Safety of and Immune Response to an HIV-1 DNA Vaccine (VRC HIVDNA009-00-VP) in HIV Uninfected Adults
NCT ID: NCT00071851
Last Updated: 2021-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
180 participants
INTERVENTIONAL
2003-12-31
2005-10-31
Brief Summary
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Detailed Description
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Participants will be randomly assigned to one of three groups and will be followed for one year. Study injections will be given by needle-free intramuscular injection at the start of study and at Months 1 and 2. Group 1 will receive 3 injections of the study vaccine; Group 2 will receive 2 injections of the study vaccine (at start and Month 2) and injection of placebo (at Month 1); Group 3 will receive 3 injections of placebo. After a screening visit, study visits will occur at enrollment (initial injection) followed by 5 visits every 14 days for the first 2.5 months, with three additional visits at Months 6, 9, and 12. All participants will undergo physical exams, blood and urine tests to assess measures of health, and blood tests to assess HIV infection and immune response to the injections.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
DOUBLE
Interventions
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VRC-HIVDNA009-00-VP
Eligibility Criteria
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Inclusion Criteria
* Willing to receive HIV test results and provide informed consent
* Good general health
* HIV negative
* Hepatitis B surface antigen negative
* Anti-hepatitis C virus (HCV) antibody negative, or negative for HCV PCR if the anti-HCV is positive
* Not pregnant and agrees to use acceptable forms of contraception
Exclusion Criteria
* Immunosuppressive medications within 168 days prior to study
* Blood products within 120 days prior to study
* Immunoglobulin within 60 days prior to study
* Live attenuated vaccines within 30 days prior to study
* Investigational research agents within 30 days prior to study
* Medically indicated subunit or killed vaccines within 14 days prior to study
* Current anti-tuberculosis prophylaxis or therapy
* Anaphylaxis or other serious adverse reactions to vaccines; a person who had an adverse reaction to pertussis vaccine as a child is not excluded
* Autoimmune disease or immunodeficiency
* Active syphilis infection
* Unstable asthma (e.g., use of oral, orally inhaled, or intravenous corticosteroids, emergent care, urgent care, hospitalization or intubation during the past 2 years)
* Diabetes mellitus; a participant with past gestational diabetes is not excluded
* Thyroid disease, including removal of thyroid and diagnoses requiring medication
* Serious angioedema
* Hypertension
* Diagnosis of bleeding disorder
* Malignancy, except those with a surgical excision and subsequent observation period that in the investigator's estimate has a reasonable assurance of sustained cure and/or is unlikely to recur during the period of the study
* Seizure disorder requiring medication within the last 3 years
* Absence of the spleen
* Mental illness that would interfere with compliance with the protocol
* Pregnant or breastfeeding
* Two or more elevated liver function tests
18 Years
50 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Julie McElrath
Role: STUDY_CHAIR
Fred Hutchinson Cancer Research Center / University of Washington
Larry Peiperl
Role: STUDY_CHAIR
San Francisco Department of Public Health / University of California - San Diego
Locations
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Alabama Vaccine CRS
Birmingham, Alabama, United States
San Francisco Vaccine and Prevention CRS
San Francisco, California, United States
Project Brave HIV Vaccine CRS
Baltimore, Maryland, United States
Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore
Baltimore, Maryland, United States
Brigham and Women's Hosp. CRS
Boston, Massachusetts, United States
Fenway Community Health Clinical Research Site (FCHCRS)
Boston, Massachusetts, United States
Saint Louis Univ. School of Medicine, HVTU
St Louis, Missouri, United States
NY Blood Ctr./Union Square CRS
New York, New York, United States
HIV Prevention & Treatment CRS
New York, New York, United States
Univ. of Rochester HVTN CRS
Rochester, New York, United States
NY Blood Ctr./Bronx CRS
The Bronx, New York, United States
Miriam Hospital's HVTU
Providence, Rhode Island, United States
Vanderbilt Vaccine CRS
Nashville, Tennessee, United States
FHCRC/UW Vaccine CRS
Seattle, Washington, United States
Countries
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References
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Mascola JR, Nabel GJ. Vaccines for the prevention of HIV-1 disease. Curr Opin Immunol. 2001 Aug;13(4):489-95. doi: 10.1016/s0952-7915(00)00246-6.
Boyer JD, Cohen AD, Vogt S, Schumann K, Nath B, Ahn L, Lacy K, Bagarazzi ML, Higgins TJ, Baine Y, Ciccarelli RB, Ginsberg RS, MacGregor RR, Weiner DB. Vaccination of seronegative volunteers with a human immunodeficiency virus type 1 env/rev DNA vaccine induces antigen-specific proliferation and lymphocyte production of beta-chemokines. J Infect Dis. 2000 Feb;181(2):476-83. doi: 10.1086/315229.
Moore JP, Parren PW, Burton DR. Genetic subtypes, humoral immunity, and human immunodeficiency virus type 1 vaccine development. J Virol. 2001 Jul;75(13):5721-9. doi: 10.1128/JVI.75.13.5721-5729.2001. No abstract available.
Osmanov S, Pattou C, Walker N, Schwardlander B, Esparza J; WHO-UNAIDS Network for HIV Isolation and Characterization. Estimated global distribution and regional spread of HIV-1 genetic subtypes in the year 2000. J Acquir Immune Defic Syndr. 2002 Feb 1;29(2):184-90. doi: 10.1097/00042560-200202010-00013.
Manam S, Ledwith BJ, Barnum AB, Troilo PJ, Pauley CJ, Harper LB, Griffiths TG 2nd, Niu Z, Denisova L, Follmer TT, Pacchione SJ, Wang Z, Beare CM, Bagdon WJ, Nichols WW. Plasmid DNA vaccines: tissue distribution and effects of DNA sequence, adjuvants and delivery method on integration into host DNA. Intervirology. 2000;43(4-6):273-81. doi: 10.1159/000053994.
Jin X, Morgan C, Yu X, DeRosa S, Tomaras GD, Montefiori DC, Kublin J, Corey L, Keefer MC; NIAID HIV Vaccine Trials Network. Multiple factors affect immunogenicity of DNA plasmid HIV vaccines in human clinical trials. Vaccine. 2015 May 11;33(20):2347-53. doi: 10.1016/j.vaccine.2015.03.036. Epub 2015 Mar 25.
Other Identifiers
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10198
Identifier Type: REGISTRY
Identifier Source: secondary_id
HVTN 052
Identifier Type: -
Identifier Source: org_study_id