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TitleHIV-1 envelope trimer vaccine induces sex-associated differences in antibody responses: a phase 1 clinical trial.
Journal, issue, pagesNat Commun, Vol. 16, Issue 1, Page 10250, Year 2025
Publish dateNov 21, 2025
AuthorsEmma I M M Reiss / Karlijn van der Straten / Laura T M Graus / Marloes Grobben / Kilian E Vlaming / Annelou I P van der Veen / Marinus H Liesdek / Gabriel Ozorowski / Martin Corcoran / Hongmei Gao / Kelli M Greene / Nicole L Yates / Sheetal Sawant / Gius Kerster / Judith A Burger / Stella Schonherr / Hannah M Cheeseman / Abbey Evans / Leon R McFarlane / Andy S Tran / Jonathan L Torres / Ryan N Lin / Gyunghee Jo / Monica Tolazzi / Philipp Mundsperger / Dietmar Katinger / Albert Cupo / John P Moore / Rob Hurks / Liffert Vogt / Maarten R Soeters / Neeltje A Kootstra / Gabriella Scarlatti / Georgia D Tomaras / David C Montefiori / Gunilla B Karlsson Hedestam / Andrew B Ward / Michelle Klouwens / Menno D de Jong / Jan M Prins / Mathieu Claireaux / Teunis B H Geijtenbeek / Robin J Shattock / Marit J van Gils / Rogier W Sanders / Godelieve J de Bree /
PubMed AbstractA protective vaccine will be the most powerful instrument to reduce HIV-1 infections worldwide and help bring about a lasting end to the AIDS epidemic. The single centre, randomised, open-label, ...A protective vaccine will be the most powerful instrument to reduce HIV-1 infections worldwide and help bring about a lasting end to the AIDS epidemic. The single centre, randomised, open-label, uncontrolled, phase 1 ACTHIVE-001 clinical trial (NCT03961438) aims to assess the safety and immunogenicity of the ConM SOSIP.v7 native-like trimer protein vaccine, based on an HIV-1 group M consensus sequence, in HIV-negative adults. Twenty-four individuals were enrolled to receive three dosages of ConM SOSIP.v7 protein vaccine in a liposome formulation containing a high dose of the TLR4-agonist MPLA. The primary outcome is vaccine reactogenicity, whereas the main secondary outcome is binding and neutralising antibody responses. Overall, the vaccine is safe and well-tolerated. Furthermore, the vaccine elicits robust strain-specific binding and neutralising antibody responses in nearly all vaccinees. Post-hoc exploratory analyses demonstrate that female-born participants have 22- and 6-fold higher neutralisation titres after the second and third vaccination, respectively. The vaccine adjuvant induces higher levels of IL-6 secretion from in vitro cultured monocytes from female compared to male participants, providing a possible mechanistic explanation for the sex-based differences. Our study highlights the need to take sex-based differences into consideration when assessing HIV-1 vaccine candidates and adjuvants.
External linksNat Commun / PubMed:41271616 / PubMed Central
MethodsEM (single particle)
Resolution30.0 Å
Structure data

EMDB-47765: Week 26 C3V5, gp41-GH and gp41-base epitope polyclonal antibodies from participant 202 in complex with ConM SOSIP
Method: EM (single particle) / Resolution: 30.0 Å

Source
  • Homo sapiens (human)

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