A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1 Infection in Women in Sub-Saharan Africa
NCT ID: NCT03060629
Last Updated: 2023-04-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
2636 participants
INTERVENTIONAL
2017-11-03
2022-02-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Group 1
Participants will receive Ad26.Mos4.HIV 5\*10\^10 virus particles (vp) as 0.5 milliliter (mL) via Intramuscular (IM) injection into the left deltoid on Months 0, 3, 6, and 12 and Clade C gp140 (250 \[microgram\] mcg) mixed with Aluminum phosphate adjuvant as 0.5 mL IM into the right deltoid on Months 6 and 12.
Ad26.Mos4.HIV
Participants will receive Ad26.Mos4.HIV 5x10\^10 virus particles (vp) as 0.5 milliliter (mL) via Intramuscular (IM) into the left deltoid on Months 0, 3, 6, and 12.
Clade C gp140
Participants will receive Clade C gp140 (250 mcg) mixed with Aluminum phosphate adjuvant as 0.5 mL IM into the right deltoid on Months 6 and 12.
Group 2
Participants will receive Placebo for Ad26.Mos4.HIV as 0.5 mL into the left deltoid on Months 0, 3, 6, and 12 and Placebo for Clade C gp140 / Aluminum phosphate adjuvant as 0.5 mL IM into the right deltoid on Months 6 and 12.
Placebo
Participants will receive matching placebo.
Interventions
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Ad26.Mos4.HIV
Participants will receive Ad26.Mos4.HIV 5x10\^10 virus particles (vp) as 0.5 milliliter (mL) via Intramuscular (IM) into the left deltoid on Months 0, 3, 6, and 12.
Clade C gp140
Participants will receive Clade C gp140 (250 mcg) mixed with Aluminum phosphate adjuvant as 0.5 mL IM into the right deltoid on Months 6 and 12.
Placebo
Participants will receive matching placebo.
Eligibility Criteria
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Inclusion Criteria
* Access to a participating HIV Vaccine Trials Network (HVTN) Clinical Research Sites (CRS) and willingness to be followed for the planned duration of the study
* Willingness to discuss HIV infection risks and willing to receive HIV risk reduction counseling and appropriate referrals to minimize HIV acquisition, as applicable
* Negative beta human chorionic gonadotropin (beta-HCG) pregnancy test performed prior to vaccination on the day of initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing
* Participants must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until 3 months after the last vaccination
Exclusion Criteria
* HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 705/HPX2008 (Protocol Safety Review Team) PSRT will determine eligibility on a case-by-case basis
* Live attenuated vaccines received within 30 days before first vaccination or scheduled within 14 days after injection (example: measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever)
* Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (example, tetanus, pneumococcal, Hepatitis A or B)
* Immunosuppressive medications received within 6 months before first vaccination
18 Years
35 Years
FEMALE
Yes
Sponsors
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Janssen Vaccines & Prevention B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Vaccines & Prevention B.V. Clinical Trial
Role: STUDY_DIRECTOR
Janssen Vaccines & Prevention B.V.
Locations
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UNC Lilongwe Project
Lilongwe, , Malawi
Polana Caniço Health Research and Training Center (CISPOC)
Maputo, , Mozambique
Josha Research
Bloemfontein, , South Africa
Masiphumelele Research Centre
Cape Town, , South Africa
Ndlovu Elandsdoorn Site
Dennilton, , South Africa
Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
Diepkloof, , South Africa
Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
Johannesburg, , South Africa
The Aurum Institute Klerksdorp Clinical Research Centre
Klerksdorp, , South Africa
Qhakaza Mbokodo Research Centre
KwaZulu-Natal, , South Africa
South African Medical Research Council Chatsworth Clinical Research Site
KwaZulu-Natal, , South Africa
Centre for the AIDS Programme of Research in South Africa
KwaZulu-Natal, , South Africa
South African Medical Research Council Tongaat Clinical Research Site
KwaZulu-Natal, , South Africa
Stanza Clinical Research Centre : Mamelodi
Mamelodi East, , South Africa
Nelson Mandela Academic Clinical Research Unit 'NeMACRU'
Mthatha, , South Africa
MeCRU Clinical Research Unit
Pretoria, , South Africa
The Aurum Institute Rustenburg Clinical Research Site
Rustenburg, , South Africa
Setshaba Research Centre
Soshanguve, , South Africa
The Aurum Institute: Tembisa - Clinic 4
Tembisa, , South Africa
Centre for Infectious Disease Research in Zambia (CIDRZ)
Lusaka, , Zambia
Center for Family Health Research in Zambia (CFHRZ)
Lusaka, , Zambia
Center for Family Health Research in Zambia (CFHRZ)
Ndola, , Zambia
St Mary's Clinic
Chitungwiza, , Zimbabwe
University of Zimbabwe-UCSF
Harare - Seke South, , Zimbabwe
Countries
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References
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Moodie Z, Li SS, Giorgi EE, Williams LD, Dintwe O, Carpp LN, Chen S, Seaton KE, Sawant SS, Zhang L, Heptinstall J, Liu S, Grunenberg N, Tomaka F, Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Ake JA, Vasan S, Pantaleo G, Frank I, Baden LR, Goepfert PA, Keefer M, Chirenje M, Hosseinipour MC, Mngadi K, Laher F, Garrett N, Bekker LG, De Rosa S, Andersen-Nissen E, Kublin JG, Lu S, Gilbert PB, Gray GE, Corey L, McElrath MJ, Tomaras GD. A polyvalent DNA prime with matched polyvalent protein/GLA-SE boost regimen elicited the most robust and broad IgG and IgG3 V1V2 binding antibody and CD4+ T cell responses among 13 HIV vaccine trials. Emerg Microbes Infect. 2025 Dec;14(1):2485317. doi: 10.1080/22221751.2025.2485317. Epub 2025 Apr 7.
Gray GE, Mngadi K, Lavreys L, Nijs S, Gilbert PB, Hural J, Hyrien O, Juraska M, Luedtke A, Mann P, McElrath MJ, Odhiambo JA, Stieh DJ, van Duijn J, Takalani AN, Willems W, Tapley A, Tomaras GD, Van Hoof J, Schuitemaker H, Swann E, Barouch DH, Kublin JG, Corey L, Pau MG, Buchbinder S, Tomaka F; Imbokodo/HVTN 705/HPX2008 Study Group. Mosaic HIV-1 vaccine regimen in southern African women (Imbokodo/HVTN 705/HPX2008): a randomised, double-blind, placebo-controlled, phase 2b trial. Lancet Infect Dis. 2024 Nov;24(11):1201-1212. doi: 10.1016/S1473-3099(24)00358-X. Epub 2024 Jul 19.
Barouch DH, Tomaka FL, Wegmann F, Stieh DJ, Alter G, Robb ML, Michael NL, Peter L, Nkolola JP, Borducchi EN, Chandrashekar A, Jetton D, Stephenson KE, Li W, Korber B, Tomaras GD, Montefiori DC, Gray G, Frahm N, McElrath MJ, Baden L, Johnson J, Hutter J, Swann E, Karita E, Kibuuka H, Mpendo J, Garrett N, Mngadi K, Chinyenze K, Priddy F, Lazarus E, Laher F, Nitayapan S, Pitisuttithum P, Bart S, Campbell T, Feldman R, Lucksinger G, Borremans C, Callewaert K, Roten R, Sadoff J, Scheppler L, Weijtens M, Feddes-de Boer K, van Manen D, Vreugdenhil J, Zahn R, Lavreys L, Nijs S, Tolboom J, Hendriks J, Euler Z, Pau MG, Schuitemaker H. Evaluation of a mosaic HIV-1 vaccine in a multicentre, randomised, double-blind, placebo-controlled, phase 1/2a clinical trial (APPROACH) and in rhesus monkeys (NHP 13-19). Lancet. 2018 Jul 21;392(10143):232-243. doi: 10.1016/S0140-6736(18)31364-3. Epub 2018 Jul 6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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VAC89220HPX2008
Identifier Type: OTHER
Identifier Source: secondary_id
HVTN 705
Identifier Type: OTHER
Identifier Source: secondary_id
HVTN 705/VAC89220HPX2008
Identifier Type: OTHER
Identifier Source: secondary_id
CR108263
Identifier Type: -
Identifier Source: org_study_id
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