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Status:

COMPLETED

Study of an HIV Preventive Vaccine Given With or Without an Adjuvant in HIV Uninfected Adults

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

Eligibility:

All Genders

18-50 years

Phase:

PHASE1

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of an experimental HIV vaccine. The vaccine will be given with or without IL-12 DNA adjuvant (at three escalating doses of 100, 500...

Detailed Description

The HIV epidemic is a major global health challenge, causing tremendous human suffering and economic loss throughout the world. The need for a safe, effective, and affordable HIV preventive vaccine is...

Eligibility Criteria

Inclusion

  • HIV uninfected
  • Access to a participating HIV Vaccine Trials Unit (HVTU)
  • Willing to receive HIV test results
  • Willing and able to comply with all study requirements
  • In good general health
  • Willing to use acceptable methods of contraception for at least 21 days prior to study entry and until the last study visit. More information about this criterion can be found in the protocol.
  • Hepatitis B surface antigen negative
  • Anti-hepatitis C virus (anti-HCV) antibody negative or negative HCV PCR if anti-HCV antibody is positive
  • Weighs of or greater than 110 pounds (50 kg)

Exclusion

  • HIV infection
  • HIV vaccines or placebos in prior HIV trial
  • Immunosuppressive medications within 168 days prior to first study vaccination
  • Blood products within 120 days prior to first study vaccination
  • Live attenuated vaccines within 30 days prior to first study vaccination
  • Medically indicated subunit or killed vaccines within 14 days prior to first study vaccination
  • Pneumococcal vaccine within 14 days prior to first study vaccination
  • Allergy treatment with antigen injections within 30 days prior to first study vaccination
  • Current anti-tuberculosis (TB) preventive therapy or treatment
  • Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health
  • Any medical, psychiatric, or social condition that would interfere with the study. More information about this criterion can be found in the protocol.
  • Any job-related responsibility that would interfere with the study
  • Allergies to local amide-type anesthetics
  • Serious adverse reactions to vaccines, including hypersensitivity and related symptoms. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
  • Autoimmune disease or immunodeficiency
  • Active syphilis infection. Participants who have been fully treated for syphilis over 6 months prior to study entry are not excluded.
  • Moderate to severe asthma. More information on this criterion can be found in the protocol.
  • Type 1 or type 2 diabetes mellitus. Participants with histories of isolated gestational diabetes are not excluded.
  • Thyroid disease or surgical removal of the thyroid requiring medication during the 12 months prior to study entry
  • Accumulation of fluid in the blood vessels (angioedema) within 3 years prior to study entry, with episodes requiring medication in the 2 years prior to study entry
  • Hypertension that is not well controlled by medication OR blood pressure of 150/100 or higher at study entry
  • Body mass index (BMI) of 40 or greater OR BMI of 35 or greater, if certain criteria are met. More information about these criteria can be found in the protocol.
  • Bleeding disorder
  • Cancer. Participants with surgically removed cancer that, in the opinion of the investigator, is unlikely to recur are not excluded.
  • Absence of the spleen
  • Plans to become pregnant during the study
  • Pregnancy or breastfeeding
  • Exclusion Criterion for Participants in Part B:
  • Allergies to yeast-derived products

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2008

Estimated Enrollment :

144 Patients enrolled

Trial Details

Trial ID

NCT00111605

End Date

May 1 2008

Last Update

October 14 2021

Active Locations (4)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (4 locations)

1

Alabama Vaccine CRS

Birmingham, Alabama, United States, 35294-2041

2

Project Brave HIV Vaccine CRS

Baltimore, Maryland, United States, 21201

3

Vanderbilt Vaccine CRS

Nashville, Tennessee, United States, 37232

4

Chiang Mai Univ. HVTN CRS

Chiang Mai, Thailand