Ongoing HVTN Trials. Protocol N Trial Collaborators HVTN HVTN VRC DAIDS. Study Product(s)

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1 HVTN HVTN DNA multiclade rad5 multiclade 09/2011 The study looks at the immune response of genital and rectal tissues to injections of a DNA vaccine followed by a recombinant adenovirus serotype 5 (rad5) vaccine. HVTN HVTN rad5 multiclade rad5 clade B 03/2011 Boston - Brigham; Chicago; Iquitos; Lausanne; Lima - Barranco; New York - NYBC; New York - NYBC - Bronx; Sao Paulo; Union Square; The study looks at whether the immune responses to 2 of the HIV genes (gag and pol) are affected by a study vaccine carrying 3 types of lab-made genes (gag, pol, and env) compared to a vaccine that contains only the gag and pol lab-made genes. HVTN HVTN rad5 multiclade 02/2012 Boston - Brigham; Chicago; Nashville; New York - NYBC; New York - NYBC - Bronx; Philadelphia; Rochester; San Francisco; Union Square; Study looks at whether the immune response to the vaccine is improved if the vaccine is given all at once in one arm, or split into 4 injections in the arms and legs (for the same final dose as the single injection), or broken into its 4 component parts with each component given in a different arm or leg. HVTN HVTN IPPOX EuroVacc DNA clade C NYVAC clade C 04/2013 Atlanta - Hope Clinic; Brigham; Chicago; Lausanne; Philadelphia; San Francisco; Study compares 2 versus 3 DNA primes, and the timing of the 3 DNA priming vaccines, followed by a NYVAC boost. As of July 5,

2 HVTN HVTN AIDSVAX B/E DNA clade C IPPOX NYVAC clade C EuroVacc GSID USMHRP 08/2012 Lausanne; Study compares the priming ability of NYVAC alone versus NYVAC + AIDSVAX B/E, and DNA alone versus DNA + AIDSVAX B/E, when followed by NYVAC + AIDSVAX B/E boosts. HVTN HVTN Inovio PENNVAX-GP IL-12 DNA adjuvant 09/2015 Atlanta - Hope Clinic; Nashville; Rochester; Study looks at the safety of a DNA vaccine given with an IL-12 plasmid DNA adjuvant and electroporation, given into the skin or into the muscle of the upper arm. It will also look at which approach results in stronger immune responses. HVTN HVTN GSK SanofiPasteur ALVAC-HIV (vcp2438) multiclade gp120/mf59 02/2015 Cape Town - Emavundleni; Durban - ethekwini; Durban - Isipingo; Klerksdorp; Soshanguve; Soweto - Bara; HVTN 100 is evaluating the safety and immune responses to a vaccine regimen similar to the RV144 regimen in HIV-uninfected adults at low risk of HIV infection. The vaccines have been adapted to the southern African region by using clade C envelope antigens.: clade C ALVAC-HIV (vcp2438) and gp120/mf59. HVTN HVTN CHAVI-ID EuroVacc LANL USMHRP DNA consensus S Env DNA trivalent mosaic Env DNA Clade B T/F natural sequence Env MVA-CMDR 01/2015 Atlanta - Hope Clinic; Brigham; Boston - Fenway; Lausanne; San Francisco; The study tests 3 different experimental HIV DNA vaccines, to see if computer-generated DNA sequences for the HIV envelope will result in different immune responses compared to a natural HIV envelope gene. The Modified Vaccinia Ankara viral vector vaccine is used in the study to boost immune responses and enhance any differences between the 3 DNA vaccines. As of July 5,

3 HVTN HVTN GSK SanofiPasteur ALVAC-HIV (vcp 2438) gp120 with MF59 (2 schedules), Alum, or no adjuvant 03/2017 Cape Town - Emavundleni; A clinical trial to evaluate clade C ALVAC prime Durban - ethekwini; Harare followed by ALVAC with - Seke South; Maputo; gp120 adjuvanted with either MF59 or alum or Soweto - Bara; Tembisa; no adjuvant; also to evaluate ALVAC coadministered with gp120/mf59 at each timepoint. HVTN HVTN GSK (formerly Novartis) IPPOX DNA Clade C gp120/mf59 gp120/as01b 12/2016 Brigham; Boston - Fenway; Cape Town - Emavundleni; Durban - ethekwini; Durban - Verulam; Klerksdorp; Ladysmith; Nashville; New York - NYBC; New York - Rochester; Soshanguve; Soweto - Bara; Soweto - Kliptown; Tembisa; The study tests experimental HIV vaccines and 2 different adjuvants in different combinations, to see if these combinations result in different immune responses in the body. (The immune system helps a person fight infections). HVTN HVTN PaxVax GSID USMHRP Ad4 multiclade AIDSVAX B/E (Subtypes B, E gp120) 03/2015 Atlanta - Hope Clinic; Brigham; Boston - Fenway; Cleveland; Nashville; New York - NYBC; New York - Philadelphia; Rochester; San Francisco; Study to test different combinations of 3 experimental HIV vaccines. Two of the study vaccines are given as a pill that people will swallow, and contain a live, weakened virus called adenovirus trype 4. The third vaccine is given as an injection. The study tests the safety of the combinations, and the immune responses of the body to the different combinations. As of July 5,

4 HVTN HVTN GSK (formerly Novartis) IPPOX DNA Clade C gp120/mf59 06/2016 Durban - Isipingo; Klerksdorp; Lusaka - Matero; Mbeya; Tembisa; The study tests 2 experimental HIV vaccines in different combinations, to see if these combinations result in different immune responses in the body. (The immune system helps a person fight infections). It also tests an injection device without needles that uses pressurized air to inject the vaccine, to see if this can improve the immune responses. HVTN HVTN Profectus Ichor DNA VSV envc 04/2016 Cleveland; Philadelphia; Study looks at the safety of a DNA vaccine with a Clade B Env gene, given with electroporation into the deltoid muscle, followed by a recombinant vesicular stomatitis virus (rvsv) vaccine boost which has a Clade C Env gene. It will also look at the immune responses to the vaccines. HVTN HVTN GeoVax GSID AIDSVAX B/E MVA/HIV62B 01/2017 Atlanta - Hope Clinic; Brigham; Iquitos; Lima - Barranco; Nashville; New York - NYBC; New York - Rochester; San Francisco; The study takes people who got MVA HIV vaccine several years ago, some of whom also got a DNA vaccine, and gives them boost vaccinations with either an HIV envelope protein vaccine, or the same MVA HIV vaccine they got earlier, or both, to see whether the envelope protein vaccine improves antibody responses to the MVA HIV vaccine. As of July 5,

5 HVTN HVTN 01 mab 01LS mab 03/2017 Cape Town - Groote This study will evaluate the infused antibody Schuur; Cleveland; 01, that is also being evaluated in the AMP Philadelphia; San Francisco; studies. Additionally, this study will assess a variant of this antibody designated 011LS. This variant is thought to last longer in peoples bloodstream and mucosal compartments (ie, rectum and vagina). In order to evaluate what happens to the infused antibodies in the mucosal compartments, participants will provide small biopsies from their rectal and vaginal tissues at several timepoints during the trial. HVTN 117/ HPX2004 Janssen phase HVTN Janssen IAVI MHRP BIDMC Ad26.Mos.HIV Ad26. Mos4.HIV Clade C gp140 07/2016 Atlanta - Hope Clinic; Brigham; Boston - Fenway; Kigali; New York - NYBC; New York - Physicians & Surgeons; Philadelphia; Rochester; San Francisco; Silver Spring; This study will examine the safety of Ad26.Mos4.HIV, a viral vector vaccine that has an additional insert (as compared to Ad26.Mos.HIV). It will further examine if the addition of this insert improves the immune responses when administered in a combination with a protein vaccine (Clade C gp140). Therefore, the study will compare congruent regimens of Ad26.Mos.HIV plus Clade C gp140 and Ad26. Mos4. HIV plus Clade C gp140. As of July 5,

6 HVTN 118/ 150 HVTN HPX2003 Janssen IAVI MHRP BIDMC Ad26.Mos4.HIV Clade C gp140 Mosaic gp140 04/2017 Atlanta - Hope Clinic; BIDMC; Boston - Brigham; Boston - Fenway; Kericho; Kigali; New York - NYBC; New York - Physicians & Surgeons; Philadelphia; Rochester; San Francisco; This study will examine the safety of a so called mosaic protein that combines features of HIV surface proteins from different clades. Simultaneously, it will examine if the addition of this mosaic protein improves the immune responses when administered in a combination with a viral vector vaccine (Ad26.Mos4.HIV) and a protein vaccine (Clade C gp140). Therefore, the study will compare congruent regimens of Ad26.Mos4.HIV plus Clade C gp140 and Ad26. Mos4. HIV plus Clade C gp140 plus Mosaic gp140. HVTN HVTN DNA multiclade rad5 multiclade 06/2009 All US sites: Annandale; Atlanta - Hope Clinic; Bethesda; Birmingham; Boston - Brigham; Boston - Fenway; Chicago; Cleveland; Dallas; Denver; East Midtown; Houston; Los Angeles; Los Angeles - Care Center; Nashville; New York - NYBC; New York - NYBC - Bronx; Orlando; Philadelphia; Rochester; San Francisco; Union Square This phase 2b study compares the rate of HIV infections and viral load in participants who become infected at Day 196 or later, comparing participants who received the vaccine regimen and those who received placebo. As of July 5,

7 HVTN HVTN (pivotal) GSK (formerly Novartis) Sanofi Pasteur MRC ALVAC-HIV (vcp2438) gp120/mf59 10/2016 Cape Town - Emavundleni; Cape Town - Khayelitsha; Durban - ethekwini; Durban - Isipingo; Durban - Verulam; Klerksdorp; Ladysmith; Medunsa; Mthatha; Rustenburg; Soshanguve; Soweto - Bara; Soweto - Kliptown; Tembisa; Botha's Hill HVTN 702 is evaluating the safety and efficacy of a vaccine regimen similar to the RV144 regimen in HIV-uninfected adults at risk for acquiring HIV infection. This study is evaluating the same vaccine regimen as the phase 1/2 trial, HVTN 100, which has been adapted to the southern African region by using clade C envelope antigens: clade C ALVAC-HIV (vcp2438) and gp120/mf59. HVTN 703/HPTN HVTN HPTN 01 mab 05/2016 Blantyre; Cape Town - Groote Schuur; Durban - Botha's Hill; Durban - Chatsworth; Durban - ethekwini; Gaborone; Harare - Parirenyatwa; Harare - Seke South; Harare - Spilhaus; Hillbrow; Kisumu; Klerksdorp; Lilongwe; Mamelodi; Maputo; Mbeya; Rustenburg; Soweto - Bara; Tembisa; Vulindlela; This phase 2b study compares the rate of HIV infections in women who receive an infusion of an antibody against HIV (01) and in women who receive the placebo infusion. The study also looks at the safety of these antibody infusions and it looks over time at how much antibody is in the blood of study participants receiving different amounts or doses of the antibody. As of July 5,

8 HVTN 2700 HVTN 704/HPTN HPTN mab 04/2016 Atlanta - Hope Clinic; This phase 2b study compares the rate of HIV Atlanta - Ponce de Leon; infections in MSM and transgender individuals who receive an infusion of an antibody against Brigham; Boston - Fenway; HIV (01) and in those who receive the Chapel Hill; Cleveland; placebo infusion. The study also looks at the Iquitos; Lausanne; Lima - safety of these antibody infusions and it looks Barranco; Lima - San over time at how much antibody is in the Marcos; Lima - San Miguel; blood of study participants receiving different Lima - Via Libre; Los amounts or doses of the antibody. Angeles - Vine Street; Nashville; New York - Bronx Prevention; New York - Harlem Prevention; New York - NYBC; New York - Newark; Philadelphia; Rio de Janeiro; Rochester; San Francisco; Washington - DC HVTN 910 Open HVTN N/A 12/2011 All sites The study follows participants who received a study vaccine in NIH-sponsored preventive HIV vaccine studies, and looks at how long vaccineinduced HIV antibodies, which are detectable on commercial test kits, last in these participants. As of July 5,