Clinical trials: Immunoglobulin
Hepatitis B
Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers
The purpose of this study is to evaluate the persistence of anti-hepatitis B surface antigen (anti-HBs) antibodies 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine.
- Trial name
- NCT00240500
- Testing
- Engerix™-B
- Where
- Thailand
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Invasive Group B Streptococcus Disease
Antibody Levels Associated With Reduced Risk of Invasive Group B Streptococcus Disease in Infants Aged Less Than 90 Days
Compare anticapsular antibody levels against Group B Streptococcus at delivery in mothers and their infants who develop disease versus those who do not.
- Trial name
- NCT02099149
- Where
- South Africa
- Volunteers
- healthy volunteers welcome
- Sponsor
- Novartis
Healthy Volunteer
Efficacy of B7A BSIgG Against E. Coli Strain B7A Challenge
Enterotoxigenic Escherichia coli (ETEC) is a major cause of diarrhea worldwide. Vaccines and therapeutics are under development to prevent ETEC disease in children and travelers.
- Trial name
- NCT03040687
- Testing
- Anti CS6 BSIgG product (Lot PD1601105CS), Anti B7A BSIgG product (Lot PD1601132ET), Bovine Immunoglobin Negative Control (Lot PD161071NC)
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Hepatitis
VaxTeen Hepatitis B Vaccine Booster Study
The purpose of this study is to determine immune status of adolescents who responded to a primary series of recombinant hepatitis B vaccine given at birth and to assess their response to a booster dose of vaccine.
- Trial name
- NCT00144313
- Testing
- hepatitis B vaccine
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention
Hepatitis A, Hepatitis A Virus
Immunogenicity and Safety of I-HAV in Healthy Thai Children and Adolescents Lacking Protective Antibody After L-HAV
Hepatitis A virus (HAV) remains a common infection in Thai children. Two HAV vaccines are available: inactivated vaccine (I-HAV, 2 doses) and live-attenuated vaccine (L-HAV, single dose), but neither is included in Thailand's…
- Conditions
- Hepatitis A, Hepatitis A Virus, Vaccine-Preventable Diseases
- Trial name
- HAV-2 (NCT06978621)
- Testing
- Inactivated hepatitis A vaccine (I-HAV)
- Where
- Thailand
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Chiang Mai University
COVID-19, Maternal Vaccine Exposure
Priming of the NEonatal Immune System by Transfer of Maternal Immunity
Newborn babies and infants are susceptible to infections as their immune system is still immature. Maternal immune factors for example antibodies and immune cells mitigate this vulnerability.
- Conditions
- COVID-19, Maternal Vaccine Exposure, Respiratory Infections in Children
- Trial name
- NEST (NCT05429047)
- Testing
- Tozinameran, COVID-19, No SARS-CoV-2 exposure
- Where
- Germany
- Volunteers
- 560 people, healthy volunteers welcome
- Sponsor
- Hannover Medical School
Tetanus, Poliomyelitis
Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™
The aim of this study is to assess antibody persistence in infants who received three doses of Infanrix hexa™ (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib™ (DTPa-IPV/Hib) at 3, 5 and 11 months of age in study NCT00307034.
- Conditions
- Tetanus, Poliomyelitis, Haemophilus Influenzae Type b, Acellular Pertussis
- Trial name
- NCT01358825
- Testing
- Blood Sampling
- Where
- 4 sites in Norway, Sweden
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV Infections
Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection in Women
This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection in high-risk, HIV-uninfected women.
- Trial name
- NCT02568215
- Testing
- VRC01
- Where
- 21 sites in Botswana, Kenya and 5 more
- Volunteers
- 1,924 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
COVID-19
Multisite Observational Maternal and Infant Study for COVID-19
This is an observational, non-interventional, prospective cohort study designed to collect clinical information and specimens to evaluate the immune responses from pregnant individuals and postpartum individuals and their infants…
- Trial name
- MOMI-Vax (NCT05031468)
- Testing
- Licensed or EUA SARS-CoV-2 vaccine
- Where
- 10 sites in United States
- Volunteers
- 562 people, healthy volunteers welcome
- Sponsor
- Emory University
COVID-19
Antibody Responses in Contacts of COVID-19 Patients
After several cases of pneumonia with an unfamiliar etiology were observed at the end of 2019, the National Health Commission of China released more details about the epidemic in early 2020.
- Trial name
- NCT04444310
- Where
- Egypt
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Assiut University
HIV-1-infection
10E8.4/iMab Bispecific Antibody in HIV-uninfected and HIV-infected Adults
Many HIV-infected individuals mount a broad neutralizing serologic response 2-3 years after infection. Broadly neutralizing antibodies might play an important role in protection from acquisition of HIV infection because they can…
- Trial name
- NCT03875209
- Testing
- 10E8.4/iMab
- Where
- 2 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- David Ho
COVID-19
Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Participants With Acute COVID-19 Disease
This study evaluates the efficacy and safety of intravenous (IV) infusions of pamrevlumab when compared with placebo in participants who are hospitalized with acute COVID-19 disease.
- Trial name
- NCT04432298
- Testing
- Pamrevlumab
- Where
- 4 sites in United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Kyntra Bio
Tetanus
Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection
A Randomized, Double-blind, Controlled, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Intramuscular Injection of Recombinant Human Anti-tetanus…
- Trial name
- NCT07149454
- Testing
- Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection, Human Tetanus Immunoglobulin
- Where
- China
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Lanzhou Institute of Biological Products Co., Ltd
Meningococcal Disease
Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of Booster Doses of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received One or Four Doses of the Same Vaccine
The proposed study V72P6E1 is an Extension Study of V72P6 (NCT00381615). The objectives of this extension study will be to explore antibody persistence at approximately 40 months of age and to evaluate the safety, tolerability…
- Trial name
- NCT01027351
- Testing
- Meningococcal (group B) multicomponent recombinant adsorbed vaccine., Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV)
- Where
- United Kingdom
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Tolerability, Safety, Immunogenicity and Pharmacokinetic of JS005
Phase I Study of Comparing Single Dose JS005 (Recombinant Humanized Monoclonal Antibody Against IL-17A) With Placebo in Tolerability, Safety, Immunogenicity and Pharmacokinetic in Healthy Volunteers
JS005-001 is one randomized, double-blind, placebo-controlled study to evaluate the tolerability, safety, immunogenicity and pharmacokinetic profile of single dose of JS005 injection in healthy volunteers.
- Trial name
- NCT04220073
- Testing
- JS005 (recombinant humanized monoclonal antibody against IL-17A)
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
Heart Failure
Safety, Pharmacokinetic and Pharmacodynamic Study of COR-1, an Anti-ß1 Receptor Antibody Cyclopeptide
Primary Trial objectives: To evaluate the pharmacokinetics and -dynamics of five strengths of COR-1 (10, 40, 80, 160, 240 mg) in 50 healthy, male volunteers after single intravenous administration (8 subjects on verum per dose…
- Trial name
- COR-1-01 (NCT01043146)
- Testing
- COR-1
- Where
- Germany
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Corimmun GmbH
Mevalonate Kinase Deficiency
Geranylgeraniol Supplementation in Patients With Mevalonate Kinase Deficiency
Mevalonate kinase deficiency (HyperIgD syndrome, HIDS) is an inborn error of immunity caused by a block in the mevalonate pathway.
- Trial name
- NCT06497829
- Testing
- geranylgeraniol
- Where
- Czechia
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- University Hospital, Motol
Covid19, Chronic Kidney Diseases
The REnal Patients COVID-19 VACcination Immune Response (RECOVAC IR) Study
Rationale: COVID-19 is associated with severely increased morbidity and mortality in patients with severely impaired kidney function, on dialysis or alive with a kidney transplant.
- Trial name
- RECOVAC-IR (NCT04741386)
- Testing
- SARS-CoV-2 vaccination
- Where
- 4 sites in Netherlands
- Volunteers
- 854 people, healthy volunteers welcome
- Sponsor
- University Medical Center Groningen
HIV Infections
Observational Study of Blood Treated With Cytolin
Primary Objective: To determine the mechanism of Cytolin's effect on HIV replication from blood drawn from HIV-positive and HIV-negative individuals after exposure to Cytolin.
- Trial name
- NCT01048372
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- CytoDyn, Inc.
Healthy Volunteers
First in Human Study of an Anti-Toll-like Receptor 4 (TLR4) Monoclonal Antibody (NI-0101) in Adult Healthy Volunteers
The purpose of this study is to determine the safety, tolerability and distribution and elimination of a novel therapeutic drug when administered to Healthy Volunteers.
- Trial name
- NI-0101-01 (NCT01808469)
- Testing
- Monoclonal antibody
- Where
- Netherlands
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Light Chain Bioscience - Novimmune SA