A Phase-I clinical trial to evaluate the safety and immunogenicity of PvDBPII vaccine formulated with adjuvant GLA-SE in healthy Indian male subjects

The study will be conducted in Bengaluru, India. The study involves administration of investigational vaccine PvDBPII/GLA-SE in three dose-escalating cohorts corresponding to three dosages of 10, 25 and 50 µg of PvDBPII with constant dosage of adjuvant GLA-SE (5µg). The control vaccine to be used is Hepatitis B. In each cohort, 12 subjects will be enrolled. Following a 3:1 randomization scheme nine subjects will receive PvDBPII/GLA-SE while three subjects will receive Hepatitis-B vaccine. Therefore in total for this Phase I study thirty six malaria naïve healthy adults will be enrolled as subjects: twenty seven subjects will receive PvDBPII/GLA-SE (9 subjects in each cohort) and 9 subjects will receive Hepatitis B vaccine (3 subjects in each cohort).

• Primary outcome: Assessment of the safety and reactogenicity of three different doses of malaria vaccine candidate.
• Secondary outcome: Humoral immune response against PvDBPIl by IgG ELISA; Test recognition of native antigen in late stage P.vivax schizonts by Immunofluorescence assay (IFA); the ability of Anti-PvDBPIi antibodies to block the interaction between PvDBPil and Duffy antigen receptor chemokine (DARC) by ELISA based Binding Inhibition Assay (BIA); Subclasses of IgG (lgG1, IgG2, IgG3, IgG4) by ELISA.  

Registration ID:           CTRI/2016/09/007289
Study Phase:               I, First-in-Man
Study Type :                Interventional
Intervention Model:     Parellel Group Assignment
Masking:                     Yes (Single Bind)
Primary Purpose:        Prevention

ICTRP - Clinical Trial Registration

P. vivax
Vaccines

Oct 2016 — Jul 2017

$244,298

India

Towards a vaccine for Plasmodium vivax