Clinical Trials

Date: 2015-05-12

Type of information: Interim results

phase: 1

Announcement: interim results

Company: J&J (USA - NJ) Oxford Vaccines Group, part of the University of Oxford (UK) Bavarian Nordic (Denmark)

Product: MVA-BN® Filo vaccine and the AdVac® vaccine (preventive Ebola vaccine)

Action mechanism:

• vaccine. The vaccine regimen, which was discovered in a collaborative research program with the National Institutes of Health (NIH), uses a prime-boost combination of two components that are based on AdVac® technology from Crucell Holland B.V. , one of the Janssen Pharmaceutical Companies, and the MVA-BN® technology from Bavarian Nordic.

Disease: Ebola fever

Therapeutic area: Infectious diseases

Country: UK

Trial details:

• The Phase 1, first-in-human study will evaluate the safety and tolerability of a prime-boost vaccine regimen, in which patients are first given a dose to prime the immune system, and then a boost intended to enhance the immune response over time. The immune response generated by the regimen will also be evaluated longer term. Different regimens combining the vaccine components or placebo will be studied in 72 healthy adult volunteers. Additional clinical studies are planned to begin in the United States later this month and soon after in Africa.
• The volunteers in this study will be enrolled into four groups and randomized to receive either active vaccine or placebo. Those getting an active dose will receive a prime vaccination in one of four regimens according to randomization on day one and then receive the boost component either one or two months apart, depending on which group they are in. Analyses of these regimens will inform decisions for future studies, such as the order in which the two components should be given and how closely together they can be given to ensure the optimal protection and sustainability. (NCT02313077)

Latest news:

• • On May 12, 2015, Bavarian Nordic announced that preliminary results from a Phase 1 first-in-human study of the Ebola prime-boost vaccine regimen of Bavarian Nordic's ("The Company") MVA-BN® Filo vaccine and the AdVac® vaccine from the Janssen Pharmaceutical Companies were presented  by Janssen at a meeting of the FDA Vaccines and Related Biological Products Advisory Committee as part of discussions on the development and licensure of Ebola vaccines.
• In the study, conducted by the Oxford Vaccines Group, 72 healthy volunteers were randomized into four groups receiving the vaccine regimen or placebo. A priming dose of either Ad26.ZEBOV or MVA-BN Filo was administered at day 1 and booster doses of the other vaccine were administered after 28 or 56 days. An open label arm with 15 healthy volunteers is also investigating a shorter prime-boost interval of 14 days for Ad26.ZEBOV prime and MVA-BN Filo boost.
• Preliminary data shows that the prime-boost vaccine regimen was immunogenic, regardless of the order of vaccine administration, and that both vaccines only provoked temporary reactions normally expected from vaccination. Immune responses post boost appeared to be well balanced with the induction of humoral and cellular immune response components, the latter being comprised of highly polyfunctional CD8+ and CD4+ T cell responses. These results confirm the preclinical results previously reported and warrant further investigation of the vaccine regimen in Phase 2 studies and efficacy trials.
• • On January 6, 2015, J&J announced the start of a Phase 1, first-in-human clinical trial of a preventive Ebola vaccine in development at its Janssen Pharmaceutical Companies. The trial is being led by the Oxford Vaccine Group , part of the University of Oxford Department of Paediatrics . Recruitment in the trial is underway, and the first volunteers have received their initial vaccine dose. Enrollment is expected to be completed by the end of January. The trial is being sponsored by Crucell Holland B.V., one of the Janssen Pharmaceutical Companies, which has chosen the Oxford Vaccine Group to carry out the study. Ongoing support from the NIHR Oxford Biomedical Research Centre has also made such a rapid response possible through funding for core research staff at the Oxford Vaccine Group.
• This is the second safety trial of an Ebola vaccine to be carried out at the University of Oxford. In September, a separate Oxford University team in the Jenner Institute began a safety trial of a different Ebola vaccine developed by GSK/US National Institutes of Health (NIH). Led by Professor Adrian Hill, the trial vaccinated 60 healthy volunteers and initial results are expected this month. Those who couldn’t take part in the earlier Jenner Institute trial because recruitment was complete can be considered for this new Oxford Vaccine Group trial of an Ebola vaccine.
• The primary objective of the Oxford Vaccine Group study is to determine the vaccine regimen’s safety profile. It will also test in which order the two vaccine components should be given in a prime-boost regime, and how far apart. The immune responses that the vaccine generates – both antibodies and T cells – will also be measured over a period of one year.
• J&J also announced that Janssen , in partnership with Bavarian Nordic A/S, has produced more than 400,000 regimens of the prime-boost vaccine for use in large-scale clinical trials by April 2015. A total of 2 million regimens will be available through the course of 2015, with the ability to quickly scale up to 5 million regimens, if required, over a 12- to 18-month period. This increased projection is an update to Janssen\'s previous goal of producing more than 1 million regimens by the end of 2015, with 250,000 regimens for broad application in clinical trials by May 2015 .

Is general: Yes