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Safety and Immune Response to a Recombinant Adenovirus HIV-1 Vaccine in Healthy Adults
This study is currently recruiting participants.
Study NCT00695877   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)
First Received: June 10, 2008   Last Updated: February 24, 2009   History of Changes

June 10, 2008
February 24, 2009
February 2009
November 2010   (final data collection date for primary outcome measure)
Local and systemic adverse reactions [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00695877 on ClinicalTrials.gov Archive Site
  • Humoral Immune response [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Cell mediated immunity [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Genotyping [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
 
Safety and Immune Response to a Recombinant Adenovirus HIV-1 Vaccine in Healthy Adults
A Phase I Randomized, Double-Blind, Placebo Controlled Dose Escalation Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Adenovirus Serotype 5 HVR48 HIV-1 Vaccine (Ad5HVR48.ENVA.01) in Healthy, HIV-1 Uninfected Adults

Successful control of the HIV epidemic will require a safe and effective vaccine to be developed. A successful vaccine will need to stimulate a widespread immune response. The purpose of this study is to determine the safety of and immune response to an adenovirus serotype HIV vaccine in HIV uninfected adults.

Control of the HIV pandemic can only be achieved with the development of a safe and effective preventive HIV vaccine. A vaccine that will prevent HIV infection will elicit a strong immune response from both CD4 and CD8 cells. Recombinant adenovirus serotype vectors have been shown to elicit just such a response. The purpose of this study is to determine the safety and immunogenicity of the recombinant adenovirus serotype 5 preventive HIV-1 vaccine.

This study will last 18 to 24 months. Participants will be randomly assigned to one of four arms that will receive different doses of the vaccine or placebo administered via intermuscular injection. Participants in Arms 1, 2, and 3 will all receive 3 injections. Each injection will contain the same dose of vaccine. Arm 4 will receive 2 injections of a dose of vaccine that will be determined by the safety data from Arms 1, 2, and 3. Participants will be enrolled sequentially, from lowest to highest dose of vaccine, into Arms 1, 2, and 3. Arms will begin enrollment only following review of safety data from the previous group. After the Day 42 safety data from Arms 1, 2, and 3 have been reviewed, the dose for Arm 4 will be determined, and enrollment into that arm will begin.

There will be 10 study visits in this study. Participants in Arms 1, 2, and 3 will receive injections on Days 0, 28, and 168. Participants in Arm 4 will receive injections on Days 0 and 168. Participants will be asked to record their temperature and other side effects in a symptom log for 3 days after each injection. Risk reduction/pregnancy prevention counseling and physical exams will occur at all visits. At most visits, blood, urine, and oral swab collection will occur. HIV testing and pregnancy testing will occur at select visits. Additionally, volunteers will be contacted at Years 2, 3, 4, and 5 by telephone, e-mail, or study visit to collect vital status, and information about any development of significant disability or incapacity, hospitalizations, or congenital anomalies.

Phase I
Interventional
Prevention, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Safety/Efficacy Study
HIV Infections
Biological: Ad5.ENVA.48 HIV-1 vaccine
  • Experimental: 3 injections of rAd5.ENVA.48 HIV-1 vaccine or placebo at 1 x 10^9 virus particles (VP) given at Days 0, 28, and 168
  • Experimental: 3 injections of rAd5.ENVA.48 HIV-1 vaccine or placebo at 1 x 10^10 virus particles (VP) given at Days 0, 28, and 168
  • Experimental: 3 injections of rAd5.ENVA.48 HIV-1 vaccine or placebo at 1 x 10^11 virus particles (VP) given at Days 0, 28, and 168
  • Experimental: 3 injections of rAd5.ENVA.48 HIV-1 vaccine or placebo at a dose to be determined by the safety data from Arms 1, 2 and 3 given at Days 0 and 168

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
48
November 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Good general health
  • Normal hematological, hepatic and renal functions
  • Demonstrated understanding of study
  • Willing to receive HIV test results
  • HIV-1 and -2 uninfected
  • Hepatitis B surface antigen negative
  • Anti-hepatitis C virus (anti-HCV) negative antibody or negative HCV PCR if anti-HCV is positive
  • Adequate contraception. For more information on this criterion can be found in the protocol.

Exclusion Criteria:

  • HIV vaccines or placebos in prior HIV vaccine trial
  • Immunosuppressive medications within 168 days prior to first injection. Participants taking corticosteroid nasal spray or topical corticosteroids are not excluded.
  • Blood products within 120 days prior to first injection
  • Immunoglobulin within 60 days prior to first injection
  • Investigational agents within 30 days prior to first injections
  • Live attenuated vaccine within 30 days prior to first injection
  • Any vaccine that is not a live attenuated vaccine within 14 days prior to first injection
  • Any clinically significant medical condition that, in the opinion of the investigator, may interfere with the study
  • Any medical, psychiatric, occupational, or social condition or responsibility that, in the opinion of the investigator, would interfere with the study
  • Serious adverse reaction to vaccines. Participants who had a nonanaphylactic adverse reaction to pertussis vaccine as a child are not excluded.
  • Known autoimmune disease
  • Known immunodeficiency
  • Asthma other than mild, well-controlled asthma
  • Diabetes mellitus type 1 or 2
  • Thyroidectomy or thyroid disease in the12 months prior to study entry
  • Angiodema in the 3 years prior to study entry
  • Hypertension. More information on this criterion can be found in the protocol.
  • Body mass index (BMI) of 40 or higher OR BMI of 35 or greater, if other cardiovascular risk factors. More information on this criterion can be found in the protocol.
  • Bleeding disorder
  • Malignancy, unless it has been surgically removed and, in the opinion of the investigator, is not likely to recur during the study period
  • Seizure disorder or occurrence of seizure in the 3 years prior to study entry. Participants who have not required medications or had a seizure for prior 3 years are not excluded.
  • Absence of spleen
  • Individuals at high-risk of acquiring HIV infection
  • Presence of pre-existing neutralizing antibodies for Adenovirus 5 or 48
  • Pregnancy or breastfeeding
Both
18 Years to 50 Years
Yes
 
United States
 
NCT00695877
Rona Siskind, DAIDS
Ad5HVR48.ENVA.01
National Institute of Allergy and Infectious Diseases (NIAID)
 
Study Chair: Lindsey Baden, MD Brigham and Women's Hospital
Study Chair: Dan Barouch, MD Beth Israel Deaconess Medical Center
National Institute of Allergy and Infectious Diseases (NIAID)
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP