Malaria, VivaxPhase 1Fase1BNCT01081847

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

A Phase 1 study testing Peptides (N,R&C) formulated in Montanide ISA 720 and Peptides (N,R&C) formulated in Montanide ISA 51 in people with Malaria, Vivax, run by Malaria Vaccine and Drug Development Center at 2 sites in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Malaria, Vivax
What is being tested?: Peptides (N,R&C) formulated in Montanide ISA 720 and Peptides (N,R&C) formulated in Montanide ISA 51
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 2 sitesColombia
Study dates: Jul 2005to Apr 2006
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

Females who intend to become pregnant within the 3 months following the screening visit or who are pregnant at screening time, ascertained by urine or serum pregnancy test (B-HCG). Women who are breast-feeding will also be excluded. Reason for exclusion: The immunological changes accompanying pregnancy and lactation could alter the results of the assays performed. If a pathological condition appear, it could be carried to the vaccine.
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.

Show all 16Show fewer

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

Trial locations and contacts

2 sites in 1 country.

Colombia2 sites

Malaria Vaccine and Drug Testing Center
Cali, Valle del Cauca Department
Malaria Vaccine of Develepmente Center
Cali, Valle del Cauca Department

Other trials in Colombia

About this study

Official title: Malaria Vaccine Phase IB Clinical Trial: Safety and Immunogenicity Study of Plasmodium Vivax CS Derived Synthetic Peptides Formulated in Two Adjuvants

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)

Read the detailed description

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.

Conditions: Malaria, Vivax
Being tested: Peptides (N,R&C) formulated in Montanide ISA 720, Peptides (N,R&C) formulated in Montanide ISA 51, Placebo
Keywords: Malaria, Synthetic peptides, Plasmodium vivax, Human volunteers
Medical subject headings: Malaria, Vivax, Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Peptides (N,R&C) formulated in Montanide ISA 720Drug
Also called Peptides (N, R & C) from P. vivax CS protein
50 ug
Peptides (N,R&C) formulated in Montanide ISA 51Drug
Also called Peptides (N, R & C) from P. vivax CS protein.
50 ug
Peptides (N,R&C) formulated in Montanide ISA 720Drug
Also called Peptides (N, R & C) from P. vivax CS protein.
100 ug
Peptides (N,R&C) formulated in Montanide ISA 51Drug
Also called Peptides (N, R & C) from P. vivax CS protein
100 ug
PlaceboOther
PLacebo: Isotonic saline solution

Study groups in NCT01081847
Study group	Role	What they receive
Group A	Active comparator	Montanide ISA 720 Dose by peptide 50ug Receives: Drug: Peptides (N,R&C) formulated in Montanide ISA 720
Group B	Active comparator	Montanide ISA 51 Dose by peptide 50ug Receives: Drug: Peptides (N,R&C) formulated in Montanide ISA 51
Group C	Active comparator	Montanide ISA 720 Dose by peptide 100ug Receives: Drug: Peptides (N,R&C) formulated in Montanide ISA 720
Group D	Active comparator	Montanide ISA 51 Dose by peptide 100ug Receives: Drug: Peptides (N,R&C) formulated in Montanide ISA 51
Group E	Placebo comparator	Control Group. no peptide. Isotonic saline solution Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Immunogenicity of Plasmodium vivax CS Derived Long Synthetic Peptides Adjuvanted with Montanide ISA 720 or Montanide ISA 51
Measured: 9 months

Secondary outcomes (7)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2005Apr 2006

First posted5 Mar 2010 (estimated)
Study startJul 2005
Primary completionMar 2006
Study completionApr 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (36)Papers the sponsor has linked to this study.
Other trials for Malaria, VivaxStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01081847
Sponsor's protocol ID: MVDC 2003-002
Other IDs: MVDC 2003-002
Acronym: Fase1B
Status last verified: Mar 2010
First submitted: 3 Mar 2010
Last updated: 8 Mar 2010
Results posted: No
Data monitoring committee: Yes

Publications

Nussenzweig RS, Vanderberg J, Most H, Orton C. Protective immunity produced by the injection of x-irradiated sporozoites of plasmodium berghei. Nature. 1967 Oct 14;216(5111):160-2. doi: 10.1038/216160a0. No abstract available.
PubMed 6057225
Clyde DF. Immunity to falciparum and vivax malaria induced by irradiated sporozoites: a review of the University of Maryland studies, 1971-75. Bull World Health Organ. 1990;68 Suppl(Suppl):9-12.
PubMed 2094597
Herrington D, Davis J, Nardin E, Beier M, Cortese J, Eddy H, Losonsky G, Hollingdale M, Sztein M, Levine M, et al. Successful immunization of humans with irradiated malaria sporozoites: humoral and cellular responses of the protected individuals. Am J Trop Med Hyg. 1991 Nov;45(5):539-47. doi: 10.4269/ajtmh.1991.45.539.
PubMed 1951863
Hoffman SL, Goh LM, Luke TC, Schneider I, Le TP, Doolan DL, Sacci J, de la Vega P, Dowler M, Paul C, Gordon DM, Stoute JA, Church LW, Sedegah M, Heppner DG, Ballou WR, Richie TL. Protection of humans against malaria by immunization with radiation-attenuated Plasmodium falciparum sporozoites. J Infect Dis. 2002 Apr 15;185(8):1155-64. doi: 10.1086/339409. Epub 2002 Apr 1.
PubMed 11930326
Egan JE, Hoffman SL, Haynes JD, Sadoff JC, Schneider I, Grau GE, Hollingdale MR, Ballou WR, Gordon DM. Humoral immune responses in volunteers immunized with irradiated Plasmodium falciparum sporozoites. Am J Trop Med Hyg. 1993 Aug;49(2):166-73. doi: 10.4269/ajtmh.1993.49.166.
PubMed 8357078
Romero P, Maryanski JL, Corradin G, Nussenzweig RS, Nussenzweig V, Zavala F. Cloned cytotoxic T cells recognize an epitope in the circumsporozoite protein and protect against malaria. Nature. 1989 Sep 28;341(6240):323-6. doi: 10.1038/341323a0.
PubMed 2477703
Tsuji M, Romero P, Nussenzweig RS, Zavala F. CD4+ cytolytic T cell clone confers protection against murine malaria. J Exp Med. 1990 Nov 1;172(5):1353-7. doi: 10.1084/jem.172.5.1353.
PubMed 2146361
Daubersies P, Thomas AW, Millet P, Brahimi K, Langermans JA, Ollomo B, BenMohamed L, Slierendregt B, Eling W, Van Belkum A, Dubreuil G, Meis JF, Guerin-Marchand C, Cayphas S, Cohen J, Gras-Masse H, Druilhe P. Protection against Plasmodium falciparum malaria in chimpanzees by immunization with the conserved pre-erythrocytic liver-stage antigen 3. Nat Med. 2000 Nov;6(11):1258-63. doi: 10.1038/81366.
PubMed 11062538
Chappel JA, Rogers WO, Hoffman SL, Kang AS. Molecular dissection of the human antibody response to the structural repeat epitope of Plasmodium falciparum sporozoite from a protected donor. Malar J. 2004 Jul 29;3:28. doi: 10.1186/1475-2875-3-28.
PubMed 15283866
Hoffman SL, Nussenzweig V, Sadoff JC, Nussenzweig RS. Progress toward malaria preerythrocytic vaccines. Science. 1991 Apr 26;252(5005):520-1. doi: 10.1126/science.2020852. No abstract available.
PubMed 2020852
Taylor-Robinson AW. Immunity to liver stage malaria: considerations for vaccine design. Immunol Res. 2003;27(1):53-70. doi: 10.1385/IR:27:1:53.
PubMed 12637768
Cerami C, Frevert U, Sinnis P, Takacs B, Clavijo P, Santos MJ, Nussenzweig V. The basolateral domain of the hepatocyte plasma membrane bears receptors for the circumsporozoite protein of Plasmodium falciparum sporozoites. Cell. 1992 Sep 18;70(6):1021-33. doi: 10.1016/0092-8674(92)90251-7.
PubMed 1326407
Frevert U, Sinnis P, Cerami C, Shreffler W, Takacs B, Nussenzweig V. Malaria circumsporozoite protein binds to heparan sulfate proteoglycans associated with the surface membrane of hepatocytes. J Exp Med. 1993 May 1;177(5):1287-98. doi: 10.1084/jem.177.5.1287.
PubMed 8478608
Stoute JA, Slaoui M, Heppner DG, Momin P, Kester KE, Desmons P, Wellde BT, Garcon N, Krzych U, Marchand M. A preliminary evaluation of a recombinant circumsporozoite protein vaccine against Plasmodium falciparum malaria. RTS,S Malaria Vaccine Evaluation Group. N Engl J Med. 1997 Jan 9;336(2):86-91. doi: 10.1056/NEJM199701093360202.
PubMed 8988885
Sun P, Schwenk R, White K, Stoute JA, Cohen J, Ballou WR, Voss G, Kester KE, Heppner DG, Krzych U. Protective immunity induced with malaria vaccine, RTS,S, is linked to Plasmodium falciparum circumsporozoite protein-specific CD4+ and CD8+ T cells producing IFN-gamma. J Immunol. 2003 Dec 15;171(12):6961-7. doi: 10.4049/jimmunol.171.12.6961.
PubMed 14662904

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Malaria Vaccine Phase IB Clinical Trial: Safety and Immunogenicity Study of Plasmodium Vivax CS Derived Synthetic Peptides Formulated in Two Adjuvants
ClinicalTrials.gov ID: NCT01081847
Acronym / sponsor ID: Fase1B / MVDC 2003-002
Conditions: Malaria, Vivax
Keywords: Malaria, Synthetic peptides, Plasmodium vivax, Human volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Malaria Vaccine and Drug Development CenterUniversity, hospital or other
Collaborators: Centro médico Imbanaco, Asoclinic Inmunología Ltda.
Study start: Jul 2005
Primary completion: Mar 2006 (actual)
Study completion: Apr 2006 (actual)
First posted: 5 Mar 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objective was to assess in malaria-naïve adults, the safety and reactogenicity of these peptides formulated in the two adjuvants

Detailed description

Study design

Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Group A	Active comparator	Drug: Peptides (N,R&C) formulated in Montanide ISA 720Montanide ISA 720 Dose by peptide 50ug
Group B	Active comparator	Drug: Peptides (N,R&C) formulated in Montanide ISA 51Montanide ISA 51 Dose by peptide 50ug
Group C	Active comparator	Drug: Peptides (N,R&C) formulated in Montanide ISA 720Montanide ISA 720 Dose by peptide 100ug
Group D	Active comparator	Drug: Peptides (N,R&C) formulated in Montanide ISA 51Montanide ISA 51 Dose by peptide 100ug
Group E	Placebo comparator	Other: PlaceboControl Group. no peptide. Isotonic saline solution

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (16 listed)

Females who intend to become pregnant within the 3 months following the screening visit or who are pregnant at screening time, ascertained by urine or serum pregnancy test (B-HCG). Women who are breast-feeding will also be excluded. Reason for exclusion: The immunological changes accompanying pregnancy and lactation could alter the results of the assays performed. If a pathological condition appear, it could be carried to the vaccine.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Peptides (N,R&C) formulated in Montanide ISA 720Also: Peptides (N, R & C) from P. vivax CS protein50 ug	Drug	Group A
Peptides (N,R&C) formulated in Montanide ISA 51Also: Peptides (N, R & C) from P. vivax CS protein.50 ug	Drug	Group B
Peptides (N,R&C) formulated in Montanide ISA 720Also: Peptides (N, R & C) from P. vivax CS protein.100 ug	Drug	Group C
Peptides (N,R&C) formulated in Montanide ISA 51Also: Peptides (N, R & C) from P. vivax CS protein100 ug	Drug	Group D
PlaceboPLacebo: Isotonic saline solution	Other	Group E

Primary outcome

Safety and Immunogenicity of Plasmodium vivax CS Derived Long Synthetic Peptides Adjuvanted with Montanide ISA 720 or Montanide ISA 51
Time frame: 9 months

7 secondary outcomes

Immunogenicity assessment
Time frame: 9 month
Adverse Events
Time frame: 9 month
Safety Laboratories
Time frame: 8 month
B-cell response
Time frame: 8 month
T-cell response evaluation
Time frame: 8 month
Cytokine Production Evaluation by ELISA
Time frame: 8 month
Cytokine Production by ELIspot
Time frame: 8 month

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2010.
Background: PubMed 6057225Nussenzweig RS, Vanderberg J, Most H, Orton C. Protective immunity produced by the injection of x-irradiated sporozoites of plasmodium berghei. Nature. 1967 Oct 14;216(5111):160-2. doi: 10.1038/216160a0. No abstract available.
Background: PubMed 2094597Clyde DF. Immunity to falciparum and vivax malaria induced by irradiated sporozoites: a review of the University of Maryland studies, 1971-75. Bull World Health Organ. 1990;68 Suppl(Suppl):9-12.
Background: PubMed 1951863Herrington D, Davis J, Nardin E, Beier M, Cortese J, Eddy H, Losonsky G, Hollingdale M, Sztein M, Levine M, et al. Successful immunization of humans with irradiated malaria sporozoites: humoral and cellular responses of the protected individuals. Am J Trop Med Hyg. 1991 Nov;45(5):539-47. doi: 10.4269/ajtmh.1991.45.539.
Background: PubMed 11930326Hoffman SL, Goh LM, Luke TC, Schneider I, Le TP, Doolan DL, Sacci J, de la Vega P, Dowler M, Paul C, Gordon DM, Stoute JA, Church LW, Sedegah M, Heppner DG, Ballou WR, Richie TL. Protection of humans against malaria by immunization with radiation-attenuated Plasmodium falciparum sporozoites. J Infect Dis. 2002 Apr 15;185(8):1155-64. doi: 10.1086/339409. Epub 2002 Apr 1.
Background: PubMed 8357078Egan JE, Hoffman SL, Haynes JD, Sadoff JC, Schneider I, Grau GE, Hollingdale MR, Ballou WR, Gordon DM. Humoral immune responses in volunteers immunized with irradiated Plasmodium falciparum sporozoites. Am J Trop Med Hyg. 1993 Aug;49(2):166-73. doi: 10.4269/ajtmh.1993.49.166.
Background: PubMed 2477703Romero P, Maryanski JL, Corradin G, Nussenzweig RS, Nussenzweig V, Zavala F. Cloned cytotoxic T cells recognize an epitope in the circumsporozoite protein and protect against malaria. Nature. 1989 Sep 28;341(6240):323-6. doi: 10.1038/341323a0.
Background: PubMed 2146361Tsuji M, Romero P, Nussenzweig RS, Zavala F. CD4+ cytolytic T cell clone confers protection against murine malaria. J Exp Med. 1990 Nov 1;172(5):1353-7. doi: 10.1084/jem.172.5.1353.
Background: PubMed 11062538Daubersies P, Thomas AW, Millet P, Brahimi K, Langermans JA, Ollomo B, BenMohamed L, Slierendregt B, Eling W, Van Belkum A, Dubreuil G, Meis JF, Guerin-Marchand C, Cayphas S, Cohen J, Gras-Masse H, Druilhe P. Protection against Plasmodium falciparum malaria in chimpanzees by immunization with the conserved pre-erythrocytic liver-stage antigen 3. Nat Med. 2000 Nov;6(11):1258-63. doi: 10.1038/81366.
Background: PubMed 15283866Chappel JA, Rogers WO, Hoffman SL, Kang AS. Molecular dissection of the human antibody response to the structural repeat epitope of Plasmodium falciparum sporozoite from a protected donor. Malar J. 2004 Jul 29;3:28. doi: 10.1186/1475-2875-3-28.
Background: PubMed 2020852Hoffman SL, Nussenzweig V, Sadoff JC, Nussenzweig RS. Progress toward malaria preerythrocytic vaccines. Science. 1991 Apr 26;252(5005):520-1. doi: 10.1126/science.2020852. No abstract available.
Background: PubMed 12637768Taylor-Robinson AW. Immunity to liver stage malaria: considerations for vaccine design. Immunol Res. 2003;27(1):53-70. doi: 10.1385/IR:27:1:53.
Background: PubMed 1326407Cerami C, Frevert U, Sinnis P, Takacs B, Clavijo P, Santos MJ, Nussenzweig V. The basolateral domain of the hepatocyte plasma membrane bears receptors for the circumsporozoite protein of Plasmodium falciparum sporozoites. Cell. 1992 Sep 18;70(6):1021-33. doi: 10.1016/0092-8674(92)90251-7.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Myriam Arevalo-Herrera, PhD study director

MVDC

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Immunogenicity of Plasmodium vivax CS Derived Long Synthetic Peptides Adjuvanted with Montanide ISA 720 or Montanide ISA 51 (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01081847, which also lists 36 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2010.