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Clinical Trials associated with HIV-1 Ad4-Env145NFL Vaccine(National Institute of Allergy & Infectious Diseases) / Active, not recruitingPhase 1IIT A First-in-human Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 16055 NFL Delta Gly4 Env Protein Trimer and Trimer 4571 Combined With 3M-052-AF + Alum Adjuvant and Ad4-Env145NFL Viral Particles as Heterologous Prime-boost Regimens in Adult Participants Without HIV
The goal of this clinical trial is to test 16055 NFL delta Gly4 Env protein trimer and Trimer 4571 combined with 3M-052-AF + Alum adjuvant and Ad4-Env145NFL viral particles as heterologous prime-boost regimens in adult participants without HIV.
The main question[s] it aims to answer are:
* Are these vaccine regimens safe and well tolerated?
* Are the prime-boost vaccine regimens that include Ad4-Env145NFL and Trimer 4571 as heterologous boosts going contribute to the development of B-cell and antibody responses?
Participants will attend scheduled study visits to receive their vaccine and will record symptoms on a daily eDiary.
Phase I Open-Label Study of Safety and Immunogenicity of AD4-HIV Envelope Vaccine Vectors in Healthy Volunteers
Background:
Researchers want see if three new HIV (human immunodeficiency virus) vaccines are safe. Two vaccines are carried by live adenoviruses, which are natural and typically cause cold symptoms or an eye infection. Researchers want to see if all the vaccines help fight HIV and if the adenoviruses are contagious.
Objectives:
To test the safety and effects of three new HIV vaccines.
Eligibility:
Healthy adults 18 49 years old (vaccinees)
Their household and intimate contacts 18 65 years old
Design:
Vaccinees will be screened with:
Physical exam
Medical history
Blood and urine tests
Questions about HIV risk
Vaccinees will learn how to prevent spreading the viruses and about required contraception during the study.
Vaccinees will get consent forms for their household and intimate contacts. All contacts must be age 18 65. All intimate contacts must sign a consent form. Contacts will have 4 visits over 8 months for blood tests and a physical exam.
All applicable participants will have a pregnancy test at every visit.
Vaccinees will have about 9 visits over 12 months. They will repeat screening tests and get:
1 of the 2 adenovirus vaccines sprayed in the nose at 2 visits
The booster vaccine by needle in an arm at 1 visit
Nasal swabs taken at some visits
Vaccinees will note their temperature and symptoms for at least 1 4 weeks after each vaccine.
Vaccinees may choose to have:
Leukapheresis. Blood will be removed by needle in a vein in one arm. A machine will remove white blood cells. The rest of the blood will be returned into the other arm.
Small pieces of the tonsil removed
Sponsoring Institute: National Institute of Allergy and Infectious Diseases
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100 Clinical Results associated with HIV-1 Ad4-Env145NFL Vaccine(National Institute of Allergy & Infectious Diseases)
100 Translational Medicine associated with HIV-1 Ad4-Env145NFL Vaccine(National Institute of Allergy & Infectious Diseases)
100 Patents (Medical) associated with HIV-1 Ad4-Env145NFL Vaccine(National Institute of Allergy & Infectious Diseases)
100 Deals associated with HIV-1 Ad4-Env145NFL Vaccine(National Institute of Allergy & Infectious Diseases)