A Phase 1 interventional study of Peptides (N,R&C) formulated in Montanide ISA 720 and Peptides (N,R&C) formulated in Montanide ISA 51 in Malaria, Vivax, sponsored by Malaria Vaccine and Drug Development Center. Completed at 2 sites in Colombia. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-03-08.
Sponsored by Malaria Vaccine and Drug Development Center · Phase 1 and Interventional
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)
The study corresponds to a clinical trial, randomized double-blind, controlled, dose escalation, Phase IB, which will assess the safety and immunogenicity of a mixture of synthetic peptides derived from CS protein of P. vivax, formulated in adjuvant Montanide ISA 720 and 51; in healthy men and nonpregnant women without previous history of malaria infection.
In order to optimize the vaccine dose, eligible participants were enrolled to receive three doses of vaccine containing peptide mixtures at a dose of 50 ug or 100 ug of each individual peptide, for a final dose of 150 ug or 300 ug respectively, in a volume of 0.5 mL. The previous clinical trial had indicated that doses between 30 ug and 100 ug produced better responses than lower doses. The first immunization dose (given at Month 0) contained the peptides N and C only, whereas the two boosting doses (given at Months 2 and 4) contained all three (N, R, and C) peptides (Table 1). Vaccination was performed by intramuscular injection in the deltoid muscle, alternating arms with each injection.
For safety reasons, participants assigned to the low vaccine dose groups were immunized first and only two weeks after initiation when no serious adverse events (SAE) had occurred, immunization of participants in the high-dose was started. Half of the participants assigned to receive placebo were immunized along with each dose level group. Clinical monitors and the IRBs of the University of Valle and IMC, evaluated the occurrence and severity of adverse events (AE) associated with immunization. The occurrence of more than three AE (severity grade 2 or higher) or one SAE related to the vaccine would have led to study termination. Participants who left the study were not replaced.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 40 is below the median of 220 across 1,027 interventional studies indexed under Malaria.
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Exclusion Criteria:
Justification: The results of the study could have a negative impact on the study if volunteers are suffering from any of these diseases.
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.
Justification: Autoimmune diseases could affect the immunological responses of volunteers and could increase the risk to the volunteer.
Justification: These drugs could affect the immunological responses of volunteers and could increase the risk to the volunteer.
Justification: Volunteers must have the capacity to provide informed consent in order to participate in any research involving humans
Montanide ISA 720 Dose by peptide 50ug
Drug: Peptides (N,R&C) formulated in Montanide ISA 720
Montanide ISA 51 Dose by peptide 50ug
Drug: Peptides (N,R&C) formulated in Montanide ISA 51
Montanide ISA 720 Dose by peptide 100ug
Drug: Peptides (N,R&C) formulated in Montanide ISA 720
Montanide ISA 51 Dose by peptide 100ug
Drug: Peptides (N,R&C) formulated in Montanide ISA 51
Control Group. no peptide. Isotonic saline solution
Other: Placebo
50 ug
Also known as: Peptides (N, R & C) from P. vivax CS protein
50 ug
Also known as: Peptides (N, R & C) from P. vivax CS protein.
100 ug
Also known as: Peptides (N, R & C) from P. vivax CS protein.
100 ug
Also known as: Peptides (N, R & C) from P. vivax CS protein
PLacebo: Isotonic saline solution
Safety and Immunogenicity of Plasmodium vivax CS Derived Long Synthetic Peptides Adjuvanted with Montanide ISA 720 or Montanide ISA 51
Time frame: 9 months
Immunogenicity assessment
Specific anti CS antibodies determination (B cell response) and specific induction of IFNγ production (T cell response). All sera samples will be kept at -70° in Immunology Institute, FCVL or Asoclinic until use.
Time frame: 9 month
Adverse Events
Each AE will be written on CRF forms and will be immediately be informed to the clinical monitor and IRB. All volunteers will be followed until recovering it the initial condition. Additional physical examination and laboratory tests will be performed in case any relation between the AE and the immunogen needs to be established.
Time frame: 9 month
Safety Laboratories
Complete blood cell count, hepatic and renal function tests will be made on months 1, 2, 3, 6, 7 y 9 after the first immunization. Every change in the laboratory results will be reported on the corresponding CRF´s; severity associated with vaccination will be established. Specific studies will be made if it is necessary the AE end will be determined when these parameters will be normal.
Time frame: 8 month
B-cell response
Specific antibody titers will be measured by ELISA technique using the corresponding peptide (N, R, C) as coating antigen and the recognition of the native protein will be assessed by Immunofluorescence technique (IFAT) using P vivax sporozoites obtained by dissection of experimentally infected Anopheles mosquitoes \[91\] Antibody titers will be considered as positive at 1:100 dilution by ELISA and 1:40 by IFAT.
Time frame: 8 month
T-cell response evaluation
Cell mediated immune (CMI) responses will be evaluated will be made by the cytokines IFN-γ production using peripheral blood mononuclear cells (PBMC) using both ELIspot and ELISA techniques.
Time frame: 8 month
Cytokine Production Evaluation by ELISA
PBMC will be stimulated with each of the three peptides (N, R or C) in a concentration of 10ug/ml and cells cultures without the peptide will be used as negative control. PBMC stimulated with phyto-hemaglutinin (PHA) will be used as positive controls.
Time frame: 8 month
Cytokine Production by ELIspot
This evaluation will be made in two phases: First the cytokine production in total PBMC, which will be stimulated with CS protein derived peptides of different length. Second, positive samples for cytokine will be used to evaluate the production of cytokines by purified T lymphocytes subpopulations CD4+ or CD8+. This will determine the subpopulation responsible for cytokine production. A positive selection of cell subpopulations will be performed using anti-CD4+ / CD8+ coated pearls using MACS, and will be further used for ELIspot.
Time frame: 8 month
This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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Malaria Vaccine and Drug Development Center