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VRC Vaccine Research Studies

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Clinical Studies Archive

Studies Closed to Accrual

VRC Clinical Trials Related to Development of Vaccines for Prevention of HIV

VRC 000 (02-I-0127):
Screening Subjects for HIV Vaccine Research Studies

VRC 001 (01-I-0079):
"Evaluation of an HIV-1 DNA Vaccine Encoding a Modified Gag-Pol Protein in Uninfected Adult Volunteers"

VRC 004 (03-I-0022):
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA009-00-VP, in Uninfected Adult Volunteers

VRC 006 (04-I-0172):
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Multiclade HIV-1 Adenoviral Vector Vaccine, VRC-HIVADV014-00-VP, in Uninfected Adult Volunteers

VRC 007 (04-I-0254):
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a 6-Plasmid Multiclade HIV-1 DNA Vaccine, VRC-HIVDNA016-00-VP, in Uninfected Adult Volunteers

VRC 008 (05-I-0148):
A Phase I Clinical Trial of a Prime-Boost HIV-1 Vaccination Schedule: Multiclade DNA Vaccine, VRC-HIVDNA016-00-VP, Followed by Multiclade Adenoviral Vector Vaccine, VRC-HIVADV014-00-VP, in Uninfected Adult Volunteers

VRC 009 (05-I-0081):
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Booster Dose of a Recombinant Multiclade HIV-1 Adenoviral Vector Vaccine, VRC-HIVADV014-00-VP, in Uninfected Subjects who were Previously Immunized with VRC-HIVDNA009-00-VP in VRC 004 (03-I-0022)

VRC 010 (05-I-0140):
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Booster Dose of a Recombinant Multiclade HIV-1 Adenoviral Vector Vaccine, VRC-HIVADV014-00-VP, in Uninfected Subjects who were Previously Immunized with VRC-HIVDNA016-00-VP in VRC 007 (04-I-0254)

VRC 011 (06-I-0149):
A Phase I Clinical Trial of Intramuscular, Subcutaneous and Intradermal Administration of an HIV-1 Multiclade DNA Vaccine, VRC-HIVDNA016-00-VP, and an HIV-1 Multiclade Adenoviral Vector Vaccine, VRC-HIVADV014-00-VP, in Uninfected Adult Volunteers

VRC 012 (07-I-0167):
A Phase I Clinical Trial of the Safety and Immunogenicity of an HIV-1 Adenoviral Vector Serotype 35 Vaccine, VRC-HIVADV027-00-VP (rAd35-EnvA): Dose Escalation as a Single Agent and Prime-Boost Schedules with an HIV-1 Adenoviral Vector Serotype 5 Vaccine, VRC-HIVADV038-00-VP (rAd5-EnvA), in Uninfected Adults

VRC 015 (08-I-0171):
A Phase I, Open-Label Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of a Multiclade Recombinant HIV-1 Adenoviral Vector Vaccine, VRC-HIVADV014-00-VP, in Uninfected Adults Randomized to Needle or Biojector Methods of Intramuscular Injection

VRC 016 (11-I-0197):
Immune Responses to Two Experimental HIV Vaccines in Healthy Adults

HVTN 505 (09-I-0163):
Phase 2b, randomized, placebo-controlled test-of-concept trial to evaluate the safety and efficacy of a multiclade HIV-1 DNA plasmid vaccine followed by a multiclade HIV-1 recombinant adenoviral vector vaccine in HIV-uninfected, adenovirus type 5 neutralizing antibody negative, circumcised men and male-to-female (MTF) transgender persons, who have sex with men

VRC 602 (14-I-0019):
A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIV MAB060-00-AB (VRC01),Administered Intravenously or Subcutaneously to Healthy Adults

VRC Clinical Trials Related to Development of Vaccines for Treatment of HIV

VRC 100 (03-I-0079):
Screening HIV-Infected Subjects for Vaccine Research Studies

VRC 101 (06-I-0056):
A Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of a Prime-Boost Vaccination Schedule of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, followed by a Recombinant Multiclade HIV-1 Adenoviral Vector Vaccine, VRC-HIVADV014-00-VP, in HIV-Infected Adult Volunteers

VRC Clinical Trials Related to Vaccines for Biodefense and Emerging Pathogens

VRC 300 (03-I-0285):
Screening of Healthy Volunteers for Clinical Trials of Investigational Vaccines to Prevent Infectious Diseases

Smallpox Vaccine Studies

VRC 201 (02-I-0316):
A Phase I/II Clinical Trial of Modified Vaccinia Virus Ankara (MVA) to Evaluate its Safety, Dosing Schedule, Immunogenicity and Protective Efficacy Against Dryvax Challenge in Vaccinia-Naive Individuals

VRC 203 (03-I-0087):
A Phase I/II Clinical Trial of Modified Vaccinia Virus Ankara (MVA) to Evaluate its Safety, Immunogenicity and Protective Efficacy Against Dryvax Challenge in Vaccinia-Immune Individuals

Ebola Vaccine Studies

VRC 204 (04-I-0028):
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiple Strain Ebola DNA Plasmid Vaccine, VRC-EBODNA012-00-VP, in Adult Volunteers

VRC 205 (06-I-0237):
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Ebola Adenoviral Vector Vaccine, VRC-EBOADV018-00-VP, in Healthy Adults

VRC 206 (08-I-0065):
A Phase I Study to Evaluate the Safety and Immunogenicity of an Ebola DNA Plasmid Vaccine, VRC-EBODNA023-00-VP, and a Marburg DNA Vaccine, VRC-MARDNA025-00-VP, in Healthy Adults

SARS Vaccine Studies

VRC 301 (05-I-0056):
A Phase I Study of the Safety and Immunogenicity of a SARS Recombinant DNA Plasmid Vaccine, VRC-SRSDNA015-00-VP, in Healthy Adult Volunteers

West Nile Virus Vaccine Studies

VRC 302 (05-I-0126):
A Phase I Study of the Safety and Immunogenicity of a West Nile Virus Recombinant DNA Plasmid Vaccine, VRC-WNVDNA017-00-VP, in Healthy Adult Volunteers

VRC 303 (06-I-0110):
A Phase I Study of the Safety and Immunogenicity of a West Nile Virus Recombinant DNA Plasmid Vaccine, VRC-WNVDNA020-00-VP, in Healthy Adult Subjects

Influenza Vaccine Studies

VRC 304 (07-I-0042):
A Phase I Study of the Safety and Immunogenicity of a Recombinant DNA Plasmid Vaccine (VRC-AVIDNA036-00-VP), Encoding for the Influenza Virus H5 Hemagglutinin Protein in Healthy Adults

VRC 305 (07-I-0172):
A Phase I Open-Label Study of the Safety and Immunogenicity of a Recombinant DNA Plasmid Vaccine, VRC-AVIDNA036-00-VP, Encoding for the Influenza Virus H5 Hemagglutinin Protein Administered Intradermally in Healthy Adults

VRC 306 (09-I-0012):
An Open-Label, Randomized Phase I Study in Healthy Adults of Four Prime-Boost Schedules with Monovalent Influenza Subunit Virion (H5N1) Vaccine, A/Indonesia/05/2005 (Sanofi Pasteur, Inc), Administered Alone or Following Recombinant DNA Plasmid (H5) Vaccine, VRC-AVIDNA036-00-VP (VRC, NIAID)

VRC 307 (09-I-0090):
A Double-Blind, Randomized Phase I Study of the Safety and Immunogenicity of a Prime-Boost Schedule of the Investigational DNA Trivalent Influenza Vaccine, VRC-FLUDNA047-00-VP, Followed by the 2008/2009 Seasonal Influenza Trivalent Inactivated Vaccine (TIV) Compared to TIV Alone in Healthy Adults Ages 18-50 and 51-70 Years

VRC 308 (09-I-0204):
An Open-Label Phase I Study of the Safety and Immunogenicity of an Investigational H1 DNA Influenza Vaccine, VRC-FLUDNA057-00-VP, in Healthy Adults 18-70 Years Old

VRC 309 (10-I-0004):
A Multi-Center, Open-Label, Randomized Phase I Study of an Investigational Influenza DNA Vaccine Followed by 2009/2010 Seasonal Influenza Trivalent Inactivated Vaccine (TIV) Compared to Two Injections of TIV in Adults 45-70 Years

VRC 310 (10-I-0069):
An Open-Label, Randomized Phase I Study in Healthy Adults of the Safety and Immunogenicity of Prime-Boost Intervals with Monovalent Influenza Subunit Virion (H5N1) Vaccine, A/Indonesia/05/2005 (Sanofi Pasteur, Inc), Administered Alone or Following Recombinant DNA Plasmid (H5) Vaccine, VRC-AVIDNA036-00-VP (VRC, NIAID)

Alphavirus Vaccine Studies

VRC 311 (12-I-0041):
Phase 1, Open Label, Dose-Escalation Clinical Trial to Evaluate the Safety and Immunogenicity of a Virus-Like Particle (VLP) Chikungunya Vaccine in Healthy Adults

Malaria Vaccine Studies

VRC 312 (11-I-0257):
Phase 1, Open-Label, Dose-Escalation Clinical Trial with Experimental Challenge to Evaluate Intravenous Administration of PfSPZ Vaccine in Malaria-Naive Adults

VRC Protocols to Obtain Laboratory Samples for Vaccine and Immunology Research

VRC PAN (02-I-0066):
Studies of Specific Immune Responses in Human Peripheral Blood Cells in HIV-Infected and HIV-Uninfected Volunteers

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Last Updated December 17, 2014