Evaluation of Reproducibility of a Sporozoite Challenge Model for Plasmodium Vivax in Human Volunteers

NCT00367380 | Completed Phase 2 Results DMC

• 1 other identifier: MVDC-2006-004
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a randomized open label clinical trial to verify the reproducibility of a sporozoite challenge model for Plasmodium vivax in humans. The verification of the reproducibility of such a model will make it possible to evaluate the efficacy of candidate P. vivax vaccines in Phase 2a trials. The study is divided into two successive steps: Step A Parasite Blood Donation: Volunteers will be recruited passively from a group of patients who present with active P. vivax infection and accept to donate infected blood. Samples of P. vivax infected blood will be collected and will be screened for infectious diseases, according to standard blood bank procedures. Colonized Anopheles albimanus mosquitoes will be fed with this blood using a Membrane Feeding Assay (MFA). Sixteen (16) days after, selected positive mosquito batches will be used for step B. Step B Challenge: After informed consent signature, a total of 18 healthy volunteers will be randomly allocated to Groups 1, 2 and 3, of 6 volunteers each and will be challenged with the bite of 3±1, P. vivax infected mosquitoes. Each group will be exposed to a different isolated parasite. Volunteers will be closely monitored post infection, and will be treated as soon as blood infection becomes patent as ascertained by microscopic examination of thick blood smears (TBS). Comparison of data obtained in the three different groups will be used to determine reproducibility of challenge model. Primary objective: To demonstrate that naïve human volunteers can be safely and reproducibly infected by the bite of An. albimanus mosquitoes carrying P. vivax sporozoites in their salivary glands. Secondary objective: To determine the influence of the type of parasite isolated on reproducibility and safety of the challenge model with P. vivax in human volunteers Hypothesis:It is possible to safely develop a reproducible P. vivax infection in human volunteers using P. vivax experimentally infected An. albimanus mosquitoes.

Conditions

MALARIA; FEVER; Sweating Fever; Chills; ANEMIA

Keywords

Malaria; Sporozoite; Challenge Model; Plasmodium vivax; Human Volunteers

Outcome Measures

Primary Outcomes (1)

• Infection for P. Vivax

  Thick blood smear was performed to patients daily on days 7 to 23, and every other day until day 29. Any prove of P. vivax infection was considered positive and confirmed later by real time polymerase chain reaction (rPCR).

  Twenty eight days

Study Arms (3)

Group 1

EXPERIMENTAL

6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 413ABM

Other: 413ABM

Group 2

EXPERIMENTAL

6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 414WRR

Other: 414WRR

Group 3

EXPERIMENTAL

6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 418JAL

Other: 418JAL

Interventions

413ABM OTHER

+/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 413ABM

Group 1

414WRR OTHER

+/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 414WRR

Group 2

418JAL OTHER

+/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 418JAL

Group 3

Eligibility Criteria

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

You may qualify if:

• Healthy, adult male or non-pregnant females (18-45 years of age).
• Capacity to sign a free informed consent form of participation along with two witnesses.
• Use of adequate contraceptive method from the initiation of the study until three months after sporozoite challenge.
• No plans to travel to malaria endemic areas during the course of the study (a year).
• No plans to travel outside the study area from the 7th day until 31st day after the challenge.
• Reachable by phone during the whole study period.
• Able to participate during the whole study period.

You may not qualify if:

• Are less than 18 and over 45 years of age.
• Are female who is pregnant at serum positive B-HCG screening, planning to become pregnant or who is nursing.
• Have a Duffy negative phenotype.
• Have a G-6-PD deficiency or any other hemoglobinopathy.
• Current or past infection with any species of malaria as demonstrated by a positive TBS on screening or history of a documented positive blood smear. P. vivax IFAT of 1
• Have a known history of allergy to antimalarial drugs or immediate type hypersensitivity reactions to mosquito bites.
• Clinical or laboratory evidence of significant systemic disease, including hepatic, renal, cardiac, immunologic or hematological disease, HIV positive or have any other known immunodeficiency (including receiving immunosuppressive therapy or a history of splenectomy); infected with hepatitis B or C virus; have a history of autoimmune disease (including inflammatory bowel disease, hemolytic anemia, autoimmune hepatitis, rheumatoid arthritis, lupus, etc.) or connective tissue disease or have any other serious underlying medical condition.
• Clinically significant laboratory abnormalities as determined by the Investigator(s).
• Plan to have surgery between enrollment and the end of the challenge follow-up.
• Previous history of alcoholism or drugs use which interfere with social activities of the volunteer
• Have any other conditions that are determined by at least two concurring investigators that may interfere with the capacity to provide free and willing informed consent.

Sponsors & Collaborators

• Malaria Vaccine and Drug Development Center: lead
• Fundacion Clinica Valle del Lili: collaborator

Study Sites (1)

Malaria Vaccine and Drug Development Center

Cali, Valle del Cauca Department, 25574, Colombia

Location

Related Publications (82)

• Arevalo-Herrera M, Roggero MA, Gonzalez JM, Vergara J, Corradin G, Lopez JA, Herrera S. Mapping and comparison of the B-cell epitopes recognized on the Plasmodium vivax circumsporozoite protein by immune Colombians and immunized Aotus monkeys. Ann Trop Med Parasitol. 1998 Jul;92(5):539-51.

  PMID: 9797827 BACKGROUND

• Arevalo-Herrera M, Herrera S. Plasmodium vivax malaria vaccine development. Mol Immunol. 2001 Dec;38(6):443-55. doi: 10.1016/s0161-5890(01)00080-3.

  PMID: 11741694 BACKGROUND

• Arevalo-Herrera M, Castellanos A, Yazdani SS, Shakri AR, Chitnis CE, Dominik R, Herrera S. Immunogenicity and protective efficacy of recombinant vaccine based on the receptor-binding domain of the Plasmodium vivax Duffy binding protein in Aotus monkeys. Am J Trop Med Hyg. 2005 Nov;73(5 Suppl):25-31. doi: 10.4269/ajtmh.2005.73.5_suppl.0730025.

  PMID: 16291763 BACKGROUND

• Arevalo-Herrera M, Solarte Y, Zamora F, Mendez F, Yasnot MF, Rocha L, Long C, Miller LH, Herrera S. Plasmodium vivax: transmission-blocking immunity in a malaria-endemic area of Colombia. Am J Trop Med Hyg. 2005 Nov;73(5 Suppl):38-43. doi: 10.4269/ajtmh.2005.73.5_suppl.0730038.

  PMID: 16291765 BACKGROUND

• Arevalo-Herrera M, Solarte Y, Yasnot MF, Castellanos A, Rincon A, Saul A, Mu J, Long C, Miller L, Herrera S. Induction of transmission-blocking immunity in Aotus monkeys by vaccination with a Plasmodium vivax clinical grade PVS25 recombinant protein. Am J Trop Med Hyg. 2005 Nov;73(5 Suppl):32-7. doi: 10.4269/ajtmh.2005.73.32.

  PMID: 16291764 BACKGROUND

• Baird JK, Tiwari T, Martin GJ, Tamminga CL, Prout TM, Tjaden J, Bravet PP, Rawlins S, Ferrel M, Carucci D, Hoffman SL. Chloroquine for the treatment of uncomplicated malaria in Guyana. Ann Trop Med Parasitol. 2002 Jun;96(4):339-48. doi: 10.1179/000349802125001023.

  PMID: 12171615 BACKGROUND

• Ballou WR, Arevalo-Herrera M, Carucci D, Richie TL, Corradin G, Diggs C, Druilhe P, Giersing BK, Saul A, Heppner DG, Kester KE, Lanar DE, Lyon J, Hill AV, Pan W, Cohen JD. Update on the clinical development of candidate malaria vaccines. Am J Trop Med Hyg. 2004 Aug;71(2 Suppl):239-47.

  PMID: 15331843 BACKGROUND

• Baton LA, Ranford-Cartwright LC. How do malaria ookinetes cross the mosquito midgut wall? Trends Parasitol. 2005 Jan;21(1):22-8. doi: 10.1016/j.pt.2004.11.001.

  PMID: 15639737 BACKGROUND

• Blair S, Lopez ML, Pineros JG, Alvarez T, Tobon A, Carmona J. [Therapeutic efficacy of 3 treatment protocols for non-complicated Plasmodium falciparum malaria, Antioquia, Colombia, 2002]. Biomedica. 2003 Sep;23(3):318-27. Spanish.

  PMID: 14582335 BACKGROUND

• Blow JA, Turell MJ, Walker ED, Silverman AL. Post-bloodmeal diuretic shedding of hepatitis B virus by mosquitoes (Diptera: Culicidae). J Med Entomol. 2002 Jul;39(4):605-12. doi: 10.1603/0022-2585-39.4.605.

  PMID: 12144291 BACKGROUND

• 11. Bosman, A., Delacollette, C., Olumese, P., Ridley, RG., Rietveld, R., Shretta, R.,Teklehaimanot, A. The use of antimalarial drugs. Report of an Informal Consultation. Roll Back Malaria. WHO. 2001.

  BACKGROUND

• Chauhan VS, Bhardwaj D. Current status of malaria vaccine development. Adv Biochem Eng Biotechnol. 2003;84:143-82. doi: 10.1007/3-540-36488-9_5.

  PMID: 12934936 BACKGROUND

• 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.

  PMID: 15283866 BACKGROUND

• Chotivanich K, Silamut K, Udomsangpetch R, Stepniewska KA, Pukrittayakamee S, Looareesuwan S, White NJ. Ex-vivo short-term culture and developmental assessment of Plasmodium vivax. Trans R Soc Trop Med Hyg. 2001 Nov-Dec;95(6):677-80. doi: 10.1016/s0035-9203(01)90113-0.

  PMID: 11816444 BACKGROUND

• Chulay JD, Schneider I, Cosgriff TM, Hoffman SL, Ballou WR, Quakyi IA, Carter R, Trosper JH, Hockmeyer WT. Malaria transmitted to humans by mosquitoes infected from cultured Plasmodium falciparum. Am J Trop Med Hyg. 1986 Jan;35(1):66-8. doi: 10.4269/ajtmh.1986.35.66.

  PMID: 3511753 BACKGROUND

• Church LW, Le TP, Bryan JP, Gordon DM, Edelman R, Fries L, Davis JR, Herrington DA, Clyde DF, Shmuklarsky MJ, Schneider I, McGovern TW, Chulay JD, Ballou WR, Hoffman SL. Clinical manifestations of Plasmodium falciparum malaria experimentally induced by mosquito challenge. J Infect Dis. 1997 Apr;175(4):915-20. doi: 10.1086/513990.

  PMID: 9086149 BACKGROUND

• Clyde DF, McCarthy VC, Miller RM, Hornick RB. Specificity of protection of man immunized against sporozoite-induced falciparum malaria. Am J Med Sci. 1973 Dec;266(6):398-403. doi: 10.1097/00000441-197312000-00001. No abstract available.

  PMID: 4590095 BACKGROUND

• Clyde DF. Immunization of man against falciparum and vivax malaria by use of attenuated sporozoites. Am J Trop Med Hyg. 1975 May;24(3):397-401. doi: 10.4269/ajtmh.1975.24.397.

  PMID: 808142 BACKGROUND

• 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.

  PMID: 2094597 BACKGROUND

• Cogswell FB. The hypnozoite and relapse in primate malaria. Clin Microbiol Rev. 1992 Jan;5(1):26-35. doi: 10.1128/CMR.5.1.26.

  PMID: 1735093 BACKGROUND

• Collins WE, Jeffery GM. Primaquine resistance in Plasmodium vivax. Am J Trop Med Hyg. 1996 Sep;55(3):243-9. doi: 10.4269/ajtmh.1996.55.243.

  PMID: 8842108 BACKGROUND

• Danis M. [Therapeutic advances against malaria in 2003]. Med Trop (Mars). 2003;63(3):267-70. French.

  PMID: 14579464 BACKGROUND

• Doolan DL, Hoffman SL. Nucleic acid vaccines against malaria. Chem Immunol. 2002;80:308-21. doi: 10.1159/000058851. No abstract available.

  PMID: 12058647 BACKGROUND

• Duarte EC, Pang LW, Ribeiro LC, Fontes CJ. Association of subtherapeutic dosages of a standard drug regimen with failures in preventing relapses of vivax malaria. Am J Trop Med Hyg. 2001 Nov;65(5):471-6. doi: 10.4269/ajtmh.2001.65.471.

  PMID: 11716100 BACKGROUND

• Edelman R, Hoffman SL, Davis JR, Beier M, Sztein MB, Losonsky G, Herrington DA, Eddy HA, Hollingdale MR, Gordon DM, et al. Long-term persistence of sterile immunity in a volunteer immunized with X-irradiated Plasmodium falciparum sporozoites. J Infect Dis. 1993 Oct;168(4):1066-70. doi: 10.1093/infdis/168.4.1066.

  PMID: 8376823 BACKGROUND

• 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.

  PMID: 8357078 BACKGROUND

• FAIRLEY NH. Sidelights on malaria in man obtained by subinoculation experiments. Trans R Soc Trop Med Hyg. 1947 May;40(5):621-76. doi: 10.1016/0035-9203(47)90025-4. No abstract available.

  PMID: 20243883 BACKGROUND

• Fernández, O.,Manzano, M.R, Murrain, B., Blanco P., Zamora F., Jordan, A. Palacios, R., Velez, D., Arevalo-Herrera, M., Herrera, S. Development of a sporozoite challenge model for Plasmodium vivax in human volunteers. ASTMH. Annual Metting 54th. 2005.

  BACKGROUND

• Fryauff DJ, Baird JK, Basri H, Sumawinata I, Purnomo, Richie TL, Ohrt CK, Mouzin E, Church CJ, Richards AL, et al. Randomised placebo-controlled trial of primaquine for prophylaxis of falciparum and vivax malaria. Lancet. 1995 Nov 4;346(8984):1190-3. doi: 10.1016/s0140-6736(95)92898-7.

  PMID: 7475658 BACKGROUND

• Genton B, Corradin G. Malaria vaccines: from the laboratory to the field. Curr Drug Targets Immune Endocr Metabol Disord. 2002 Oct;2(3):255-67. doi: 10.2174/1568008023340613.

  PMID: 12476490 BACKGROUND

• George FW 4th, Law JL, Rich KA, Martin WJ. Identification of a T-cell epitope on the circumsporozoite protein of Plasmodium vivax. Infect Immun. 1990 Feb;58(2):575-8. doi: 10.1128/iai.58.2.575-578.1990.

  PMID: 1688828 BACKGROUND

• Glynn JR. Infecting dose and severity of malaria: a literature review of induced malaria. J Trop Med Hyg. 1994 Oct;97(5):300-16.

  PMID: 7932927 BACKGROUND

• Glynn JR, Bradley DJ. Inoculum size, incubation period and severity of malaria. Analysis of data from malaria therapy records. Parasitology. 1995 Jan;110 ( Pt 1):7-19. doi: 10.1017/s0031182000080999.

  PMID: 7845714 BACKGROUND

• Glynn JR, Collins WE, Jeffery GM, Bradley DJ. Infecting dose and severity of falciparum malaria. Trans R Soc Trop Med Hyg. 1995 May-Jun;89(3):281-3. doi: 10.1016/0035-9203(95)90540-5.

  PMID: 7660433 BACKGROUND

• Golenda CF, Li J, Rosenberg R. Continuous in vitro propagation of the malaria parasite Plasmodium vivax. Proc Natl Acad Sci U S A. 1997 Jun 24;94(13):6786-91. doi: 10.1073/pnas.94.13.6786.

  PMID: 9192643 BACKGROUND

• Good MF, Pombo D, Quakyi IA, Riley EM, Houghten RA, Menon A, Alling DW, Berzofsky JA, Miller LH. Human T-cell recognition of the circumsporozoite protein of Plasmodium falciparum: immunodominant T-cell domains map to the polymorphic regions of the molecule. Proc Natl Acad Sci U S A. 1988 Feb;85(4):1199-203. doi: 10.1073/pnas.85.4.1199.

  PMID: 2448793 BACKGROUND

• Grassi, B., Bignami, A., Bastianelli, G. Ulteriori ricerche sul ciclo dei parassiti malarici umani nel corpo del zanzarone. Atti Reale Accademia dei Lincei. 1899.5:8-21.

  BACKGROUND

• Hermsen CC, de Vlas SJ, van Gemert GJ, Telgt DS, Verhage DF, Sauerwein RW. Testing vaccines in human experimental malaria: statistical analysis of parasitemia measured by a quantitative real-time polymerase chain reaction. Am J Trop Med Hyg. 2004 Aug;71(2):196-201.

  PMID: 15306710 BACKGROUND

• Safety and immunogenecity of a Plasmodium vivax circumsporozoite protein-derived synthetic vaccine in two Montanide ISA formulations.2006a. Manuscrito en preparacion.

  BACKGROUND

• Herrera S, Bonelo A, Perlaza BL, Fernandez OL, Victoria L, Lenis AM, Soto L, Hurtado H, Acuna LM, Velez JD, Palacios R, Chen-Mok M, Corradin G, Arevalo-Herrera M. Safety and elicitation of humoral and cellular responses in colombian malaria-naive volunteers by a Plasmodium vivax circumsporozoite protein-derived synthetic vaccine. Am J Trop Med Hyg. 2005 Nov;73(5 Suppl):3-9. doi: 10.4269/ajtmh.2005.73.3.

  PMID: 16291760 BACKGROUND

• Herrera MA, de Plata C, Gonzalez JM, Corradin G, Herrera S. Immunogenicity of multiple antigen peptides containing Plasmodium vivax CS epitopes in BALB/c mice. Mem Inst Oswaldo Cruz. 1994;89 Suppl 2:71-6. doi: 10.1590/s0074-02761994000600017.

  PMID: 7565136 BACKGROUND

• Herrera S, De Plata C, Gonzalez M, Perlaza BL, Bettens F, Corradin G, Arevalo-Herrera M. Antigenicity and immunogenicity of multiple antigen peptides (MAP) containing P. vivax CS epitopes in Aotus monkeys. Parasite Immunol. 1997 Apr;19(4):161-70. doi: 10.1046/j.1365-3024.1997.d01-193.x.

  PMID: 9149283 BACKGROUND

• Herrera S, Escobar P, de Plata C, Avila GI, Corradin G, Herrera MA. Human recognition of T cell epitopes on the Plasmodium vivax circumsporozoite protein. J Immunol. 1992 Jun 15;148(12):3986-90.

  PMID: 1376347 BACKGROUND

• Herrera, S., Manzano, M., Fernandez, O., Solarte, Y., Rocha, L., Vergara, J., Bermans, M., Acuña, L., Londoño, C., Palacios, R., Rincon, A., Yansot, MF., Arevalo-Herrera, M. Establishment of a sporozoite challenge model for Plasmodium vivax in human volunteers. 2006b. Manuscrito en preparación.

  BACKGROUND

• Herrera S, Perlaza BL, Bonelo A, Arevalo-Herrera M. Aotus monkeys: their great value for anti-malaria vaccines and drug testing. Int J Parasitol. 2002 Dec 4;32(13):1625-35. doi: 10.1016/s0020-7519(02)00191-1.

  PMID: 12435447 BACKGROUND

• 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.

  PMID: 1951863 BACKGROUND

• Hisaeda H, Yasutomo K. Development of malaria vaccines that block transmission of parasites by mosquito vectors. J Med Invest. 2002 Aug;49(3-4):118-23.

  PMID: 12323000 BACKGROUND

• Hoffman SL. Experimental challenge of volunteers with malaria. Ann Intern Med. 1997 Aug 1;127(3):233-5. doi: 10.7326/0003-4819-127-3-199708010-00010. No abstract available.

  PMID: 9245231 BACKGROUND

• 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.

  PMID: 11930326 BACKGROUND

• Hurtado S, Salas ML, Romero JF, Zapata JC, Ortiz H, Arevalo-Herrera M, Herrera S. Regular production of infective sporozoites of Plasmodium falciparum and P. vivax in laboratory-bred Anopheles albimanus. Ann Trop Med Parasitol. 1997 Jan;91(1):49-60. doi: 10.1080/00034983.1997.11813111.

  PMID: 9093429 BACKGROUND

• Jordan, A., Cellular and humoral response of P vivax irradiated sporozoites in Aotus monkeys. Am. J. Trop. Med Hyg., 2006 .Manuscrito en preparación.

  BACKGROUND

• Krotoski WA. The hypnozoite and malarial relapse. Prog Clin Parasitol. 1989;1:1-19.

  PMID: 2491691 BACKGROUND

• Luke TC, Hoffman SL. Rationale and plans for developing a non-replicating, metabolically active, radiation-attenuated Plasmodium falciparum sporozoite vaccine. J Exp Biol. 2003 Nov;206(Pt 21):3803-8. doi: 10.1242/jeb.00644.

  PMID: 14506215 BACKGROUND

• Manzano, M.R, Rocha, L., Hurtado, Solarte, Y., Arévalo-Herrera, M., Herrera, S., Development of a sporozoite challenge model of naïve voluntieers using Anopheles albimanus infected with Plasmodium vivax. 2006. Manuscrito en preparación.

  BACKGROUND

• McCarthy VC, Clyde DF. Plasmodium vivax: correlation of circumsporozoite precipitation (CSP) reaction with sporozoite-induced protective immunity in man. Exp Parasitol. 1977 Feb;41(1):167-71. doi: 10.1016/0014-4894(77)90142-4. No abstract available.

  PMID: 320027 BACKGROUND

• McGready R, Thwai KL, Cho T, Samuel, Looareesuwan S, White NJ, Nosten F. The effects of quinine and chloroquine antimalarial treatments in the first trimester of pregnancy. Trans R Soc Trop Med Hyg. 2002 Mar-Apr;96(2):180-4. doi: 10.1016/s0035-9203(02)90297-x.

  PMID: 12055810 BACKGROUND

• MCGREGOR IA, GILLES HM, WALTERS JH, DAVIES AH, PEARSON FA. Effects of heavy and repeated malarial infections on Gambian infants and children; effects of erythrocytic parasitization. Br Med J. 1956 Sep 22;2(4994):686-92. doi: 10.1136/bmj.2.4994.686. No abstract available.

  PMID: 13356045 BACKGROUND

• Meis JF, Ponnudurai T, Mons B, van Belkum A, van Eerd PM, Druilhe P, Schellekens H. Plasmodium falciparum: studies on mature exoerythrocytic forms in the liver of the chimpanzee, Pan troglodytes. Exp Parasitol. 1990 Jan;70(1):1-11. doi: 10.1016/0014-4894(90)90080-v.

  PMID: 2403931 BACKGROUND

• Mendis K, Sina BJ, Marchesini P, Carter R. The neglected burden of Plasmodium vivax malaria. Am J Trop Med Hyg. 2001 Jan-Feb;64(1-2 Suppl):97-106. doi: 10.4269/ajtmh.2001.64.97.

  PMID: 11425182 BACKGROUND

• Ministerio de Salud, Republica de Colombia. 2000. Guía de atención de la malariahttp://www.metrosalud.gov.co/Paginas/Protocolos/MinSalud/guias/31-MALARIA.htm.

  BACKGROUND

• Ministerio de la Protección Social. República de Colombia. 2005. http://www.minproteccionsocial.gov.co/MseContent/images/news/DocNewsNo603701.pdf

  BACKGROUND

• Nardin E, Clavijo P, Mons B, van Belkum A, Ponnudurai T, Nussenzweig RS. T cell epitopes of the circumsporozoite protein of Plasmodium vivax. Recognition by lymphocytes of a sporozoite-immunized chimpanzee. J Immunol. 1991 Mar 1;146(5):1674-8.

  PMID: 1704402 BACKGROUND

• NCI.,NIH., DCTD., DHHS. Common Terminology Criteria for Adverse Events v3.0. 2003. http://ctep.cancer.gov/forms/CTCAEv3.pdf

  BACKGROUND

• Nosten F, McGready R, Simpson JA, Thwai KL, Balkan S, Cho T, Hkirijaroen L, Looareesuwan S, White NJ. Effects of Plasmodium vivax malaria in pregnancy. Lancet. 1999 Aug 14;354(9178):546-9. doi: 10.1016/s0140-6736(98)09247-2.

  PMID: 10470698 BACKGROUND

• OMS. 2005. World Malaria Report 2005. Prepared by Roll Back Malaria, WHO and Unicef. http://www.rbm.who.int/wmr2005/pdf/WMReport_lr.pdf.

  BACKGROUND

• Padilla, JC., Guhl, F., Soto, J., Alvarez, G. Diagnóstico y terapéutica de las enfermedades transmitidas por vectores en Colombia.1999, v.2500. p.128

  BACKGROUND

• Perlaza BL, Zapata C, Valencia AZ, Hurtado S, Quintero G, Sauzet JP, Brahimi K, Blanc C, Arevalo-Herrera M, Druilhe P, Herrera S. Immunogenicity and protective efficacy of Plasmodium falciparum liver-stage Ag-3 in Aotus lemurinus griseimembra monkeys. Eur J Immunol. 2003 May;33(5):1321-7. doi: 10.1002/eji.200323339.

  PMID: 12731057 BACKGROUND

• Phillips-Howard PA. Epidemiological and control issues related to malaria in pregnancy. Ann Trop Med Parasitol. 1999 Dec;93 Suppl 1:S11-7. doi: 10.1080/00034989957691.

  PMID: 10715684 BACKGROUND

• Powell RD, McNamara JV. Infection with chloroquine-resistant Plasmodium falciparum in man: prepatent periods, incubation periods, and relationships between parasitemia and the onset of fever in nonimmune persons. Ann N Y Acad Sci. 1970 Oct 30;174(2):1027-41. doi: 10.1111/j.1749-6632.1970.tb45625.x. No abstract available.

  PMID: 4993529 BACKGROUND

• Rieckmann KH. Human immunization with attenuated sporozoites. Bull World Health Organ. 1990;68 Suppl(Suppl):13-6.

  PMID: 2094578 BACKGROUND

• Rieckmann KH, Beaudoin RL, Cassells JS, Sell KW. Use of attenuated sporozoites in the immunization of human volunteers against falciparum malaria. Bull World Health Organ. 1979;57 Suppl 1(Suppl):261-5.

  PMID: 120773 BACKGROUND

• Salas ML, Romero JF, Solarte Y, Olano V, Herrera MA, Herrera S. Development of sporogonic cycle of Plasmodium vivax in experimentally infected Anopheles albimanus mosquitoes. Mem Inst Oswaldo Cruz. 1994;89 Suppl 2:115-9. doi: 10.1590/s0074-02761994000600024.

  PMID: 7565121 BACKGROUND

• Singh N, Shukla MM, Sharma VP. Epidemiology of malaria in pregnancy in central India. Bull World Health Organ. 1999;77(7):567-72.

  PMID: 10444880 BACKGROUND

• Snounou G, Viriyakosol S, Jarra W, Thaithong S, Brown KN. Identification of the four human malaria parasite species in field samples by the polymerase chain reaction and detection of a high prevalence of mixed infections. Mol Biochem Parasitol. 1993 Apr;58(2):283-92. doi: 10.1016/0166-6851(93)90050-8.

  PMID: 8479452 BACKGROUND

• Soto J, Toledo J, Gutierrez P, Luzz M, Llinas N, Cedeno N, Dunne M, Berman J. Plasmodium vivax clinically resistant to chloroquine in Colombia. Am J Trop Med Hyg. 2001 Aug;65(2):90-3. doi: 10.4269/ajtmh.2001.65.90.

  PMID: 11508397 BACKGROUND

• Talisuna AO, Bloland P, D'Alessandro U. History, dynamics, and public health importance of malaria parasite resistance. Clin Microbiol Rev. 2004 Jan;17(1):235-54. doi: 10.1128/CMR.17.1.235-254.2004.

  PMID: 14726463 BACKGROUND

• Trigg, PI., and Kondrachine, AV. 1998. The current global malaria situation, p. 11-22. In I. Sherman (ed.), Malaria: Parasite biology, pathogenesis and protection. AMS Press, Washington DC.

  BACKGROUND

• Valderrama-Aguirre A, Quintero G, Gomez A, Castellanos A, Perez Y, Mendez F, Arevalo-Herrera M, Herrera S. Antigenicity, immunogenicity, and protective efficacy of Plasmodium vivax MSP1 PV200l: a potential malaria vaccine subunit. Am J Trop Med Hyg. 2005 Nov;73(5 Suppl):16-24. doi: 10.4269/ajtmh.2005.73.16.

  PMID: 16291762 BACKGROUND

• Wilairatana P, Krudsood S, Treeprasertsuk S, Chalermrut K, Looareesuwan S. The future outlook of antimalarial drugs and recent work on the treatment of malaria. Arch Med Res. 2002 Jul-Aug;33(4):416-21. doi: 10.1016/s0188-4409(02)00371-5.

  PMID: 12234533 BACKGROUND

• Walther M, Dunachie S, Keating S, Vuola JM, Berthoud T, Schmidt A, Maier C, Andrews L, Andersen RF, Gilbert S, Poulton I, Webster D, Dubovsky F, Tierney E, Sarpotdar P, Correa S, Huntcooke A, Butcher G, Williams J, Sinden RE, Thornton GB, Hill AV. Safety, immunogenicity and efficacy of a pre-erythrocytic malaria candidate vaccine, ICC-1132 formulated in Seppic ISA 720. Vaccine. 2005 Jan 4;23(7):857-64. doi: 10.1016/j.vaccine.2004.08.020.

  PMID: 15603885 BACKGROUND

• Yagmur Y, Kara IH, Aldemir M, Buyukbayram H, Tacyildiz IH, Keles C. Spontaneous rupture of malarial spleen: two case reports and review of literature. Crit Care. 2000;4(5):309-13. doi: 10.1186/cc713. Epub 2000 Aug 10.

  PMID: 11056757 BACKGROUND

• Zapata JC, Perlaza BL, Hurtado S, Quintero GE, Jurado D, Gonzalez I, Druilhe P, Arevalo-Herrera M, Herrera S. Reproducible infection of intact Aotus lemurinus griseimembra monkeys by Plasmodium falciparum sporozoite inoculation. J Parasitol. 2002 Aug;88(4):723-9. doi: 10.1645/0022-3395(2002)088[0723:RIOIAL]2.0.CO;2.

  PMID: 12197121 BACKGROUND

Related Links

• Institutional Site
• register clinical trials
• World Health Organization

MeSH Terms

Conditions

Malaria; Fever; Chills; Anemia; Malaria, Vivax

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Sócrates Herrera MD, principal investigator
• Organization: Malaria Vaccine and Drug Development

sherrera@inmuno.org

(572) 5216232 - 5574929

Study Officials

• Socrates Herrera, MD

  Director

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2006
• First Posted: August 22, 2006
• Study Start: December 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: March 1, 2007
• Last Updated: March 22, 2021
• Results First Posted: June 3, 2014

Record last verified: 2021-02

Locations

CO (1)