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Title in clinicaltrials.gov:

Safety, Tolerability, Immunogenicity and Protective Efficacy of PfSPZ Vaccine and PfSPZ-CVac in Indonesian Adults Against Naturally-Transmitted Malaria

 

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

 

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

 

Co-Investigators:

Amin Soebandrio, MD, Ph.D. 

Herawati Sudoyo, MD, Ph.D.

Rintis Noviyanti, Ph.D.

Inge Sutanto, MD, Ph.D.

Soroy Lardo, MD, Ph.D.

Waras Budiman, MD, Ph.D.

Bidik Catur Prasetya, MD

Lenny Ekawati, MPH

Iqbal Elyazar, D.Phil

Ari Satyagraha, Ph.D.

Raph L. Hamers, MD Ph.D.

Krisin Chand, MD (clinical trial medical officer)

 

This study is being done by the Eijkman Institute for Molecular Biology (EIMB) in collaboration with the Eijkman Oxford Clinical Research Unit (EOCRU), and the Faculty of Medicine, University of Indonesia (FMUI) together with their partners in research in Indonesian Army Medical Corps. The study is sponsored by Sanaria, Inc. (Sanaria) and funded by the Congressionally Directed Medical Research Program (CDMRP) of the United States Congress. 

 

Objectives

Primary:

  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.

Secondary:

1.  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.

2.  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.

3.  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).

4.  To determine the immunogenicity of PfSPZ Vaccine and PfSPZ-CVac.

5.  To determine if any immune responses to Pf or Pv are predictive of VE.

 

 

Related unit(s):

Coordinator: John Kevin Baird