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Principal Investigator:
Erni Juwita Nelwan, PhD, MD (Faculty of Medicine, University of Indonesia)

Responsible Investigator:
J. Kevin Baird, PhD (EOCRU)

Co-Investigators:

Sponsor: Sanaria Incorporated, USA

Funder: US Congressionally Directed Medical Research Program

Background

An effective vaccine with a good safety and tolerability profile that induces sterilizing and long-lasting immunity against malaria would vastly improve our ability to control and eliminate malaria. No such vaccine is now available. The most advanced malaria vaccine is a product called RTSS composed of molecular subunits of Plasmodium falciparum. That vaccine induced limited non-sterilizing immunity of short duration. Over the past decade another approach to vaccination using whole, living parasites of P. falciparum (invasive sporozoite forms) has made great strides toward that ideal vaccine product. One of the leaders of that technological approach is Sanaria Inc. (USA) and they have two US FDA-registered investigational new drug (IND) vaccine products called PfSPZ and PfSPZ-CVac. Each product represents a distinct approach to whole live parasite vaccination technology, i.e., radiation vs. chloroquine (drug) attenuation.

EOCRU and the scientists at Sanaria joined forces to conduct a highly novel malaria vaccine trial involving those two vaccines. The trial offers several firsts: 1) first trial of a malaria vaccine of any kind in Indonesia; 2) first trial of live sporozoite vaccines in the Asia-Pacific region; 3) first head-to-head trial of the radiation- vs. drug-attenuated live vaccine technologies; 4) first examination of possible cross-species protection for a P. falciparum vaccine against P. vivax, both primary and latent forms. Uniquely, the trial will leverage non-immune subjects exposed to high risk of natural malaria infection who will return to a non-endemic area.

Objectives

  1. To assess the safety and tolerability of PfSPZ Vaccine and PfSPZ-CVac compared to placebo among men naturally exposed to malaria.
  2. To assess the protective efficacy (vaccine efficacy = VE) against P. falciparum (Pf) naturally transmitted mosquito-borne attack diagnosed by thick blood smear (TBS) microscopy of PfSPZ Vaccine and PfSPZ-CVac compared to placebo among men naturally exposed to Pf.
  3. To assess the protective efficacy of PfSPZ Vaccine and PfSPZ-CVac against naturally transmitted mosquito-borne P. vivax (Pv) primary attack diagnosed by TBS microscopy.
  4. To assess the protective efficacy of PfSPZ Vaccine and PfSPZ-CVac against secondary attacks from latent liver stages of Pv by TBS during the six months post-exposure period in a malaria-free area.
  5. To assess the protective efficacy of PfSPZ Vaccine and PfSPZ-CVac against naturally transmitted Pf and Pv primary and secondary attacks diagnosed by quantitative polymerase chain reaction (qPCR).
  6. To determine the immunogenicity of PfSPZ Vaccine and PfSPZ-CVac.
  7. To determine if any immune responses to Pf or Pv are predictive of VE.
In 2018, the study team developed the study protocol, which was submitted for ethical and regulatory approvals, and conducted further trial preparations. Participants will be recruited in early 2019 from an Indonesian Army battalion based at a malaria-free area of West Java (Cianjur). All volunteers will be healthy males aged 18 to 55 years. Standard safety, tolerability, and parasitology data will be collected during the immunization period (before deployment). After immunization is completed through a 4-month period, the soldiers will begin a scheduled regular military deployment to a heavily malarious site in eastern Indonesia for a period of 9 months. While there, the subjects will be closely monitored by the clinical trial team. The team will also monitor the soldiers for a period of 4 months following their repatriation to Java.

 

 

Related unit(s):

Coordinator: John Kevin Baird