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

Tahapan Penelitian : Awal
Sponsor:
Mitra Pelaksana:
Divisi Penyakit Tropik dan Infeksi, Departemen Ilmu Penyakit Dalam FKUI-RSCM; Lembaga Biologi Molekular Eijkman; TNI Angkatan Darat
No Registry
INA-ZN6M5MG
Tanggal Input Registry : 23-07-2019

01-10-2019
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.
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. 6.To identify markers of latent infection with Pv.
 
Safety, Tolerability, Immunogenicity and Protective Efficacy of PfSPZ Vaccine and PfSPZ-CVac in Indonesian Adults Against Naturally-Transmitted Malaria
Safety, Tolerability, Immunogenicity and Protective Efficacy of PfSPZ Vaccine and PfSPZ-CVac in Indonesian Adults Against Naturally-Transmitted Malaria
Eksperimental
Sanaria® PfSPZ Vaccine: Radiation attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ) administered by direct venous inoculation (DVI). Normal Saline (0.9% NaCl): The placebo control administered by DVI. Sanaria® PfSPZ-CVac: Infectious, aseptic, purified, cryopreserved PfSPZ (Sanaria® PfSPZ Challenge) administered by DVI to individuals taking chloroquine (CQ) chemoprophylaxis. Normal Saline (0.9% NaCl): The placebo control administered by DVI to individuals taking CQ chemoprophylaxis. Diluent. The diluent for PfSPZ Vaccine and PfSPZ Challenge will be phosphate buffered saline (PBS) with 1% human serum albumin.
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Inclusion Criteria:

1.A male aged 18-55 years at the time of screening. 2.Assigned to the battalion of study and programmed to accompany it to eastern Indonesia for the duration of the deployment. 3.Freely provides written informed consent to participate in the study. 4.Agrees to adhere to Indonesian military medical guidance regarding screening and treatment of malaria. 5.Physical examination and laboratory results without clinically significant findings and a body mass index (BMI) ≤35 kg/m2.

Exclusion Criteria:

1.Previous vaccination with an investigational malaria vaccine. 2.Use of an investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days before the first study vaccination, or planned use up to 30 days after last vaccination. 3.Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs within six months before the first vaccination. This includes any dose level of oral steroids, but not inhaled steroids or topical steroids. 4.Administration or planned administration of 1 live or 3 or more other type vaccines in the period beginning 28 days before the first study vaccination and ending 28 days after the last vaccination. 5.Confirmed or suspected immunosuppressive or immunodeficient condition. 6.Confirmed or suspected autoimmune disease. 7.History of allergic reactions or anaphylaxis to CQ or other 4-aminoquinolone derivatives. 8.History of serious allergic reactions to a drug (anaphylaxis, or requiring hospitalization). 9.History of allergy to phosphate buffered saline or human serum albumin. 10.Use or planned use of any drug with anti-malarial activity during the course of the study except for antimalarial medication administered by study clinicians. 11.History of splenectomy. 12.Laboratory evidence of liver disease (the final decision will be made by the PI and clinical officers, but in general a volunteer will be excluded if any of the screening liver function tests (ALT, bilirubin, gamma GTP) are > double the upper limit of normal measured twice without an explanation for the abnormal values). 13.Laboratory evidence of renal disease (serum creatinine > 1.5 mg/dL, measured twice) 14.Laboratory evidence of hematologic disease (platelet count or hemoglobin 5% 5-year cardiovascular risk (fatal and non-fatal) based on the Gaziano scoring system (Appendix A); subjects in the 18–34-year-old age group will be assessed as though they are in the 35-44 age group. 24.History of psychiatric disorders (such as personality disorders, anxiety disorders, or schizophrenia) or behavioral tendencies (including active alcohol or drug abuse) discovered during the screening process that in the opinion of the investigator would make compliance with the protocol difficult.
 
Ethical Approval from Ethics Committee Faculty of Medicine University of Indonesia, letter no. 0228/UN2.F1/ETIK/2018 dated 19 Mar 2018; Ethical Approval from Oxford Tropical Research Ethics Committee (OxTREC) dated 07 Sep 2018
Not Applicable
PPUK No. B-PN.01.06.3.321.05.19.1739 dated 10 May 2019
NCT03503058
Ms. Fitria Wulandari. Email address: fwulandari@eocru.org; Telephone no.: +622131900971; Office address: Eijkman Oxford Clinical Research Unit, Jl. P. Diponegoro No. 69, Jakarta Pusat, 10430, Indonesia