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NCT00071851 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00071851
Other study ID # HVTN 052
Secondary ID 10198
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date December 2003
Est. completion date October 2005

Study information
Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date October 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria - 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 Exclusion Criteria - 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 - 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• VRC-HIVDNA009-00-VP

Locations
Country Name City State
United States Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore Baltimore Maryland
United States Project Brave HIV Vaccine CRS Baltimore Maryland
United States Alabama Vaccine CRS Birmingham Alabama
United States Brigham and Women's Hosp. CRS Boston Massachusetts
United States Fenway Community Health Clinical Research Site (FCHCRS) Boston Massachusetts
United States NY Blood Ctr./Bronx CRS Bronx New York
United States Vanderbilt Vaccine CRS Nashville Tennessee
United States HIV Prevention & Treatment CRS New York New York
United States NY Blood Ctr./Union Square CRS New York New York
United States Miriam Hospital's HVTU Providence Rhode Island
United States Univ. of Rochester HVTN CRS Rochester New York
United States Saint Louis Univ. School of Medicine, HVTU Saint Louis Missouri
United States San Francisco Vaccine and Prevention CRS San Francisco California
United States FHCRC/UW Vaccine CRS Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

Mascola JR, Nabel GJ. Vaccines for the prevention of HIV-1 disease. Curr Opin Immunol. 2001 Aug;13(4):489-95. Review. — View Citation

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. Review. — View Citation

Osmanov S, Pattou C, Walker N, Schwardländer 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. — View Citation

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