Controlled human malaria infection by intramuscular and direct venous inoculation of cryopreserved Plasmodium falciparum sporozoites in malaria-naïve volunteers: effect of injection volume and dose on infectivity rates

Controlled human malaria infection (CHMI) by mosquito bite is a powerful tool for evaluation of vaccines and drugs against Plasmodium falciparum malaria. However, only a small number of research centres have the facilities required to perform such studies. CHMI by needle and syringe could help to ac...

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Published in:Malaria journal 2015-08, Vol.14 (1), p.306, Article 306
Main Authors: Gómez-Pérez, Gloria P, Legarda, Almudena, Muñoz, Jose, Sim, B Kim Lee, Ballester, María Rosa, Dobaño, Carlota, Moncunill, Gemma, Campo, Joseph J, Cisteró, Pau, Jimenez, Alfons, Barrios, Diana, Mordmüller, Benjamin, Pardos, Josefina, Navarro, Mireia, Zita, Cecilia Justino, Nhamuave, Carlos Arlindo, García-Basteiro, Alberto L, Sanz, Ariadna, Aldea, Marta, Manoj, Anita, Gunasekera, Anusha, Billingsley, Peter F, Aponte, John J, James, Eric R, Guinovart, Caterina, Antonijoan, Rosa M, Kremsner, Peter G, Hoffman, Stephen L, Alonso, Pedro L
Format: Article
Language:English
Subjects:
Adolescent
Adult
Animals
Dose-Response Relationship, Drug
Female
Humans
Injections, Intramuscular
Malaria
Malaria vaccine
Malaria, Falciparum - immunology
Malaria, Falciparum - parasitology
Male
Malària
Middle Aged
Parasitemia - immunology
Parasitemia - parasitology
Plasmodium falciparum
Plasmodium falciparum - immunology
Spain
Sporozoites - immunology
Vacuna de la malària
Volunteers
Young Adult
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cited_by cdi_FETCH-LOGICAL-c535t-1f168c4fc4b1257633df5ec1e0e2c373695787c5742477bcd935bdb1a5c7a8b03
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container_end_page
container_issue 1
container_start_page 306
container_title Malaria journal
container_volume 14
creator Gómez-Pérez, Gloria P
Legarda, Almudena
Muñoz, Jose
Sim, B Kim Lee
Ballester, María Rosa
Dobaño, Carlota
Moncunill, Gemma
Campo, Joseph J
Cisteró, Pau
Jimenez, Alfons
Barrios, Diana
Mordmüller, Benjamin
Pardos, Josefina
Navarro, Mireia
Zita, Cecilia Justino
Nhamuave, Carlos Arlindo
García-Basteiro, Alberto L
Sanz, Ariadna
Aldea, Marta
Manoj, Anita
Gunasekera, Anusha
Billingsley, Peter F
Aponte, John J
James, Eric R
Guinovart, Caterina
Antonijoan, Rosa M
Kremsner, Peter G
Hoffman, Stephen L
Alonso, Pedro L
description Controlled human malaria infection (CHMI) by mosquito bite is a powerful tool for evaluation of vaccines and drugs against Plasmodium falciparum malaria. However, only a small number of research centres have the facilities required to perform such studies. CHMI by needle and syringe could help to accelerate the development of anti-malaria interventions by enabling centres worldwide to employ CHMI. An open-label CHMI study was performed with aseptic, purified, cryopreserved P. falciparum sporozoites (PfSPZ Challenge) in 36 malaria naïve volunteers. In part A, the effect of the inoculation volume was assessed: 18 participants were injected intramuscularly (IM) with a dose of 2,500 PfSPZ divided into two injections of 10 µL (n = 6), 50 µL (n = 6) or 250 µL (n = 6), respectively. In part B, the injection volume that resulted in highest infectivity rates in part A (10 µL) was used to formulate IM doses of 25,000 PfSPZ (n = 6) and 75,000 PfSPZ (n = 6) divided into two 10-µL injections. Results from a parallel trial led to the decision to add a positive control group (n = 6), each volunteer receiving 3,200 PfSPZ in a single 500-µL injection by direct venous inoculation (DVI). Four/six participants in the 10-µL group, 1/6 in the 50-µL group and 2/6 in the 250-µL group developed parasitaemia. Geometric mean (GM) pre-patent periods were 13.9, 14.0 and 15.0 days, respectively. Six/six (100%) participants developed parasitaemia in the 25,000 and 75,000 PfSPZ IM and 3,200 PfSPZ DVI groups. GM pre-patent periods were 12.2, 11.4 and 11.4 days, respectively. Injection of PfSPZ Challenge was well tolerated and safe in all groups. IM injection of 75,000 PfSPZ and DVI injection of 3,200 PfSPZ resulted in infection rates and pre-patent periods comparable to the bite of five PfSPZ-infected mosquitoes. Remarkably, it required 23.4-fold more PfSPZ administered IM than DVI to achieve the same parasite kinetics. These results allow for translation of CHMI from research to routine use, and inoculation of PfSPZ by IM and DVI regimens. ClinicalTrials.gov NCT01771848.
doi_str_mv 10.1186/s12936-015-0817-x
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However, only a small number of research centres have the facilities required to perform such studies. CHMI by needle and syringe could help to accelerate the development of anti-malaria interventions by enabling centres worldwide to employ CHMI. An open-label CHMI study was performed with aseptic, purified, cryopreserved P. falciparum sporozoites (PfSPZ Challenge) in 36 malaria naïve volunteers. In part A, the effect of the inoculation volume was assessed: 18 participants were injected intramuscularly (IM) with a dose of 2,500 PfSPZ divided into two injections of 10 µL (n = 6), 50 µL (n = 6) or 250 µL (n = 6), respectively. In part B, the injection volume that resulted in highest infectivity rates in part A (10 µL) was used to formulate IM doses of 25,000 PfSPZ (n = 6) and 75,000 PfSPZ (n = 6) divided into two 10-µL injections. Results from a parallel trial led to the decision to add a positive control group (n = 6), each volunteer receiving 3,200 PfSPZ in a single 500-µL injection by direct venous inoculation (DVI). Four/six participants in the 10-µL group, 1/6 in the 50-µL group and 2/6 in the 250-µL group developed parasitaemia. Geometric mean (GM) pre-patent periods were 13.9, 14.0 and 15.0 days, respectively. Six/six (100%) participants developed parasitaemia in the 25,000 and 75,000 PfSPZ IM and 3,200 PfSPZ DVI groups. GM pre-patent periods were 12.2, 11.4 and 11.4 days, respectively. Injection of PfSPZ Challenge was well tolerated and safe in all groups. IM injection of 75,000 PfSPZ and DVI injection of 3,200 PfSPZ resulted in infection rates and pre-patent periods comparable to the bite of five PfSPZ-infected mosquitoes. Remarkably, it required 23.4-fold more PfSPZ administered IM than DVI to achieve the same parasite kinetics. These results allow for translation of CHMI from research to routine use, and inoculation of PfSPZ by IM and DVI regimens. 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However, only a small number of research centres have the facilities required to perform such studies. CHMI by needle and syringe could help to accelerate the development of anti-malaria interventions by enabling centres worldwide to employ CHMI. An open-label CHMI study was performed with aseptic, purified, cryopreserved P. falciparum sporozoites (PfSPZ Challenge) in 36 malaria naïve volunteers. In part A, the effect of the inoculation volume was assessed: 18 participants were injected intramuscularly (IM) with a dose of 2,500 PfSPZ divided into two injections of 10 µL (n = 6), 50 µL (n = 6) or 250 µL (n = 6), respectively. In part B, the injection volume that resulted in highest infectivity rates in part A (10 µL) was used to formulate IM doses of 25,000 PfSPZ (n = 6) and 75,000 PfSPZ (n = 6) divided into two 10-µL injections. Results from a parallel trial led to the decision to add a positive control group (n = 6), each volunteer receiving 3,200 PfSPZ in a single 500-µL injection by direct venous inoculation (DVI). Four/six participants in the 10-µL group, 1/6 in the 50-µL group and 2/6 in the 250-µL group developed parasitaemia. Geometric mean (GM) pre-patent periods were 13.9, 14.0 and 15.0 days, respectively. Six/six (100%) participants developed parasitaemia in the 25,000 and 75,000 PfSPZ IM and 3,200 PfSPZ DVI groups. GM pre-patent periods were 12.2, 11.4 and 11.4 days, respectively. Injection of PfSPZ Challenge was well tolerated and safe in all groups. IM injection of 75,000 PfSPZ and DVI injection of 3,200 PfSPZ resulted in infection rates and pre-patent periods comparable to the bite of five PfSPZ-infected mosquitoes. Remarkably, it required 23.4-fold more PfSPZ administered IM than DVI to achieve the same parasite kinetics. These results allow for translation of CHMI from research to routine use, and inoculation of PfSPZ by IM and DVI regimens. 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Legarda, Almudena ; Muñoz, Jose ; Sim, B Kim Lee ; Ballester, María Rosa ; Dobaño, Carlota ; Moncunill, Gemma ; Campo, Joseph J ; Cisteró, Pau ; Jimenez, Alfons ; Barrios, Diana ; Mordmüller, Benjamin ; Pardos, Josefina ; Navarro, Mireia ; Zita, Cecilia Justino ; Nhamuave, Carlos Arlindo ; García-Basteiro, Alberto L ; Sanz, Ariadna ; Aldea, Marta ; Manoj, Anita ; Gunasekera, Anusha ; Billingsley, Peter F ; Aponte, John J ; James, Eric R ; Guinovart, Caterina ; Antonijoan, Rosa M ; Kremsner, Peter G ; Hoffman, Stephen L ; Alonso, Pedro L</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c535t-1f168c4fc4b1257633df5ec1e0e2c373695787c5742477bcd935bdb1a5c7a8b03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Animals</topic><topic>Dose-Response Relationship, Drug</topic><topic>Female</topic><topic>Humans</topic><topic>Injections, Intramuscular</topic><topic>Malaria</topic><topic>Malaria vaccine</topic><topic>Malaria, Falciparum - immunology</topic><topic>Malaria, Falciparum - parasitology</topic><topic>Male</topic><topic>Malària</topic><topic>Middle Aged</topic><topic>Parasitemia - immunology</topic><topic>Parasitemia - parasitology</topic><topic>Plasmodium falciparum</topic><topic>Plasmodium falciparum - immunology</topic><topic>Spain</topic><topic>Sporozoites - immunology</topic><topic>Vacuna de la malària</topic><topic>Volunteers</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Gómez-Pérez, Gloria P</creatorcontrib><creatorcontrib>Legarda, Almudena</creatorcontrib><creatorcontrib>Muñoz, Jose</creatorcontrib><creatorcontrib>Sim, B Kim Lee</creatorcontrib><creatorcontrib>Ballester, María Rosa</creatorcontrib><creatorcontrib>Dobaño, Carlota</creatorcontrib><creatorcontrib>Moncunill, Gemma</creatorcontrib><creatorcontrib>Campo, Joseph J</creatorcontrib><creatorcontrib>Cisteró, Pau</creatorcontrib><creatorcontrib>Jimenez, Alfons</creatorcontrib><creatorcontrib>Barrios, Diana</creatorcontrib><creatorcontrib>Mordmüller, Benjamin</creatorcontrib><creatorcontrib>Pardos, Josefina</creatorcontrib><creatorcontrib>Navarro, Mireia</creatorcontrib><creatorcontrib>Zita, Cecilia Justino</creatorcontrib><creatorcontrib>Nhamuave, Carlos Arlindo</creatorcontrib><creatorcontrib>García-Basteiro, Alberto L</creatorcontrib><creatorcontrib>Sanz, Ariadna</creatorcontrib><creatorcontrib>Aldea, Marta</creatorcontrib><creatorcontrib>Manoj, Anita</creatorcontrib><creatorcontrib>Gunasekera, Anusha</creatorcontrib><creatorcontrib>Billingsley, Peter F</creatorcontrib><creatorcontrib>Aponte, John J</creatorcontrib><creatorcontrib>James, Eric R</creatorcontrib><creatorcontrib>Guinovart, Caterina</creatorcontrib><creatorcontrib>Antonijoan, Rosa M</creatorcontrib><creatorcontrib>Kremsner, Peter G</creatorcontrib><creatorcontrib>Hoffman, Stephen L</creatorcontrib><creatorcontrib>Alonso, Pedro L</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Entomology Abstracts (Full archive)</collection><collection>Virology and AIDS Abstracts</collection><collection>Health &amp; 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Fisheries Abstracts (ASFA) 1: Biological Sciences &amp; Living Resources</collection><collection>Aquatic Science &amp; Fisheries Abstracts (ASFA) 3: Aquatic Pollution &amp; Environmental Quality</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Aquatic Science &amp; Fisheries Abstracts (ASFA) Professional</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Recercat</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Malaria journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gómez-Pérez, Gloria P</au><au>Legarda, Almudena</au><au>Muñoz, Jose</au><au>Sim, B Kim Lee</au><au>Ballester, María Rosa</au><au>Dobaño, Carlota</au><au>Moncunill, Gemma</au><au>Campo, Joseph J</au><au>Cisteró, Pau</au><au>Jimenez, Alfons</au><au>Barrios, Diana</au><au>Mordmüller, Benjamin</au><au>Pardos, Josefina</au><au>Navarro, Mireia</au><au>Zita, Cecilia Justino</au><au>Nhamuave, Carlos Arlindo</au><au>García-Basteiro, Alberto L</au><au>Sanz, Ariadna</au><au>Aldea, Marta</au><au>Manoj, Anita</au><au>Gunasekera, Anusha</au><au>Billingsley, Peter F</au><au>Aponte, John J</au><au>James, Eric R</au><au>Guinovart, Caterina</au><au>Antonijoan, Rosa M</au><au>Kremsner, Peter G</au><au>Hoffman, Stephen L</au><au>Alonso, Pedro L</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Controlled human malaria infection by intramuscular and direct venous inoculation of cryopreserved Plasmodium falciparum sporozoites in malaria-naïve volunteers: effect of injection volume and dose on infectivity rates</atitle><jtitle>Malaria journal</jtitle><addtitle>Malar J</addtitle><date>2015-08-07</date><risdate>2015</risdate><volume>14</volume><issue>1</issue><spage>306</spage><pages>306-</pages><artnum>306</artnum><issn>1475-2875</issn><eissn>1475-2875</eissn><abstract>Controlled human malaria infection (CHMI) by mosquito bite is a powerful tool for evaluation of vaccines and drugs against Plasmodium falciparum malaria. However, only a small number of research centres have the facilities required to perform such studies. CHMI by needle and syringe could help to accelerate the development of anti-malaria interventions by enabling centres worldwide to employ CHMI. An open-label CHMI study was performed with aseptic, purified, cryopreserved P. falciparum sporozoites (PfSPZ Challenge) in 36 malaria naïve volunteers. In part A, the effect of the inoculation volume was assessed: 18 participants were injected intramuscularly (IM) with a dose of 2,500 PfSPZ divided into two injections of 10 µL (n = 6), 50 µL (n = 6) or 250 µL (n = 6), respectively. In part B, the injection volume that resulted in highest infectivity rates in part A (10 µL) was used to formulate IM doses of 25,000 PfSPZ (n = 6) and 75,000 PfSPZ (n = 6) divided into two 10-µL injections. Results from a parallel trial led to the decision to add a positive control group (n = 6), each volunteer receiving 3,200 PfSPZ in a single 500-µL injection by direct venous inoculation (DVI). Four/six participants in the 10-µL group, 1/6 in the 50-µL group and 2/6 in the 250-µL group developed parasitaemia. Geometric mean (GM) pre-patent periods were 13.9, 14.0 and 15.0 days, respectively. Six/six (100%) participants developed parasitaemia in the 25,000 and 75,000 PfSPZ IM and 3,200 PfSPZ DVI groups. GM pre-patent periods were 12.2, 11.4 and 11.4 days, respectively. Injection of PfSPZ Challenge was well tolerated and safe in all groups. IM injection of 75,000 PfSPZ and DVI injection of 3,200 PfSPZ resulted in infection rates and pre-patent periods comparable to the bite of five PfSPZ-infected mosquitoes. Remarkably, it required 23.4-fold more PfSPZ administered IM than DVI to achieve the same parasite kinetics. These results allow for translation of CHMI from research to routine use, and inoculation of PfSPZ by IM and DVI regimens. ClinicalTrials.gov NCT01771848.</abstract><cop>England</cop><pub>BioMed Central</pub><pmid>26245196</pmid><doi>10.1186/s12936-015-0817-x</doi><tpages>13</tpages><oa>free_for_read</oa></addata></record>
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subjects Adolescent
Adult
Animals
Dose-Response Relationship, Drug
Female
Humans
Injections, Intramuscular
Malaria
Malaria vaccine
Malaria, Falciparum - immunology
Malaria, Falciparum - parasitology
Male
Malària
Middle Aged
Parasitemia - immunology
Parasitemia - parasitology
Plasmodium falciparum
Plasmodium falciparum - immunology
Spain
Sporozoites - immunology
Vacuna de la malària
Volunteers
Young Adult
title Controlled human malaria infection by intramuscular and direct venous inoculation of cryopreserved Plasmodium falciparum sporozoites in malaria-naïve volunteers: effect of injection volume and dose on infectivity rates
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