Trial record 12 of 49 for:    " January 30, 2008":" February 29, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Safety of and Immune Response to an Adenoviral HIV-1 Vaccine in Healthy Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00618605
First received: February 18, 2008
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
HIV Infections
Biological: Ad26.ENVA.01 HIV-1 vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: A Phase 1 Randomized, Double-Blind, Placebo Controlled Dose Escalation Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Adenovirus Serotype 26 HIV-1 Vaccine (Ad26.ENVA.01) in Healthy, HIV-1 Uninfected Adults

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Local and systemic reactions to injection [ Time Frame: After each injection ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Humoral immune responses, such as neutralizing and binding antibodies to HIV and Ad26 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Cell mediated immunity, including T-cell gamma interferon responses and assessment of T-cell responses by flow cytometry [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Genotyping [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Stored samples may be used to perform additional assays for further evaluation of immunogenicity and to support standardization and validation of new assays such as epitope mapping, flow cytometry, and/or tetramer analysis. [ Time Frame: After study follow-up ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: February 2008
Arms Assigned Interventions
Experimental: 1
3 injections of Ad26.ENVA.01 HIV-1 vaccine or placebo at 1 x 10^9 virus particles (VP) given at Days 0, 28, and 168
Biological: Ad26.ENVA.01 HIV-1 vaccine
Recombinant adenovirus serotype 26 HIV-1 vaccine
Experimental: 2
3 injections of Ad26.ENVA.01 HIV-1 vaccine or placebo at 1 x 10^10 VP given at Days 0, 28, and 168
Biological: Ad26.ENVA.01 HIV-1 vaccine
Recombinant adenovirus serotype 26 HIV-1 vaccine
Experimental: 3
3 injections of Ad26.ENVA.01 HIV-1 vaccine or placebo at 1 x 10^11 VP given at Days 0, 28, and 168
Biological: Ad26.ENVA.01 HIV-1 vaccine
Recombinant adenovirus serotype 26 HIV-1 vaccine
Experimental: 4
2 injections of Ad26.ENVA.01 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
Biological: Ad26.ENVA.01 HIV-1 vaccine
Recombinant adenovirus serotype 26 HIV-1 vaccine

Detailed Description:

HIV infection continues to spread at pandemic levels throughout the world. Control of this 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 26 preventive HIV-1 vaccine.

This study will last 12 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, occurring at baseline and after 0.5, 1, 1.5, 2, 6, 6.5, 7, and 12 months. 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 7 days after each injection. Risk reduction/pregnancy prevention counseling will occur at visits 1 through 9, and physical exams and assessments of illness or adverse events will occur at all visits. At most visits, blood, urine, and oral swab collection will occur. At some visits, HIV testing and pregnancy testing will occur.

Once a year for 5 years following study entry, participants will attend a study visit or will be contacted by study staff by telephone or e-mail for follow-up safety and health monitoring. Some participants will also undergo a blood collection at these visits.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Good general health with 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
  • Appropriate hemoglobin, white blood cell, lymphocyte, and platelet count values as defined in the study protocol
  • Certain laboratory values as defined in the study protocol
  • Adequate contraception from at least 21 days prior to study entry through visit 10

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 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 and/or well-controlled asthma
  • Active syphilis infection. Those fully treated for syphilis over 6 months prior to study entry are not excluded.
  • Diabetes mellitus type 1 or 2
  • Thyroidectomy or thyroid disease requiring medication within 12 months prior to study entry
  • Angioedema in the 3 years prior to study entry if the episodes are considered serious or have required medication within the last 2 years
  • 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 a functional spleen
  • Psychiatric condition within the last 3 years. More information on this criterion can be found in the study protocol.
  • Individuals at high-risk of acquiring HIV infection
  • Presence of pre-existing neutralizing antibodies for Adenovirus 26
  • Pregnancy or breastfeeding
  Contacts and Locations
Choosing 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: NCT00618605

Locations
United States, Massachusetts
Brigham and Women's Hosp. Novel Adenoviral Vector Prophylactic HIV Vaccine CRS
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Investigators
Study Chair: Lindsey Baden, MD Brigham and Women's Hospital
Study Chair: Dan Barouch, MD, PhD Beth Israel Deaconess Medical Center
Study Chair: Raphael Dolin, MD Brigham and Women's Hospital
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00618605     History of Changes
Other Study ID Numbers: Ad26.ENVA.01/IPCAVD-001, 10623, Ad26.ENVA.01
Study First Received: February 18, 2008
Last Updated: December 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Seronegativity
HIV Preventative Vaccine

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014