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  1. AU="Koutsoukos, Marguerite"
  2. AU="Webster, Kara"
  3. AU=Tremoulet Adriana H.
  4. AU="Foggia, Maria"
  5. AU=Eccles Michael R
  6. AU="Karrison, Theodore"
  7. AU="Espigado, I"
  8. AU="Dean, Andrew"

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  1. Artikel ; Online: Beta variant COVID-19 protein booster vaccine elicits durable cross-neutralization against SARS-CoV-2 variants in non-human primates.

    Pavot, Vincent / Berry, Catherine / Kishko, Michael / Anosova, Natalie G / Li, Lu / Tibbitts, Tim / Huang, Dean / Raillard, Alice / Gautheron, Sylviane / Gutzeit, Cindy / Koutsoukos, Marguerite / Chicz, Roman M / Lecouturier, Valerie

    Nature communications

    2023  Band 14, Heft 1, Seite(n) 1309

    Abstract: The rapid spread of the SARS-CoV-2 Omicron subvariants, despite the implementation of booster vaccination, has raised questions about the durability of protection conferred by current vaccines. Vaccine boosters that can induce broader and more durable ... ...

    Abstract The rapid spread of the SARS-CoV-2 Omicron subvariants, despite the implementation of booster vaccination, has raised questions about the durability of protection conferred by current vaccines. Vaccine boosters that can induce broader and more durable immune responses against SARS-CoV-2 are urgently needed. We recently reported that our Beta-containing protein-based SARS-CoV-2 spike booster vaccine candidates with AS03 adjuvant (CoV2 preS dTM-AS03) elicited robust cross-neutralizing antibody responses at early timepoints against SARS-CoV-2 variants of concern in macaques primed with mRNA or protein-based subunit vaccine candidates. Here we demonstrate that the monovalent Beta vaccine with AS03 adjuvant induces durable cross-neutralizing antibody responses against the prototype strain D614G as well as variants Delta (B.1.617.2), Omicron (BA.1 and BA.4/5) and SARS-CoV-1, that are still detectable in all macaques 6 months post-booster. We also describe the induction of consistent and robust memory B cell responses, independent of the levels measured post-primary immunization. These data suggest that a booster dose with a monovalent Beta CoV2 preS dTM-AS03 vaccine can induce robust and durable cross-neutralizing responses against a broad spectrum of variants.
    Mesh-Begriff(e) Animals ; Humans ; SARS-CoV-2/genetics ; COVID-19/prevention & control ; COVID-19 Vaccines ; Broadly Neutralizing Antibodies ; Protein Subunits ; Macaca ; Primates ; Antibodies, Viral ; Antibodies, Neutralizing
    Chemische Substanzen COVID-19 Vaccines ; Broadly Neutralizing Antibodies ; Protein Subunits ; Antibodies, Viral ; Antibodies, Neutralizing
    Sprache Englisch
    Erscheinungsdatum 2023-03-10
    Erscheinungsland England
    Dokumenttyp Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
    ZDB-ID 2553671-0
    ISSN 2041-1723 ; 2041-1723
    ISSN (online) 2041-1723
    ISSN 2041-1723
    DOI 10.1038/s41467-023-36908-z
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  2. Artikel ; Online: Beta-containing bivalent SARS-CoV-2 protein vaccine elicits durable broad neutralization in macaques and protection in hamsters.

    Berry, Catherine / Pavot, Vincent / Anosova, Natalie G / Kishko, Michael / Li, Lu / Tibbitts, Tim / Raillard, Alice / Gautheron, Sylviane / Cummings, Sheila / Bangari, Dinesh S / Kar, Swagata / Atyeo, Caroline / Deng, Yixiang / Alter, Galit / Gutzeit, Cindy / Koutsoukos, Marguerite / Chicz, Roman M / Lecouturier, Valerie

    Communications medicine

    2023  Band 3, Heft 1, Seite(n) 75

    Abstract: Background: Since the beginning of the COVID-19 pandemic, several variants of concern (VOC) have emerged for which there is evidence of an increase in transmissibility, more severe disease, and/or reduced vaccine effectiveness. Effective COVID-19 ... ...

    Abstract Background: Since the beginning of the COVID-19 pandemic, several variants of concern (VOC) have emerged for which there is evidence of an increase in transmissibility, more severe disease, and/or reduced vaccine effectiveness. Effective COVID-19 vaccine strategies are required to achieve broad protective immunity against current and future VOC.
    Methods: We conducted immunogenicity and challenge studies in macaques and hamsters using a bivalent recombinant vaccine formulation containing the SARS-CoV-2 prefusion-stabilized Spike trimers of the ancestral D614 and the variant Beta strains with AS03 adjuvant (CoV2 preS dTM-AS03) in a primary immunization setting.
    Results: We show that a primary immunization with the bivalent CoV2 preS dTM-AS03 elicits broader and durable (1 year) neutralizing antibody responses against VOC including Omicron BA.1 and BA.4/5, and SARS-CoV-1 as compared to the ancestral D614 or Beta variant monovalent vaccines in naïve non-human primates. In addition, the bivalent formulation confers protection against viral challenge with SARS-CoV-2 prototype D614G strain as well as Alpha and Beta variant strains in hamsters.
    Conclusions: Our findings demonstrate the potential of a Beta-containing bivalent CoV2 preS dTM-AS03 formulation to provide broad and durable immunogenicity, as well as protection against VOC in naïve populations.
    Sprache Englisch
    Erscheinungsdatum 2023-05-26
    Erscheinungsland England
    Dokumenttyp Journal Article
    ISSN 2730-664X
    ISSN (online) 2730-664X
    DOI 10.1038/s43856-023-00302-z
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  3. Artikel ; Online: Protein-based SARS-CoV-2 spike vaccine booster increases cross-neutralization against SARS-CoV-2 variants of concern in non-human primates.

    Pavot, Vincent / Berry, Catherine / Kishko, Michael / Anosova, Natalie G / Huang, Dean / Tibbitts, Tim / Raillard, Alice / Gautheron, Sylviane / Gutzeit, Cindy / Koutsoukos, Marguerite / Chicz, Roman M / Lecouturier, Valerie

    Nature communications

    2022  Band 13, Heft 1, Seite(n) 1699

    Abstract: The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants that partly evade neutralizing antibodies raises concerns of reduced vaccine effectiveness and increased infection. We previously demonstrated that the SARS-CoV-2 ... ...

    Abstract The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants that partly evade neutralizing antibodies raises concerns of reduced vaccine effectiveness and increased infection. We previously demonstrated that the SARS-CoV-2 spike protein vaccine adjuvanted with AS03 (CoV2 preS dTM-AS03) elicits robust neutralizing antibody responses in naïve subjects. Here we show that, in macaques primed with mRNA or protein-based subunit vaccine candidates, one booster dose of CoV2 preS dTM-AS03 (monovalent D614 or B.1.351, or bivalent D614 + B.1.351 formulations), significantly boosts the pre-existing neutralizing antibodies against the parental strain from 177- to 370-fold. Importantly, the booster dose elicits high and persistent cross-neutralizing antibodies covering five former or current SARS-CoV-2 variants of concern (Alpha, Beta, Gamma, Delta and Omicron) and, unexpectedly, SARS-CoV-1. Interestingly, we show that the booster specifically increases the functional antibody responses as compared to the receptor binding domain (RBD)-specific responses. Our findings show that these vaccine candidates, when used as a booster, have the potential to offer cross-protection against a broad spectrum of variants. This has important implications for vaccine control of SARS-CoV-2 variants of concern and informs on the benefit of a booster with the vaccine candidates currently under evaluation in clinical trials.
    Mesh-Begriff(e) Animals ; Antibodies, Viral ; COVID-19/prevention & control ; COVID-19 Vaccines ; Humans ; Primates ; SARS-CoV-2/genetics ; Spike Glycoprotein, Coronavirus ; Viral Vaccines
    Chemische Substanzen Antibodies, Viral ; COVID-19 Vaccines ; Spike Glycoprotein, Coronavirus ; Viral Vaccines ; spike protein, SARS-CoV-2
    Sprache Englisch
    Erscheinungsdatum 2022-03-31
    Erscheinungsland England
    Dokumenttyp Journal Article ; Research Support, U.S. Gov't, Non-P.H.S. ; Research Support, Non-U.S. Gov't
    ZDB-ID 2553671-0
    ISSN 2041-1723 ; 2041-1723
    ISSN (online) 2041-1723
    ISSN 2041-1723
    DOI 10.1038/s41467-022-29219-2
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  4. Artikel ; Online: Safety and immunogenicity of a subtype C ALVAC-HIV (vCP2438) vaccine prime plus bivalent subtype C gp120 vaccine boost adjuvanted with MF59 or alum in healthy adults without HIV (HVTN 107): A phase 1/2a randomized trial.

    Moodie, Zoe / Andersen-Nissen, Erica / Grunenberg, Nicole / Dintwe, One B / Omar, Faatima Laher / Kee, Jia J / Bekker, Linda-Gail / Laher, Fatima / Naicker, Nivashnee / Jani, Ilesh / Mgodi, Nyaradzo M / Hunidzarira, Portia / Sebe, Modulakgota / Miner, Maurine D / Polakowski, Laura / Ramirez, Shelly / Nebergall, Michelle / Takuva, Simbarashe / Sikhosana, Lerato /
    Heptinstall, Jack / Seaton, Kelly E / De Rosa, Stephen / Diazgranados, Carlos A / Koutsoukos, Marguerite / Van Der Meeren, Olivier / Barnett, Susan W / Kanesa-Thasan, Niranjan / Kublin, James G / Tomaras, Georgia D / McElrath, M Juliana / Corey, Lawrence / Mngadi, Kathryn / Goepfert, Paul

    PLoS medicine

    2024  Band 21, Heft 3, Seite(n) e1004360

    Abstract: Background: Adjuvants are widely used to enhance and/or direct vaccine-induced immune responses yet rarely evaluated head-to-head. Our trial directly compared immune responses elicited by MF59 versus alum adjuvants in the RV144-like HIV vaccine regimen ... ...

    Abstract Background: Adjuvants are widely used to enhance and/or direct vaccine-induced immune responses yet rarely evaluated head-to-head. Our trial directly compared immune responses elicited by MF59 versus alum adjuvants in the RV144-like HIV vaccine regimen modified for the Southern African region. The RV144 trial of a recombinant canarypox vaccine vector expressing HIV env subtype B (ALVAC-HIV) prime followed by ALVAC-HIV plus a bivalent gp120 protein vaccine boost adjuvanted with alum is the only trial to have shown modest HIV vaccine efficacy. Data generated after RV144 suggested that use of MF59 adjuvant might allow lower protein doses to be used while maintaining robust immune responses. We evaluated safety and immunogenicity of an HIV recombinant canarypox vaccine vector expressing HIV env subtype C (ALVAC-HIV) prime followed by ALVAC-HIV plus a bivalent gp120 protein vaccine boost (gp120) adjuvanted with alum (ALVAC-HIV+gp120/alum) or MF59 (ALVAC-HIV+gp120/MF59) or unadjuvanted (ALVAC-HIV+gp120/no-adjuvant) and a regimen where ALVAC-HIV+gp120 adjuvanted with MF59 was used for the prime and boost (ALVAC-HIV+gp120/MF59 coadministration).
    Methods and findings: Between June 19, 2017 and June 14, 2018, 132 healthy adults without HIV in South Africa, Zimbabwe, and Mozambique were randomized to receive intramuscularly: (1) 2 priming doses of ALVAC-HIV (months 0 and 1) followed by 3 booster doses of ALVAC-HIV+gp120/MF59 (months 3, 6, and 12), n = 36; (2) 2 priming doses of ALVAC-HIV (months 0 and 1) followed by 3 booster doses of ALVAC-HIV+gp120/alum (months 3, 6, and 12), n = 36; (3) 4 doses of ALVAC-HIV+gp120/MF59 coadministered (months 0, 1, 6, and 12), n = 36; or (4) 2 priming doses of ALVAC-HIV (months 0 and 1) followed by 3 booster doses of ALVAC-HIV+gp120/no adjuvant (months 3, 6, and 12), n = 24. Primary outcomes were safety and occurrence and mean fluorescence intensity (MFI) of vaccine-induced gp120-specific IgG and IgA binding antibodies at month 6.5. All vaccinations were safe and well-tolerated; increased alanine aminotransferase was the most frequent related adverse event, occurring in 2 (1.5%) participants (1 severe, 1 mild). At month 6.5, vaccine-specific gp120 IgG binding antibodies were detected in 100% of vaccinees for all 4 vaccine groups. No significant differences were seen in the occurrence and net MFI of vaccine-specific IgA responses between the ALVAC-HIV+gp120/MF59-prime-boost and ALVAC-HIV+gp120/alum-prime-boost groups or between the ALVAC-HIV+gp120/MF59-prime-boost and ALVAC-HIV+gp120/MF59 coadministration groups. Limitations were the relatively small sample size per group and lack of evaluation of higher gp120 doses.
    Conclusions: Although MF59 was expected to enhance immune responses, alum induced similar responses to MF59, suggesting that the choice between these adjuvants may not be critical for the ALVAC+gp120 regimen.
    Trial registration: HVTN 107 was registered with the South African National Clinical Trials Registry (DOH-27-0715-4894) and ClinicalTrials.gov (NCT03284710).
    Mesh-Begriff(e) Adult ; Humans ; Adjuvants, Immunologic ; AIDS Vaccines/adverse effects ; Alum Compounds ; HIV Antibodies ; HIV Infections/prevention & control ; HIV-1 ; Immunogenicity, Vaccine ; Immunoglobulin A ; Immunoglobulin G ; Polysorbates ; Squalene ; Vaccines, Combined ; Vaccines, Synthetic
    Chemische Substanzen Adjuvants, Immunologic ; AIDS Vaccines ; AIDSVAX ; Alum Compounds ; aluminum sulfate (34S289N54E) ; HIV Antibodies ; Immunoglobulin A ; Immunoglobulin G ; MF59 oil emulsion ; Polysorbates ; Squalene (7QWM220FJH) ; Vaccines, Combined ; Vaccines, Synthetic
    Sprache Englisch
    Erscheinungsdatum 2024-03-19
    Erscheinungsland United States
    Dokumenttyp Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article ; Randomized Controlled Trial
    ZDB-ID 2185925-5
    ISSN 1549-1676 ; 1549-1277
    ISSN (online) 1549-1676
    ISSN 1549-1277
    DOI 10.1371/journal.pmed.1004360
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  5. Artikel ; Online: Early and Long-Term HIV-1 Immunogenicity Induced in Macaques by the Combined Administration of DNA, NYVAC and Env Protein-Based Vaccine Candidates: The AUP512 Study.

    Perdiguero, Beatriz / Asbach, Benedikt / Gómez, Carmen E / Köstler, Josef / Barnett, Susan W / Koutsoukos, Marguerite / Weiss, Deborah E / Cristillo, Anthony D / Foulds, Kathryn E / Roederer, Mario / Montefiori, David C / Yates, Nicole L / Ferrari, Guido / Shen, Xiaoying / Sawant, Sheetal / Tomaras, Georgia D / Sato, Alicia / Fulp, William J / Gottardo, Raphael /
    Ding, Song / Heeney, Jonathan L / Pantaleo, Giuseppe / Esteban, Mariano / Wagner, Ralf

    Frontiers in immunology

    2022  Band 13, Seite(n) 939627

    Abstract: To control HIV infection there is a need for vaccines to induce broad, potent and long-term B and T cell immune responses. With the objective to accelerate and maintain the induction of substantial levels of HIV-1 Env-specific antibodies and, at the same ...

    Abstract To control HIV infection there is a need for vaccines to induce broad, potent and long-term B and T cell immune responses. With the objective to accelerate and maintain the induction of substantial levels of HIV-1 Env-specific antibodies and, at the same time, to enhance balanced CD4 and CD8 T cell responses, we evaluated the effect of concurrent administration of MF59-adjuvanted Env protein together with DNA or NYVAC vectors at priming to establish if early administration of Env leads to early induction of antibody responses. The primary goal was to assess the immunogenicity endpoint at week 26. Secondary endpoints were (i) to determine the quality of responses with regard to RV144 correlates of protection and (ii) to explore a potential impact of two late boosts. In this study, five different prime/boost vaccination regimens were tested in rhesus macaques. Animals received priming immunizations with either NYVAC or DNA alone or in combination with Env protein, followed by NYVAC + protein or DNA + protein boosts. All regimens induced broad, polyfunctional and well-balanced CD4 and CD8 T cell responses, with DNA-primed regimens eliciting higher response rates and magnitudes than NYVAC-primed regimens. Very high plasma binding IgG titers including V1/V2 specific antibodies, modest antibody-dependent cellular cytotoxicity (ADCC) and moderate neutralization activity were observed. Of note, early administration of the MF59-adjuvanted Env protein in parallel with DNA priming leads to more rapid elicitation of humoral responses, without negatively affecting the cellular responses, while responses were rapidly boosted after repeated immunizations, indicating the induction of a robust memory response. In conclusion, our findings support the use of the Env protein component during priming in the context of an heterologous immunization regimen with a DNA and/or NYVAC vector as an optimized immunization protocol against HIV infection.
    Mesh-Begriff(e) AIDS Vaccines ; Animals ; Antibodies, Neutralizing ; DNA ; Gene Products, env ; HIV Antibodies ; HIV Infections/prevention & control ; HIV Seropositivity ; HIV-1 ; Macaca mulatta
    Chemische Substanzen AIDS Vaccines ; Antibodies, Neutralizing ; Gene Products, env ; HIV Antibodies ; DNA (9007-49-2)
    Sprache Englisch
    Erscheinungsdatum 2022-07-22
    Erscheinungsland Switzerland
    Dokumenttyp Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 2606827-8
    ISSN 1664-3224 ; 1664-3224
    ISSN (online) 1664-3224
    ISSN 1664-3224
    DOI 10.3389/fimmu.2022.939627
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  6. Artikel ; Online: Efficacy of a monovalent (D614) SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant in adults: a phase 3, multi-country study.

    Dayan, Gustavo H / Rouphael, Nadine / Walsh, Stephen R / Chen, Aiying / Grunenberg, Nicole / Allen, Mary / Antony, Johannes / Bhate, Amit Suresh / Beresnev, Tatiana / Bonaparte, Matthew I / Celle, Médéric / Ceregido, Maria Angeles / Corey, Lawrence / Fu, Bo / Grillet, Marie-Helene / Keshtkar-Jahromi, Maryam / Juraska, Michal / Kee, Jia Jin / Kaali, Seyram /
    Koutsoukos, Marguerite / Masotti, Roger / Michael, Nelson L / Neuzil, Kathleen M / Reynales, Humberto / Robb, Merlin L / Uchiyama, Akiyoshi / Sawe, Fredrick / Schuerman, Lode / Shrestha, Rajeev / Tong, Tina / Treanor, John / Diazgranados, Carlos A / Chicz, Roman M / Gurunathan, Sanjay / Savarino, Stephen / Sridhar, Saranya

    EClinicalMedicine

    2023  Band 64, Seite(n) 102168

    Abstract: Background: The literature on first generation COVID-19 vaccines show they were less effective against new SARS-CoV-2 variants of concern including Omicron (BA.1, BA.2, BA.4 and BA.5 subvariants). New vaccines developed against variant strains may ... ...

    Abstract Background: The literature on first generation COVID-19 vaccines show they were less effective against new SARS-CoV-2 variants of concern including Omicron (BA.1, BA.2, BA.4 and BA.5 subvariants). New vaccines developed against variant strains may provide cross-protection against emerging variants when used as boosters and facilitate vaccination across a range of countries, healthcare settings and populations. However, there are no data on such vaccines when used as a primary series.
    Methods: A global Phase 3, multi-stage efficacy study (NCT04904549) among adults (≥18 years) was conducted in 53 research centres in eight countries (United States, Honduras, Japan, Colombia, Kenya, India, Ghana, Nepal). Participants were randomized 1:1 to receive two intramuscular injections of a monovalent SARS-CoV-2 recombinant protein vaccine with AS03-adjuvant (10 μg of the spike (S) protein from the ancestral D614 strain) or placebo on Day 1 (D01) and Day 22 (D22). The primary efficacy endpoint was prevention of virologically confirmed SARS-CoV-2 infection with symptoms of COVID-19-like illness (CLI) ≥14 days after the second injection (post-dose 2 [PD2]) in participants who were SARS-CoV-2 naïve on D01 + D22. Safety and reactogenicity were also evaluated.
    Findings: Between May 26 and November 7, 2021, 10,114 participants received ≥1 study injection, and 9441 participants received both injections. 2108 (20.8%) participants were SARS-CoV-2 naïve at D01 and D22. The primary endpoint was analysed in a subset of the full analysis set (the modified full analysis set PD2 [mFAS-PD2], excluding participants who did not complete the vaccination schedule or received vaccination despite meeting one of the contraindication criteria, had onset of symptomatic COVID-19 between the first injection and before 14 days after the second injection, or participants who discontinued before 14 days after the second injection [n = 9377; vaccine, n = 4702; placebo, n = 4675]). Data were available for 2051 SARS-CoV-2 naïve and 7159 non-naïve participants. At the cut-off date (January 28, 2022), symptomatic COVID-19 was reported in 169 naïve participants (vaccine, n = 81; placebo, n = 88) ≥14 days PD2, with a vaccine efficacy (VE) of 15.3% (95% CI, -15.8; 38.2). VE regardless of D01/D22 serostatus was 32.9% (95% CI, 15.3; 47.0) and VE in non-naïve participants was 52.7% (95% CI, 31.2; 67.9). Viral genome sequencing was performed up to the data cut-off point and identified the infecting strain in 99/169 adjudicated cases in the PD2 naïve population (Delta [25], Omicron [72], other variants [3], one participant had infection with both Delta and Omicron variants and has been included in the totals for both Delta and Omicron). The vaccine was well-tolerated with an acceptable safety profile.
    Interpretation: In the context of changing circulating viral variants, it is challenging to induce protection in naïve individuals with a two-dose priming schedule based on the parental D614 strain. However, while the primary endpoint of this trial was not met, the results show that a monovalent D614 vaccine can still be of value in individuals previously exposed to SARS-CoV-2.
    Funding: This study was funded in whole or in part by Sanofi and by federal funds from the Biomedical Advanced Research and Development Authority, part of the office of the Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services under contract number HHSO100201600005I, and in collaboration with the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense under contract number W15QKN-16-9-1002. The views presented here are those of the authors and do not purport to represent those of the Department of the Army, the Department of Health and Human Services, or the U.S. government.
    Sprache Englisch
    Erscheinungsdatum 2023-09-12
    Erscheinungsland England
    Dokumenttyp Journal Article
    ISSN 2589-5370
    ISSN (online) 2589-5370
    DOI 10.1016/j.eclinm.2023.102168
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  7. Artikel ; Online: Protein dose-sparing effect of AS01B adjuvant in a randomized preventive HIV vaccine trial of ALVAC-HIV (vCP2438) and adjuvanted bivalent subtype C gp120.

    Chirenje, Zvavahera Mike / Laher, Fatima / Dintwe, One / Muyoyeta, Monde / deCamp, Allan C / He, Zonglin / Grunenberg, Nicole / Laher Omar, Faatima / Seaton, Kelly E / Polakowski, Laura / Woodward Davis, Amanda S / Maganga, Lucas / Baden, Lindsey R / Mayer, Kenneth / Kalams, Spyros / Keefer, Michael / Edupuganti, Srilatha / Rodriguez, Benigno / Frank, Ian /
    Scott, Hyman / Stranix-Chibanda, Lynda / Gurunathan, Sanjay / Koutsoukos, Marguerite / Van Der Meeren, Olivier / DiazGranados, Carlos A / Paez, Carmen / Andersen-Nissen, Erica / Kublin, James / Corey, Lawrence / Ferrari, Guido / Tomaras, Georgia / McElrath, M Juliana

    The Journal of infectious diseases

    2023  

    Abstract: Background: HVTN 120 is a phase 1/2a randomized double-blind placebo-controlled 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 two dose levels ... ...

    Abstract Background: HVTN 120 is a phase 1/2a randomized double-blind placebo-controlled 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 two dose levels in healthy HIV-uninfected adults. Trial registration URL https://clinicaltrials.gov/ct2/show/NCT03122223 and registration number NCT03122223.
    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 200μg of bivalent subtype C gp120 adjuvanted with MF59 or AS01B, or ALVAC-HIV (vCP2438) with 40μg of bivalent subtype C gp120 adjuvanted with AS01B. Primary outcomes were safety and immune responses.
    Results: We enrolled 160 participants, 55% females, 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 40μg gp120/AS01B group were higher than in either of the 200μg gp120 groups.
    Conclusions: The 40μg dose gp120/AS01B regimen elicited the highest CD4+ T-cell and binding antibody responses.
    Sprache Englisch
    Erscheinungsdatum 2023-10-05
    Erscheinungsland United States
    Dokumenttyp Journal Article
    ZDB-ID 3019-3
    ISSN 1537-6613 ; 0022-1899
    ISSN (online) 1537-6613
    ISSN 0022-1899
    DOI 10.1093/infdis/jiad434
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  8. Artikel: Efficacy of a bivalent (D614 + B.1.351) SARS-CoV-2 Protein Vaccine.

    Dayan, Gustavo H / Rouphael, Nadine / Walsh, Stephen R / Chen, Aiying / Grunenberg, Nicole / Allen, Mary / Antony, Johannes / Asante, Kwaku Poku / Bhate, Amit Suresh / Beresnev, Tatiana / Bonaparte, Matthew I / Ceregido, Maria Angeles / Dobrianskyi, Dmytro / Fu, Bo / Grillet, Marie-Helene / Keshtkar-Jahromi, Maryam / Juraska, Michal / Kee, Jia Jin / Kibuuka, Hannah /
    Koutsoukos, Marguerite / Masotti, Roger / Michael, Nelson L / Reynales, Humberto / Robb, Merlin L / Villagómez Martínez, Sandra M / Sawe, Fredrick / Schuerman, Lode / Tong, Tina / Treanor, John / Wartel, T Anh / Diazgranados, Carlos A / Chicz, Roman M / Gurunathan, Sanjay / Savarino, Stephen / Sridhar, Saranya

    medRxiv : the preprint server for health sciences

    2023  

    Abstract: Background: COVID-19 vaccines with alternative strain compositions are needed to provide broad protection against newly emergent SARS-CoV-2 variants of concern.: Methods: We conducted a global Phase 3, multi-stage efficacy study (NCT04904549) among ... ...

    Abstract Background: COVID-19 vaccines with alternative strain compositions are needed to provide broad protection against newly emergent SARS-CoV-2 variants of concern.
    Methods: We conducted a global Phase 3, multi-stage efficacy study (NCT04904549) among adults aged ≥18 years. Participants were randomized 1:1 to receive two intramuscular injections 21 days apart of a bivalent SARS-CoV-2 recombinant protein vaccine with AS03-adjuvant (5 μg of ancestral (D614) and 5 μg of B.1.351 [beta] variant spike protein) or placebo. Symptomatic COVID-19 was defined as laboratory-confirmed COVID-19 with COVID-19-like illness (CLI) symptoms. The primary efficacy endpoint was the prevention of symptomatic COVID-19 ≥14 days after the second injection (post-dose 2 [PD2]).
    Results: Between 19 Oct 2021 and 15 Feb 2022, 12,924 participants received ≥1 study injection. 75% of participants were SARS-CoV-2 non-naïve. 11,416 participants received both study injections (efficacy-evaluable population [vaccine, n=5,736; placebo, n=5,680]). Up to 15 March 2022, 121 symptomatic COVID-19 cases were reported (32 in the vaccine group and 89 in the placebo group) ≥14 days PD2 with a vaccine efficacy (VE) of 64.7% (95% confidence interval [CI] 46.6; 77.2%). VE was 75.1% (95% CI 56.3; 86.6%) in non-naïve and 30.9% (95% CI -39.3; 66.7%) in naïve participants. Viral genome sequencing identified the infecting strain in 68 cases (Omicron [BA.1 and BA.2 subvariants]: 63; Delta: 4; Omicron and Delta: 1). The vaccine was well-tolerated and had an acceptable safety profile.
    Conclusions: A bivalent vaccine conferred heterologous protection against symptomatic infection with newly emergent Omicron (BA.1 and BA.2) in non-naïve adults 18-59 years of age.
    Sprache Englisch
    Erscheinungsdatum 2023-01-13
    Erscheinungsland United States
    Dokumenttyp Preprint
    DOI 10.1101/2022.12.05.22282933
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  9. Artikel ; Online: SARS-CoV-2 preS dTM vaccine booster candidates increase functional antibody responses and cross-neutralization against SARS-CoV-2 variants of concern in non-human primates

    Pavot, Vincent / Berry, Catherine / Kishko, Michael / Anosova, Natalie G / Huang, Dean / Tibbitts, Tim / Raillard, Alice / Gautheron, Sylviane / Gutzeit, Cindy / Koutsoukos, Marguerite / Chicz, Roman M / Lecouturier, Valerie

    bioRxiv

    Abstract: The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants that partly evade neutralizing antibodies has raised concerns of reduced vaccine effectiveness and increased infection. We previously demonstrated in preclinical ... ...

    Abstract The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants that partly evade neutralizing antibodies has raised concerns of reduced vaccine effectiveness and increased infection. We previously demonstrated in preclinical models and in human clinical trials that our SARS-CoV-2 recombinant spike protein vaccine adjuvanted with AS03 (CoV2 preS dTM-AS03) elicits robust neutralizing antibody responses in naive subjects. Here, the objective was to document the potency of various booster vaccine formulations in macaques previously vaccinated with mRNA or protein subunit vaccine candidates. We show that one booster dose of AS03-adjuvanted CoV2 preS dTM, D614 (parental) or B.1.351 (Beta), in monovalent or bivalent (D614 + B.1.351) formulations, significantly boosted pre-existing neutralizing antibodies and elicited high and stable cross-neutralizing antibodies covering the four known SARS-CoV-2 variants of concern (Alpha, Beta, Gamma and Delta) and, unexpectedly, SARS-CoV-1, in primed macaques. Interestingly, the non-adjuvanted CoV2 preS dTM B.1.351 vaccine formulation also significantly boosted and broadened the neutralizing antibody responses. Our findings show that these vaccine candidates used as a booster have the potential to offer cross-protection against a broad spectrum of variants. This has important implications for vaccine control of SARS-CoV-2 variants of concern and informs on the benefit of a booster with our vaccine candidates currently under evaluation in phase 2 and 3 clinical trials (NCT04762680 and NCT04904549).
    Schlagwörter covid19
    Sprache Englisch
    Erscheinungsdatum 2021-09-21
    Verlag Cold Spring Harbor Laboratory
    Dokumenttyp Artikel ; Online
    DOI 10.1101/2021.09.20.461023
    Datenquelle COVID19

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  10. Artikel ; Online: Persistence of vaccine-elicited immune response up to 14 years post-HIV gp120-NefTat/AS01

    Van Der Meeren, Olivier / Jongert, Erik / Seaton, Kelly E / Koutsoukos, Marguerite / Aerssens, Annelies / Brackett, Caroline / Debois, Muriel / Janssens, Michel / Leroux-Roels, Geert / Mesia Vela, Doris / Sawant, Sheetal / Yates, Nicole L / Tomaras, Georgia D / Leroux-Roels, Isabel / Roman, François

    Vaccine

    2020  Band 38, Heft 7, Seite(n) 1678–1689

    Abstract: Background: Vaccines eliciting protective and persistent immune responses against multiple human immunodeficiency virus type 1 (HIV-1) clades are needed. This study evaluated the persistence of immune responses induced by an investigational, AS01- ... ...

    Abstract Background: Vaccines eliciting protective and persistent immune responses against multiple human immunodeficiency virus type 1 (HIV-1) clades are needed. This study evaluated the persistence of immune responses induced by an investigational, AS01-adjuvanted HIV-1 vaccine as long as 14 years after vaccination.
    Methods: This phase I, open-label, descriptive, mono-centric, extension study with a single group (NCT03368053) was conducted in adults who received ≥3 doses of the clade B gp120-NefTat/AS01
    Results: At Year 14, positive IgG binding antibody responses were detected in 15 out of the 16 antigens from the BAMA V1V2 breadth panel, with positive response rates ranging from 7.1% to 60.7%. The highest response rates were observed for clade B strain V1V2 antigens, with some level of binding antibodies against clade C strains. Anti-V1V2 IgG3 response magnitude breadth, which correlated with decreased risk of infection in a previous efficacy trial, was of limited amplitude. Response rates to the antigens from the gp120 and gp140 breadth panels ranged from 7.7% to 94.1% and from 15.4% to 96.2% at Year 14, respectively. Following stimulation with gp120 peptide pool, highly polyfunctional gp120-specific CD4+ T-cells persisted up to Year 14, with high frequencies of CD40L tumor necrosis factor alpha (TNF-α), CD40L interleukin-2 (IL-2), CD40L TNF-α IL-2 and CD40L interferon gamma (IFN-γ) TNF-α IL-2 CD4+ T-cells, but no CD8+ T-cells detected.
    Conclusions: Persistent antibodies binding to HIV-1 envelope glycoproteins, including the V1V2-scaffold, and gp120-specific cellular immunity were observed in volunteers vaccinated 14 years earlier with the gp120-NefTat/AS01
    Mesh-Begriff(e) AIDS Vaccines/immunology ; Adult ; Antibody Formation ; HIV Antibodies/blood ; HIV Envelope Protein gp120/immunology ; HIV Infections/prevention & control ; HIV-1 ; Humans ; Immunity, Cellular ; Vaccination
    Chemische Substanzen AIDS Vaccines ; HIV Antibodies ; HIV Envelope Protein gp120
    Sprache Englisch
    Erscheinungsdatum 2020-01-10
    Erscheinungsland Netherlands
    Dokumenttyp Clinical Trial, Phase I ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2019.12.058
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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