Last Updated: 02/12/2024
Phase 1b age de-escalation study of BK-SE36/Alhydrogel, subcutaneously or intramuscularly, in healthy malaria exposed African children living in Burkina Faso
Objectives
The primary objective of this study is to assess the safety and reactogenicity of 3 doses of 100 µg BK-SE36 malaria vaccine candidate with aluminium hydroxide gel as an adjuvant, in either subcutaneous or intramuscular route, in healthy African children exposed to the parasite Plasmodium falciparum.
The secondary objectives of this study are:
1. to assess the quality of the humoral immune response by measuring IgG1, IgG3 subclasses
2. to assess T cell cytokines IL-5, IL-13, and IFN production
3. to assess the humoral immune response to the vaccine antigens administered subcutaneously or intramuscularly by measuring the level of IgG.
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 proposed clinical phase Ib trial conducted in Burkina Faso will allow for (i) testing of the vaccine candidate in a younger age group (1-5 years old), (ii) generation of additional information/data on safety, immunogenicity and preliminary possible efficacy, and (iii) comparison of clinical trial results from two different African countries with different malaria endemicity -Uganda and Burkina Faso
Study type: Interventional
Enrollment: 108 participant
Primary purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel assignment
Masking : Double (participants, outcome assessors)
Trial Number: PACTR201411000934120
Phase: Phase I
Nov 2014 — Feb 2017
$3.08M
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