Evaluation of the Protective Efficacy of a Vaccine Derived From the Synthetic CS Protein of Plasmodium Vivax

NCT02083068 | Completed Phase 2

• 1 other identifier: 2304-493-26202
• Study Type: interventional
• Target: 32
• 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) who were made 3 immunizations with a synthetic derivative of the CS protein of Plasmodium vivax in order to determine their protective efficacy. Then volunteers will be subject to an infectious challenge to assess the infectivity of gametocytes in the blood early stage of P. vivax in Anopheles albimanus mosquitoes.

Conditions

Malaria

Keywords

Malaria, vaccine, P. vivax

Outcome Measures

Primary Outcomes (1)

• Protective efficacy against P. vivax infection on volunteers exposed to infected mosquito bites

  Vaccine protective efficacy against P. vivax infection on volunteers exposed to infected mosquito bites

  Thirty days after the last immunization

Secondary Outcomes (5)

• Evolution of antibody titers

  At months 0, 2, 4 and 6 of the trial

• Specific cytokine induction

  At months 0, 2, 4 and 6 of the trial

• Changes on vaccine biological security

  On the day next to immunization and 1 or 2 weeks before the next immunization

• Antibody functionality in vitro through inhibition of sporozoite invasion (ISI) to Hep-G2 cells.

  Every 2 months

• Vaccine-induced protection for P. vivax

  28 days after mosquito bites

Study Arms (2)

Experimental

EXPERIMENTAL

10 individuals per sub- group to be immunized with the Vaccine PvCS N+C at month 0 and the Vaccine PvCS N+C+R at months 2 and 6

Biological: Vaccine PvCS N+C+R; Biological: Vaccine PvCS N+C

Control

PLACEBO COMPARATOR

six individuals for each sub- group to be immunized with placebo SSN Montanide ISA-51

Biological: SSN Montanide ISA-51

Interventions

Vaccine PvCS N+C+R BIOLOGICAL

Vaccine PvCS N+C+R 60 mcg, freeze dried powder, Batch n°P0RGB, Exp: 18.10.2015 At month 2 and 6

Experimental

Vaccine PvCS N+C BIOLOGICAL

Vaccine PvCS N+C 60 mcg, freeze dried powder, Batch n°P0RGA, Exp: 18.10.2015, at month 0

Experimental

SSN Montanide ISA-51 BIOLOGICAL

SSN Montanide ISA-51 1 mL

Control

Eligibility Criteria

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

You may qualify if:

• Naïve group
• Healthy men and women aged 18-45 years. Signing freely and voluntary informed consent , accompanied by two witnesses who also sign.
• Not have a history of malaria infection. For women, use of adequate contraception from the star restriction to be lifted by a doctor for contraception study. Accept not to travel to areas considered endemic for malaria during Trophies infectious period (1 month ) ( Buenaventura , Tierralta , Pretoria , Tumaco ,Urabá and Bajo Cauca) .
• Be reachable by phone throughout the study period. Being Duffy positive ( Fy +) . Levels of hemoglobin ( Hb) \> 11 g / dl. Availability to participate during the period in which they develop the study. Do not be participating in another clinical study
• \. Preimmune group
• Healthy men and women aged 18-45 years. Signing freely and voluntary informed consent , accompanied by two witnesses who also sign .
• Having a history of infection (s ) and serological tests for malaria positive for P. vivax.
• For women, use adequate contraception from the start restriction to be lifted by a doctor for contraception study .
• Accept not to travel to areas considered endemic for malaria during Trophies infectious period (1 month ) ( Buenaventura , Tierralta , Pretoria , Tumaco Urabá and Bajo Cauca) .
• Be reachable by phone throughout the study period. Availability to participate during the period in which they develop the study.
• \. Voluntary blood donors
• Healthy men and women aged 18-45 years.
• Be positive diagnosis of P. vivax determined by thick smear examination .
• The patient must not have circulating malaria parasites such as P. falciparum or P. malariae .
• Have a parasitemia ≥ 0.1 %. by thick smear .

You may not qualify if:

• Step 1
• Negative IFAT (\< 1:20) for P. vivax on screening tests
• Other criteria used in the case of naive volunteers, except a history of having lived in an endemic area for the past 6 months.
• Step 2 Patients that have chronic or acute disease, different from malaria by P. vivax.
• Having a history of disease or clinical conditions that according to medical criteria might increase significantly the risk related with participation on this study Hemoglobin levels \<9 g/dL at the time of recruitment Have received antimalarial treatment before the diagnosis

Sponsors & Collaborators

• Malaria Vaccine and Drug Development Center: lead
• The Administrative Department of Science, Technology and Innovation, Colciencias: collaborator

Study Sites (1)

Malaria Vaccine and Drug Development Center

Cali, Valle del Cauca Department, Colombia

Location

Related Publications (2)

• 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

• Arevalo-Herrera M, Gaitan X, Larmat-Delgado M, Caicedo MA, Herrera SM, Henao-Giraldo J, Castellanos A, Devaud JC, Pannatier A, Onate J, Corradin G, Herrera S. Randomized clinical trial to assess the protective efficacy of a Plasmodium vivax CS synthetic vaccine. Nat Commun. 2022 Mar 25;13(1):1603. doi: 10.1038/s41467-022-29226-3.

  PMID: 35338131 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 11, 2014
• Study Start: August 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: July 1, 2017
• Last Updated: March 23, 2018

Record last verified: 2018-03

Locations

CO (1)