Clinical trials: Immunoglobulin Prophylaxis
Respiratory Syncytial Virus Infections
Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children
The primary objective of this study was to compare the safety and efficacy of motavizumab to palivizumab when administered monthly by intramuscular (IM) injection for the reduction of the incidence of RSV hospitalization among…
- Trial name
- NCT00129766
- Testing
- motavizumab (MEDI-524), palivizumab
- Where
- 344 sites in United States, Argentina and 22 more
- Volunteers
- 6,635 people
- Sponsor
- MedImmune LLC
Rabies, Japanese Encephalitis
Evalution of Immunogenicity, Safety and Booster Response of a Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine in Toddlers
This study evaluated the safety and immunogenicity of rabies vaccine and Japanese encephalitis vaccine in toddlers. All children developed adequate immune responses.
- Conditions
- Rabies, Japanese Encephalitis, Pre-Exposure Prophylaxis
- Trial name
- NCT00694460
- Testing
- Three 1 mL doses of Rabies vaccine and two JE vaccine, Three 0.5 mL doses of Rabies vaccine and two JE vaccine, Three 0.1mL doses of Rabies Vaccine and two JE vaccine
- Where
- Thailand
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Novartis
Symptomatic Venous Thromboembolism (VTE)
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called Acetylsalicylic Acid (ASA).
- Trial name
- ROXI-ASPEN (NCT07213778)
- Testing
- REGN7508, Acetylsalicylic Acid (ASA)
- Where
- 51 sites in United States, Greece and 3 more
- Volunteers
- 2,000 people
- Sponsor
- Regeneron Pharmaceuticals
Atrial Fibrillation (AF)
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called apixaban.
- Trial name
- ROXI-EVEREST (NCT07626411)
- Testing
- REGN7508, Apixaban
- Where
- 54 sites in United States, Canada and 1 more
- Volunteers
- 15,364 people
- Sponsor
- Regeneron Pharmaceuticals
Chronic Hepatitis B
Truvada Versus Truvada Plus Hepatitis B Immunoglobulin (HBIg) in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant
The objective of this 96-week study was to evaluate the safety and antiviral efficacy of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF, coformulated; Truvada®) with or without hepatitis B immunoglobulin (HBIg) in…
- Trial name
- NCT00507689
- Testing
- FTC/TDF, Hepatitis B Immunoglobulin (HBIg)
- Where
- 7 sites in United States
- Volunteers
- 40 people
- Sponsor
- Gilead Sciences
Ebola Virus Disease
Open-Label Expanded Access for Ebola-Infected Patients to Receive Human MAb Ansuvimab As Therapeutic or for HR PEP
The human monoclonal antibody (mAb), ansuvimab (mAb114), will be provided to Ebola-infected patients as either a treatment or as PEP under an expanded access protocol.
- Trial name
- NCT05067166
- Testing
- Ansuvimab
- Sponsor
- Ridgeback Biotherapeutics, LP
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
Rabies
Rabies Virus Neutralizing Activity and Safety of CL184, a Monoclonal Antibody Cocktail, in Simulated Rabies Post-Exposure Prophylaxis in Healthy Adults
Study design: Single-blind (subject and observer-blinded), active-controlled, randomized [6:2:1:2:1; CL184 + purified vero cell rabies vaccine (PVRV) vs. human rabies immune globulin (HRIG) + PVRV vs. placebo + PVRV vs.
- Trial name
- NCT01228383
- Testing
- Rabies virus-specific monoclonal antibodies, human polyclonal rabies immune globulin (HRIG), Human diploid cell vaccine (HDCV)
- Where
- India
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
Healthy
Dose-finding Study of LFB-R593, A Monoclonal Anti-RhD Antibody, in Healthy RhD Negative Volunteers
This phase II study is designed to demonstrate the ability of LFB-R593 to effectively eliminate exogenously-administered RhD-positive red blood cells from the circulation of an RhD-negative individual, thereby preventing…
- Trial name
- NCT00952575
- Testing
- polyclonal anti-D immunoglobulin, monoclonal anti-D immunoglobulin
- Where
- Germany
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
Stage V Chronic Kidney Disease
Safety & Efficacy Of Eculizumab In The Prevention Of AMR In Sensitized Recipients Of A Kidney Transplant From A Deceased Donor
Primary Objective: To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants.
- Trial name
- NCT01567085
- Testing
- Eculizumab
- Where
- 15 sites in Australia, France and 4 more
- Volunteers
- 80 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Rabies Infection
Safety and Immunogenicity of Two Intradermal Rabies Vaccine Regimens Administered With and Without Human Rabies Immunoglobulin in Subjects ≥ 1 Years of Age
Demonstrate non-inferiority of the immune response between new versus the currently recommended intradermal regimens of rabies vaccine when administered with or without rabies immunoglobulins in healthy subjects ≥ 1 years of age.
- Trial name
- NCT02177032
- Testing
- Rabies vaccine, Rabies vaccines + Rabies immunoglobulins
- Where
- 6 sites in Philippines, Thailand
- Volunteers
- 885 people, healthy volunteers welcome
- Sponsor
- Novartis
Respiratory Syncytial Virus Infections
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy preterm infants who are between 29 and 35 weeks gestational age (GA) and entering…
- Trial name
- MEDI8897 Ph2b (NCT02878330)
- Testing
- MEDI8897
- Where
- 161 sites in United States, Argentina and 21 more
- Volunteers
- 1,453 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Rabies, Communicable Disease
A Phase III Clinical Study to Evaluate SYN023's Efficacy and Safety
This is a Phase 3, blinded, randomized study of SYN023 compared to a China licensed Human Rabies Immunoglobulin (a Rabies immune globulin from human sources, HRIG) for the prevention of rabies as part of post-exposure prophylaxis…
- Conditions
- Rabies, Communicable Disease, Virus Diseases, Rhabdoviridae Infections
- Trial name
- NCT04644484
- Testing
- SYN023, Human Rabies Immune Globulin (HRIG), Rabies Vaccine
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Synermore Biologics (Suzhou) Co., Ltd.
End Stage Renal Disease, Renal Transplant
Evaluating Safety and Efficacy of TOL101 Induction Versus Anti-Thymocyte Globulin to Prevent Kidney Transplant Rejection
Induction therapy with antibodies is administered during transplant surgery and for a short period of time following transplant surgery in an effort to render the immune system less able to mount an initial rejection response.
- Trial name
- NCT01154387
- Testing
- Anti-Thymocyte Globulin, TOL101, Steroids
- Where
- 12 sites in United States
- Volunteers
- 85 people
- Sponsor
- Tolera Therapeutics, Inc
Prevention of Meningococcal Infection
Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in Healthy Children
Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in healthy children
- Trial name
- NCT00311415
- Testing
- Meningococcal C conjugate vaccine
- Where
- 2 sites in Germany, Poland
- Volunteers
- 257 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
HIV Prevention
Evaluating the Safety and Immunogenicity of Polyvalent DNA and Recombinant gp120 Protein HIV Vaccine (PDPHV) in Healthy, HIV-uninfected Adults
The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of polyvalent env (A,B,C,A/E)/gag (C) DNA prime and gp120 (A,B,C,A/E) protein HIV-1 vaccines boost (PDPHV) with either Alhydrogel or GLA-SE in…
- Trial name
- NCT07675629
- Testing
- PDPHV Plasmid DNA Vaccines (env (A, B, C, A/E)/gag (C)), PDPHV Recombinant Protein Vaccines (gp120 (A, B, C, A/E)), Alhydrogel adjuvant
- Where
- 2 sites in United States, South Africa
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Worcester HIV Vaccine
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