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1 HVTN HVTN HVTN HVTN HVTN HVTN HVTN HVTN IPPOX EuroVacc GSID USMHRP HVTN HVTN Inovio clade B AIDSVAX B/E clade C NYVAC clade C PENNVAX-GP IL-12 adjuvant September-11 Seattle The study looks at the immune response of genital and rectal tissues to injections of a vaccine followed by a recombinant adenovirus serotype 5 () vaccine. March-11 February-12 Boston - Brigham; Chicago; Iquitos; Lausanne; Lima - Barranco; Sao Paulo; New York Bronx Prevention, New York Columbia; New York Union Square Boston; Chicago; Nashville; New York; San Francisco 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. 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. August-12 Lausanne compares the priming ability of NYVAC alone versus NYVAC + AIDSVAX B/E, and alone versus + AIDSVAX B/E, when followed by NYVAC + AIDSVAX B/E boosts. September-15 Atlanta-Hope Clinic; Nashville; Rochester; Seattle looks at the safety of a vaccine given with an IL-12 plasmid 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. As of December
2 HVTN HVTN SanofiPasteur HVTN HVTN CHAVI-ID EuroVacc LANL USMHRP HVTN HVTN GSK SanofiPasteur HVTN HVTN IPPOX ALVAC-HIV (vcp2438) [] MVA ALVAC-HIV (vcp 2438) gp120 with MF59 (2 schedules), Alum, or no adjuvant Clade C gp120/as01b February-15 January-15 Cape Town; DurbaneThekwini; Durban Isipingo; Klerksdorp; Soshanguve; Soweto - Bara Atlanta-Hope Clinic; Birmingham; Boston- Brigham; Boston- Fenway; San Francisco; Seattle; Lausanne March-17 South Africa: Soweto - Bara; CapeTown - Emavundleni; Tembisa; Durban -ethekwini; Maputo, Mozambique; Seke South, Zimbabwe Dec-16 (US), Jan-17 (RSA) Birmingham; Boston - Brigham; New York - Columbia P&S; Boston - Fenway; Nashville; New York - NYBC ; Rochester; Seattle; Soweto- Bara; Cape Town - Emavundleni; Durban - ethekwini; 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. The study tests 3 different experimental HIV vaccines, to see if computer-generated 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 vaccines. A clinical trial to evaluate clade C ALVAC prime followed by ALVAC with gp120 adjuvanted with either MF59 or alum or no adjuvant; also to evaluate ALVAC co-administered with at each timepoint. 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). As of December
3 Klerksdorp; Soshanguve; Tembisa; Ladysmith; Soweto - Kliptown; Durban - Verulam HVTN HVTN PaxVax GSID USMHRP HVTN HVTN IPPOX HVTN HVTN Profectus Ichor Ad4 AIDSVAX B/E (Subtypes B, E gp120) Clade C VSV envc March-15 May-16 Atlanta-Hope Clinic; Birmingham; Boston- Brigham; Boston- Fenway; Cleveland; New York- Physicians & Surgeons; Nashville; New York-NYBC; San Francisco; Seattle Isipingo; Tembisa; Klerksdorp; Matero; Mbeya 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. 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. April-16 Cleveland; Philadelphia looks at the safety of a 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. As of December
4 HVTN HVTN GeoVax GSID HVTN HVTN HVTN 117/HPX HVTN Janssen AIDSVAX B/E MVA/HIV62B 01 mab 01LS mab Ad26.Mos.HIV Ad26. Mos4.HIV Clade C gp140 Jan-17 March-17 July-16 Atlanta, Birmingham, Boston-Brigham, New York-Columbia P&S, New York-NYBC, Nashville, Rochester, Seattle, SFDPH, Iquitos (Peru), Lima-Barranco (Peru) Cleveland; Philadelphia; San Francisco; Seattle; Cape Town - Groote Schuur Atlanta - Hope Clinic; Birmingham; Boston - Brigham; New York - Columbia P&S; Boston - Fenway; Nashville; New York - NYBC ; San Francisco; Seattle The study looks at antibody responses in people who got and/or MVA HIV vaccines several years ago, after giving them boost vaccinations with either a Clade B / Clade E gp120 envelope protein vaccine, or the same MVA HIV vaccine they got earlier, or both. This study will evaluate the infused antibody 01, that is also being evaluated in the AMP 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. 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 December
5 HVTN HVTN HVTN 702 (licensure) HVTN 703/HPTN HVTN Sanofi Pasteur MRC 1500 HVTN HPTN ALVAC-HIV (vcp2438) June-09 All US sites 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. October-16 Brits; Cape Town - Emavundleni; Cape Town - Khayelitsha; Durban - ethekwini; Durban - Isipingo; Durban - Verulam; Klerksdorp; Ladysmith; Medunsa; Mthatha; Rustenburg; Soshanguve; Soweto - Bara; Soweto - Kliptown; Tembisa 01 mab May-16 Blantyre; Cape Town- Groote Schuur; Durban Chatsworth; Durban ethekwini; Gaborone; Harare Parirenyatwa; Harare - Seke South; Harare Spilhaus; Johannesburg -WRHI; Kisumu; Vulindlela; Lilongwe; Maputo; Mbeya; Soweto -Bara, Botha's Hill, Tongaat, Mamelodi, Tembisa, Klerksdorp, Rusteburg A pivotal phase 2b/3 multi-site, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of ALVAC-HIV (vcp2438) and in preventing HIV-1 infection in adults in South Africa 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 December
6 HVTN 704/HPTN HVTN HPTN HVTN 910 Open HVTN 01 mab April-16 Atlanta - Hope Clinic; Atlanta - Ponce de Leon; Birmingham; Boston Brigham; Boston Fenway; Chapel Hill; Cleveland; Columbia Bronx Prevention; Columbia Harlem Prevention; Columbia NYBC; Columbia - Physicians & Surgeons; Los Angeles Vine Street; Nashville; Newark; San Francisco; Seattle; Washington, DC; Iquitos; Lima Barranco; Lima - San Miguel; Lima Via Libre; Lausanne CHUV, Lima - San Marcos This phase 2b study compares the rate of HIV infections in MSM and transgender individuals who receive an infusion of an antibody against HIV (01) and in those 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. N/A December-11 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 December
Start Date* Sites Description
076 17 083 180 084 100 085 90 098 94 Inovio rad35 clade A clade A rad clade B clade B PENNVAX-GP IL-12 adjuvant September-11 Seattle The study looks at the immune response of genital and rectal tissues
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