Safety and Immunogenicity of Ad4-HIV Envelope Vaccine Vectors in Healthy Volunteers (NCT03878121) | Clinical Trial Compass
RecruitingPhase 1
Safety and Immunogenicity of Ad4-HIV Envelope Vaccine Vectors in Healthy Volunteers
United States300 participantsStarted 2019-04-17
Plain-language summary
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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Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age 18 to 49 years for vaccinees. Age 18 to 65 years for household and intimate contacts.
✓. Negative FDA-approved HIV test.
✓. Available and willing to participate in follow-up visits and tests for the duration of the study.
✓. Willing to have samples stored for future research.
✓. In good general health without clinically significant medical history.
✓. Assessed as low risk for HIV infection by agreeing to discuss HIV infection risks with the study clinicians, agreeing to HIV risk reduction counseling, and agreeing to avoid behavior associated with high risk of HIV exposure through the last required clinic visit in the protocol schedule.
✓. Negative beta-HCG pregnancy test for females presumed to be of reproductive potential.
✓. Female vaccinees and male intimate contacts must meet one of the following criteria:
Exclusion criteria
✕
What they're measuring
1
Safety and immunogenicity
Timeframe: ongoing
Trial details
NCT IDNCT03878121
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. History of any prior disease or therapy which would affect immune or pulmonary function.
✕. Prior malignancy, except curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
✕. History of radiation therapy or cytotoxic/cancer chemotherapy.
✕. History of uncontrolled diabetes mellitus (DM). Type 2 DM controlled with diet alone (and confirmed by HgbA1c \<= 8% within the last 6 months) or a history of isolated gestational diabetes are not exclusionary. Enrollment of individuals with Type 2 DM that is well controlled on hypoglycemic agent(s) may be considered on a case-by-case basis, provided that the HgbA1c is \<= 8% within the last 6 months
✕. Immunodeficiency or autoimmune disease.
✕. Acute infection or a recent history (within 6 months) of chronic infection suggestive of immunodeficiency.
✕. Taking any glucocorticoids or other immunosuppressive medications.
✕. Asthma is excluded if the participant has ANY of the following: