@article{fdi:010077138,
  title = {{F}irst-in-human, randomized, double-blind clinical trial of differentially adjuvanted {PAMVAC}, a vaccine candidate to prevent pregnancy-associated malaria},
  author = {{M}ordmuller, {B}. and {S}ulyok, {M}. and {E}gger-{A}dam, {D}. and {R}esende, {M}. and de {J}ongh, {W}. {A}. and {J}ensen, {M}. {H}. and {S}medegaard, {H}. {H}. and {D}itlev, {S}. {B}. and {S}oegaard, {M}. and {P}oulsen, {L}. and {D}yring, {C}. and {C}alle, {C}. {L}. and {K}noblich, {A}. and {I}banez, {J}. and {E}sen, {M}. and {D}eloron, {P}hilippe and {N}dam, {N}. and {I}ssifou, {S}. and {H}ouard, {S}. and {H}oward, {R}. {F}. and {R}eed, {S}. {G}. and {L}eroy, {O}. and {L}uty, {A}drian and {T}heander, {T}. {G}. and {K}remsner, {P}. {G}. and {S}alanti, {A}. and {N}ielsen, {M}. {A}.},
  editor = {},
  language = {{ENG}},
  abstract = {{B}ackground. {M}alaria in pregnancy has major impacts on mother and child health. {T}o complement existing interventions, such as intermittent preventive treatment and use of impregnated bed nets, we developed a malaria vaccine candidate with the aim of reducing sequestration of asexual "blood-stage" parasites in the placenta, the major virulence mechanism. {M}ethods. {T}he vaccine candidate {PAMVAC} is based on a recombinant fragment of {VAR}2{CSA}, the {P}lasmodium falciparum protein responsible for binding to the placenta via chondroitin sulfate {A} ({CSA}). {H}ealthy, adult malaria-naive volunteers were immunized with 3 intramuscular injections of 20 mu g (n = 9) or 50 mu g (n = 27) {PAMVAC}, adjuvanted with {A}lhydrogel or glucopyranosyl lipid adjuvant in stable emulsion ({GLA}-{SE}) or in a liposomal formulation with {QS}21 ({GLA}-{LSQ}). {A}llocation was random and double blind. {T}he vaccine was given every 4 weeks. {V}olunteers were observed for 6 months following last immunization. {R}esults. {A}ll {PAMVAC} formulations were safe and well tolerated. {A} total of 262 adverse events ({AE}s) occurred, 94 (10 grade 2 and 2 grade 3) at least possibly related to the vaccine. {N}o serious {AE}s occurred. {D}istribution and severity of {AE}s were similar in all arms. {PAMVAC} was immunogenic in all participants. {PAMVAC}-specific antibody levels were highest with {PAMVAC}-{GLA}-{SE}. {T}he antibodies inhibited binding of {VAR}2{CSA} expressing {P}. falciparum-infected erythrocytes to {CSA} in a standardized functional assay. {C}onclusions. {PAMVAC} formulated with {A}lhydrogel or {GLA}-based adjuvants was safe, well tolerated, and induced functionally active antibodies. {N}ext, {PAMVAC} will be assessed in women before first pregnancies in an endemic area.},
  keywords = {malaria vaccine ; {VAR}2{CSA} ; pregnancy-associated malaria ; first-in-human ; phase 1 clinical trial ; {ALLEMAGNE} ; {TUBINGEN} ; {BENIN} ; {COTONOU}},
  booktitle = {},
  journal = {{C}linical {I}nfectious {D}iseases},
  volume = {69},
  numero = {9},
  pages = {1509--1516},
  ISSN = {1058-4838},
  year = {2019},
  DOI = {10.1093/cid/ciy1140},
  URL = {https://www.documentation.ird.fr/hor/fdi:010077138},
}