Clinical trials: Immunoglobulin Prophylaxis
Respiratory Syncytial Virus Infections
Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants
The purpose of this study was to evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of suptavumab (REGN2222) in infants born no more than 35 weeks, 6 days gestational age who are no more than 6 months of age…
- Trial name
- NCT02325791
- Testing
- Suptavumab 30 mg/kg, Suptavumab 30 mg/kg- 1 Dose, Suptavumab 30 mg/kg - 2 Doses
- Where
- 205 sites in United States, Australia and 17 more
- Volunteers
- 1,177 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
Malaria
Trial to Evaluate L9LS in Healthy Adults
Background: Malaria is a parasitic disease carried by mosquitoes in tropical areas. There is no vaccine to prevent malaria infection. If not treated right away, it can become serious or deadly.
- Trial name
- VRC 614 (NCT05019729)
- Testing
- VRC-MALMAB0114-00-AB, Plasmodium falciparum (P. falciparum) sporozoite challenge
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Malaria
Trial to Evaluate CIS43LS in Healthy Adults
Background: People get malaria when they are bitten by an infected mosquito. Malaria can be serious and sometimes deadly. Although there are medicines to treat malaria, there is no vaccine that fully prevents infection.
- Trial name
- NCT04206332
- Testing
- VRC-MALMAB0100-00-AB, Plasmodium falciparum (P. falciparum) sporozoite challenge
- Where
- 2 sites in United States
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Meningococcal Disease
One Year Antibody Persistence After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine Administered Starting From 12 Months of Age and Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age
One year antibody persistence after the fourth dose boost or two catch-up doses administered starting from 12 months of age and to evaluate the response to a a third dose boost or two catch-up dose starting at 24 months of age.
- Trial name
- NCT01139021
- Testing
- rMenB+OMV NZ
- Where
- 19 sites in Czechia, Finland
- Volunteers
- 508 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
HIV
A Phase 1 Trial to Evaluate CAP256V2LS in Healthy Adults
Background: HIV is a serious disease with no cure or vaccine to prevent it. Using antibodies could be a way to prevent HIV infection. Antibodies are made by the human body to fight germs.
- Trial name
- VRC 611 (NCT04408963)
- Testing
- VRC-HIVMAB0102-00-AB
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
HIV, Sexually Transmitted Infections (STI)
Monoclonal Antibody-based Multipurpose Microbicides
The purpose of this project is to explore women's thoughts, opinions, and ideas about vaginal products. Women who enroll in the project will complete a brief demographics and sexual behavior questionnaire.
- Trial name
- Project WIND (NCT01859195)
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- The Miriam Hospital
Healthy Participants
Influenza Virus Vaccine Plus Vitamin A and D Supplements for Prevention of Respiratory Virus Infections in Children
Children are particularly vulnerable to respiratory virus infections, especially influenza. Vitamin A \& D deficiencies are associated with vulnerability to infectious diseases of the respiratory tract.
- Trial name
- NCT02649192
- Testing
- Influenza virus vaccine, Vitamins A and D
- Where
- United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- St. Jude Children's Research Hospital
Meningococcal Disease
Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received Three Doses of the Same Vaccine
The proposed study V72P9E1 is an Extension Study of V72P9. The objectives of this extension study will be to explore antibody persistence in children at approximately 40 months of age and to evaluate the safety, tolerability and…
- Trial name
- NCT01026974
- Testing
- rMenB, rMenB+OMV NZ
- Where
- United Kingdom
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Rabies
Phase II/III Study of the Safety and Effectiveness of HRIG With Active Rabies Vaccine in Healthy Subjects
The purpose of this study is to: 1. Evaluate the safety and tolerability of KamRAB in comparison with Human rabies immune globulin (HRIG) comparator product. 2.
- Trial name
- KAMRAB-003 (NCT02040090)
- Testing
- Active rabies vaccine (US-FDA approved)
- Where
- United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Kamada, Ltd.
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
Respiratory Syncytial Virus Infections
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and…
- Trial name
- MELODY (NCT03979313)
- Testing
- MEDI8897
- Where
- 198 sites in United States, Argentina and 29 more
- Volunteers
- 3,012 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
MEDI-524 (Motavizumab) for the Prevention of Respiratory Sycytial Virus (RSV) Disease Among Native American Indian Infants in the Southwestern United States
MI-CP117 was a Phase 3, randomized, double-blind, placebo-controlled trial designed to determine if motavizumab is more effective than placebo in reducing RSV hospitalization in otherwise healthy Native American Infants in the…
- Trial name
- NCT00121108
- Testing
- Motavizumab
- Where
- 12 sites in United States
- Volunteers
- 2,127 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Meningococcal Disease
Evaluation of Meningococcal ACWY Immune Response in Children Aged 40 and 60 Months
The purpose of this study is to evaluate how well the immuno response against meningococcal serogroups A, C, W and Y lasts in children who were vaccinated with MenACWY as infants.
- Trial name
- NCT00601731
- Testing
- MenACWY-CRM197, Blood test
- Where
- 3 sites in Canada, United Kingdom
- Volunteers
- 382 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
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
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
SARS-CoV-2
Study of Monoclonal Antibody Cocktail Being Tested for the Prevention of COVID-19
This is a phase 1, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, pharmacokinetics, and immunogenicity of ADM03820 administered as IM injections in healthy adults for the prevention of…
- Trial name
- NCT04592549
- Testing
- ADM03820
- Where
- 2 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Alachua Government Services, Inc.
Healthy Adult Immune Response
Phase I Study to Evaluate a Human Monoclonal Antibody (MAb) 10E8VLS Administered Alone or Concurrently With MAb VRC07-523LS Via Subcutaneous Injection in Healthy Adults
Background: Human immunodeficiency virus (HIV) infection is a serious disease. There is no cure or vaccine to prevent infection. Using antibodies might be a good way to treat or prevent HIV.
- Trial name
- NCT03565315
- Testing
- VRC-HIVMAB095-00-AB (10E8VLS), VRC-HIVMAB075-00-AB (VRC07-523LS)
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
West Nile Fever
Safety and Immunogenicity of ChimeriVax-WN02 West Nile Vaccine in Healthy Adults
The purpose of this study is to determine whether a single subcutaneous injection of ChimeriVax-WN02 vaccine is well tolerated, safe and induces protective antibodies against West Nile Disease.
- Trial name
- NCT00442169
- Testing
- ChimeriVax-WN02 Low Dose, ChimeriVax-WN02 Medium Dose, ChimeriVax-WN02 High Dose
- Where
- 5 sites in United States
- Volunteers
- 208 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company