ONGOING AND PLANNED TRIALS OF PREVENTIVE HIV/AIDS VACCINES (MAY 2012) Vaccine Sponsor/Funder/ Number of Status / Expected Trial 1 Phase Start Date Vaccine(s) 3 Trial Site 2 Clade abbreviation 3 Developer 2 Participants Completion Phase IIb (safety and efficacy) US (Nashville, TN; Birmingham, AL; Los Angeles, CA; San Francisco, CA; Denver, CO; Orlando, FL; Atlanta, VRC-HIVDNA016-00-VP; GA; Chicago, IL; DNA VRC-HIVADV014-00-VP Bethesda, MD; Boston, Ongoing / Expected HVTN 505 Phase IIb June 2009 DAIDS, NIAID, VRC 2,200 A, B, C Ad5 Prime: VRC-HIVDNA016- MA; New York, NY; 2013 00-VP Rochester, NY; Cleveland, OH; Philadelphia, PA; Dallas, TX; Houston, TX; Annandale, VA; Seattle, WA) Phase II (safety, adherence, acceptability, feasibility) ANRS 149 September DNA GTU-MultiHIV B DNA and Planned / Expected Phase II ANRS France (Créteil) 105 B LIGHT 2012 Lipopeptide LIPO-5 vaccines December 2014 ALVAC-HIV (vCP1521) U.S. Army Medical Canarypox Priming With VaxGen RV 305 Phase II March 2012 Research and Thailand (Chon Buri) 162 Ongoing / June 2013 gp120 B/E (AIDSVAX B/E) gp120 Materiel Command Boosting JS7 plasmid DNA and MVA62B vaccine Peru (Lima), US Ongoing, fully enrolled administered as (1) DNA January DNA DAIDS, GeoVax Labs (Birmingham, AL; San / August 2012, long- HVTN 205 Phase IIa at months 0 and 2 and 299 B 2009 Inc. Francisco, CA; New York, term follow-up Aug MVA MVA at months 4 and 6 NY; Seattle, WA) 2014 or (2) MVA at months 0, 2 and 6 Phase I/II and Ib (safety, adherence, acceptability, feasibility) January Modified Vaccinia Karolinska Institutet, Planned / September HIVIS 06 Phase I/II MVA Tanzania 20 2012 Ankara SMl, WRAIR 2012 US (Chicago, IL; New York, NY; Nashville, TN; Ongoing / Expect to December HVTN 085 Phase Ib Ad5 VRC rAd5 HIV vaccine DAIDS, NIAID, VRC Philadelphia, PA; 90 A, B, C close to accrual August 2011 Rochester, NY; San 2012 Francisco, CA) VRC-HIVDNA016-00-VP clade B gag, pol, and nef, clade A env, clade DNA B env, clade C env HVTN 076 Phase Ib May 2011 DAIDS, NIAID, VRC US (Seattle) 45 A, B, C Ongoing Ad5 VRC-HIVADV014-00-VP clade B gag-pol, clade A env, clade B env, clade C env Single dose: VRC- Brazil (Sao Paulo), Peru Ongoing / Expect to HIVADV014-00-VP or (Iquitos, Barranco), close to enrollment January HVTN 084 Phase Ib Ad5 VRC-HIVADV054-00-VP DAIDS, HVTN, VRC Switzerland (Lausanne), 100 A, B, C March 2012, then 2011 (adenoviral vectors) US (Boston, MA; New participants in follow- Inserts: ADV014:clade B York, NY and Chicago, IL) up gag-pol; clades A, B, C env; ADV054: clade B gag-pol Prime: VRC-HIVDNA016- 00-VP (DNA vaccine) ; Boost VRC-HIVADV014- 00-VP (adenoviral Ongoing / Closed to January DNA vector) US (Boston, MA; Seattle, HVTN 082 Phase Ib DAIDS, NIAID, VRC 8 A, B, C enrollment, participants 2010 Inserts: ADV014:clade B WA; San Francisco, CA) Ad5 in follow-up gag-pol; clades A, B, C env; ADV016: clade B gag, pol, and nef, clades A, B and C env October vaccinia virus NYVAC-B; VRC- EuroVacc, HVTN, HVTN 078 Phase Ib Switzerland (Lausanne) 80 A, B, C Ongoing 2009 Ad5 HIVADV038-00-VP NIAID, VRC Recombinant Adenoviral Subtype 35 (rAd35) and Subtype 5 (rAd5) HIV-1 Vaccines When Given as a US (Birmingham, AL; San Heterologous Prime- Francisco, CA; Atlanta, Ongoing / Closed to January Boost Regimen or as HVTN 077 Phase Ib DNA/Ad35 DAIDS, NIAID, VRC GA; Boston,MA; New 192 A enrollment, participants 2007 Boosts to a Recombinant York, NY; Rochester, NY; in follow-up DNA Vaccine in Healthy, Seattle, WA) Ad5-Naïve and Ad5- Exposed (VRC- HIVDNA044-00-VP;VRC- HIVADV027-00-VP;VRC- HIVADV038-00-VP) Phase I (safety, adherence, acceptability, feasibility) Targeted MAVEN Ad26 Phase I start date of Ad26/MVA mosaic MHRP Thailand, Uganda, US 120 Planned (RV 307) 2014 MVA DNA Targeted vaccinia virus DNA/NYVAC/Tenofovir HVTN 095 Phase I start date HVTN, MTN TBD 144 Planned gel/Truvada Q4 2012 Tenofovir gel Truvada Targeted DNA HVTN 092 Phase I start date DNA schedule/NYVAC HVTN TBD 204 Planned Q3 2012 vaccinia virus Targeted gp120 RV 306 Phase I start date of AIDSVAX /ALVAC B/E MHRP Thailand 460 Planned Q3 2012 Canarypox Targeted RV 328 Phase I start date of gp120 AIDSVAX B/E MHRP Thailand 40 Planned Q3 2012 Targeted DNA HVTN 087 Phase I start date of IL12 DNA/IL-12/VSV NIAID US 100 Planned Q2 2012 VSV Targeted DNA DNA/NYVAC/AIDSVAX HVTN 096 Phase I start date of vaccinia virus HVTN US 96 Planned B/E Q2 2012 gp120 GEO-D03 plasmid DNA B, DNA Planned / Expect to and MVA62B vaccine US (Boston, MA; Targeted co- open April 2012 and DNA administered as DNA at DAIDS, GeoVax Labs Rochester, NY; San HVTN 094 Phase I start date of 48 expresses expect to close to months 0 and 2 and Inc., NIAID, Francisco, CA; Q2 2012 MVA GM-CSF accrual November MVA at months 4, 6, and Birmingham, AL) adjuvant 2012 8 Sumagen, Living Killed-Whole Killed-Whole HIV-1 24 HIV-positive SAV-CT01 Phase I March 2012 Hope Clinical US (Los Angeles, CA) Ongoing / March 2013 Vaccine (SAV001-H) participants HIV Foundation European January Ongoing / January EuroNeut41 Phase I gp41 EN41-FPA2 HIV Vaccine Commission; UK (Surrey) 48 2012 2013 PX'Therapeutics Multiantigen HIV (HIV- MAG) Plasmid DNA (pDNA) Vaccine Co- Rwanda (Kigali); Kenya administered With IAVI, Ichor, Profectus and Uganda sites in 2012 December DNA Recombinant Human IL- and three clinical IAVI B004 Phase I pending approvals 75 Ongoing / April 2013 2011 12 pDNA (GENEVAX® IL- research partners in IL2 12) Followed or Africa Preceded by Recombinant Ad35- GRIN/ENV HIV Vaccine SAAVI DNA-C2 prime and SAAVI MVA-C boost, with and without concurrent Novartis November DNA subtype C gp140/MF59 DAIDS, NIAID, South Africa (Klerksdorp; HVTN 086 Phase I 184 C Ongoing 2011 gp140 boost; SAAVI MVA-C Novartis, SAAVI Soweto; Cape Town) with concurrent or subsequent Novartis subtype C gp140/MF59 vaccine. SGUL, the Wellcome Trust under Grand November United Kingdom (London, Ongoing / November Mucovac2 Phase I Gp140 CN54gp140 Challenges in Global 36 C 2011 York) 2012 Health Initiative, UKHVC US (Boston, NY; October Novartis Sub C gp140 Rochester,NY), South HVTN 073E Phase I gp 140 DAIDS, NIAID, SAAVI 36 C Ongoing 2011 with MF59 Africa (Cape Town, Soweto) US (Atlanta, GA; October VSV IN HIV gag vaccine Nashville, TN ; HVTN 090 Phase I VSV DAIDS, NIAID 60 B Ongoing 2011 (rVSVN4CT1gag1) Philadelphia, PA; San Francisco, CA) Clade B HIV-1 Tat HIV-1 Tat/delta-V2 Env Istituto Superiore di protein; combined vaccine Sanita in cooperation ISS P-002 September Italy (Modena, Monza, clade C Recruiting / February Phase I Tat HIV-1 delta-V2 Env with Novartis 50 2011 Rome) HIV-1 2014 vaccine Vaccines & delta-V2 HIV-1 Tat vaccine Diagnostics Env protein DNA Env EDTCP, Imperial ABC, gag College, INS, MHRP, Mozambique AB, Rtmut DNA Prime: HIVIS-DNA Muhimbili University (Maputo),Tanzania Ongoing / December TaMoVac I Phase I August 2011 240 B, rev B; Boost: MVA- CMDR of Health and Allied (Dar es Salaam and 2012 MVA MVA Env Sciences, SMI, Mbeya) E, gag A, University of Munich pol A US (Birmingham, AL; Novartis Sub C gp140 Ongoing, participants HVTN 088 Phase I August 2011 gp 140 DAIDS, NIAID Nashville, TN; Rochester, 40 C with MF59 in follow-up NY; Seattle, WA Novartis Sub C gp140 HVTN 073E DNA with MF59 US (Boston, NY; (Extension Adjuvant, as a Boost Rochester, NY), South Phase I August 2011 MVA DAIDS, NIAID, SAAVI 36 C Ongoing HVTN 073E / Following SAAVI DNA-C2 Africa (Cape Town, SAAVI 102) gp140 Vaccine and SAAVI Soweto) MVA-C Vaccine CN54gp140- hsp70 CN54gp140 Ongoing / February Conjugate Phase I July 2011 gp140 glycoprotein-hsp70 EU, SGUL UK (London) 8 C 2012 Vaccine conjugate vaccine (TL01) DNA VRC-HIVADV014-00-VP VRC 016 Phase I June 2011 and VRC-HIVDNA016-00- NIAID, VRC US (Bethesda, MD) 24 A, B, C Ongoing / July 2014 Ad5 VP Ad26.ENVA.01 and AD35ENV (adenoviral vectors) given in 80 for HVTN Ongoing / Closed to Ad26 heterologous or South Africa (Klerksdorp; HVTN 091 Phase I May 2011 IAVI (SA) sites; 212 A enrollment, participants homolgous prime-boost Soweto; Cape Town) Ad35 for entire study in follow-up doses inserts: Clade A env gp140 February DNA Ad35 investigational HIV Ongoing / November IAVI B002 Phase I GSK, IAVI Kenya, Uganda, Zambia 140 2011 Ad35 vaccine 2012 October Ad5 rAD35 env A/rAd5 env HVTN 083 Phase I VRC US 180 Ongoing/ In follow-up 2010 Ad35 A/B pSG2.HIVconsv DNA, October DNA Ongoing / October HIV-CORE002 Phase I ChAdV63.HIVconsv and University of Oxford UK (Oxford) 32 2010 2012 MVA MVA.HIVconsv rAd35:(VRC-HIVADV027- 00-VP); rAd5: (VRC- US (Birmingham, AL; San HIVADV038-00-VP); rAd5: Francisco, CA; Atlanta, Ongoing / Closed to October Ad5 HVTN 083 Phase I (VRC-HIVADV052-00-VP) DAIDS, NIAID, VRC GA; Boston, MA; New 180 A, B enrollment, participants 2010 Ad35 Inserts: rAD35: env clade York, NY; Rochester, NY; in follow- up A; rAD5(038): env clade Nashville, TN) A; rAD5(052) env clade B Beth Israel Kenya (Kangemi), Deaconess Medical Recombinant Rwanda (Kigali), South Center, Brigham and IAVI B003 October Ad26 Adenovirus HIV-1 Africa (Cape Town, Ongoing, not recruiting Phase I Women's Hospital, 217 (52 at BWH) A (IPCAVD 004) 2010 Vaccine, Ad26.ENVA.01 Johannesburg, & / September 2012 Ad35 Crucell, IAVI, and Ad35-ENV Klerksdorp), US (Boston, IPCAVD, HVTN, NIAID, MA) Ragon Institute Beth Israel Deaconess Medical Ad26.ENVA.0 Recombinant September Center, Brigham and Ongoing, not recruiting 1 (IPCAVD Phase I Ad26 Adenovirus HIV-1 US (Boston, MA) 24 A 2010 Women's Hospital, / November 2012 003) Vaccine, Ad26.ENVA.01 Crucell, IPCAVD, NIAID Prime: PENNVAX-G DNA (ENV & GAG) Administered by September Intramuscular Biojector Ongoing / Not yet 2010, will Kenya (Kericho), Uganda DNA 2000 or CELLECTRA A, B, C, open to recruitment at RV 262 Phase I start in MHRP, NIAID (Kampala), Tanzania 92 Intramuscular D, E African sites, US fully Africa in Q2 MVA (Mbeya) Electroporation Device enrolled 2012 Boost: MVA-CMDR (HIV- 1 CM235 ENV/CM240 GAG/POL) JS7 plasmid DNA and GeoVax MVA62B vaccine US (Atlanta, GA; Therapeutic DNA Ongoing, recruiting/ Phase I June 2010 administered as DNA at GeoVax Labs, Inc.