Safety, Immunogenicity, and Protective Efficacy of Intradermal Immunization with Aseptic, Purified, Cryopreserved Plasmodium falciparum Sporozoites in Volunteers under Chloroquine Prophylaxis: A Randomized Controlled Trial
Immunization of volunteers under chloroquine prophylaxis by bites of Plasmodium falciparum sporozoite (PfSPZ)–infected mosquitoes induces > 90% protection against controlled human malaria infection (CHMI). We studied intradermal immunization with cryopreserved, infectious PfSPZ in volunteers taki...
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The American Society of Tropical Medicine and Hygiene
2016
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| Online Access: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4775905/ |
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pubmed-47759052016-03-18 Safety, Immunogenicity, and Protective Efficacy of Intradermal Immunization with Aseptic, Purified, Cryopreserved Plasmodium falciparum Sporozoites in Volunteers under Chloroquine Prophylaxis: A Randomized Controlled Trial Bastiaens, Guido J. H. van Meer, Maurits P. A. Scholzen, Anja Obiero, Joshua M. Vatanshenassan, Mansoureh van Grinsven, Tim Kim Lee Sim, B. Billingsley, Peter F. James, Eric R. Gunasekera, Anusha Bijker, Else M. van Gemert, Geert-Jan van de Vegte-Bolmer, Marga Graumans, Wouter Hermsen, Cornelus C. de Mast, Quirijn van der Ven, André J. A. M. Hoffman, Stephen L. Sauerwein, Robert W. Articles Immunization of volunteers under chloroquine prophylaxis by bites of Plasmodium falciparum sporozoite (PfSPZ)–infected mosquitoes induces > 90% protection against controlled human malaria infection (CHMI). We studied intradermal immunization with cryopreserved, infectious PfSPZ in volunteers taking chloroquine (PfSPZ chemoprophylaxis vaccine [CVac]). Vaccine groups 1 and 3 received 3× monthly immunizations with 7.5 × 104 PfSPZ. Control groups 2 and 4 received normal saline. Groups 1 and 2 underwent CHMI (#1) by mosquito bite 60 days after the third immunization. Groups 3 and 4 were boosted 168 days after the third immunization and underwent CHMI (#2) 137 days later. Vaccinees (11/20, 55%) and controls (6/10, 60%) had the same percentage of mild to moderate solicited adverse events. After CHMI #1, 8/10 vaccinees (group 1) and 5/5 controls (group 2) became parasitemic by microscopy; the two negatives were positive by quantitative real-time polymerase chain reaction (qPCR). After CHMI #2, all vaccinees in group 3 and controls in group 4 were parasitemic by qPCR. Vaccinees showed weak antibody and no detectable cellular immune responses. Intradermal immunization with up to 3 × 105 PfSPZ-CVac was safe, but induced only minimal immune responses and no sterile protection against Pf CHMI. The American Society of Tropical Medicine and Hygiene 2016-03-02 /pmc/articles/PMC4775905/ /pubmed/26711509 http://dx.doi.org/10.4269/ajtmh.15-0621 Text en ©The American Society of Tropical Medicine and Hygiene This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
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Open Access Journal |
| institution_category |
Foreign Institution |
| institution |
US National Center for Biotechnology Information |
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NCBI PubMed |
| collection |
Online Access |
| language |
English |
| format |
Online |
| author |
Bastiaens, Guido J. H. van Meer, Maurits P. A. Scholzen, Anja Obiero, Joshua M. Vatanshenassan, Mansoureh van Grinsven, Tim Kim Lee Sim, B. Billingsley, Peter F. James, Eric R. Gunasekera, Anusha Bijker, Else M. van Gemert, Geert-Jan van de Vegte-Bolmer, Marga Graumans, Wouter Hermsen, Cornelus C. de Mast, Quirijn van der Ven, André J. A. M. Hoffman, Stephen L. Sauerwein, Robert W. |
| spellingShingle |
Bastiaens, Guido J. H. van Meer, Maurits P. A. Scholzen, Anja Obiero, Joshua M. Vatanshenassan, Mansoureh van Grinsven, Tim Kim Lee Sim, B. Billingsley, Peter F. James, Eric R. Gunasekera, Anusha Bijker, Else M. van Gemert, Geert-Jan van de Vegte-Bolmer, Marga Graumans, Wouter Hermsen, Cornelus C. de Mast, Quirijn van der Ven, André J. A. M. Hoffman, Stephen L. Sauerwein, Robert W. Safety, Immunogenicity, and Protective Efficacy of Intradermal Immunization with Aseptic, Purified, Cryopreserved Plasmodium falciparum Sporozoites in Volunteers under Chloroquine Prophylaxis: A Randomized Controlled Trial |
| author_facet |
Bastiaens, Guido J. H. van Meer, Maurits P. A. Scholzen, Anja Obiero, Joshua M. Vatanshenassan, Mansoureh van Grinsven, Tim Kim Lee Sim, B. Billingsley, Peter F. James, Eric R. Gunasekera, Anusha Bijker, Else M. van Gemert, Geert-Jan van de Vegte-Bolmer, Marga Graumans, Wouter Hermsen, Cornelus C. de Mast, Quirijn van der Ven, André J. A. M. Hoffman, Stephen L. Sauerwein, Robert W. |
| author_sort |
Bastiaens, Guido J. H. |
| title |
Safety, Immunogenicity, and Protective Efficacy of Intradermal Immunization with Aseptic, Purified, Cryopreserved Plasmodium falciparum Sporozoites in Volunteers under Chloroquine Prophylaxis: A Randomized Controlled Trial |
| title_short |
Safety, Immunogenicity, and Protective Efficacy of Intradermal Immunization with Aseptic, Purified, Cryopreserved Plasmodium falciparum Sporozoites in Volunteers under Chloroquine Prophylaxis: A Randomized Controlled Trial |
| title_full |
Safety, Immunogenicity, and Protective Efficacy of Intradermal Immunization with Aseptic, Purified, Cryopreserved Plasmodium falciparum Sporozoites in Volunteers under Chloroquine Prophylaxis: A Randomized Controlled Trial |
| title_fullStr |
Safety, Immunogenicity, and Protective Efficacy of Intradermal Immunization with Aseptic, Purified, Cryopreserved Plasmodium falciparum Sporozoites in Volunteers under Chloroquine Prophylaxis: A Randomized Controlled Trial |
| title_full_unstemmed |
Safety, Immunogenicity, and Protective Efficacy of Intradermal Immunization with Aseptic, Purified, Cryopreserved Plasmodium falciparum Sporozoites in Volunteers under Chloroquine Prophylaxis: A Randomized Controlled Trial |
| title_sort |
safety, immunogenicity, and protective efficacy of intradermal immunization with aseptic, purified, cryopreserved plasmodium falciparum sporozoites in volunteers under chloroquine prophylaxis: a randomized controlled trial |
| description |
Immunization of volunteers under chloroquine prophylaxis by bites of Plasmodium falciparum sporozoite (PfSPZ)–infected mosquitoes induces > 90% protection against controlled human malaria infection (CHMI). We studied intradermal immunization with cryopreserved, infectious PfSPZ in volunteers taking chloroquine (PfSPZ chemoprophylaxis vaccine [CVac]). Vaccine groups 1 and 3 received 3× monthly immunizations with 7.5 × 104 PfSPZ. Control groups 2 and 4 received normal saline. Groups 1 and 2 underwent CHMI (#1) by mosquito bite 60 days after the third immunization. Groups 3 and 4 were boosted 168 days after the third immunization and underwent CHMI (#2) 137 days later. Vaccinees (11/20, 55%) and controls (6/10, 60%) had the same percentage of mild to moderate solicited adverse events. After CHMI #1, 8/10 vaccinees (group 1) and 5/5 controls (group 2) became parasitemic by microscopy; the two negatives were positive by quantitative real-time polymerase chain reaction (qPCR). After CHMI #2, all vaccinees in group 3 and controls in group 4 were parasitemic by qPCR. Vaccinees showed weak antibody and no detectable cellular immune responses. Intradermal immunization with up to 3 × 105 PfSPZ-CVac was safe, but induced only minimal immune responses and no sterile protection against Pf CHMI. |
| publisher |
The American Society of Tropical Medicine and Hygiene |
| publishDate |
2016 |
| url |
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4775905/ |
| _version_ |
1613546541689077760 |