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Ebola vaccines enter phase 2 trial
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The Walter Reed Army Institute of Research recently launched a phase 2 clinical trial to evaluate the safety and efficacy of a prime-boost Ebola vaccine regimen in both healthy patients and patients with HIV, according to a press release.
“Infectious diseases such as Ebola pose a significant threat to the United States military and the global community,” Col. Stephen Thomas, MD, deputy commander of operations at the Walter Reed Army Institute of Research (WRAIR), said in the release. “WRAIR has extensive expertise in infectious diseases and an international research network in countries where diseases are endemic, giving us an ideal platform to conduct these types of studies.”
Figure 1. A prime-boost Ebola vaccine regimen is being assessed in a phase 2 trial at the Walter Reed Army Institute of Research in Silver Spring, Maryland.
Source: The Walter Reed Army Institute of Research
The study initially will enroll 75 volunteers up to 70 years of age, including those with suppressed HIV-infection.
“It is an important consideration given that both of these viruses can be present in the same communities,” Col. Nelson Michael, MD, PhD, director of the U.S. Military HIV Research Program (MHRP), said in the release.
Participants will receive two vaccines as part of a “prime-boost” strategy. The MVA-BN-Filo (Bavarian Nordic) vaccine will be given as the prime dose. This vaccine will be multivalent, expressing Ebola virus (EBOV) Mayinga glycoprotein (GP), Sudan virus, Marburg virus GP and the Tai Forest virus nucleoprotein. The boost vaccine, Ad26.ZEBOV (Johnson & Johnson) will be monovalent, only expressing the full length EBOV GP.
The study initially will be conducted at the WRAIR in Silver Spring, Maryland, then expand to six sites in Kenya, Uganda, Mozambique, Nigeria and Tanzania early this year, enrolling up to 575 volunteers, the release said. While the trial is underway in Africa, the vaccines will switch roles as prime dose and booster.
“It is critical that we know these vaccines are safe and immunogenic in the communities where they will be used in Africa,” Lt. Col. Julie Ake, MD, principal deputy director of the U.S. MHRP, said in the release.