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

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ClinicalTrials.gov Identifier: NCT02083068
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : March 23, 2018
Sponsor:
Collaborator:
The Administrative Department of Science, Technology and Innovation, Colciencias
Information provided by (Responsible Party):
Socrates Herrera Valencia, Malaria Vaccine and Drug Development Center

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.

Condition or disease Intervention/treatment Phase
Malaria Biological: Vaccine PvCS N+C+R Biological: Vaccine PvCS N+C Biological: SSN Montanide ISA-51 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Evaluation of the Protective Efficacy of a Vaccine Derived From the Synthetic CS Protein of Plasmodium Vivax
Study Start Date : August 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

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

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

Placebo Comparator: Control
six individuals for each sub- group to be immunized with placebo SSN Montanide ISA-51
Biological: SSN Montanide ISA-51
SSN Montanide ISA-51 1 mL




Primary Outcome Measures :
  1. Protective efficacy against P. vivax infection on volunteers exposed to infected mosquito bites [ Time Frame: Thirty days after the last immunization ]
    Vaccine protective efficacy against P. vivax infection on volunteers exposed to infected mosquito bites


Secondary Outcome Measures :
  1. Evolution of antibody titers [ Time Frame: At months 0, 2, 4 and 6 of the trial ]
    Follow up every 2 months (month 0, 2, 4 and 6) until the end of the trial will be done to assess the evolution of P. vivax antibody titers.

  2. Specific cytokine induction [ Time Frame: At months 0, 2, 4 and 6 of the trial ]
    Specific cytokine induction will be measured by IFN- γ, TNF-α, IL-2; IL- 4, IL-6, IL-10

  3. Changes on vaccine biological security [ Time Frame: On the day next to immunization and 1 or 2 weeks before the next immunization ]
    Changes on vaccine biological security will be measured by renal, hepatic and hematologic function and pregnancy test.

  4. Antibody functionality in vitro through inhibition of sporozoite invasion (ISI) to Hep-G2 cells. [ Time Frame: Every 2 months ]
    Antibody functionality will be tested in vitro through essays of inhibition of sporozoite invasion (ISI) to Hep-G2 cells.

  5. Vaccine-induced protection for P. vivax [ Time Frame: 28 days after mosquito bites ]
    Vaccine-induced protection for P. vivax will be assessed by pre-patent period onset after infected mosquito bites exposure



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

2. 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.

3. 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 .
  • Hb ≥ 9 g / dL at the time of diagnosis of malaria.
  • The patient must have the capacity to provide informed consent freely and voluntarily . Should be illiterate may assert its decision to participate by putting their fingerprint in the format consent. Minors who are between 15 and 17 and wishing to participate must sign the informed consent and one of its Parents must sign the informed consent, accompanied by 2 witnesses who also sign

Exclusion Criteria:

  • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083068


Locations
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Colombia
Malaria Vaccine and Drug Development Center
Cali, Valle Del Cauca, Colombia
Sponsors and Collaborators
Malaria Vaccine and Drug Development Center
The Administrative Department of Science, Technology and Innovation, Colciencias
Publications:
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Responsible Party: Socrates Herrera Valencia, MD, Malaria Vaccine and Drug Development Center
ClinicalTrials.gov Identifier: NCT02083068    
Other Study ID Numbers: 2304-493-26202
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Keywords provided by Socrates Herrera Valencia, Malaria Vaccine and Drug Development Center:
Malaria, vaccine, P. vivax
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Infections
Vector Borne Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs