Completed
A Phase I Safety and Immunogenicity Trial of Orally Administered Live Attenuated Recombinant Salmonella Typhi CVD 908 Delta-asd (pW57-asd+) Expressing HIV-1 LAI gp120 (VVG 203) and Parenterally Administered HIV-1 MN rgp120 in Alum in HIV-1-Uninfected Volunteers
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-28
27
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety and effectiveness of giving healthy volunteers a new oral HIV vaccine which has been incorporated into a bacterial cell. This oral vaccine (HIV-1 LAI gp120) will be given with or without a different injected HIV vaccine (HIV-1 MN rgp120). Vaccines are preparations that are introduced into the body to try to prevent infection or create resistance to infection. This study examines a new oral vaccine to see if it can improve the immune system's ability to fight the HIV virus when given alone or with another injected vaccine.
CONDITIONS
Official Title
A Study to Evaluate the Safety and Effectiveness of HIV-1 LAI gp120 (an HIV Vaccine) Given With or Without HIV-1 MN rgp120 (Another HIV Vaccine) to HIV-Negative Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
You may be eligible for this study if you:
- Are 18-50 years old.
- Are HIV-negative.
- Are healthy and have a normal history and physical exam.
- Agree to practice abstinence or use of effective birth control for 1 month before and during the study.
Exclusion Criteria
You will not be eligible for this study if you:
- Have a history of immune deficiency, chronic illness, or autoimmune disease.
- Have received immunosuppressive medications, blood products, trial drugs, immunoglobulins, or an HIV or typhoid vaccine.
- Have a history of severe allergic reactions.
- Have had prior suicidal attempts or have a psychiatric condition or job commitments which would prevent you from completing the study.
- Have a history of cancer (unless the cancer has been successfully cured), gallbladder disease, typhoid fever, migraines or other severe headaches, cardiac valve defects, or congenital heart disease.
- Have active syphilis or tuberculosis.
- Are allergic to certain medications.
- Are pregnant or breast-feeding.
- Have household contact with infants or persons who are pregnant, immunodeficient, or HIV-positive.
- Are unavailable for 12 months of follow-up.
- Have hepatitis B.
- Have a history of injection drug use within 12 months of enrollment or have higher or intermediate risk sexual behavior.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 1 location
1
JHU AVEG
Baltimore, Maryland, United States, 21205
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
N/A
Model
N/A
Primary Purpose
PREVENTION
Number of Arms
0
Similar Trials
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here