First-in-human study will test novel malaria vaccine approach

An international team of researchers will collaborate to study a new approach to malaria vaccine development, involving a rodent version of the malaria-causing parasite, in humans for the first time, according to a press release.

Researchers from the PATH Malaria Vaccine Initiative, Radboud University in the Netherlands and the Instituto de Medicina Molecular Lisboa in Portugal aim to test this concept similarly to how Edward Jenner developed the vaccine against smallpox.

“Bringing together the concept underlying the first vaccine ever developed, when Edward Jenner used the cowpox virus to immunize people against smallpox, with modern genetic manipulation tools, has resulted in a truly innovative approach to malaria vaccination,” Miguel Prudêncio, PhD, lead researcher of the project at the Instituto de Medicina Molecular Lisboa (iMM Lisboa), said in the release.

Using data from prior animal studies conducted by iMM Lisboa, the investigators seek to determine whether a rodent version of the malaria-causing parasite, Plasmodium berghei, can induce protection against Plasmodium falciparum infection. A specific gene, known as the circumsporozoite protein (CS), from P. falciparum will be inserted into the rodent parasite, which will modify its genetics. The researchers hope that the modified rodent parasite will help induce a protective response in healthy human volunteers when they insert the gene for CS.

In the first phase of the trial, 18 healthy adult volunteers allocated to three groups will receive a varying, carefully controlled, number of bites from mosquitoes infected with the genetically modified P. berghei parasite. Researchers will closely monitor participants for signs of infection. If the phase 1 study results are promising, participants from the highest dose group will enroll in the second phase of the study, which will assess the protective efficacy of the approach.

“Although much progress has been made to drive down the malaria burden with currently available interventions, a highly effective vaccine would be an important new tool for malaria elimination,” Ashley Birkett, PhD, director of PATH’s Malaria Vaccine Initiative, added in the release.

Disclosure: The researchers report no relevant financial disclosures.

An international team of researchers will collaborate to study a new approach to malaria vaccine development, involving a rodent version of the malaria-causing parasite, in humans for the first time, according to a press release.

Researchers from the PATH Malaria Vaccine Initiative, Radboud University in the Netherlands and the Instituto de Medicina Molecular Lisboa in Portugal aim to test this concept similarly to how Edward Jenner developed the vaccine against smallpox.

“Bringing together the concept underlying the first vaccine ever developed, when Edward Jenner used the cowpox virus to immunize people against smallpox, with modern genetic manipulation tools, has resulted in a truly innovative approach to malaria vaccination,” Miguel Prudêncio, PhD, lead researcher of the project at the Instituto de Medicina Molecular Lisboa (iMM Lisboa), said in the release.

Using data from prior animal studies conducted by iMM Lisboa, the investigators seek to determine whether a rodent version of the malaria-causing parasite, Plasmodium berghei, can induce protection against Plasmodium falciparum infection. A specific gene, known as the circumsporozoite protein (CS), from P. falciparum will be inserted into the rodent parasite, which will modify its genetics. The researchers hope that the modified rodent parasite will help induce a protective response in healthy human volunteers when they insert the gene for CS.

In the first phase of the trial, 18 healthy adult volunteers allocated to three groups will receive a varying, carefully controlled, number of bites from mosquitoes infected with the genetically modified P. berghei parasite. Researchers will closely monitor participants for signs of infection. If the phase 1 study results are promising, participants from the highest dose group will enroll in the second phase of the study, which will assess the protective efficacy of the approach.

“Although much progress has been made to drive down the malaria burden with currently available interventions, a highly effective vaccine would be an important new tool for malaria elimination,” Ashley Birkett, PhD, director of PATH’s Malaria Vaccine Initiative, added in the release.

Disclosure: The researchers report no relevant financial disclosures.