Safety and Immunogenicity Study of Plasmodium Vivax CS Derived Synthetic Peptides Formulated in Two Adjuvants

NCT01081847 | Completed Phase 1 DMC

• 1 other identifier: MVDC 2003-002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This was a phase I double blind controlled vaccine trial, evaluating safety, tolerability and immunogenicity of mixtures of N, R and C LSP derived from the P. vivax CS protein formulated in two adjuvants Montanide ISA 720 and Montanide ISA 51. The primary objective was to assess in malaria-naïve adults, the safety and reactogenicity of these peptides formulated in the two adjuvants We recruited 40 healthy men and women volunteers from Cali, Colombia, a city non-endemic for malaria. Volunteers were 19--41 years of age and had no history of malaria. During a period of three months a total of 100 volunteers were assessed for eligibility criteria in order to select a total of 40 volunteers willing to participate in the clinical trial. By consecutive allocation, eight participants were allocated to each of the five experimental groups (A--E): four groups (A--D) were immunized with the vaccine formulations at two different dose concentrations and formulated in two different adjuvants. A control group (E) was injected with placebo (saline solution)

Conditions

Malaria, Vivax

Keywords

Malaria; Synthetic peptides; Plasmodium vivax; Human volunteers

Outcome Measures

Primary Outcomes (1)

• Safety and Immunogenicity of Plasmodium vivax CS Derived Long Synthetic Peptides Adjuvanted with Montanide ISA 720 or Montanide ISA 51

  9 months

Secondary Outcomes (7)

• Immunogenicity assessment

  9 month

• Adverse Events

  9 month

• Safety Laboratories

  8 month

• B-cell response

  8 month

• T-cell response evaluation

  8 month

Study Arms (5)

Group A

ACTIVE COMPARATOR

Montanide ISA 720 Dose by peptide 50ug

Drug: Peptides (N,R&C) formulated in Montanide ISA 720

Group B

ACTIVE COMPARATOR

Montanide ISA 51 Dose by peptide 50ug

Drug: Peptides (N,R&C) formulated in Montanide ISA 51

Group C

ACTIVE COMPARATOR

Montanide ISA 720 Dose by peptide 100ug

Drug: Peptides (N,R&C) formulated in Montanide ISA 720

Group D

ACTIVE COMPARATOR

Montanide ISA 51 Dose by peptide 100ug

Drug: Peptides (N,R&C) formulated in Montanide ISA 51

Group E

PLACEBO COMPARATOR

Control Group. no peptide. Isotonic saline solution

Other: Placebo

Interventions

Peptides (N,R&C) formulated in Montanide ISA 720 DRUG

50 ug

Also known as: Peptides (N, R & C) from P. vivax CS protein

Group A

Peptides (N,R&C) formulated in Montanide ISA 51 DRUG

50 ug

Also known as: Peptides (N, R & C) from P. vivax CS protein.

Group B

Placebo OTHER

PLacebo: Isotonic saline solution

Group E

Eligibility Criteria

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

You may qualify if:

• Healthy adults (male and non-pregnant female) 18- 45 years old, without previously malaria infection (naïve volunteers), capable to pass a comprehension test on the study and able to provide written informed consent to participate in the trial.
• Use of adequate contraceptive method since the initiation of the study and until two months after the end of the study.
• No plans to travel to a malaria endemic area during the course of the study.
• Reachable by phone during the study period (1 year).
• No use of other vaccines since 3 months before the beginning of the study and during it.

You may not qualify if:

• Duffy negative phenotype. Justification: Individuals with this phenotype are refractory to P. vivax infection.
• G-6-PD deficiency or any genetic defect (hemoglobinopathy). Justification: These conditions influence the development of P. vivax infection.
• History of previous experimental malaria vaccination. Justification: Individuals who have been previously immunized may show a response due to the past immunization and not to the present one.
• Clinical or laboratory evidence of significant systemic disease, including hepatic, renal, cardiac, immunologic or hematological disease.
• Justification: The results of the study could have a negative impact on the study if volunteers are suffering from any of these diseases.
• Evidence of active hepatitis B or C or HIV infection. Justification: Serious underlying medical condition could affect the immunological responses of volunteers or could increase the risk or severity of adverse events associated with participation in this study.
• Clinically significant laboratory abnormalities as determined by the investigator(s).
• Justification: Baseline abnormal laboratory values may indicate a serious underlying medical condition and also will make it difficult to evaluate AE´s during the conduct of the study.
• Known history of autoimmune (including inflammatory bowel disease, rheumatoid arthritis, lupus) or connective tissue disease.
• Justification: Autoimmune diseases could affect the immunological responses of volunteers and could increase the risk to the volunteer.
• Individuals receiving treatment with steroids or non-steroidal anti-inflammatory drugs or any immunosuppressive therapy.
• Justification: These drugs could affect the immunological responses of volunteers and could increase the risk to the volunteer.
• Known history of drug or alcohol abuse interfering with normal social function. Justification: Pharmaco-dependency alters the capacity of free decision and produce physical or psychiatric undesirable condition that could affect the study.
• Volunteers unable to give written informed consent or with difficulties to understand the study.
• Justification: Volunteers must have the capacity to provide informed consent in order to participate in any research involving humans

Sponsors & Collaborators

• Malaria Vaccine and Drug Development Center: lead
• Centro médico Imbanaco: collaborator
• Asoclinic Inmunología Ltda.: collaborator

Study Sites (2)

Malaria Vaccine and Drug Testing Center

Cali, Valle del Cauca Department, Colombia

Location

Malaria Vaccine of Develepmente Center

Cali, Valle del Cauca Department, Colombia

Location

Related Publications (36)

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Related Links

• Related Info

MeSH Terms

Conditions

Malaria, Vivax; Malaria

Interventions

Peptides; mannide monooleate; montanide ISA 51

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Myriam Arevalo-Herrera, PhD

  MVDC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 3, 2010
• First Posted: March 5, 2010
• Study Start: July 1, 2005
• Primary Completion: March 1, 2006
• Study Completion: April 1, 2006
• Last Updated: March 8, 2010

Record last verified: 2010-03

Locations

CO (2)