Safety of an Oral HIV Vaccine in HIV Uninfected Volunteers - Full Text View

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00062530

Purpose

This study will test the safety of and immune response to an oral HIV vaccine in healthy volunteers. The vaccine in this study uses a weakened bacterium called Salmonella typhi to deliver an HIV gene into the body through the mouth. The body then produces an HIV protein from the gene; this protein stimulates an anti-HIV immune response. The vaccine contains only one of the many substances that HIV needs to make more copies of itself, so the vaccine itself cannot cause HIV or AIDS.

Condition	Intervention	Phase
HIV Infections	Biological: SCBaL/M9	Phase I

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
Official Title:	Development of an Oral Prime-Boost AIDS Vaccine to Elicit Broadly Neutralizing Antibodies Against HIV-1

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Safety, as judged by the lack of an immune response to CD4 epitopes or other significant adverse events as defined by the HVTN toxicity tables [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Neutralizing antibody response against HIV-1 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:

38

Arms	Assigned Interventions
1: Experimental All participants will receive oral vaccine at study entry, although dosage will vary	Biological: SCBaL/M9 Oral recombinant Salmonella typhi HIV-1 gp120 vaccine

Detailed Description:

The transmission of HIV-1 by both sexual and parenteral routes makes it likely that a successful preventive vaccine against this virus will need to induce protective immunity in both mucosal and systemic compartments. The long-term objective of this program is to develop an HIV-1 vaccine that elicits protective immunity in both the mucosal and systemic compartments.

The study will evaluate the safety and immunogenicity of an oral recombinant Salmonella typhi HIV-1 gp120 vaccine (SCBaL/M9) in healthy human volunteers. This will be the first study in volunteers to use an intracellular bacterium to deliver a recombinant vector vaccine mucosally. The study will also develop an Env immunogen that elicits a broader spectrum of neutralizing antibodies than gp120 and that can be delivered by Salmonella typhi or as a soluble protein immunogen.

This is a Phase I dose-escalation study of two vaccine components that will be combined in a larger prime-boost protocol should the desired safety endpoints be obtained. Both components use a conformationally constrained gp120 that expresses epitopes recognized by broadly neutralizing antibodies. The priming immunogen will be the conformationally constrained gp120 gene delivered orally by live attenuated Salmonella typhi. The boosting immunogen will be a soluble subunit protein comprised solely of the conformationally constrained gp120.

All participants in this study will receive the vaccine. Participants will be randomized to different vaccine doses. Participants will have eight study visits over 20 weeks. Study visits will include brief medical interview, physical exam, blood and urine tests, and counseling on avoiding HIV infection and pregnancy. Participants will be tested for HIV infection 3 times during the study.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria

HIV uninfected
Low risk sexual behavior
Negative for Hepatitis B surface antigen
Negative for Hepatitis C viral sequences and antibody
Availability for follow-up for planned duration of the study (12 months)
Acceptable methods of contraception

Exclusion Criteria

Receipt of HIV vaccines or placebo in a previous HIV vaccine trial
History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications
History of cancer unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of cure
Medical or psychiatric condition or occupational responsibilities which preclude compliance with the protocol
History of suicide attempts, recent suicidal ideation, or psychosis
High risk behavior for HIV infection as determined by screening questionnaire
History of injection drug use within 12 months of study entry
Live attenuated vaccines within 60 days of study entry. Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) are not exclusionary, but should be given at least 2 weeks away from HIV immunizations.
Use of experimental agents within 30 days of study entry
Receipt of blood products or immunoglobulin within 6 months of study entry
Active syphilis
Active tuberculosis
History of anaphylaxis or serious adverse reactions to vaccines
History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension)
Pregnant or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00062530

Contacts

Contact: George K. Lewis, PhD

410- 706-4688

lewisg@umbi.umd.edu

Locations

United States, Maryland
Institute of Human Virology
Baltimore, Maryland, United States, 21201

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator:

George K. Lewis, PhD

Univesity of Maryland

More Information

Additional Information:

Click here for more information on preventive HIV vaccines This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Maryland ( Greg K. Lewis, PhD )
Study ID Numbers:	P01AI47490, P01 AI47490
Study First Received:	June 9, 2003
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00062530 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

AIDS
HIV seronegativity
HIV preventive vaccine

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on February 08, 2010