Age de-escalation study of BK-SE36/CpG intramuscularly in healthy malaria exposed African adults and children living in Burkina Faso

The malaria vaccine candidate BK-SE36 is based on a recombinant form of the Plasmodium falciparum serine repeat antigen (SERA). The vaccine candidate was selected for clinical development on the following basis: (i)epidemiological studies showing high antibody titers that inversely correlate with malaria symptoms and severe disease; (ii) in vitro studies demonstrating induction of antibodies that are inhibitors of parasite growth, exert antibody-dependent complement-mediated lysis of schizonts, or antibody-dependent monocyte-mediated parasite growth inhibition; and (iii) animal studies demonstrating protection against P. falciparum challenge in non-human primates. The safety and immunogenicity of BK-SE36 were demonstrated in a phase Ia trial in malaria naive Japanese adults; and in a phase Ib trial conducted in healthy subjects aged 6-32 years from a malaria endemic area in Northern Uganda. The trial’s promising results justified the conduct of a phase Ib trial of BK-SE36 in younger cohorts aged from 1 – 5 years old toddlers in Burkina Faso. This ongoing trial aims at testing the immune response in younger cohorts that have so far not been included in the BK-SE36 malaria vaccine clinical trial, compare clinical trial results from two African countries with different malaria endemicity, and generate additional data on safety, immunogenicity, and possible preliminary efficacy of BK-SE36. The immune response to BK-SE36 may still be improved with the use of DNA sequences containing CpG motifs that can selectively promote cellular and/or humoral immune responses. A phase Ia clinical trial using BK-SE36/CpG was conducted in healthy adults in Japan where the vaccine was deemed safe and elicited antibody titers that were 3- to 4-fold higher as compared to BK-SE36 alone.

Study type: Interventional
Enrollment: 135 participants
Primary purpose: Prevention
Allocation:Randomized
Interventional Model: Parallel assignment
Masking:Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Trial Number: PACTR201701001921166
Phase: Phase I

ICTRP registrationPACTR registration

Vaccines (Immune Correlates)

Apr 2018 — Apr 2020

Burkina Faso

Multi-Stage Malaria Vaccine Consortium (MMVC): A four-strike vaccine against malaria