Protective Efficacy of Plasmodium vivax Radiation-Attenuated Sporozoites in Colombian Volunteers: A Randomized Controlled Trial
Immunizing human volunteers by mosquito bite with radiation-attenuated Plasmodium falciparum sporozoites (RAS) results in high-level protection against infection. Only two volunteers have been similarly immunized with P. vivax (Pv) RAS, and both were protected. A phase 2 controlled clinical trial wa...
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| Published in | PLoS neglected tropical diseases Vol. 10; no. 10; p. e0005070 |
|---|---|
| Main Authors | , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Public Library of Science
19.10.2016
Public Library of Science (PLoS) |
| Subjects | |
| Online Access | Get full text |
| ISSN | 1935-2735 1935-2727 1935-2735 |
| DOI | 10.1371/journal.pntd.0005070 |
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| Abstract | Immunizing human volunteers by mosquito bite with radiation-attenuated Plasmodium falciparum sporozoites (RAS) results in high-level protection against infection. Only two volunteers have been similarly immunized with P. vivax (Pv) RAS, and both were protected. A phase 2 controlled clinical trial was conducted to assess the safety and protective efficacy of PvRAS immunization.
A randomized, single-blinded trial was conducted. Duffy positive (Fy+; Pv susceptible) individuals were enrolled: 14 received bites from irradiated (150 ± 10 cGy) Pv-infected Anopheles mosquitoes (RAS) and 7 from non-irradiated non-infected mosquitoes (Ctl). An additional group of seven Fy- (Pv refractory) volunteers was immunized with bites from non-irradiated Pv-infected mosquitoes. A total of seven immunizations were carried out at mean intervals of nine weeks. Eight weeks after last immunization, a controlled human malaria infection (CHMI) with non-irradiated Pv-infected mosquitoes was performed. Nineteen volunteers completed seven immunizations (12 RAS, 2 Ctl, and 5 Fy-) and received a CHMI. Five of 12 (42%) RAS volunteers were protected (receiving a median of 434 infective bites) compared with 0/2 Ctl. None of the Fy- volunteers developed infection by the seventh immunization or after CHMI. All non-protected volunteers developed symptoms 8-13 days after CHMI with a mean pre-patent period of 12.8 days. No serious adverse events related to the immunizations were observed. Specific IgG1 anti-PvCS response was associated with protection.
Immunization with PvRAS was safe, immunogenic, and induced sterile immunity in 42% of the Fy+ volunteers. Moreover, Fy- volunteers were refractory to Pv malaria.
Identifier: NCT01082341. |
|---|---|
| AbstractList | Background Immunizing human volunteers by mosquito bite with radiation-attenuated Plasmodium falciparum sporozoites (RAS) results in high-level protection against infection. Only two volunteers have been similarly immunized with P. vivax (Pv) RAS, and both were protected. A phase 2 controlled clinical trial was conducted to assess the safety and protective efficacy of PvRAS immunization. Methodology/Principal Findings A randomized, single-blinded trial was conducted. Duffy positive (Fy+; Pv susceptible) individuals were enrolled: 14 received bites from irradiated (150 ± 10 cGy) Pv-infected Anopheles mosquitoes (RAS) and 7 from non-irradiated non-infected mosquitoes (Ctl). An additional group of seven Fy- (Pv refractory) volunteers was immunized with bites from non-irradiated Pv-infected mosquitoes. A total of seven immunizations were carried out at mean intervals of nine weeks. Eight weeks after last immunization, a controlled human malaria infection (CHMI) with non-irradiated Pv-infected mosquitoes was performed. Nineteen volunteers completed seven immunizations (12 RAS, 2 Ctl, and 5 Fy-) and received a CHMI. Five of 12 (42%) RAS volunteers were protected (receiving a median of 434 infective bites) compared with 0/2 Ctl. None of the Fy- volunteers developed infection by the seventh immunization or after CHMI. All non-protected volunteers developed symptoms 8-13 days after CHMI with a mean pre-patent period of 12.8 days. No serious adverse events related to the immunizations were observed. Specific IgG1 anti-PvCS response was associated with protection. Conclusion Immunization with PvRAS was safe, immunogenic, and induced sterile immunity in 42% of the Fy+ volunteers. Moreover, Fy- volunteers were refractory to Pv malaria. Trial registration Identifier: NCT01082341. Background Immunizing human volunteers by mosquito bite with radiation-attenuated Plasmodium falciparum sporozoites (RAS) results in high-level protection against infection. Only two volunteers have been similarly immunized with P. vivax (Pv) RAS, and both were protected. A phase 2 controlled clinical trial was conducted to assess the safety and protective efficacy of PvRAS immunization. Methodology/Principal Findings A randomized, single-blinded trial was conducted. Duffy positive (Fy+; Pv susceptible) individuals were enrolled: 14 received bites from irradiated (150 ± 10 cGy) Pv-infected Anopheles mosquitoes (RAS) and 7 from non-irradiated non-infected mosquitoes (Ctl). An additional group of seven Fy- (Pv refractory) volunteers was immunized with bites from non-irradiated Pv-infected mosquitoes. A total of seven immunizations were carried out at mean intervals of nine weeks. Eight weeks after last immunization, a controlled human malaria infection (CHMI) with non-irradiated Pv-infected mosquitoes was performed. Nineteen volunteers completed seven immunizations (12 RAS, 2 Ctl, and 5 Fy-) and received a CHMI. Five of 12 (42%) RAS volunteers were protected (receiving a median of 434 infective bites) compared with 0/2 Ctl. None of the Fy- volunteers developed infection by the seventh immunization or after CHMI. All non-protected volunteers developed symptoms 8-13 days after CHMI with a mean pre-patent period of 12.8 days. No serious adverse events related to the immunizations were observed. Specific IgG1 anti-PvCS response was associated with protection. Conclusion Immunization with PvRAS was safe, immunogenic, and induced sterile immunity in 42% of the Fy+ volunteers. Moreover, Fy- volunteers were refractory to Pv malaria. Trial registration Identifier: NCT01082341. Immunizing human volunteers by mosquito bite with radiation-attenuated Plasmodium falciparum sporozoites (RAS) results in high-level protection against infection. Only two volunteers have been similarly immunized with P. vivax (Pv) RAS, and both were protected. A phase 2 controlled clinical trial was conducted to assess the safety and protective efficacy of PvRAS immunization. A randomized, single-blinded trial was conducted. Duffy positive (Fy+; Pv susceptible) individuals were enrolled: 14 received bites from irradiated (150 ± 10 cGy) Pv-infected Anopheles mosquitoes (RAS) and 7 from non-irradiated non-infected mosquitoes (Ctl). An additional group of seven Fy- (Pv refractory) volunteers was immunized with bites from non-irradiated Pv-infected mosquitoes. A total of seven immunizations were carried out at mean intervals of nine weeks. Eight weeks after last immunization, a controlled human malaria infection (CHMI) with non-irradiated Pv-infected mosquitoes was performed. Nineteen volunteers completed seven immunizations (12 RAS, 2 Ctl, and 5 Fy-) and received a CHMI. Five of 12 (42%) RAS volunteers were protected (receiving a median of 434 infective bites) compared with 0/2 Ctl. None of the Fy- volunteers developed infection by the seventh immunization or after CHMI. All non-protected volunteers developed symptoms 8-13 days after CHMI with a mean pre-patent period of 12.8 days. No serious adverse events related to the immunizations were observed. Specific IgG1 anti-PvCS response was associated with protection. Immunization with PvRAS was safe, immunogenic, and induced sterile immunity in 42% of the Fy+ volunteers. Moreover, Fy- volunteers were refractory to Pv malaria. Despite the advances in Plasmodium falciparum ( Pf ) vaccine development, progress in developing P . vivax ( Pv ) vaccines lags far behind. Immunization via mosquito bites with Pf radiation-attenuated sporozoites (RAS) has been the gold standard model for induction of sterile protection against malaria infection and has allowed the study of the complex mechanisms of immunity. The first trials using Pf RAS were performed in the late 1960’s, and thereafter greatly contributed to the development of vaccines against Pf . However, Pv RAS immunization in humans has only been carried out in two volunteers since 1974. To our knowledge, this is the first clinical trial using significant numbers of volunteers for Pv RAS immunization. Our findings confirm that immunization with Pv RAS is safe, immunogenic and induces sterile immunity in 42% of the volunteers. It demonstrates that it is possible to induce sterile protection with Pv RAS as seen with Pf RAS and confirms that immunity against the Pv CS protein (IgG1 levels) correlates with protection. Research findings and reagents generated in this study are expected to yield insights on key immune determinants of sterile protection against Pv , which may guide the development of a cost-effective vaccine against this parasite species. Immunizing human volunteers by mosquito bite with radiation-attenuated Plasmodium falciparum sporozoites (RAS) results in high-level protection against infection. Only two volunteers have been similarly immunized with P. vivax (Pv) RAS, and both were protected. A phase 2 controlled clinical trial was conducted to assess the safety and protective efficacy of PvRAS immunization. A randomized, single-blinded trial was conducted. Duffy positive (Fy+; Pv susceptible) individuals were enrolled: 14 received bites from irradiated (150 ± 10 cGy) Pv-infected Anopheles mosquitoes (RAS) and 7 from non-irradiated non-infected mosquitoes (Ctl). An additional group of seven Fy- (Pv refractory) volunteers was immunized with bites from non-irradiated Pv-infected mosquitoes. A total of seven immunizations were carried out at mean intervals of nine weeks. Eight weeks after last immunization, a controlled human malaria infection (CHMI) with non-irradiated Pv-infected mosquitoes was performed. Nineteen volunteers completed seven immunizations (12 RAS, 2 Ctl, and 5 Fy-) and received a CHMI. Five of 12 (42%) RAS volunteers were protected (receiving a median of 434 infective bites) compared with 0/2 Ctl. None of the Fy- volunteers developed infection by the seventh immunization or after CHMI. All non-protected volunteers developed symptoms 8-13 days after CHMI with a mean pre-patent period of 12.8 days. No serious adverse events related to the immunizations were observed. Specific IgG1 anti-PvCS response was associated with protection. Immunization with PvRAS was safe, immunogenic, and induced sterile immunity in 42% of the Fy+ volunteers. Moreover, Fy- volunteers were refractory to Pv malaria. Identifier: NCT01082341. Immunizing human volunteers by mosquito bite with radiation-attenuated Plasmodium falciparum sporozoites (RAS) results in high-level protection against infection. Only two volunteers have been similarly immunized with P. vivax (Pv) RAS, and both were protected. A phase 2 controlled clinical trial was conducted to assess the safety and protective efficacy of PvRAS immunization.A randomized, single-blinded trial was conducted. Duffy positive (Fy+; Pv susceptible) individuals were enrolled: 14 received bites from irradiated (150 ± 10 cGy) Pv-infected Anopheles mosquitoes (RAS) and 7 from non-irradiated non-infected mosquitoes (Ctl). An additional group of seven Fy- (Pv refractory) volunteers was immunized with bites from non-irradiated Pv-infected mosquitoes. A total of seven immunizations were carried out at mean intervals of nine weeks. Eight weeks after last immunization, a controlled human malaria infection (CHMI) with non-irradiated Pv-infected mosquitoes was performed. Nineteen volunteers completed seven immunizations (12 RAS, 2 Ctl, and 5 Fy-) and received a CHMI. Five of 12 (42%) RAS volunteers were protected (receiving a median of 434 infective bites) compared with 0/2 Ctl. None of the Fy- volunteers developed infection by the seventh immunization or after CHMI. All non-protected volunteers developed symptoms 8-13 days after CHMI with a mean pre-patent period of 12.8 days. No serious adverse events related to the immunizations were observed. Specific IgG1 anti-PvCS response was associated with protection.Immunization with PvRAS was safe, immunogenic, and induced sterile immunity in 42% of the Fy+ volunteers. Moreover, Fy- volunteers were refractory to Pv malaria.Identifier: NCT01082341. |
| Audience | Academic |
| Author | Oñate, José Richie, Thomas L. Amado-Garavito, Andrés B. Herrera, Sócrates Céspedes, Nora Vásquez-Jiménez, Juan M. Vallejo, Andrés F. Arévalo-Herrera, Myriam Castellanos, Angélica Epstein, Judith E. Trejos, Johanna Lopez-Perez, Mary Molina, Karen |
| AuthorAffiliation | George Washington University School of Medicine and Health Sciences, UNITED STATES 3 Asoclinic Inmunología LTDA, Cali, Colombia 1 Malaria Vaccine and Drug Development Center (MVDC), Cali, Colombia 7 Caucaseco Scientific Research Center, Cali, Colombia 2 Faculty of Health, Universidad del Valle, Cali, Colombia 4 Centro Médico Imbanaco, Cali, Colombia 5 Naval Medical Research Center, Malaria Department, Silver Spring, Maryland, United States of America 6 Sanaria Inc, Rockville, Maryland, United States of America |
| AuthorAffiliation_xml | – name: 5 Naval Medical Research Center, Malaria Department, Silver Spring, Maryland, United States of America – name: George Washington University School of Medicine and Health Sciences, UNITED STATES – name: 1 Malaria Vaccine and Drug Development Center (MVDC), Cali, Colombia – name: 3 Asoclinic Inmunología LTDA, Cali, Colombia – name: 2 Faculty of Health, Universidad del Valle, Cali, Colombia – name: 6 Sanaria Inc, Rockville, Maryland, United States of America – name: 4 Centro Médico Imbanaco, Cali, Colombia – name: 7 Caucaseco Scientific Research Center, Cali, Colombia |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/27760143$$D View this record in MEDLINE/PubMed |
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| Copyright | COPYRIGHT 2016 Public Library of Science 2016 Public Library of Science. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited: Radiation-Attenuated Sporozoites in Colombian Volunteers: A Randomized Controlled Trial. PLoS Negl Trop Dis 10(10): e0005070. doi:10.1371/journal.pntd.0005070 2016 Public Library of Science. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited: Radiation-Attenuated Sporozoites in Colombian Volunteers: A Randomized Controlled Trial. PLoS Negl Trop Dis 10(10): e0005070. doi:10.1371/journal.pntd.0005070 |
| Copyright_xml | – notice: COPYRIGHT 2016 Public Library of Science – notice: 2016 Public Library of Science. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited: Radiation-Attenuated Sporozoites in Colombian Volunteers: A Randomized Controlled Trial. PLoS Negl Trop Dis 10(10): e0005070. doi:10.1371/journal.pntd.0005070 – notice: 2016 Public Library of Science. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited: Radiation-Attenuated Sporozoites in Colombian Volunteers: A Randomized Controlled Trial. PLoS Negl Trop Dis 10(10): e0005070. doi:10.1371/journal.pntd.0005070 |
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| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 Conceptualization: MAH SH. Formal analysis: MLP JMVJ. Funding acquisition: MAH SH. Investigation: JMVJ MLP AFV ABAG NC AC KM JT. Methodology: MAH SH JEE TLR. Project administration: MAH SH JMVJ. Resources: JMVJ ABAG KM JO. Supervision: MAH SH. Validation: MAH SH. Visualization: MLP JMVJ AFV. Writing – original draft: JMVJ MLP. Writing – review & editing: JMVJ MLP MAH SH JEE TLR. I have read the journal's policy and the authors of this manuscript have the following competing interests: TLR is a salaried, full time employee of Sanaria Inc., the developer and sponsor of Sanaria PfSPZ vaccine. JT and JO are full time employee of Asoclinic Inmunología LTDA and Centro Médico Imbanaco, respectively. The other authors have declared that no competing interests exist. |
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| Snippet | Immunizing human volunteers by mosquito bite with radiation-attenuated Plasmodium falciparum sporozoites (RAS) results in high-level protection against... Background Immunizing human volunteers by mosquito bite with radiation-attenuated Plasmodium falciparum sporozoites (RAS) results in high-level protection... Despite the advances in Plasmodium falciparum ( Pf ) vaccine development, progress in developing P . vivax ( Pv ) vaccines lags far behind. Immunization via... Background Immunizing human volunteers by mosquito bite with radiation-attenuated Plasmodium falciparum sporozoites (RAS) results in high-level protection... |
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| SubjectTerms | Adolescent Adult Animals Anopheles - parasitology Antibodies, Protozoan - blood Aquatic insects Biology and Life Sciences Causes of Clinical trials Colombia Duffy Blood-Group System Female Genetic aspects Health aspects Humans Immunization Immunization - adverse effects Immunization - methods Immunoglobulin G - blood Insect bites Insect Bites and Stings Malaria Malaria vaccines Malaria Vaccines - administration & dosage Malaria Vaccines - immunology Malaria, Vivax - ethnology Malaria, Vivax - immunology Malaria, Vivax - parasitology Malaria, Vivax - prevention & control Male Medicine and Health Sciences Middle Aged Mosquitoes Pharmaceutical industry Physiological aspects Plasmodium vivax Plasmodium vivax - immunology Plasmodium vivax - physiology Plasmodium vivax - radiation effects Prevention Research and Analysis Methods Single-Blind Method Sporozoites - radiation effects Tropical diseases Vaccines Vaccines, Attenuated - administration & dosage Vaccines, Attenuated - immunology Vector-borne diseases Volunteers Young Adult |
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| Title | Protective Efficacy of Plasmodium vivax Radiation-Attenuated Sporozoites in Colombian Volunteers: A Randomized Controlled Trial |
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