INTRODUCING SANARIA® PfSPZ vaccine:
In the first half of the 20th century there were first attempts to protect people from malaria. At the beginning Pasteur´s approach of developing bacterial vaccines was used as a big hope in eradication of this fatal disease. But inactivated malaria sporozoites (by formalin) were ineffective in inducing the protection.
Later, modern adjuvants and the possibility of preparing of single parasite proteins started another way to obtain malaria vaccine. Today, a vaccine called RTS,S based on coat protein of sporozoites of the Plasmodium falciparum is the most advanced subunit vaccine and is in the phase III clinical trials. It protects about 50% of subjects infected by controlled human malaria infection (CHMI) after 2 – 3 weeks and about 23% at 5 months after last immunization.[4] In large III phase trial in Africa RTS,S/AS01 reduced acquired malaria over a 12 months period by 31,3% and 36,6%.
SANARIA® PfSPZ vaccine is a preventative malaria
vaccine which is made of non-replicating irradiated whole sporozoites developed by Sanaria Inc. PfSPZ is the acronym of words: Plasmodium falciparum (Pf) and sporozoites (SPZ).
Candidate vaccines based on injectable Plasmodium falciparum (Pf) sporozoites (SPZ), are
being developed and tested, including PfSPZ Vaccine, in which the PfSPZ are attenuated by
irradiation, PfSPZ-CVac, in which fully infectious PfSPZ, PfSPZ Challenge, are attenuated in
vivo by concomitant administration of an anti-malarial drug, to allow liver stage maturation but
not blood stage infection, and PfSPZ-GA1, in which the PfSPZ are attenuated by gene
deletions.
Thirty-seven research groups in 15 countries, organized as the International PfSPZ Consortium
(I-PfSPZ-C), are collaborating to advance this program by providing intellectual, clinical, and
financial support. Eleven clinical trials of these products are completed in the USA, Europe and
Africa, six are underway and at least 10 more are planned for 2015-2016 in the US (four sites),
Germany, the Netherlands, Tanzania, Kenya, Mali, Burkina Faso, Ghana, Equatorial Guinea,
and Indonesia. The I-PfSPZ-C has evolved since initial discussions in 2012 to integrate the
planning and governance of the commercial (Sanaria) and academic partners collaborating in
the efforts to take the PfSPZ vaccines through to licensure. The I-PfSPZ-C has an inclusive
structure in which any individual, group, institution or funding organization involved in studies
with Sanaria’s PfSPZ products participates in the data sharing and planning of trials,
reviewing data on safety, immunology and protective efficacy and contributing to the efforts to
raise funds towards the program.
The I-PfSPZ-C has met at least annually since November 2011 at sessions organized in
association with the annual meeting of the American Society of Tropical Medicine and Hygiene,
with additional meetings held as needed (e.g. Basel, June 2014). The most recent meeting was
at the University of Tübingen, Germany, in March 2015. The meeting truly reflected
the tremendous excitement and enthusiasm generated by the impetus of strong results from
PfSPZ Vaccine and PfSPZ-CVac clinical trials conducted in the US, Europe and Africa. The
meeting was attended by 81 individuals from 35 different institutions based in the USA and 13
different countries in Europe and Africa. Participants represented researchers, African
governments, policy agencies, regulatory authorities and funding agencies.
SOURCES: WIKIPEDIA; SANARIA INC.
In the first half of the 20th century there were first attempts to protect people from malaria. At the beginning Pasteur´s approach of developing bacterial vaccines was used as a big hope in eradication of this fatal disease. But inactivated malaria sporozoites (by formalin) were ineffective in inducing the protection.
Later, modern adjuvants and the possibility of preparing of single parasite proteins started another way to obtain malaria vaccine. Today, a vaccine called RTS,S based on coat protein of sporozoites of the Plasmodium falciparum is the most advanced subunit vaccine and is in the phase III clinical trials. It protects about 50% of subjects infected by controlled human malaria infection (CHMI) after 2 – 3 weeks and about 23% at 5 months after last immunization.[4] In large III phase trial in Africa RTS,S/AS01 reduced acquired malaria over a 12 months period by 31,3% and 36,6%.
SANARIA® PfSPZ vaccine is a preventative malaria
vaccine which is made of non-replicating irradiated whole sporozoites developed by Sanaria Inc. PfSPZ is the acronym of words: Plasmodium falciparum (Pf) and sporozoites (SPZ).
Candidate vaccines based on injectable Plasmodium falciparum (Pf) sporozoites (SPZ), are
being developed and tested, including PfSPZ Vaccine, in which the PfSPZ are attenuated by
irradiation, PfSPZ-CVac, in which fully infectious PfSPZ, PfSPZ Challenge, are attenuated in
vivo by concomitant administration of an anti-malarial drug, to allow liver stage maturation but
not blood stage infection, and PfSPZ-GA1, in which the PfSPZ are attenuated by gene
deletions.
Thirty-seven research groups in 15 countries, organized as the International PfSPZ Consortium
(I-PfSPZ-C), are collaborating to advance this program by providing intellectual, clinical, and
financial support. Eleven clinical trials of these products are completed in the USA, Europe and
Africa, six are underway and at least 10 more are planned for 2015-2016 in the US (four sites),
Germany, the Netherlands, Tanzania, Kenya, Mali, Burkina Faso, Ghana, Equatorial Guinea,
and Indonesia. The I-PfSPZ-C has evolved since initial discussions in 2012 to integrate the
planning and governance of the commercial (Sanaria) and academic partners collaborating in
the efforts to take the PfSPZ vaccines through to licensure. The I-PfSPZ-C has an inclusive
structure in which any individual, group, institution or funding organization involved in studies
with Sanaria’s PfSPZ products participates in the data sharing and planning of trials,
reviewing data on safety, immunology and protective efficacy and contributing to the efforts to
raise funds towards the program.
The I-PfSPZ-C has met at least annually since November 2011 at sessions organized in
association with the annual meeting of the American Society of Tropical Medicine and Hygiene,
with additional meetings held as needed (e.g. Basel, June 2014). The most recent meeting was
at the University of Tübingen, Germany, in March 2015. The meeting truly reflected
the tremendous excitement and enthusiasm generated by the impetus of strong results from
PfSPZ Vaccine and PfSPZ-CVac clinical trials conducted in the US, Europe and Africa. The
meeting was attended by 81 individuals from 35 different institutions based in the USA and 13
different countries in Europe and Africa. Participants represented researchers, African
governments, policy agencies, regulatory authorities and funding agencies.
SOURCES: WIKIPEDIA; SANARIA INC.
