Exposure of Naive and Pre-immune Subjects to P. Vivax Challenge

NCT01585077 | Completed Phase 1

• 1 other identifier: CIV - 08 - 102010
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized clinical trial designed to compare the susceptibility of naive and pre-immune volunteers to infectious challenge with viable Plasmodium vivax sporozoites. The term preimmune hereafter denoted only previous experience with infection by this parasite and not a definite state of immunity to malaria infection. The study hypothesis is that pre-immune volunteers present a delayed onset of malaria clinical and parasitological manifestations when compared to naive individuals. The development of this study will establish a protocol for evaluating the effectiveness of vaccine candidates against P. vivax in subsequent Phases IIa and IIb clinical trials.

Conditions

Malaria

Keywords

Plasmodium vivax; Malaria; Challenge; Anopheles albimanus

Outcome Measures

Primary Outcomes (1)

• Pre-patent period onset

  begining at day 7 after mosquito bites exposure, both groups of volunteers will be evaluated with dayly Thick blood smear to compare the malaria onset between the pre-immune and naive groups.

  Two months after the challenge

Secondary Outcomes (1)

• Immune response

  Two months after the malaria challenge

Study Arms (2)

Naive volunteers

EXPERIMENTAL

Volunteers without previous exposure to malaria, and negative antibody titers (\<1:20) against native protein of P. vivax.

Biological: P. vivax infected mosquito bites

Pre-immune volunteers

EXPERIMENTAL

Volunteers with previous exposure to malaria, and positive antibody titers against native protein of P. vivax

Biological: P. vivax infected mosquito bites

Interventions

P. vivax infected mosquito bites BIOLOGICAL

All volunteers will receive one dose of 2-4 P. vivax infected mosquito bites. All the mosquitoes will correspond to the same mosquito batch to make sure that all volunteers receive the same P. vivax strain.

Naive volunteers; Pre-immune volunteers

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Step 1:
• Age 15 to 60 years.
• Hemoglobin levels \> 9g/dL.
• Presence of Current P. vivax infection.
• Absence of other Plasmodium species determined by thick blood smear and PCR.
• Blood parasite count of 0.1% or more.
• Absence of other acute or chronic diseases.
• Being able to sign an informed consent form.
• Step 2:
• Healthy 18 to 45 years old man or non-pregnant women.
• To have the capacity to sign an informed consent in a free and voluntary way.
• To have an acceptable understanding of the clinical trial through the approval of a questionnaire regarding the information given in the consent process.
• Obligatory use of adequate contraceptive method from beginning of recruitment and screening time up to three months after last immunization.
• Do not have chronic or acute diseases. These conditions will be determined by clinical history, physical exam and laboratory tests.
• To accept not traveling to malaria endemic areas during the clinical trial should

You may not qualify if:

• Step 1:
• history of blood transfusion in the last six months.
• Pregnancy in women.
• Have received antimalarial treatment before the diagnosis.
• Step 2:
• Pregnant or nursing women.
• History of moderate or severe insect, or food allergies.
• G-6PD deficiency or any Hb genetic defect.
• Symptoms, signs or data from laboratory test that suggests any systemic disorder like renal, hepatic, cardiovascular, pulmonary, psychiatric disorders or other illnesses that could interfere with results of clinical trial or could compromise the health of the volunteer.
• To have antibodies against hepatitis C, VIH, or hepatitis B superficial antigen and/or hepatitis B core antibodies.
• To have any abnormality in the parameters assessed by blood laboratory tests
• Presence or history of an auto-immune disease.
• History of surgical removal of the spleen (splenectomy).
• Use of medical treatment known to alter the immune system before 3 months to recruitment.

Sponsors & Collaborators

• Socrates Herrera Valencia: lead

Study Sites (1)

Malaria Vaccine and Drug development Center (MVDC)

Cali, Valle del Cauca Department, Colombia

Location

Related Publications (3)

• Herrera S, Solarte Y, Jordan-Villegas A, Echavarria JF, Rocha L, Palacios R, Ramirez O, Velez JD, Epstein JE, Richie TL, Arevalo-Herrera M. Consistent safety and infectivity in sporozoite challenge model of Plasmodium vivax in malaria-naive human volunteers. Am J Trop Med Hyg. 2011 Feb;84(2 Suppl):4-11. doi: 10.4269/ajtmh.2011.09-0498.

  PMID: 21292872 BACKGROUND

• Herrera S, Fernandez O, Manzano MR, Murrain B, Vergara J, Blanco P, Palacios R, Velez JD, Epstein JE, Chen-Mok M, Reed ZH, Arevalo-Herrera M. Successful sporozoite challenge model in human volunteers with Plasmodium vivax strain derived from human donors. Am J Trop Med Hyg. 2009 Nov;81(5):740-6. doi: 10.4269/ajtmh.2009.09-0194.

  PMID: 19861603 BACKGROUND

• Arevalo-Herrera M, Forero-Pena DA, Rubiano K, Gomez-Hincapie J, Martinez NL, Lopez-Perez M, Castellanos A, Cespedes N, Palacios R, Onate JM, Herrera S. Plasmodium vivax sporozoite challenge in malaria-naive and semi-immune Colombian volunteers. PLoS One. 2014 Jun 25;9(6):e99754. doi: 10.1371/journal.pone.0099754. eCollection 2014.

  PMID: 24963662 DERIVED

Related Links

• Malaria Vaccine and Drug Development Center web page

MeSH Terms

Conditions

Malaria; Malaria, Vivax

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Sócrates Herrera, MD

  Malaria Vaccine and Drug Development Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 23, 2012
• First Posted: April 25, 2012
• Study Start: October 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 15, 2014

Record last verified: 2014-01

Locations

CO (1)