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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

VRC 207 (14-I-0183):
A Phase 1/1b, Open-Label, Dose-Escalation Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Ebola Chimpanzee Adenovirus Vector Vaccines VRC-EBOADC069-00-VP (cAd3-EBO), and VRC-EBOADC076-00-VP (cAd3-EBOZ), 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 314 (14-I-0035):
A Phase 1, Open-Label, Clinical Trial With Experimental Controlled Human Malaria Infections (CHMI) to Evaluate Safety and Durability of Protection Following Intravenous and Intramuscular Administration of PFSPZ Vaccine in Malaria-Naive Adults

VRC 315 (14-I-0160):
A Phase I Open-Label, Randomized Study of H7 Influenza Prime-Boost Regimens in Healthy Adults: Recombinant H7 DNA Plasmid Vaccine, VRC-FLUDNA071-00-VP, Administered Alone or With Monovalent Influenza Subunit Virion H7N9 Vaccine (MIV) as Prime With MIV Boost Compared to MIV Prime With MIV Boost

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 June 01, 2015