The government of Equatorial Guinea is launching a clinical trial with a malaria vaccine developed by US-based biotechnology company Sanaria and riding high on promising results from a Phase I study.
The West African nation has followed Tanzania as the second country in Africa to sponsor a clinical trial with PfSPZ, the vaccine for malaria caused by the pathogen Plasmodium falciparum.
Malaria causes more than 600,000 deaths a year, and most of the victims are young African children.
Equatorial Guinea’s Ministry of Health and Social Security and the Ministry of Mines, Industry and Energy have partnered with Sanaria and the Ifakara Health Institute, Tanzania’s health research organisation, for the trial, which will evaluate both the safety and efficacy of the PfSPZ vaccine.
Other sponsors are Marathon Oil, Noble Energy, EG LNG (Equatorial Guinea LNG) and AMPCO (Atlantic Methanol Production Company).
Protocol review
The PfSPZ trial is scheduled to start recruiting in the first quarter of 2014. A study protocol is being assessed by Equatorial Guinea’s Ethics Review Committee.
Once this is approved, the committee members will present the protocol to the other 16 countries making up the African Forum on the Regulation of Vaccines.
Phase I results
Results from a US Phase I clinical trial with PfSPZ, conducted by researchers at the National Institute of Allergy and Infectious Diseases along with colleagues from the Walter Reed Army Institute of Research and the Naval Medical Research Center, were published in the journal Science last month.
They showed that the PfSPZ vaccine was safe, generated an immune-system response and offered protection against malaria infection in healthy adults.
Among the 40 volunteers who received ascending doses of PfSPZ by intravenous injection and were then exposed to Plasmodium falciparum parasites through infected mosquitos, just three of the 15 participants given higher dosages contracted the disease, compared with 16 of 17 volunteers in the lower dosage group.
None of the six volunteers who received the highest dose of the PfSPZ vaccine developed malaria after exposure to the mosquitoes, Sanaria reported.
