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Safety and immunogenicity of BK-SE36 in a blinded, randomized, controlled, age de-escalating phase Ib clinical trial

Edith Christiane Bougouma1,2, Nirianne Marie Q Palacpac3, Alfred B Tiono1,2

  • 1Groupe de Recherche Action en Santé, Ouagadougou (GRAS), Ouagadougou, Burkina Faso.

Frontiers in Immunology
|September 19, 2022
PubMed

Insights

The BK-SE36 malaria vaccine candidate is safe and immunogenic in children under five. It showed a higher immune response in younger children, regardless of intramuscular or subcutaneous administration.

Area of Science:

  • Malariology
  • Vaccinology
  • Pediatric Infectious Diseases

Background:

  • A blood-stage malaria vaccine targeting Plasmodium falciparum erythrocytic stages could prevent clinical disease.
  • Antibodies against P. falciparum serine repeat antigen 5 (SE47 and SE36 domains) correlate with protection.
  • Previous trials of BK-SE36 showed promise; this study evaluates it in young children.

Purpose of the Study:

  • To assess the safety and immunogenicity of the BK-SE36 vaccine candidate in children aged 12-60 months.
  • To compare intramuscular (IM) versus subcutaneous (SC) administration routes for BK-SE36.
  • To evaluate the vaccine's efficacy in different age groups.

Main Methods:

  • Phase Ib, double-blind, randomized, controlled trial in Burkinabe children.
  • Two age cohorts (12-24 months and 25-60 months) received three doses of BK-SE36 (IM or SC) or a control vaccine.
  • Safety and immunogenicity were monitored at multiple time points.

Main Results:

  • BK-SE36 was well-tolerated, with mostly mild to moderate local reactions.
  • The vaccine was immunogenic, inducing a significant increase in antibody titers.
  • Younger children (12-24 months) exhibited a higher immune response compared to older children.
  • Antibody titers waned before the third dose but were boosted post-vaccination.

Conclusions:

  • BK-SE36 is safe and immunogenic in children under five via both IM and SC routes.
  • The vaccine elicits a stronger immune response in younger children.
  • Further evaluation of BK-SE36 for malaria prevention is warranted.
Abstract

Keywords:
Plasmodium falciparumSE36SERA5immunogenicitymalaria blood-stage vaccinesafetyserine repeat antigen

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