A clinical trial has
seen Sanaria’s PfSPZ-CVac vaccine achieving a high level protection against
Malaria, reports NaijaAgroNet.
A report by the Nature described the achievement as a complete
protection after 10 weeks with three doses of PfSPZ-CVac, investigators from the University of Tübingen noted
that all nine subjects (100 per cent) immunized with three doses of Sanaria PfSPZ-CVac
malaria vaccine in a recently completed clinical trial were protected against Plasmodium
falciparum malaria.
This, NaijaAgroNet gathered was after they were exposed to the
disease 10 weeks after their last vaccine dose, according to the Director of
the Institute of Tropical Medicine at the University, led by Professor Peter
Kremsner.
He explained that PfSPZ-CVac
was administered to the nine subjects three times over eight weeks; the
research demonstrated the three doses were also safe and effective when
administered over just 10 days. Scientists at the Vaccine Research Center,
National Institute of Allergy and Infectious Diseases (NIAID), U.S. National
Institutes of Health (NIH) found that assays of the subjects’ cellular immunity
correlated with vaccine-induced protection. A team from Antigen Discovery Inc.
that studied the antibody responses of the nine protected individuals,
identified 22 malaria parasite proteins that could be the targets of protective
immune responses.
Sanaria founder and
CEO, Stephen L. Hoffman, MD said, “We are extremely encouraged by these
findings. Clinical trials of PfSPZ-CVac underway in Germany, the U.S., and
Equatorial Guinea, and soon to start in Mali, Ghana, the U.S., and Gabon will
lead to an optimized vaccination regimen that we expect to move rapidly into
phase 3 clinical trials and licensure. The ability to complete an immunization
regimen in 10 days will facilitate the use of PfSPZ-CVac in mass
vaccination programs to eliminate the malaria parasite and to prevent malaria
in travelers.”
PfSPZ-CVac is composed
of live, purified malaria parasites and the antimalarial drug chloroquine.
Volunteers in the clinical trial received three 0.5 mL injections of the
vaccine by rapid direct venous inoculation. Ten weeks after their last
immunization, all nine subjects who received the highest dose of malaria
parasites were protected against the injection of live malaria parasites.
The clinical trial
included 42 adult volunteers, 21-45 years old. Twenty-seven volunteers received
PfSPZ-CVac at varying doses to evaluate alternative dosage regimens. There was
no difference in adverse events between volunteers who received the vaccine and
those who received the saltwater placebo. They were enrolled, vaccinated and
assessed under the direction of Benjamin Mordmüller, MD at the Institute of
Tropical Medicine, University of Tübingen.
The German Center for
Infection Research funded the current trial with additional support from
Sanaria. Sanaria receives research support and funding from NIAID, which
supported vaccine manufacture for this trial, and multiple other institutions
in the United States, Europe, and Africa, most of which participate in the
International PfSPZ Consortium and will continue its fund-raising efforts to
expand its research and clinical programs.
According to the World
Health Organization, African children are hardest hit by malaria. The WHO
estimates that in 2015 malaria caused 214M clinical episodes and 438,000 deaths
worldwide; others have estimated
up to 730,500 malaria deaths in 2015. This enormous morbidity and mortality
occurs despite investment of billions of dollars in malaria control efforts. Malaria is also a concern for tourists,
diplomats, business travelers, aid workers, industrial workers, and military
personnel worldwide.
Professor Ogobara
Doumbo, Director of the Bamako Malaria Research Training Center at the
University of Bamako, Mali, said, “Those of us in countries where people’s
lives are devastated by malaria have been waiting for a highly effective
malaria vaccine for decades. We are excited about these new results with
PfSPZ-CVac in Germany, and are proud to be able to initiate the first field
trials of PfSPZ-based vaccines in Mali, West Africa in collaboration with our
colleagues from the Laboratory of Malaria Immunology and Vaccinology, NIAID,
NIH and the University of Maryland School of Medicine.”
Also commenting, Professor
of Tropical Medicine and Travel Medicine, Dr. Martin Grobusch, who also is the Director
of the Center of Tropical Medicine at the University of Amsterdam’s Academic
Medical Center, a clinic that cares for more than 16,000 travelers annually,
said, “Travelers continue to be at high risk of acquiring malaria. A vaccine
like PfSPZ-CVac that provides complete protective immunity for 10 weeks and can
be administered in less than two weeks will be an ideal tool for the prevention
of malaria in the traveling population.”
Isaac Oyimah/GEE
... Linking agrobiz, sustainable environs, people & technology
