Ongoing Trials of Preventive AIDS Vaccines
Trial No. Title Start Date Organizer, Developer Countries (No. of sites) Vaccine Name Antigen (Clade)
PHASE III Large trials in high-risk populations to test vaccine efficacy
RV 144 A trial of Sanofi Pasteur live recombinant ALVAC-HIV (vCP1521) priming with VaxGen gp120 B/E (AIDSVAX B/E) boosting Oct-03 DoD, Thailand MOPH, NIAID Thailand (8) TAVEG, Sanofi, VaxGen Prime: ALVAC vCP1521 Boost: AIDSVAX B/E env (B,E); gag/pol, env (B,E)
PHASE II Mid-sized trials in low- and high-risk populations to test vaccine safety and immunogenicity
HVTN 204 A clinical trial to evaluate the safety and immunogenicity of a Sep-05 NIAID, Vical, GenVec multiclade HIV-1 DNA plasmid vaccine, VRC-HIVDNA-01600-VP, followed by a multiclade recombinant adenoviral vector HIV-1 vaccine boost, VRC-ADV-014-00-VP US (7), Brazil (2), South Africa (3) Later: Haiti, Jamaica Prime: VRC-HIVDNA-016-00-VP Boost: VRC-ADV-014-00-VP gag, pol, nef (B), env (A,B,C); gag, pol (B), env (A,B,C)
PHASE I/II Small trials moving into mid-sized trials in low- and high-risk populations to test vaccine safety and immunogenicity
ANRSVAC20/ A trial to compare the immunogenicity and safety of 3 DNA Aug-07 ANRS, EuroVacc EV03 C prime followed by 1 NYVAC C boost to 2 DNA C prime followed by 2 NYVAC C boost NCHECR-AE1 A randomized, placebo-controlled, double-blind, clinical trial to evaluate the safety and immunogenicity of a candidate prophylactic, pHIS-HIV-AE prime followed by rFPV-HIV-AE boost (a non-replicating, recombinant fowlpox virus vector delivering same genes as prime) HIVIS 03 A clinical trial to assess the safety and immunogenicity of a plasmid DNA-MVA prime-boost HIV-1 vaccine candidate France (5), UK, Switzerland, Germany DNA-C, NYVAC-C env, gag, pol, nef (C); env, gag, pol, nef (C) gag, pol, tat/rev, env (A,E)
Feb-07 The National Centre in HIV Thailand Epidemiology and Clinical Research, The University of South Wales Dec-06 MUCHS, Karolinska Institute, Tanzania SMI, Vecura, USMHRP
Prime: pHIS-HIV-AE Boost: rFPV-HIV-AE
Prime: HIVIS DNA Boost: MVA-CMDR
env (A,B,C), gag (A,B), RT (B), rev (B); env (E), gag (A), pol (E)
PHASE I Small trials in low-risk populations to test vaccine safety and immunogenicity
Ad26.ENVA.01 A clinical trial to evaluate the safety and immunogenicity of a recombinant adenovirus serotype 26 HIV-1 vaccine (Ad26.ENVA.01) IAVI C004/ DHO-614 Feb-08 NIAID US Ad26.ENVA.01 env (A)
A study to evaluate the local and systemic reactogenicity Oct-07 Rockefeller University, following serial administration of ADVAX, ADVAX e/g + ADARC, Bill & Melinda Gates Foundation, Ichor ADVAX p/n-t, by Ichor TriGridTM in vivo electroporation Medical Systems, IAVI A Phase Ib clinical trial to evaluate the safety and immunogenicity of recombinant adenoviral serotype 35 (rAd35) and serotype 5 (rAd5) vaccine when given in heterologous prime-boost regimens or as a boost to a recombinant DNA vaccine in adults with pre-existing immunity to adenovirus serotype 5 infection A clinical trial in female volunteers to evaluate the reactogenicity and immunogenicity of nine vaginal immunizations with HIV ZM96gp140 glycoprotein Aug-07 NIAID
US
ADVAX (ADVAX e/g and ADVAX p/n-t)
env, gag, pol, nef, tat (C)
HVTN 072
US
VRC-HIVADV027-00VP VRC-HIVADV038-00VP VRC-HIVDNA044-00-VP
env (A); env (A); env (A)
SGO6RS02
Jul-07
SGUL
UK
ZM96gp140
gp140; env (C)
VRC 012 (07-I-0167)
A clinical trial to evaluate the safety and immunogenicity of Jun-07 NIAID, VRC an HIV-1 adenoviral vector serotype 35 vaccine using dose escalation as a single agent and prime-boost schedules with an HIV-1 adenoviral vector serotype 5 vaccine A clinical trial to evaluate the tolerability and safety of a multi-envelope, prime-boost HIV vaccine (DVP) A clinical trial to evaluate the safety and immunogenicity of DNA vaccine EP-1233 and recombinant MVA-HIV polytope vaccine MVA-mBN32, separately and in a combined prime-boost regimen, when given to vaccinianaive adults May-07 St. Jude Apr-07 NIAID, PharmexaEpimmune
US
VRC-HIVADV027-00-VP VRC-HIVADV038-00-VP
env (A); env (A)
DVP-1 HVTN 067
US US (3)
EnvDNA, PolyEnv1, EnvPro DNA vaccine EP-1233 and env, gag, pol, vpu (B); recombinant MVA-HIV gag, pol, vpr, nef polytope vaccine MVA-mBN32 (A,B,C,D,E,G)
HVTN 069
A Phase Ib trial to compare safety, tolerability, and Nov-06 NIAID immunogenicity of an adenoviral vector boost administered intramuscularly, intradermally, or subcutaneously after a DNA plasmid vaccine prime administered intramuscularly to adenovirus type 5 seropositive adults A study to evaluate the safety and immunogenicity of ALVAC- Oct-06 NIAID, Sanofi HIV vCP1521 in infants born to HIV-1 infected women A clinical trial of intramuscular, subcutaneous, and May-06 NIAID intradermal administration of an HIV-1 multiclade DNA vaccine, VRC-HIVDNA-016-00-VP, and an HIV-1 multiclade adenoviral vector vaccine, VRC-ADV-014-00-VP A clinical trial to evaluate the safety and immunogenicity Apr-06 NIAID, Geovax of pGA2/JS7#2 DNA vaccine and recombinant MVA-HIV 62 vaccine
US (6)
Prime: VRC-HIVDNA-009-00-VP gag, pol, nef (B), env Boost: VRC-ADV-014-00-VP (A,B,C); gag, pol (B), env (A,B,C)
HPTN 027 VRC 011 (06-I-0149)
Uganda US
ALVAC-HIV vCP1521
env (B,E)
Prime: VRC-HIVDNA-016-00-VP gag, pol, nef (B), env Boost: VRC-ADV-014-00-VP (A,B,C); gag, pol (B), env (A,B,C) Prime: HIVB DNA pGA2/JS7#2 gag, pro, RT, env, tat, Boost: MVA-HIV 62 rev, vpu (B); gag, pol, env (B)
HVTN 065
US (5)
Ongoing Trials of Preventive AIDS Vaccines
Trial No. Title Start Date Organizer, Manufacturer Countries (No. of sites) Vaccine Name Antigen (Clade)
PHASE I Small trials in low-risk populations to test vaccine safety and immunogenicity (continued)
HVRF-380131004 A clinical trial to evaluate safety and tolerability of Mar-06 Moscow Institute of administering VICHREPOL, carrying chimeric recombinant Immunology, Russian Federation Ministry of protein comprised of C-terminal p17, full p24, and immunoreactive fragment of gp41 with polyoxidonium Education and Science adjuvant A study of Sanofi Pasteur live recombinant ALVAC-HIV (vCP205, HIV-1 env/gag/pol) administered subcutaneously via ex vivo transfected, autologous dendritic cells, intradermally or intramuscularly A clinical trial to assess the safety and immunogenicity of administering MVA, carrying HIV-1 genes env, gag, and pol in volunteers who previously received plasmid DNA with analogous HIV-1 genes in HIVIS 01 Mar-06 USMHRP Russian Federation VICHREPOL with polyoxidonium adjuvant env, gag (B)
RV 138/ WR 811
US
ALVAC-HIV vCP205
env, gag, pol (B)
HIVIS 02
Jan-06 Karolinska Institute, SMI, USMHRP
Sweden
MVA-CMDR
env (E), gag (A), pol (E)
RV 158/ WR 1143
A double-blind, randomized, dose escalating, placeboJul-05 controlled, study of safety and immunogenicity of WRAIR/ NIH live recombinant MVA-CMDR (HIV-CM235 env/CM240 gag/pol) administered intramuscularly or intradermally A clinical trial to evaluate the safety and tolerability of a recombinant HIV-1 multi-envelope DNA plasmid vaccine (EnvDNA) A randomized, placebo-controlled, double-blind trial to evaluate the safety and immunogenicity of a multiclade HIV-1 DNA plasmid vaccine A dose-escalating study of the safety, tolerability, and immunogenicity of a 3-dose regimen of the MRKAd5 HIV-1 gag vaccine
USMHRP, WRAIR
US Later: Thailand
MVA-CMDR
gp160, gag, pol (A,E)
EnvDNA
May-05 St. Jude, NIAID
US
EnvDNA
env (A,B,C,D,E)
N/A
Mar-05 Guangxi CDC
China
DNA Vaccine
DNA plasmids (B,C)
HVTN 050/ Merck 018
Jun-03 NIAID, Merck
Thailand, Brazil Haiti, Puerto Rico
MRKAd5 HIV-1 gag
gag (B)
NIAID: US National Institute of Allergy and Infectious Diseases. The Vaccine Research Center (VRC) is a NIAID intramural program that develops and manufactures vaccine candidates, conducts Phase I clinical trials, and performs comprehensive immunological analyses. The Division of AIDS (DAIDS) is a NIAID extramural organization that provides regulatory sponsorship and funding for extramural clinical trials. The HIV Vaccine Trials Network (HVTN) is a clinical trial organization funded by a cooperative agreement from DAIDS that conducts Phase I through Phase III studies and a full spectrum of immunological and statistical analyses. For more information on specific trials go to www.clinicaltrials.gov.
ADARC: Aaron Diamond AIDS Research Center; AFRIMS: Armed Forces Research Institute of Medical Sciences; ANRS: Agence Nationale de Recherches sur le SIDA; DoD: US Department of Defense; DR: Dominican Republic; Guangxi CDC: Guangxi Centre for Disease Control and Prevention; HPTN: HIV Prevention Trials Network; IAVI: International AIDS Vaccine Initiative; KI: Karolinska Institute; MII: Moscow Institute of Immunology; Thailand MOPH: Ministry of Public Health Thailand; MUCHS: Muhimbili University College of Health Sciences; MVA: modified vaccinia Ankara; NARI: National AIDS Research Institute in Pune, India; NV: Novartis Vaccines; RFMES: Russian Federation Ministry of Education and Science; RPh.: Richmond Pharmacology; SGUL: St. George’s, University of London; SMI: Swedish Institute for Infectious Disease Control; St. Jude: St. Jude Children’s Research Hospital; TAVEG: Thai AIDS Vaccine Evaluation Group; USMHRP: US Military HIV Research Program; WRAIR: Walter Reed Army Institute of Research
All data as of June 2008.