Efficacy of a Synthetic Vaccine Derived From Plasmodium Vivax Circumsporozoite Protein (PvCS) in naïve and Semi-immune Volunteers

NCT04739917 | Unknown Phase 2 DMC

• 1 other identifier: MVDC-2021-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, controlled, which seeks to compare two groups of volunteers (naive and previously exposed to malaria) vaccinated with three doses of a synthetic derivative of the CS protein of Plasmodium vivax to determine their protective efficacy. Then volunteers will be subject to an infectious challenge (Controlled Human Malaria Infection) to assess the infectivity of gametocytes in the blood early stage of P. vivax in Anopheles albimanus mosquitoes.

Conditions

Malaria, Vivax

Keywords

Malaria; Vaccine; Vivax

Outcome Measures

Primary Outcomes (1)

• Frequency of first case of P. vivax malaria after CHMI and meeting the primary case definition.

  The first case of malaria meeting the primary case definition will be defined as the first or only episodes with the presence of Plasmodium vivax parasitemia ≥ 0.1% by thick blood smear and malaria qPCR.

  Assessed over average of 16-18 days post CHMI (range 7 to 60 days)

Secondary Outcomes (28)

• Concentration of specific anti-PvCS IgG antibodies IgG (isotypes) against the different functional fragments of the Pv-CS protein.

  Days 0, 30, 60, 90, 120, 180, 210 and 240.

• Specific cytokine induction

  Days 0, 30, 60, 90, 120, 180, 210 and 240.

• T-cell response measurement - Flow cytometry

  Days 0, 30, 60, 90, 120, 180, 210 and 240.

• T-cell response measurement - ELIspot

  Days 0, 30, 60, 90, 120, 180, 210 and 240.

• T-cell response measurement - Bioplex

  Days 0, 30, 60, 90, 120, 180, 210 and 240.

Study Arms (4)

Arm N Vaccine

EXPERIMENTAL

30 malaria-naïve subjects from non-endemic areas of Cali, Colombia.

Biological: Vaccine PvCS N+C+R 150 mcg

Arm N Placebo

PLACEBO COMPARATOR

30 malaria-naïve subjects from non-endemic areas of Cali, Colombia.

Other: Placebo SSN Montanide ISA-51 1 mL

Arm S Vaccine

EXPERIMENTAL

30 semi-immune subjects from malaria endemic areas of Chocó, Colombia.

Biological: Vaccine PvCS N+C+R 150 mcg

Arm S Placebo

PLACEBO COMPARATOR

30 semi-immune subjects from malaria endemic areas of Chocó, Colombia.

Other: Placebo SSN Montanide ISA-51 1 mL

Interventions

Vaccine PvCS N+C+R 150 mcg BIOLOGICAL

Vaccine PvCS N+C+R 150 mcg (Montanide ISA-51), freeze dried powder.

Arm N Vaccine; Arm S Vaccine

Placebo SSN Montanide ISA-51 1 mL OTHER

SSN Montanide ISA-51 1 mL

Arm N Placebo; Arm S Placebo

Eligibility Criteria

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

You may qualify if:

• Naïve group:
• Non-pregnant, healthy men and women between 18-45 years old.
• Freely and voluntarily sign an IC, accompanied by two witnesses who must also sign.
• Absence history of malaria infection.
• To have negative serology for the PvCS protein by the ELISA test.
• For women, not be pregnant.
• Use of an adequate contraceptive method from the beginning until the contraceptive restriction is lifted by a study doctor, at the end of the study.
• To accept not to travel to areas considered as endemic for malaria from the infectious challenge period and to the end of its follow-up (1 month).
• Be reachable by phone throughout the study period.
• To be Duffy positive (Fy +).
• Have Hemoglobin (Hb) levels\> 11 g / dl.
• Be willing to participate during the period in which the study will take place.
• Not be participating in another clinical study.
• Be affiliated with the general health social security system of Colombia, in any of its regimes (subsidized or contributory)
• Semi-immune group:

You may not qualify if:

• Naïve group:
• Glucose 6 phosphate dehydrogenase deficiency (G-6-P-D).
• Present any hemoglobinopathy (eg HbS).
• Personal history of allergies to medications or insect bites.
• Have received vaccination against malaria.
• Clinical or laboratory abnormalities determined by the investigator (s).
• IFAT\> 1:20 for P. vivax in screening tests.
• Have lived in a malaria-endemic region during the 12 months before the study.
• Clinical or laboratory evidence of systemic disease, including kidney, liver, cardiovascular, pulmonary, psychiatric, or other diseases that may negatively impact and alter study results.
• Evidence of active hepatitis B or Hepatitis C infection
• Evidence of active HIV infection.
• History of transfusion of any blood product in the 6 (six) months before the study.
• Plan to have surgery from the recruitment period to the end of the post-challenge follow-ups.
• Presence or history of autoimmune disease (lupus, rheumatoid arthritis, thyroiditis, or other).
• Splenectomized volunteers.

Sponsors & Collaborators

• Malaria Vaccine and Drug Development Center: lead

Study Sites (1)

Malaria Vaccine and Drug Development Center

Cali, Valle del Cauca Department, Colombia

Location

Related Publications (26)

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MeSH Terms

Conditions

Malaria, Vivax; Malaria

Condition Hierarchy (Ancestors)

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

Study Officials

• Sócrates Herrera, MD

  Director

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sócrates Herrera, MD

CONTACT

575216231; sherrera@inmuno.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 5, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 1, 2021

Record last verified: 2021-02

Locations

CO (1)