the development of high titer anti-idursulfase antibodies in treatment-naïve participants with Hunter…
- Trial name
- NCT05494593
- Testing
- ELAPRASE, Rituximab, Methotrexate
- Where
- 8 sites in United States
- Sponsor
- Takeda
Household Contacts
A Study to Evaluate AAV9 Neutralizing Antibody Seroconversion in Household Contacts.
This study will include male and female participants who live or work in the same household as a patient in one of the fordadistrogene movaparvovec interventional studies.
- Trial name
- NCT04543357
- Testing
- Blood Draw
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Pfizer
HIV -1 Infection
Early Neutralizing Antibodies in Infants Living With HIV to Enhance Their Life
The goal of this clinical trial is to learn if subcutaneous ePGT121v1-LS added to standard antiretroviral therapy (ART) is safe and helps improve HIV viral suppression in infants living with HIV in South Africa.
- Trial name
- ENABLE 1 (NCT07655128)
- Testing
- Broadly neutralizing antibody (bNAb) ePGT121v1-LS, Saline (0.9% NaCl)
- Volunteers
- 87 people
- Sponsor
- Hospital Universitario 12 de Octubre
Diabetes Mellitus, Type 1
AbATE Follow-Up Study
This study proposes to conduct a non-interventional, multi-center trial that will look at C-peptide results from one or two Mixed Meal Tolerance Tests (MMTT) in participants who received anti-CD3 treatment or placebo on the Abate…
- Trial name
- NCT02067923
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Yale University
Virus Diseases
A Study to Evaluate Persistence of Immune Responses After Post-exposure Prophylaxis of Rabipur® (Purified Chicken-embryo Cell Rabies Vaccine) in Chinese Children
The purpose of this study is to evaluate the long-term persistence of immune responses approximately 5 years or more after simulated rabies post-exposure prophylaxis provided in 2012 according to Essen (1-1-1-1-1) or Zagreb…
- Trial name
- NCT02991872
- Testing
- Blood draw
- Where
- China
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV, HIV Infections
The Tatelo Plus Study
The purpose of this study is to advance pediatric HIV treatment and cure research by evaluating the impact of a combination of three anti-HIV-1 broadly neutralizing antibodies (bNAbs) or analytic treatment interruption (ATI) on…
- Trial name
- NCT06508749
- Testing
- PGDM1400LS, VRC07-523LS, PGT121.414.LS
- Where
- 2 sites in Botswana
- Volunteers
- 41 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)