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
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
First received: November 2, 1999
Last updated: May 16, 2012
Last Verified: May 2012
History of Changes
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.
Biological : Salmonella typhi CVD 908-HIV-1 LAI gp 120 (VVG 203)
Biological : Aluminum hydroxide
Biological : MF59
Biological : rgp120/HIV-1MN
Primary Purpose: Prevention
|Official Title:||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|
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
|Study Completion Date:||May 2000|
Although recent advances have been made in antiviral therapy for AIDS, there is no cure for
HIV-1 infection or AIDS, and drug therapy is too expensive for most affected populations. The
development of safe, effective vaccines to prevent HIV-1 infection and AIDS worldwide is a
global priority. One promising approach in the development of HIV-1 vaccines utilizes live
vaccines as vectors to express HIV-1 antigens. The potential advantages of the live vector
approach include the ability of live vector recombinants to induce long-lasting humoral and
cell-mediated immunity (particularly neutralizing antibody and CD8+ cytotoxic T-cell
activity) and the relatively low cost of production. Moreover, live vector recombinant
vaccines administered orally might be able to stimulate the production of secretory IgA
vaccine-specific antibodies locally at relevant mucosal sites.
Part I of this study is conducted as an open-label, dose-escalation trial. The first 5 volunteers (Group A) receive a single oral dose of Salmonella typhi CVD 908-HIV-1 LAI gp 120 (VVG203). If no typhoid fever-like illness is seen in these volunteers during at least 14 days of follow-up, the next 5 patients (Group B) receive a single dose of VVG203. If this higher dose is well-tolerated, Phase II of the study is initiated once all Phase I volunteers have been assessed for safety for at least 21 days. [AS PER AMENDMENT 11/07/97: Groups A and B are expanded to 10 patients each.] Part II of this study is a randomized, placebo-controlled, double-blind trial. Nine volunteers are randomized to each of treatment groups, with oral VVG203 given alone or sequentially with HIV-1 SF-2 rgp 120 in MF59 (SF) given intramuscularly. [AS PER AMENDMENT 11/07/97: Randomization is to VVG 203 alone or sequentially with HIV-1 MN rgp120 in alum (MN).] A total of 3 vaccinations are administered within each 9-person cohort, 1 volunteer serves as a control and receives a sodium bicarbonate buffer rather than VVG203 or a vaccine placebo rather than SF. Group C receives VVG at Month 0 and SF at Months 2 and 6. Group D receives VVG at Months 0, 2, and 6. Group E receives SF at Months 0 and 2 and VVG at Month 6. [AS PER AMENDMENT 11/07/97: MN is given in place of SF in all Groups C, D, and E.]
|Ages Eligible for Study:||18 Years to 50 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
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.
- 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
You will not be eligible for this study if you:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000868
Locations Show More
|United States, Maryland|
|Baltimore, Maryland, United States, 21205|
Sponsors and CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)
|Study Chair:||M Clements|
|Study Chair:||D Schwartz|
|Responsible Party:||National Institute of Allergy and Infectious Diseases (NIAID)|
|ClinicalTrials.gov Identifier:||NCT00000868 History of Changes|
|Other Study ID Numbers:||AVEG 028|
|Study First Received:||November 2, 1999|
|Last Updated:||May 16, 2012|
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):Vaccines, Synthetic
HIV Envelope Protein gp120
HIV Preventive Vaccine
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.