Clinical trial NCT00027365: An Investigational Combination Vaccine Given to People Who Are Not Infected With HIV
Official title: A Phase I Safety and Immunogenicity Trial of a Combination Vaccine (NefTat and gp120w61d) Formulated With AS02A (GlaxoSmithKline Biologicals) Given Intramuscularly in HIV-1 Uninfected Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: HIV Seronegativity
HIV Preventive Vaccine
Injections, Intramuscular
HIV Antibodies
HIV-1
HIV Envelope Protein gp120
Gene Products, tat
AIDS Vaccines
Neutralization Tests
Vaccines, Combined
AIDS Seronegativity
Gene Products, nef
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-12-05
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to see if the investigational vaccines NefTat and gp120w61d are safe and tolerable in humans and to see how the immune system responds to the vaccines.

There have been advances in the treatment and prevention of HIV, but the spread of HIV/AIDS is getting worse. HIV/AIDS is the main infectious cause of death in the world. A vaccine to prevent HIV disease is the best way to try to deal with this situation. Several vaccine products have been tested, but only 2 are still in trial. There is a need for a new product.

Detailed description: Despite recent advances in the treatment and prevention of HIV disease, the epidemic is worsening throughout most of the world. HIV/AIDS is the leading cause of death in sub-Saharan Africa and the leading infectious cause of death in the world. An effective and inexpensive vaccine to prevent HIV disease remains as the best option to try to deal with this expanding epidemic. A number of vaccine products have been tested; however, only 2 have progressed to a Phase III trial, underscoring the need for new vaccine strategies.

Prior to study entry, participants have their risk status for HIV infection determined by a series of questions. Further eligibility is determined by results of physical exam, laboratory tests, and further questions. Blood is drawn on each study visit. Participants are assigned randomly to 1 of 4 study groups:

Group I: NefTat or placebo. Groups II, III, and IV: NefTat and gp120 or placebo. Each group receives a different concentration of gp120.

All immunizations are admixed with AS02A adjuvant. Vaccinations are administered intramuscularly at 3 time points (entry, 1 month, and 3 months). Product safety and immunogenicity are performed at designated time points; participants have about 11 clinic visits.

Eligibility criteria: Inclusion Criteria

Participants may be eligible for this study if they:

* Are between 18 and 60 years of age.
* Are in good general health and meet laboratory test requirements.
* Have a CD4 count of 400 or more cells/mm3.
* Agree to use at least 1 of the following methods of contraception for at least 21 days before enrollment until the last protocol visit: condoms (male or female) with or without a spermicide, diaphragm or cervical cap with spermicide, IUD, or hormonal-based therapy (applies to women who are able to have children).
* Have access to a participating site and are willing to have follow-up for the entire study (12 months).
* Answer questions about their understanding of the study.
* Do not have hepatitis B or C.
* Are HIV-uninfected.

Exclusion Criteria

Participants may not be eligible for this study if they:

* Are pregnant or breast-feeding.
* Have recently received a vaccine.
* Have used experimental agents within 30 days before enrollment.
* Have received HIV vaccines or placebo in a previous HIV vaccine study.
* Have received blood products 120 days before HIV screening.
* Have received immunoglobulin (antibodies) 60 days before HIV screening.
* Have serious reactions to vaccines.
* Have problems with their immune system.
* Have cancer.
* Have used drugs that affect the immune system within the past 6 months.
* Have diabetes.
* Have a thyroid disease.
* Have unstable asthma.
* Are taking anti-tuberculosis drugs.
* Have seizures.
* Have a bleeding disorder.
* Have had their spleen removed.
* Have angioedema (a certain type of body tissue swelling).
* Have active syphilis.
* Have high blood pressure (unless controlled by medication).
* Have mental or emotional problems that make them unsuitable for the study.
* Have any medical, mental, or social condition; job responsibilities; or other responsibility that, in the opinion of the doctor, would interfere with the study.
* Have reactions to components of the vaccines.
* Are at high risk for contracting HIV.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Vaccine CRS
state: Alabama
city: San Francisco
country: United States
facility: San Francisco Vaccine and Prevention CRS
state: California
city: Baltimore
country: United States
facility: Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research, Project SAVE-Baltimore
state: Maryland
city: Baltimore
country: United States
facility: Project Brave HIV Vaccine CRS
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hosp. CRS
state: Massachusetts
city: Boston
country: United States
facility: Fenway Community Health Clinical Research Site (FCHCRS)
state: Massachusetts
city: Saint Louis
country: United States
facility: Saint Louis Univ. School of Medicine, HVTU
state: Missouri
city: Bronx
country: United States
facility: NY Blood Ctr./Bronx CRS
state: New York
city: New York
country: United States
facility: NY Blood Ctr./Union Square CRS
state: New York
city: New York
country: United States
facility: HIV Prevention & Treatment CRS
state: New York
city: Rochester
country: United States
facility: Univ. of Rochester HVTN CRS
state: New York
city: Providence
country: United States
facility: Miriam Hospital's HVTU
state: Rhode Island
city: Nashville
country: United States
facility: Vanderbilt Vaccine CRS
state: Tennessee
city: Annandale
country: United States
facility: Infectious Diseases Physicians, Inc.
state: Virginia
city: Seattle
country: United States
facility: FHCRC/UW Vaccine CRS
state: Washington
Study officials:
name: Tom Evans
role: STUDY_CHAIR
References:
citation: Vaine M, Wang S, Liu Q, Arthos J, Montefiori D, Goepfert P, McElrath MJ, Lu S. Profiles of human serum antibody responses elicited by three leading HIV vaccines focusing on the induction of Env-specific antibodies. PLoS One. 2010 Nov 9;5(11):e13916. doi: 10.1371/journal.pone.0013916.