Browsing by Author "Van Der Meeren O"

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Final Analysis of a Trial of M72/AS01
(2019-Dec-19) Tait DR; Hatherill M; Van Der Meeren O; Ginsberg AM; Van Brakel E; Salaun B; Scriba TJ; Akite EJ; Ayles HM; Bollaerts A; Demoitié MA; Diacon A; Evans TG; Gillard P; Hellström E; Innes JC; Lempicki M; Malahleha M; Martinson N; Mesia Vela D; Muyoyeta M; Nduba V; Pascal TG; Tameris M; Thienemann F; Wilkinson RJ; Roman F; From the International AIDS Vaccine Initiative (IAVI) (D.R.T.), the South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology (M.H., T.J.S., M.T.), and the Wellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine (F.T., R.J.W.), University of Cape Town, TASK Applied Science (E.V.B., A.D.), and Stellenbosch University (A.D.), Cape Town, the Be Part Yoluntu Centre, Paarl (E.H.), the Aurum Institute, Klerksdorp Research Centre, Klerksdorp (J.C.I.), the Aurum Institute, Tembisa Research Centre, Tembisa (J.C.I.), Setshaba Research Centre, Pretoria (M. Malahleha), and the Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, South African Medical Research Council Collaborating Centre for HIV/AIDS and TB, and National Research Foundation Centre of Excellence for Biomedical Tuberculosis Research, University of the Witwatersrand, Johannesburg (N.M.) - all in South Africa; GlaxoSmithKline, Wavre, and GlaxoSmithKline, Rixensart - both in Belgium (O.V.D.M., B.S., E.J.A., A.B., M.-A.D., P.G., D.M.V., T.G.P., F.R.); the IAVI, New York (A.M.G., T.G.E., M.L.); Zambart, University of Zambia (H.M.A.), and the Centre for Infectious Disease Research in Zambia (M. Muyoyeta) - both in Lusaka; the London School of Hygiene and Tropical Medicine (H.M.A.) and Francis Crick Institute and the Department of Medicine, Imperial College London (R.J.W.) - all in London; Johns Hopkins University Center for Tuberculosis Research, Baltimore (N.M.); the Kenya Medical Research Institute Centre for Respiratory Diseases Research, Nairobi (V.N.); and the Department of Internal Medicine, University Hospital of Zurich, Zurich, Switzerland (F.T.).; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
BACKGROUND: Results of an earlier analysis of a trial of the M72/AS01 METHODS: From August 2014 through November 2015, we enrolled adults 18 to 50 years of age with RESULTS: A total of 3575 participants underwent randomization, of whom 3573 received at least one dose of M72/AS01 CONCLUSIONS: Among adults infected with
Phase 1 Human Immunodeficiency Virus (HIV) Vaccine Trial to Evaluate the Safety and Immunogenicity of HIV Subtype C DNA and MF59-Adjuvanted Subtype C Envelope Protein.
(2021-Jan-23) Hosseinipour MC; Innes C; Naidoo S; Mann P; Hutter J; Ramjee G; Sebe M; Maganga L; Herce ME; deCamp AC; Marshall K; Dintwe O; Andersen-Nissen E; Tomaras GD; Mkhize N; Morris L; Jensen R; Miner MD; Pantaleo G; Ding S; Van Der Meeren O; Barnett SW; McElrath MJ; Corey L; Kublin JG; National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.; NIMR-Mbeya Medical Research Center, Mbeya, Tanzania.; Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.; Aurum Institute, Klerksdorp, South Africa.; GSK Vaccines, Rixensart, Belgium.; Cape Town HVTN Immunology Laboratory, Cape Town, South Africa.; EuroVacc Foundation, Lausanne, Switzerland.; UNC Project-Malawi, Lilongwe, Malawi.; University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.; Aurum Institute, Tembisa, South Africa.; HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.; GSK Vaccines, Cambridge, Massachusetts, USA.; Division of Immunology and Allergy, Centre Hospitalier Universitaire Vaudois, University of Lausanne, Lausanne, Switzerland.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, USA.; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
BACKGROUND: The Pox-Protein Public-Private Partnership is performing a suite of trials to evaluate the bivalent subtype C envelope protein (TV1.C and 1086.C glycoprotein 120) vaccine in the context of different adjuvants and priming agents for human immunodeficiency virus (HIV) type 1 (HIV-1) prevention. METHODS: In the HIV Vaccine Trials Network 111 trial, we compared the safety and immunogenicity of DNA prime followed by DNA/protein boost with DNA/protein coadministration injected intramuscularly via either needle/syringe or a needle-free injection device (Biojector). One hundred thirty-two healthy, HIV-1-uninfected adults were enrolled from Zambia, South Africa, and Tanzania and were randomized to 1 of 6 arms: DNA prime, protein boost by needle/syringe; DNA and protein coadministration by needle/syringe; placebo by needle/syringe; DNA prime, protein boost with DNA given by Biojector; DNA and protein coadministration with DNA given by Biojector; and placebo by Biojector. RESULTS: All vaccinations were safe and well tolerated. DNA and protein coadministration was associated with increased HIV-1 V1/V2 antibody response rate, a known correlate of decreased HIV-1 infection risk. DNA administration by Biojector elicited significantly higher CD4+ T-cell response rates to HIV envelope protein than administration by needle/syringe in the prime/boost regimen (85.7% vs 55.6%; P = .02), but not in the coadministration regimen (43.3% vs 48.3%; P = .61). CONCLUSIONS: Both the prime/boost and coadministration regimens are safe and may be promising for advancement into efficacy trials depending on whether cellular or humoral responses are desired. CLINICAL TRIALS REGISTRATION: South African National Clinical Trials Registry (application 3947; Department of Health [DoH] no. DOH-27-0715-4917) and ClinicalTrials.gov (NCT02997969).
Phase 2b Controlled Trial of M72/AS01
(2018-Oct-25) Van Der Meeren O; Hatherill M; Nduba V; Wilkinson RJ; Muyoyeta M; Van Brakel E; Ayles HM; Henostroza G; Thienemann F; Scriba TJ; Diacon A; Blatner GL; Demoitié MA; Tameris M; Malahleha M; Innes JC; Hellström E; Martinson N; Singh T; Akite EJ; Khatoon Azam A; Bollaerts A; Ginsberg AM; Evans TG; Gillard P; Tait DR; From GlaxoSmithKline, Wavre, Belgium (O.V.D.M., M.-A.D., T.S., E.J.A., A.K.A., A.B., P.G.); South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology (M.H., T.J.S., M.T.), and Wellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine (R.J.W., F.T.), University of Cape Town, Task Applied Science (E.V.B., A.D.), Stellenbosch University (A.D.), and Aeras Global TB Vaccine Foundation (D.R.T.) Cape Town, Setshaba Research Centre, Pretoria (M. Malahleha), the Aurum Institute, Klerksdorp and Tembisa Research Centres (J.C.I.), and the Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, South African Medical Research Council Collaborating Centre for HIV/AIDS and TB, and National Research Foundation Centre of Excellence for Biomedical Tuberculosis Research, University of the Witwatersrand (N.M.), Johannesburg, and Be Part Yoluntu Centre, Paarl (E.H.) - all in South Africa; Kenya Medical Research Institute, Nairobi (V.N.); Francis Crick Institute (R.J.W.), the Department of Medicine, Imperial College London (R.J.W.), and the London School of Hygiene and Tropical Medicine (H.M.A.) - all in London; Centre for Infectious Disease Research in Zambia (M. Muyoyeta, G.H.) and Zambart, University of Zambia (H.M.A.) - both in Lusaka, Zambia; the Department of Internal Medicine, University Hospital of Zurich, Zurich, Switzerland (F.T.); and Aeras, Rockville (G.L.B., A.M.G., T.G.E.), and Johns Hopkins University Center for Tuberculosis Research, Baltimore (N.M.) - both in Maryland.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
BACKGROUND: A vaccine to interrupt the transmission of tuberculosis is needed. METHODS: We conducted a randomized, double-blind, placebo-controlled, phase 2b trial of the M72/AS01 RESULTS: We report the primary analysis (conducted after a mean of 2.3 years of follow-up) of the ongoing trial. A total of 1786 participants received M72/AS01 CONCLUSIONS: M72/AS01
Protein Dose-Sparing Effect of AS01B Adjuvant in a Randomized Preventive HIV Vaccine Trial of ALVAC-HIV (vCP2438) and Adjuvanted Bivalent Subtype C gp120.
(2024-Aug-16) Chirenje ZM; Laher F; Dintwe O; Muyoyeta M; deCamp AC; He Z; Grunenberg N; Laher Omar F; Seaton KE; Polakowski L; Woodward Davis AS; Maganga L; Baden LR; Mayer K; Kalams S; Keefer M; Edupuganti S; Rodriguez B; Frank I; Scott H; Stranix-Chibanda L; Gurunathan S; Koutsoukos M; Van Der Meeren O; DiazGranados CA; Paez C; Andersen-Nissen E; Kublin J; Corey L; Ferrari G; Tomaras G; McElrath MJ; Department of Medicine, University of Rochester, Rochester, NewYork, USA.; SanFrancisco Department of Public Health, San Francisco, California, USA.; Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, USA.; Faculty of Medicine and Health Science, University of Zimbabwe Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.; National Institute for Medical Research-Mbeya Medical Research Centre, Mbeya, Tanzania.; Division of Infectious Diseases, Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Beth Israel Deaconess Medical Center, Harvard University, Boston, Massachusetts, USA.; Cape Town HIV Vaccine Trials Network Immunology Laboratory, Cape Town, South Africa.; Department of Obstetrics and Gynecology, University of California San Francisco, San Francisco, California, USA.; Department of Medicine, Emory University, Atlanta, Georgia, USA.; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.; Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.; School of Medicine, University of Pennsylvania, Philadelphia, USA.; GSK, Wavre, Belgium.; GSK, Rixensart, Belgium.; Center for Human Systems Immunology, Duke University School of Medicine, Durham, North Carolina, USA.; Division of Infectious Diseases and HIV Medicine, Department of Medicine, Case Western Reserve University/University Hospitals, Cleveland Medical Center, Cleveland, Ohio, USA.; Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.; Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.; Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA.; The Fenway Institute, Fenway Health, Boston, Massachusetts, USA.; Centre for Infectious Diseases Research in Zambia, Livingstone, Zambia.; Sanofi Pasteur, Swiftwater, Pennsylvania, USA.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
BACKGROUND: HVTN 120 is a phase 1/2a randomized double-blind placebo-controlled human immunodeficiency virus (HIV) vaccine trial that evaluated the safety and immunogenicity of ALVAC-HIV (vCP2438) and MF59- or AS01B-adjuvanted bivalent subtype C gp120 Env protein at 2 dose levels in healthy HIV-uninfected adults. METHODS: Participants received ALVAC-HIV (vCP2438) alone or placebo at months 0 and 1. At months 3 and 6, participants received either placebo, ALVAC-HIV (vCP2438) with 200 μg of bivalent subtype C gp120 adjuvanted with MF59 or AS01B, or ALVAC-HIV (vCP2438) with 40 μg of bivalent subtype C gp120 adjuvanted with AS01B. Primary outcomes were safety and immune responses. RESULTS: We enrolled 160 participants, 55% women, 18-40 years old (median age 24 years) of whom 150 received vaccine and 10 placebo. Vaccines were generally safe and well tolerated. At months 6.5 and 12, CD4+ T-cell response rates and magnitudes were higher in the AS01B-adjuvanted groups than in the MF59-adjuvanted group. At month 12, HIV-specific Env-gp120 binding antibody response magnitudes in the 40 μg gp120/AS01B group were higher than in either of the 200 μg gp120 groups. CONCLUSIONS: The 40 μg dose gp120/AS01B regimen elicited the highest CD4+ T-cell and binding antibody responses. Clinical Trials Registration . NCT03122223.