A Phase 1, Double-Blind, Placebo-Controlled Study to Assess the Safety and Immunogenicity of MVA3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in Vaccinia-Naive Human Immunodeficiency Virus (HIV)-Seropositive Subjects

The purpose of this study is to assess the safety and immunogenicity of two MVA smallpox vaccine injections in healthy adults that are 18-35 years of age with HIV infection

Start Date01 Oct 2006

Sponsor / Collaborator

Sanofi Pasteur

NCT00389103 / WithdrawnPhase 1

A Phase 1, Placebo-Controlled, Double-Blind Study of the Safety and Immunogenicity of Two Injections of MVA3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in Vaccinia Naive Adult Subjects With a History of Atopic Dermatitis (AD)

purpose of this study is to assess the safety and immunogenicity of two MVA smallpox vaccine injections in healthy adults that are 18-35 years of age with a history of mild to moderate Atopic Dermatitis.

Start Date01 Oct 2006

Sponsor / Collaborator

Sanofi Pasteur

NCT00079820 / CompletedPhase 1

The Safety, Tolerability, and Immunogenicity of Three Dose Levels of ACAM3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine, in Adults Without Previous Smallpox Vaccination

The purpose of this study is to gather information on the safety and the effectiveness of an investigational vaccine for the prevention of smallpox disease. Smallpox was one of the major causes of death and sickness through the first half of the 20th century, but a global program of smallpox eradication resulted in the elimination of the natural disease. The last cases of smallpox in the United States occurred in 1949 in Texas. Today, only laboratory workers who work with smallpox-related viruses, military personnel, and health care workers are vaccinated.
Historically, individuals in the US were vaccinated with a product such as Dryvax®, which contains the virus vaccinia in the same family as smallpox. This virus could promote immunity to smallpox, but not produce the disease itself. Although effective, these vaccines are not safe to use in people with atopic dermatitis (eczema, allergic immune response to allergens), children less than 1 year of age, and people with a compromised immune system, occurring in certain diseases (HIV positive individuals and AIDS), and following treatment with certain types of drugs. It is important to find a safe vaccine that can be used to protect people who cannot receive routine vaccinia-based smallpox vaccine.
The vaccine in this study is known as Modified Vaccinia Ankara or MVA vaccine. It is the objective of this study to find out if MVA vaccine is safe and effective in providing immunity to smallpox. The effectiveness of this vaccine will be measured in two ways. The first way is to find out if there are specific antibodies in your blood following MVA vaccination. Antibodies are chemicals your body produces to fight smallpox virus.
The second way is to see whether or not there is a typical skin reaction following vaccination with a traditional smallpox vaccine, given about three months after vaccination with the MVA vaccine. The typical reaction in an unvaccinated person to smallpox vaccine is formation of a blister or "pox" which occurs at the site of vaccination. In a person with immunity to smallpox the skin reaction is much less, and typically consists of a little swelling at the site of vaccination.

Start Date01 Apr 2004

Sponsor / Collaborator

Sanofi Pasteur

100 Clinical Results associated with ACAM-3000

100 Translational Medicine associated with ACAM-3000

100 Patents (Medical) associated with ACAM-3000

Literatures (Medical) associated with ACAM-3000

02 Sep 2023·Expert Review of Clinical Pharmacology

Emerging pharmacological strategies for treating and preventing mpox

Review

Author: Russo, Andrew T ; Grosenbach, Douglas W ; Blum, Emily D ; Hruby, Dennis E

INTRODUCTIONSince May 2022, there have been nearly 87,000 documented cases of mpox worldwide, with 119 deaths. Pharmacological interventions for mpox include the MVA-BN smallpox vaccine, tecovirimat, cidofovir, its pro-drug brincidofovir, and vaccinia immune globulin intravenous (VIGIV).AREAS COVEREDThe literature search and information gathering for this review included the PubMed database focusing on mpox and monkeypox, in combination with tecovirimat, brincidofovir, cidofovir, VIGIV, and smallpox vaccine. WHO.int, CDC.gov, FDA.gov, and ClinicalTrials.gov websites were accessed for the most recent information on the mpox outbreak. Mechanisms for deployment and access to treatment including expanded access, emergency use, and clinical trials will be discussed. Treatment outcomes with safety data will be presented.EXPERT OPINIONThe vaccine as a preventive measure, along with numerous treatment options, largely controlled the outbreak, although deployment of each could be improved upon to hasten and broaden access. More widespread coverage by the vaccine is necessary to prevent future resurgence of mpox. Tecovirimat has emerged as a safe frontline treatment for mpox, while brincidofovir use has been limited by safety concerns. VIGIV and cidofovir should be reserved for the most severe cases in which other options are not fully effective.

01 Jul 2023·The Lancet Infectious Diseases

Effectiveness of one dose of MVA–BN smallpox vaccine against mpox in England using the case-coverage method: an observational study

Article

Author: Campbell, Colin ; Mohammed, Hamish ; Andrews, Nick ; Ladhani, Shamez N ; Dugbazah, Bennet ; Cordery, Rebecca ; Bernal, Jamie Lopez ; Bertran, Marta ; Turner, Charlie ; Lunt, Rachel ; Ramsay, Mary ; Blomquist, Paula ; Amirthalingam, Gayatri ; Boateng, Jacob ; Green, Melanie ; Mandal, Sema ; Hardstaff, Joanne ; Davison, Chloe

BACKGROUNDThe UK experienced a national outbreak of mpox (formerly known as monkeypox) disease that started in May, 2022, as did many other countries worldwide, with case numbers rising rapidly, mainly among gay, bisexual, and other men who have sex with men (GBMSM). To control the outbreak, Modified Vaccinia Ankara-Bavaria Nordic (MVA-BN), an attenuated smallpox vaccine, was offered to at-risk GBMSM. We aimed to assess the effectiveness of a single MVA-BN dose against symptomatic mpox disease in at-risk GBMSM.METHODSIn this case-coverage study, mpox cases in England were sent questionnaires collecting information on demographics, vaccination history, symptoms, and sexual orientation. Returned questionnaires were linked to laboratory data and a public health case management system (HP Zone) to obtain additional information on symptom onset and specimen date. Cases with a rash onset date (or alternative proxy) between July 4 and Oct 9, 2022, were included. Females, heterosexual men, and those with missing vaccination information were excluded. Vaccine effectiveness was calculated using the case-coverage method in which vaccine coverage among cases is compared with coverage in the eligible population, estimated from doses given to GBMSM and the estimated size of at-risk GBMSM. Sensitivity analyses included an increase and decrease of 20% differences in the estimated high-risk GBMSM population size.FINDINGSBy Nov 3, 2022, 1102 people had responded to questionnaires, of which 739 were excluded (52 females or self-declared male heterosexuals, 590 with an index date outside of the study period, and 97 missing a vaccination date). 363 cases were included in the analyses. Vaccine uptake among eligible GBMSM increased steadily from July, 2022, reaching 47% by Oct 9, 2022. Of the 363 confirmed cases, eight cases either did occur or were likely to have occurred at least 14 days after vaccination, 32 within 0-13 days after vaccination, and the rest were unvaccinated. The estimated vaccine effectiveness against symptomatic mpox at least 14 days after a single dose was 78% (95% CI 54 to 89) ranging from 71 to 85 in sensitivity analyses. Vaccine effectiveness within 0-13 days after vaccination was -4% (95% CI -50 to 29).INTERPRETATIONA single MVA-BN dose was highly protective against symptomatic mpox disease among at-risk GBMSM, making it a useful tool for mpox outbreak control when rapid protection is needed. For cases in which numbers at highest risk of infection exceed vaccine supply, there might be benefit in prioritising delivery of first doses.FUNDINGUK Health Security Agency.

01 Apr 2023·AIDS

Smallpox vaccine acceptability among French men having sex with men living with HIV in settings of monkeypox outbreak

Letter

Author: Zucman, David ; Chan Hew Wai, Aurélie ; Vallée, Alexandre ; Faucheron, Antoine ; Fourn, Erwan ; Farfour, Eric ; Von Tokarski, Florent

News (Medical) associated with ACAM-3000

22 Dec 2022

·www.globenewswire.com

Bavarian Nordic Completes Enrollment in Global Phase 3 Trial of RSV Vaccine Candidate for Older Adults

20,000 adults aged 60 years and older have been enrolled according to planTop-line results are anticipated in mid-2023 COPENHAGEN, Denmark, December 22, 2022 – Bavarian Nordic A/S (OMX: BAVA) announced today that the Company has completed the planned enrollment of subjects in the global, randomized, double-blind Phase 3 clinical trial of its investigational respiratory syncytial virus (RSV) vaccine candidate, MVA-BN® RSV in adults ≥60 years of age. The trial was initiated in April 2022 and has now enrolled over 20,000 subjects within the expected time frame at 120 sites across the U.S. and Germany. The primary objective of the study will assess the efficacy of the vaccine candidate against lower-respiratory tract disease (LTRD) caused by RSV compared to placebo. Topline results are anticipated in mid-2023. In parallel, Bavarian Nordic is also running a global Phase 3 trial of its COVID-19 booster vaccine candidate. Enrollment in this trial is progressing well and on target to allow for initial results to become available in early 2023 as previously communicated. “The RSV Phase 3 trial is our largest single study to-date, and we are pleased to complete target enrollment within the projected timeframe. We would like to thank all the clinical trial sites and their personnel for their significant contribution to advancing our RSV vaccine candidate, and not least the many volunteers without whom innovation and progress in the development of novel vaccines would not be possible. Our RSV vaccine has shown great promise in clinical trials thus far confirming its significant potential to change the lives of adults at risk from RSV-related disease, and we look forward to seeing the results from the Phase 3 trial next year, “ said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic. About Respiratory Syncytial Virus (RSV)RSV is a common virus that usually causes mild, cold-like symptoms, but in serious cases can lead to severe lung infections, including bronchiolitis and pneumonia, which ultimately can lead to death. At-risk individuals typically include infants and older adults as well as immunocompromised individuals. A prospective study in the U.S. has estimated the disease burden from RSV-induced infections and subsequent deaths to be similar to that of non-pandemic influenza in adults aged 65 years and older1. Accordingly, preventing RSV-induced infections is a top priority for governments and medical professionals globally. Currently there is no approved vaccine against RSV, thus representing a large and critical unmet medical need and a potential multi-billion-dollar vaccines market annually. About MVA-BN RSVMVA-BN RSV is based on Bavarian Nordic’s proprietary vaccine platform technology, MVA-BN, and incorporates five distinct RSV antigens to stimulate a broad immune response against both RSV subtypes (A and B). In a clinical Phase 2 double-blinded, placebo-controlled human challenge trial, a significant reduction in viral load was reported in vaccinated subjects versus placebo and MVA-BN RSV demonstrated a vaccine efficacy of up to 79% in preventing symptomatic RSV infections2. MVA-BN RSV has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration as well as access to the European Medicines Agency’s priority medicines (PRIME) scheme for active immunization for prevention of LTRD caused by RSV in adults ≥60 years of age. About Bavarian NordicBavarian Nordic is a fully integrated vaccines company focused on the development, manufacturing and commercialization of life-saving vaccines. We are a global leader in smallpox vaccines and have been a long-term supplier to the U.S. Government of a non-replicating smallpox vaccine, which has been approved by the FDA, also for the protection against mpox. The vaccine is also approved in Canada and Europe. Our commercial product portfolio furthermore contains market-leading vaccines against rabies and tick-borne encephalitis. Using our live virus vaccine platform technology, MVA-BN®, we have created a diverse portfolio of proprietary and partnered product candidates designed to save and improve lives by unlocking the power of the immune system, including an Ebola vaccine, which is licensed to the Janssen Pharmaceutical Companies of Johnson & Johnson. We are also committed to the development of a next generation COVID-19 vaccine. For more information visit www.bavarian-nordic.com. Forward-looking statements This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law. ContactsEurope: Rolf Sass Sørensen, Vice President Investor Relations, Tel: +45 61 77 47 43US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600 1 Falsey AR, Hennessey PA, Formica MA, Cox C, Walsh EE. Respiratory syncytial virus infection in elderly and high-risk adults. N Engl J Med. 2005 Apr 28;352(17):1749–59 2 https://www.resvinet.org/uploads/2/2/2/7/22271200/abstract_booklet_rsvvw21.pdf Attachment 2022-12-22-en

Phase 2Phase 3VaccineBreakthrough TherapyClinical Result

08 Dec 2022

·www.globenewswire.com

Report of transactions of shares and related securities of Bavarian Nordic by persons holding managerial responsibilities and/or persons/companies closely associated with such

COPENHAGEN, Denmark, December 8, 2022 – Bavarian Nordic A/S (OMX: BAVA) has today received information about the following transactions of the company’s shares/related securities by persons holding managerial responsibilities and/or persons/companies closely associated with such. 1.Details of the person discharging managerial responsibilities/person closely associated a)NamePaul Chaplin2.Reason for the notificationa)Position/status President and Chief Executive Officer of Bavarian Nordic A/S b)Initial notification/AmendmentInitial notification3.Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitora)NameBavarian Nordic A/Sb)LEI2138006JCDVYIN6INP514.Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducteda)Description of the financial instrument, type of instrument Identification codeWarrants DK0015998017b)Nature of the transactionGrantc)Price(s) and volume(s)Price(s)Volume(s) DKK 0.0088,325d)Aggregated information Aggregated volumePrice 88,325DKK 0.00e)Date of the transaction2022-12-08f)Place of the transactionOutside a trading venue 1.Details of the person discharging managerial responsibilities/person closely associated a)NameHenrik Juuel2.Reason for the notificationa)Position/status Executive Vice President and Chief Financial Officer of Bavarian Nordic A/Sb)Initial notification/AmendmentInitial notification3.Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitora)NameBavarian Nordic A/Sb)LEI2138006JCDVYIN6INP514.Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducteda)Description of the financial instrument, type of instrument Identification codeWarrants DK0015998017b)Nature of the transactionGrantc)Price(s) and volume(s)Price(s)Volume(s) DKK 0.0038,162d)Aggregated information Aggregated volumePrice 38,162DKK 0.00e)Date of the transaction2022-12-08f)Place of the transactionOutside a trading venue1.Details of the person discharging managerial responsibilities/person closely associated a)NameJean-Christophe May2.Reason for the notificationa)Position/status Executive Vice President and Chief Commercial Officer of Bavarian Nordic A/Sb)Initial notification/AmendmentInitial notification3.Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitora)NameBavarian Nordic A/Sb)LEI2138006JCDVYIN6INP514.Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducteda)Description of the financial instrument, type of instrument Identification codeWarrants DK0015998017b)Nature of the transactionGrantc)Price(s) and volume(s)Price(s)Volume(s) DKK 0.0034,263d)Aggregated information Aggregated volumePrice 34,263DKK 0.00e)Date of the transaction2022-12-08f)Place of the transactionOutside a trading venue1.Details of the person discharging managerial responsibilities/person closely associated a)NameLaurence De Moerlooze2.Reason for the notificationa)Position/status Executive Vice President and Chief Medical Officer of Bavarian Nordic A/Sb)Initial notification/AmendmentInitial notification3.Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitora)NameBavarian Nordic A/Sb)LEI2138006JCDVYIN6INP514.Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducteda)Description of the financial instrument, type of instrument Identification codeWarrants DK0015998017b)Nature of the transactionGrantc)Price(s) and volume(s)Price(s)Volume(s) DKK 0.0032,934d)Aggregated information Aggregated volumePrice 32,934DKK 0.00e)Date of the transaction2022-12-08f)Place of the transactionOutside a trading venue1.Details of the person discharging managerial responsibilities/person closely associated a)NameAnu Helena Kerns2.Reason for the notificationa)Position/status Executive Vice President People & Organization of Bavarian Nordic A/Sb)Initial notification/AmendmentInitial notification3.Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitora)NameBavarian Nordic A/Sb)LEI2138006JCDVYIN6INP514.Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducteda)Description of the financial instrument, type of instrument Identification codeWarrants DK0015998017b)Nature of the transactionGrantc)Price(s) and volume(s)Price(s)Volume(s) DKK 0.0022,902d)Aggregated information Aggregated volumePrice 22,902DKK 0.00e)Date of the transaction2022-12-08f)Place of the transactionOutside a trading venue1.Details of the person discharging managerial responsibilities/person closely associated a)NameRussell Thirsk2.Reason for the notificationa)Position/status Executive Vice President and Chief Operating Officer of Bavarian Nordic A/Sb)Initial notification/AmendmentInitial notification3.Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitora)NameBavarian Nordic A/Sb)LEI2138006JCDVYIN6INP514.Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducteda)Description of the financial instrument, type of instrument Identification codeWarrants DK0015998017b)Nature of the transactionGrantc)Price(s) and volume(s)Price(s)Volume(s) DKK 0.0032,201d)Aggregated information Aggregated volumePrice 32,201DKK 0.00e)Date of the transaction2022-12-08f)Place of the transactionOutside a trading venue About Bavarian NordicBavarian Nordic is a fully integrated vaccines company focused on the development, manufacturing and commercialization of life-saving vaccines. We are a global leader in smallpox vaccines and have been a long-term supplier to the U.S. Government of a non-replicating smallpox vaccine, which has been approved by the FDA, also for the protection against mpox (monkeypox). The vaccine is also approved in Canada and Europe. Our commercial product portfolio furthermore contains market-leading vaccines against rabies and tick-borne encephalitis. Using our live virus vaccine platform technology, MVA-BN®, we have created a diverse portfolio of proprietary and partnered product candidates designed to save and improve lives by unlocking the power of the immune system, including an Ebola vaccine, which is licensed to the Janssen Pharmaceutical Companies of Johnson & Johnson. We are also committed to the development of a next generation COVID-19 vaccine. For more information visit www.bavarian-nordic.com. ContactsEurope: Rolf Sass Sørensen, Vice President Investor Relations, Tel: +45 61 77 47 43US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600 Company Announcement no. 44 / 2022 Attachment 2022-44-en

VaccineDrug Approval

08 Dec 2022

·www.globenewswire.com

New Incentive Program Established for Members of Executive Management and Selected Employees in Bavarian Nordic

COPENHAGEN, Denmark, December 8, 2022 – Bavarian Nordic A/S (OMX: BAVA) announced today that the Board of Directors has decided to issue warrants to members of the Executive Management and selected employees in the Bavarian Nordic Group. As a new initiative, vesting of the warrants for members of the Executive Management will be based on successful achievement of relevant Key Performance Indicators (KPI's). The decision is made in accordance with the shareholder authorizations for the Board of Directors adopted as Articles 5b and 5c of the Articles of Association and the Remuneration Policy. A total of 248,787 warrants is granted to members of Executive Management with a subscription price of DKK 224.70 per share equivalent to the market price of Bavarian Nordic's shares at the time of grant. Vesting of the warrants is subject to prior fulfilment of KPI's as determined by the Board of Directors. A total of 683,264 warrants is granted to selected employees in the Bavarian Nordic Group with a subscription price of DKK 270.91 per share, determined as the average market price (closing price) of the Company's shares on Nasdaq Copenhagen over a period of 15 business days prior to grant plus 15 %. Collectively, under the new warrant programs a total of 932,051 warrants are granted, which entitle the holders to subscribe for up to 932,051 shares in total with a nominal value of DKK 10 each. Vested warrants may be exercised wholly or partly during eight fixed subscription periods during 2026 and 2027, however subject to predefined caps on the maximum value of the exercise for each individual warrant holder at the time of exercise as laid out in the Remuneration Policy. Calculated on the Black-Scholes model, the theoretical value of each warrant granted to members of Executive Management equals DKK 78.36 and the value of each warrant granted to selected employees equals DKK 64.33. The calculations are based on a share price of DKK 224.70, a risk-free interest rate of 2.04 per cent and on the historical volatility of the shares in relevant peers. The value of warrants granted to members of Executive Management will further be adjusted for the historic probability of achievement of KPIs. About Bavarian NordicBavarian Nordic is a fully integrated vaccines company focused on the development, manufacturing and commercialization of life-saving vaccines. We are a global leader in smallpox vaccines and have been a long-term supplier to the U.S. Government of a non-replicating smallpox vaccine, which has been approved by the FDA, also for the protection against mpox (monkeypox). The vaccine is also approved in Canada and Europe. Our commercial product portfolio furthermore contains market-leading vaccines against rabies and tick-borne encephalitis. Using our live virus vaccine platform technology, MVA-BN®, we have created a diverse portfolio of proprietary and partnered product candidates designed to save and improve lives by unlocking the power of the immune system, including an Ebola vaccine, which is licensed to the Janssen Pharmaceutical Companies of Johnson & Johnson. We are also committed to the development of a next generation COVID-19 vaccine. For more information visit www.bavarian-nordic.com. Forward-looking statements This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law. ContactsEurope: Rolf Sass Sørensen, Vice President Investor Relations, Tel: +45 61 77 47 43US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600 Company Announcement no. 43 / 2022 Attachment 2022-43-en

Drug ApprovalVaccine

100 Deals associated with ACAM-3000

External Link

KEGG	Wiki	ATC	Drug Bank
-	ACAM-3000	-	DB14711

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Dermatitis, Atopic	Phase 2	US	Sanofi Pasteur	01 Oct 2006
HIV Seropositivity	Phase 2	US	Sanofi Pasteur	01 Oct 2006
Smallpox	Phase 2	-	Baxter International, Inc.	-
Smallpox	Phase 2	-	Acambis Plc	-

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