AzTrials
AzTrials

HIV InfectionsPhase 1/2NCT00071851

Safety of and Immune Response to an HIV-1 DNA Vaccine (VRC HIVDNA009-00-VP) in HIV Uninfected Adults

A Phase 1/2 study testing VRC-HIVDNA009-00-VP in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine, VRC-HIVDNA009-00-VP, in HIV uninfected participants. Two different doses of the vaccine will be tested. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
VRC-HIVDNA009-00-VP
How many people
180 participants
Where
14 sitesUnited States
Study dates
Dec 2003to Oct 2005
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Understanding of vaccination procedure
  • 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

Who cannot join

  • HIV vaccines or placebo in a prior HIV vaccine trial
  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Project Brave HIV Vaccine CRS

    Baltimore, Maryland, 21201

  • Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore

    Baltimore, Maryland, 21205

  • Alabama Vaccine CRS

    Birmingham, Alabama, 35294

  • Brigham and Women's Hosp. CRS

    Boston, Massachusetts, 02115

  • Fenway Community Health Clinical Research Site (FCHCRS)

    Boston, Massachusetts, 02215

  • Vanderbilt Vaccine CRS

    Nashville, Tennessee, 37232

  • NY Blood Ctr./Union Square CRS

    New York, New York, 10003

  • HIV Prevention & Treatment CRS

    New York, New York, 10032

  • Miriam Hospital's HVTU

    Providence, Rhode Island, 02906

  • Univ. of Rochester HVTN CRS

    Rochester, New York, 14642

  • San Francisco Vaccine and Prevention CRS

    San Francisco, California, 94102

  • FHCRC/UW Vaccine CRS

    Seattle, Washington, 98104

  • Saint Louis Univ. School of Medicine, HVTU

    St Louis, Missouri, 63110

  • NY Blood Ctr./Bronx CRS

    The Bronx, New York, 10455

Other trials in United States

About this study

Official title: A Phase IB Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA009-00-VP, Administered at 2 Different Dosing Schedules, in HIV-1-Uninfected Adult Participants

The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine, VRC-HIVDNA009-00-VP, in HIV uninfected participants. Two different doses of the vaccine will be tested.

Read the detailed description

The worldwide HIV epidemic highlights the importance of developing an affordable, globally successful vaccine for HIV prevention. The VRC-HIVDNA009-00-VP vaccine used in this study was developed to incorporate HIV genes from multiple virus clades, representing the viral subtypes responsible for about 90% of new HIV infections in the world. The purpose of this study is to determine the safety and immunogenicity of VRC-HIVDNA009-00-VP in healthy, HIV uninfected individuals.

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
HIV Infections
Being tested
VRC-HIVDNA009-00-VP
Keywords
HIV Seronegativity, HIV Preventive Vaccine
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VRC-HIVDNA009-00-VPBiological

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2003 (estimated)
  2. Study startDec 2003
  3. Study completionOct 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Enrolment
180 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00071851
Sponsor's protocol ID
HVTN 052
Other IDs
10198
Status last verified
Oct 2021
First submitted
3 Nov 2003
Last updated
14 Oct 2021
Results posted
No

Publications

  • 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.

    PubMed 11498307

  • 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.

    PubMed 10669329

  • 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.

    PubMed 11390574

  • 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.

    PubMed 11832690

  • 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.

    PubMed 11251382

  • 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.

    PubMed 25820067

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing VRC-HIVDNA009-00-VP in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00071851, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.

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