Scholarlink

<p>The ANRS VRI06 trial investigated CD40.HIVRI.Env, an Antibody Mediated Vaccine composed by a CD40 monoclonal antibody fused with gp140 Env, designed to target antigen to dendritic cells. Initial results in 72 HIV-uninfected volunteers showed that administration of 0.3-3.0 mg of CD40.HIVRI.Env, given alone or with DNA-HIV-PT123, was safe and immunogenic up to 48 weeks. After week 48 in the trial, 45 volunteers were randomized to receive a late boost (LB) of 0.3 mg CD40.HIVRI.Env, either with or without adjuvant, to assess continued safety and immunogenicity at 2 and 24 weeks post-LB. The median LB interval from VRI06 baseline was 80 and 79 weeks in unadjuvanted (n=23) and adjuvanted (n=22) groups, respectively. Env-specific IgG and functional CD4+ T-cells persisted at the time of the LB, a median of 55 weeks after the last injection at W24. The LB was well tolerated and markedly boosted immune responses. In particular: i) IgG response rates against gp140 and 9 gp120 antigens reached 100% (vaccine-matched) and 82-100% (heterologous) by 24 weeks post-LB; ii) response rates to gp70 V1V2 antigens increased substantially (e.g., from 0-5% to 5-35%) against autologous 96ZM651 and heterologous V1V2 antigens; iii) neutralizing titers against Tier 1 MW965.26 rose from 14-22% to 35-59%; iv) the frequency of polyfunctional Env-specific CD4+ T-cells increased and persisted 24 weeks post-LB. No marked differences were observed between adjuvanted and unadjuvanted LB groups. CD40.HIVRI.Env vaccination is safe and induced broad, potent and long-lasting anti-HIV immune responses recalled by a single late boost, even without adjuvant. <b>Trial registration:</b> Clinical Trials.gov NCT04842682 ||<a href="https://www.clinicaltrials.gov/">https://www.clinicaltrials.gov/</a> (2021-04-13)</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

CD40.HIVEnv, an antibody mediated vaccine, induces long-term and recall immunogenicity in non-HIV-1 infected volunteers

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年5月29日

查看全文
  • Yves Levy,
  • Christiane Moog,
  • Aurélie Wiedemann,
  • Odile Launay,
  • Fabio Candotti,
  • Lucile Hardel,
  • Mélany Durand,
  • Boris P. Hejblum,
  • Véronique Rieux,
  • Alpha Diallo,
  • Christine Lacabaratz,
  • Sylvain Cardinaud,
  • Sandra Zurawski,
  • Gerard Zurawski,
  • Georgia D. Tomaras,
  • Song Ding,
  • Mireille Centlivre,
  • Rodolphe Thiebaut,
  • Giuseppe Pantaleo,
  • Jean-Daniel Lelièvre,
  • Laura Richert,
  • Tugba Agyar,
  • Motolete Alaba Tanah,
  • Frédéric Batteux,
  • Raida Ben Rayana,
  • Laurène Borie,
  • Magali Bouvier,
  • Kahina Cheref,
  • Vanessa Christinet,
  • Thomas Decoville,
  • Mathilde Desvallées,
  • Harouna Diombera,
  • Mathilde Favreau,
  • Craig Fenwick,
  • Emile Foucat,
  • Camille Gilbert,
  • Tapia Gonzalo,
  • Sophie Grabar,
  • Pascal Grange,
  • Corinne Guerin,
  • Laurent Hanot,
  • Hakim Hocini,
  • Emma Jousseaume,
  • Philippe Kiehl,
  • Corinne Krief,
  • Marie Lachatre,
  • Géraldine Laumond,
  • Léa Levoyer,
  • Li-Yun Li,
  • Liem Binh Luong,
  • Hanane Mehawej,
  • Noémie Mercier,
  • Laura Molinari,
  • Stéphane Paul,
  • Béatrice Parfait,
  • Hélène Pollard,
  • Sylvie Schmidt,
  • Isabelle Sommer,
  • Laure Surgers,
  • Francesco Tommasini,
  • Muriel Verlinde-Carvalho,
  • Jean-Paul Viard,
  • Aline Voidey,
  • Linda Wittkop,
  • Marta Zatta

摘要

The ANRS VRI06 trial investigated CD40.HIVRI.Env, an Antibody Mediated Vaccine composed by a CD40 monoclonal antibody fused with gp140 Env, designed to target antigen to dendritic cells. Initial results in 72 HIV-uninfected volunteers showed that administration of 0.3-3.0 mg of CD40.HIVRI.Env, given alone or with DNA-HIV-PT123, was safe and immunogenic up to 48 weeks. After week 48 in the trial, 45 volunteers were randomized to receive a late boost (LB) of 0.3 mg CD40.HIVRI.Env, either with or without adjuvant, to assess continued safety and immunogenicity at 2 and 24 weeks post-LB. The median LB interval from VRI06 baseline was 80 and 79 weeks in unadjuvanted (n=23) and adjuvanted (n=22) groups, respectively. Env-specific IgG and functional CD4+ T-cells persisted at the time of the LB, a median of 55 weeks after the last injection at W24. The LB was well tolerated and markedly boosted immune responses. In particular: i) IgG response rates against gp140 and 9 gp120 antigens reached 100% (vaccine-matched) and 82-100% (heterologous) by 24 weeks post-LB; ii) response rates to gp70 V1V2 antigens increased substantially (e.g., from 0-5% to 5-35%) against autologous 96ZM651 and heterologous V1V2 antigens; iii) neutralizing titers against Tier 1 MW965.26 rose from 14-22% to 35-59%; iv) the frequency of polyfunctional Env-specific CD4+ T-cells increased and persisted 24 weeks post-LB. No marked differences were observed between adjuvanted and unadjuvanted LB groups. CD40.HIVRI.Env vaccination is safe and induced broad, potent and long-lasting anti-HIV immune responses recalled by a single late boost, even without adjuvant. Trial registration: Clinical Trials.gov NCT04842682 ||https://www.clinicaltrials.gov/ (2021-04-13)