Ebola Vaccine Zabdeno® and Mvabea® Clinical Trials, Dosage, Indication, News
The J&J Innovative Medicine Ebola vaccine consists of two components, Zabdeno® (Ad26.ZEBOV) and Mvabea® (MVA-BN-Filo). Zabdeno is given first, and Mvabea is administered approximately eight weeks later as a vaccine booster. This prime-boost vaccination method is an established approach for preventing infectious diseases during Ebola outbreaks for individuals at risk of exposure and preventively before episodes, says J&J.
J&J developed Zabdeno, a monovalent vaccine designed to provide active, specific, acquired immunity to the Ebola virus. The vaccine is based on an adenovirus type 26 (Ad26) vector expressing the glycoprotein of the Ebola virus Mayinga variant. Bavarian Nordic's Mvabea (MVA-BN-Filo) is a multivalent vaccine preparation designed to provide active acquired immunity to Sudan, Ebola, Marburg, and Tai Forest (formerly Côte d'Ivoire ebolavirus). The Zabdeno and Mvabea combination was evaluated under the European Medicines Agency (EMA) (EMEA/H/C/005337) accelerated assessment. However, as a precautionary measure, a Zabdeno booster vaccination should be considered for individuals at imminent risk of exposure to the Ebola virus, for example, healthcare professionals and those living in or visiting areas with an ongoing Ebola virus outbreak who completed the Zabdeno, Mvabea 2-dose primary vaccination regimen.
On June 4, 2021, J&J welcomed a new recommendation by the WHO's Strategic Advisory Group of Experts on Immunization (SAGE) that supports the use of the Ebola vaccine regimen both during outbreaks for individuals at risk of Ebola exposure and preventively in the absence of an outbreak, as protection against Ebola virus disease (EVD) is considered a significant public health interest. Accordingly, African countries began evaluating a single dose of Bavarian Nordic's Mvabea (MVA-BN-Filo) to treat the Marburg virus disease in August 2021.
The Lancet published a study on September 13, 2021, concluding, 'The Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimens were well tolerated in a clinical trial (NCT02509494), with no safety concerns in children. The vaccine induced robust humoral immune responses. Data from two papers published in The Lancet Infectious Diseases demonstrated that Zabdno and Mvabea generated robust humoral immune responses in adults and children, with the immune responses persisting in adults for at least two years. The data also showed that booster vaccination with Ad26.ZEBOV, administered to adults two years after the initial immunization, induced a robust anamnestic response within seven days. On December 14, 2022, a study published by the New England Journal of Medicine concurred with The Lancet's findings. In addition, the JAMA Network published Ebola Vaccines Safe and Immunogenic in Clinical Trials on January 24, 2023. On March 26, 2024, The Lancet Infectious Diseases published results from a study that found the J&J vaccine regimen and booster dose were well tolerated. A similar and robust humoral immune response was observed for participants boosted one year and two years after the first dose, supporting the use of the regimen and flexibility of booster dose administration for prophylactic vaccination in at-risk populations.
Janssen is now Johnson & Johnson Innovative Medicine.
Zabdeno and Mvabea Vaccine History
The U.S. National Institutes of Health sponsored the initial development of the Mvabea (MVA-BN-Filo) vaccine. The U.S. NIAID, BARDA, and other funding partners supported the development, preclinical, and clinical testing of this investigational vaccine regimen designed to protect against the virus responsible for the 2014-2016 Ebola outbreak in West Africa. On May 29, 2020, the EMA human medicines committee recommended granting Zabdeno and Mvabea a positive opinion for marketing authorizations under exceptional circumstances because the applicant was able to demonstrate that it is not possible to conduct a randomized controlled study that might generate comprehensive clinical data on the efficacy of the latest Ebola vaccine even after authorization. The EMA has approved its use in individuals aged one year or older.
Zabdeno and Mvabea Indication
The Ad26.ZEBOV / MVA-BN-Filo combination is indicated to provide an active acquired immunity to the Ebola virus. Clinical results suggest that Ad26.ZEBOV prime immunization readily induces an immune response enhanced by MVA-BN-Filo boosting. Heterologous 2-dose vaccination with Ad26.ZEBOV and MVA-BN-Filowere were used against the Ebola virus and were well tolerated and immunogenic in healthy volunteers. The vaccine is administered as an intramuscular injection. A study published in 2020 found that the two-dose heterologous regimen with Ad26.ZEBOV and MVA-BN-Filo were safe, well-tolerated, and immunogenic, with humoral and cellular immune responses persisting for one year after vaccination.
Zabdeno and Mvabea Side Effects
The most common side effects found in participants in the clinical trials were injection-site reactions (pain, warmth, and swelling), fatigue, headache, myalgia, arthralgia, and chills reported by the EMA. In a phase 1 study, the reporting of A.E.s was identical to that described for the VAC52150EBL1003 trial. Briefly, solicited A.E.s were recorded in a diary by participants for seven days following each vaccination, and unsolicited A.E.s were collected at all visits until 21 days after dose 2.
Zabdeno and Mvabea Safety
In November 2023, The Lancet Global Health published: Safety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in infants: a phase 2, randomized, double-blind, active-controlled trial in Guinea and Sierra Leone. This analysis that included Ad26.ZEBOV and MVA-BN-Filo were well tolerated and induced strong humoral responses in infants younger than one-year-old. There were no safety concerns related to vaccination.
Zabdeno and Mvabea News
March 26, 2024 - The Innovative Medicines Initiative 2 Joint Undertaking and Coalition for Epidemic Preparedness Innovations funded a study: Ad26.ZEBOV, MVA-BN-Filo Ebola virus disease vaccine regimen plus Ad26.ZEBOV booster at one year versus two years in healthcare and front-line workers in the Democratic Republic of the Congo: secondary and exploratory outcomes of an open-label, randomized, phase 2 trial.
January 31, 2023 - The JAMA Network published a review of three vaccine regimens against Zaire Ebola virus disease that safely produced immune responses for up to 12 months, according to two clinical trials of adults and children reported in the New England Journal of Medicine.
December 9, 2021 - The peer-reviewed journal PLOS Pathogens published: Current state of Ebola virus vaccines: A snapshot.
October 4, 2021 - The journal PLOS Medicine published a RESEARCH ARTICLE: Safety and immunogenicity of 2-dose heterologous Ad26.ZEBOV, MVA-BN-Filo Ebola vaccination in healthy and HIV-infected adults: A randomized, placebo-controlled Phase II clinical trial in Africa. Conclusions - Ad26.ZEBOV, MVA-BN-Filo vaccination was well tolerated and immunogenic in healthy and HIV-infected African adults.
September 13, 2021 - A study published by the journal The Lancet assessed the Safety and immunogenicity of a two-dose heterologous vaccine regimen comprising the adenovirus type 26 vector-based vaccine encoding the Ebola virus glycoprotein (Ad26.ZEBOV) and the modified vaccinia Ankara vector-based vaccine, encoding glycoproteins from the Ebola virus, Sudan virus, and Marburg virus, and the nucleoprotein from the Tai Forest virus (MVA-BN-Filo), in a pediatric population in Sierra Leone, Africa. Ebola virus glycoprotein-specific binding antibody responses at 21 days after the second dose of the Ebola virus vaccine were observed in about 97% of the children. And there were no treatment-related deaths.
August 17, 2021 - The World Health Organization Africa confirmed it helped the vaccine deployment from Guinea to Cote d'Ivoire of about 3,000 vaccine doses manufactured by Johnson & Johnson, which will be used to boost the vaccination in areas not experiencing active Ebola transmission.
June 4, 2021 - Johnson & Johnson announced it 'welcomes the Strategic Advisory Group of Experts on Immunization recommendation for the WHO.
November 17, 2020 - Study published by The Lancet: Vaccine - Study Interpretation - The two-dose heterologous regimen with Ad26.ZEBOV and MVA-BN-Filo were safe, well-tolerated, and immunogenic, with humoral and cellular immune responses one year after vaccination. Together, these data support the intended prophylactic indication for the vaccine regimen.
July 1, 2020 - The European Commission adopted the decision granting marketing authorizations to Janssen, a Johnson & Johnson company, for a vaccine against Ebola.
June 12, 2020 - Bavarian Nordic A/S announced that the Company has entered into a new supply contract with Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson valued at USD 13.9 million. Under the agreement, Bavarian Nordic will manufacture and deliver bulk drug substances of its MVA-BN® Filo vaccine, which Janssen has licensed as part of its Ebola vaccine regimen.
April 19, 2019 - A phase 1 study of healthy volunteers, immunization with Ad26.ZEBOV or MVA-BN-Filo did not result in any vaccine-related serious adverse events.
March 14, 2017 - Immune Responses to Novel Adenovirus Type 26 and Modified Vaccinia Virus Ankara–Vectored Ebola Vaccines at 1 Year.
September 12, 2016 – Bavarian Nordic A/S announced that Janssen Vaccines & Prevention B.V. (Janssen) had completed a submission to the WHO for Emergency Use Assessment and Listing for its Ebola prime-boost vaccine regimen, which includes the MVA-BN® Filo vaccine.
October 22, 2014 – Bavarian Nordic A/S announced a global license and supply agreement for its MVA-BN Filovirus (Ebola and Marburg) vaccine candidate with Crucell Holland B.V., one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo) Ebola Vaccine Clinical Trials
As a result of these collaborations, more than 6,500 individuals have now participated in clinical studies for the Ebola vaccine across the U.S., Europe, and Africa. So far, the data from these studies suggest that the vaccine stimulates a robust immune response and has a favorable safety profile.
ClinicalTrials.gov: NCT0—9494—Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo (EBOVAC-SaThe lone). It was last posted on June 29, 2020.