This is a prospective observational phase IV study of a novel, replication-deficient smallpox vaccine that has been recently been approved by FDA. The purpose of this study is to determine if there are any abnormalities detected by electrocardiographic testing and/or blood tests within 35 days of receiving the second dose of smallpox vaccine either alone or co-administered with other vaccines that may/may not be suggestive of myopericarditis.

Start Date01 Mar 2029

Sponsor / Collaborator

Womack Army Medical Center

[+1]

NCT06839989

/ Not yet recruitingPhase 2IIT

The Mpox Biology, Outcome, Transmission and Epidemiology Project - HIV Immunization and Vaccination Against Mpox EXposure Trial

This is an open-label, phase 2, immunogenicity and safety trial of the MVA-BN vaccine for the prevention of mpox in adults living with HIV with different level of CD4 counts in Kinshasa, DRC.
The study team aims to investigate whether the administration of 2 standard subcutaneous doses of the Modified Vaccinia Ankara of Bavarian Nordic (MVA-BN) vaccine given 28 days apart, is immunogenic and safe when administered to People Living with HIV (PLHIV) with different levels of CD4 counts in the Democratic Republic of the Congo (DRC).
Enrollment will be stratified according to three different subgroups based on CD4 counts assessed during visit 1A: <200 cells/µL; 200 to 499 cells/µL; ≥ 500 cells/µL. A total of 600 participants will be included in the trial, with 200 participants per subgroup.
All participants will be invited to 6 trial visits over a period of 7 months.
This study will take place in cooperation with the National Programme for the Fight against AIDS (PNLS), the 'Programme Elargi de Vaccination (PEV)' and the 'Institut National de Santé Publique (INSP)'. As part of the response to the current mpox epidemic in DRC, a large cohort of about 10,000 individuals living in Kinshasa will be vaccinated in this program. Vaccination will take place in the Centre Hospitalier Kabinda (CHK) and the Pakadjuma Health Centre. All people living with HIV (PLHIV) with the intention to be vaccinated in the CHK, will be asked for their willingness to participate in the MBOTE-HIVAX clinical trial until the sample size of 600 participants needed for this clinical trial is reached.

Start Date01 May 2025

Sponsor / Collaborator

MSF Medecins Sans Frontieres

NCT06829238

/ RecruitingPhase 4IIT

Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals With a History of Injection Drug Use (MET-IH)

This randomized clinical trial (RCT) evaluates whether metformin can reduce systemic inflammation and improve immune function in individuals with a history of injection drug use, with or without HIV. Participants will receive metformin or placebo and undergo immune system assessments, including vaccine response evaluations.

Start Date07 Apr 2025

Sponsor / Collaborator

The University of Alabama at Birmingham

[+1]

100 Clinical Results associated with Smallpox vaccine(Bavarian Nordic A/S)

100 Translational Medicine associated with Smallpox vaccine(Bavarian Nordic A/S)

100 Patents (Medical) associated with Smallpox vaccine(Bavarian Nordic A/S)

286

Literatures (Medical) associated with Smallpox vaccine(Bavarian Nordic A/S)

31 Dec 2025·Virulence

Mpox: Global epidemic situation and countermeasures

Review

Author: Quan, Quan ; Wu, Nan ; Jin, Chenghao ; Tang, Yanjun ; Hou, Wenshuang ; Luo, Yinghua ; Liu, Yanzhi

Mpox, is a zoonotic disease caused by the monkeypox virus and is primarily endemic to Africa. As countries gradually stop smallpox vaccination, resistance to the smallpox virus is declining, increasing the risk of infection with mpox and other viruses. On 14 August 2024, the World Health Organization announced that the spread of mpox constituted a public health emergency of international concern. Mpox's transmission routes and symptoms are complex and pose new challenges to global health. Several vaccines (such as ACAM2000, JYNNEOS, LC16m8, and genetically engineered vaccines) and antiviral drugs (such as tecovirimat, brincidofovir, cidofovir, and varicella immunoglobulin intravenous injection) have been developed and marketed to prevent and control this disease. This review aims to introduce the epidemic situation, epidemiological characteristics, physiological and pathological characteristics, and preventive measures for mpox in detail, to provide a scientific basis for the prevention and control of mpox viruses worldwide.

01 May 2025·The Lancet Regional Health - Europe

Correction to “Impact of vaccination with third generation modified vaccinia Ankara and sexual behaviour on mpox incidence in men who have sex with men: analysis among participants of the ANRS-174 DOXYVAC trial” [The Lancet Regional Health—Europe 45, October 2024, 101020]

Author: Viard, Jean-Paul ; Costagliola, Dominique ; Gibowski, Severine ; Surgers, Laure ; Duvivier, Claudine ; Rubenstein, Emma ; Katlama, Christine ; Ghosn, Jade ; Assoumou, Lambert ; Pialoux, Gilles ; Ollivier, Manon ; Ouattara, Moussa ; Molina, Jean-Michel ; Algarte-Genin, Michèle ; Pavie, Juliette

[This corrects the article DOI: 10.1016/j.lanepe.2024.101020.].

15 Apr 2025·The Journal of Infectious Diseases

Monkeypox Virus Infection Stimulates a More Robust and Durable Neutralizing Antibody Response Compared to Modified Vaccinia Virus Ankara Vaccination

Article

Author: Monticelli, Stephanie R ; DeMouth, Megan E ; Battini, Leandro ; Miller, Emily Happy ; Lasso, Gorka ; Meyerowitz, Eric ; Guardado-Calvo, Pablo ; Jaleta, Yakin M ; Herbert, Andrew S ; Batchelor, Thomas G ; Berrigan, Jacob ; Selverian, Christopher N ; Chandran, Kartik ; Meola, Annalisa

AbstractMonkeypox virus (MPXV) has recently caused a global disease outbreak in humans. Differences in the neutralizing antibody response to vaccination versus MPXV infection remain poorly understood. Here, we examined the neutralization of MPXV and vaccinia virus by sera from a cohort of convalescent and vaccinated individuals at 1 and 8 months postexposure. Convalescent individuals displayed higher neutralizing antibody titers against MPXV than vaccinated and MPXV-naive persons at 1 month postexposure. Neutralizing antibody titers had waned significantly in both groups at 8 months. This study suggests that additional vaccine strategies are needed to elicit a durable humoral response and prevent breakthrough infections.

275

News (Medical) associated with Smallpox vaccine(Bavarian Nordic A/S)

05 May 2025

·www.globenewswire.com

Tonix Pharmaceuticals Presented Data on Potential Mpox Vaccine TNX-801 at World Vaccine Congress Washington 2025

TNX-801 is a single-dose, live virus vaccine in development to protect against mpox and smallpox TNX-801 protects immunocompromised animals from a lethal challenge with clade IIa monkeypox virus Durability of TNX-801 vaccination shown by six-month protection of animals from a lethal challenge with rabbitpox Tolerability of TNX-801 demonstrated in immunocompromised animals by no spreading to blood or tissues, even at high doses April 24, 2025 -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, presented data in an oral presentation at the World Vaccine Congress Washington 2025, held April 21-24, 2025, in Washington, D.C. The presentation titled, “A Novel Single-Dose, Attenuated Live, Minimally Replicative Mpox Vaccine”, highlighted positive preclinical efficacy data, demonstrating that TNX-801 protected animals from mpox and rabbitpox and was well tolerated, even in immunocompromised animals. A copy of the Company’s presentation is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com. “TNX-801 shows promise as a potential mpox and smallpox vaccine by providing protective immunity to animals with a single-dose,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-801 was generally well tolerated, even in immunocompromised animals. The new data show durable six-month protection against a lethal challenge with rabbitpox virus and protection of immunocompromised animals against a lethal challenge with monkeypox clade IIa virus. These new data build upon prior studies showing protection of animals against a lethal challenge with intratracheal clade Ia mpox virus. In all of these studies, after a single dose vaccination, TNX-801 prevented both clinical disease and formation of lesions.” Dr. Lederman continued, “The ongoing clade IIb mpox epidemic that started in 2022, and the more recent and ongoing clade Ib mpox epidemic, highlight the need for additional vaccine options, particularly single-dose options. Both the 2022 clade IIb and the 2024 clade Ib mpox epidemics have been declared by the World Health Organization (WHO) to be Public Health Emergencies of International Concern (PHEICs). We believe TNX-801 has the potential to make an impact towards preventing mpox and controlling future mpox epidemics.” TNX-801 is a minimally replicative, live-virus vaccine based on synthesized horsepox that has been shown to provide single-dose immune protection against a monkeypox challenge with better tolerability than 20th century vaccinia live-virus vaccines in animals. In September 2024, Tonix announced that the WHO’s preferred target product profile (TPP), released at the WHO sponsored Mpox Research and Innovation Scientific Conference, aligns with the characteristics of TNX-801. Key elements of the WHO draft TPP include single-dose, durable protection, administration without special equipment, and stability at ambient temperature. Other potential beneficial characteristics include the ability to limit forward transmission, use in case-contact vaccination strategies and suitability for use in immunocompromised individuals. TNX-801 (recombinant horsepox virus) is a single-dose, attenuated, minimally replicative, live virus vaccine based on horsepox in pre-clinical development to prevent mpox and smallpox. Tonix reported positive preclinical efficacy data, demonstrating that TNX-801 vaccination protected non-human primates against lethal challenge with monkeypox. After a single dose vaccination, TNX-801 prevented clinical disease and lesions and decreased shedding in the mouth and lungs of non-human primates. The findings are consistent with mucosal immunity and suggest the ability to block forward transmission, similar to Dr. Edward Jenner’s vaccine, which eradicated smallpox and kept mpox out of the human population. TNX-801 is based on synthesized horsepox which is believed to be more closely related to Dr. Jenner’s vaccine than 20th century vaccinia viruses.6 Smallpox vaccines descended from Jenner’s vaccine used prior to 1900 would be called horsepox by modern nomenclature. TNX-801 is delivered percutaneously with only one dose and therefore may achieve higher rates of community protection than two-dose vaccines by eliminating drop-out between doses and limiting forward transmission. Tonix has received official written response from a Type B pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) to develop TNX-801 as a potential vaccine to protect against mpox disease and smallpox. Tonix has announced a collaboration with the Kenya Medical Research Institute (KEMRI) to design, plan and seek regulatory approval for a Phase I clinical study of TNX-801 in Kenya. The Company believes TNX-801 has the potential to make a global impact on mpox and the risk of smallpox because of its durable T-cell immune response, the potential to manufacture at scale, and the use of a lower dose than non-replicating vaccines. The FDA-approved non-replicating mpox vaccine Jynneos® requires two doses and provides a relatively short duration of protection. FDA also recently approved ACAM2000, a live, replicating vaccinia vaccine for prevention of mpox. ACAM200 is a clone from DryVax®, a 20th century vaccinia vaccine derived from the NYCBH strain. Pre-clinical results from an mRNA vaccine recently showed some protection from a Clade I monkeypox challenge, but with multiple break-through lesions in vaccinated animals. Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the National Institute on Drug Abuse. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. Department of Defense’s (DoD’s) Defense Threat Reduction Agency (DTRA) for up to $34 million over five years. TNX-4200 is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults. * Tonix’s product development candidates are investigational new drugs or biologics. Their efficacy and safety have not been established and have not been approved for any indication. Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners. The content above comes from the network. if any infringement, please contact us to modify.

VaccineFast TrackDrug ApprovalClinical Result

02 May 2025

·www.globenewswire.com

Bavarian Nordic Receives Marketing Authorization for Chikungunya Vaccine for Persons Aged 12 and Older in the United Kingdom

COPENHAGEN, Denmark, May 2, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in the United Kingdom (UK) for VIMKUNYA® (recombinant, adsorbed) for active immunization for the prevention of disease caused by chikungunya virus in individuals 12 years and older. The vaccine was approved following MHRA review under the international recognition procedure, which is a targeted assessment that recognizes approvals from certain other regulatory bodies, in this case the recent approval by the European Commission. Bavarian Nordic is targeting launch of the vaccine in the UK during the summer of 2025. “Chikungunya mostly represents a risk for UK citizens traveling overseas to affected regions in the Americas, Africa and Asia, but as recent research has shown, invasive mosquitos known to carry the disease have established themselves in many parts of Southern Europe and are moving further north due to climate change1,” said Paul Chaplin, President and CEO of Bavarian Nordic. “The mosquitos cannot be stopped, but with preventative measures such as vaccines, we can mitigate the impact of emerging diseases like chikungunya for those at risk, and we look forward to launching our vaccine in the UK later this year.” The UK approval of VIMKUNYA marks the third approval of Bavarian Nordic’s chikungunya vaccine, which was approved by the U.S. Food and Drug Administration (FDA) and the European Commission in February 2025.2,3 Bavarian Nordic has also submitted an application to Health Canada, potentially supporting approval of the chikungunya vaccine in the first half of 2026. About chikungunyaChikungunya is a mosquito-borne disease caused by the chikungunya virus (CHIKV). In the past 20 years, the virus has emerged across several regions in Asia, Africa, and the Americas, including many popular travel destinations, often causing large unpredictable outbreaks. Since its discovery, CHIKV has been identified in more than 110 countries, with evidence of transmission confirmed in more than 50 countries over the past five years4. Chikungunya typically presents with acute symptoms, including fever, rash, fatigue, headache, and often severe and incapacitating joint pain. Most patients recover within 1-2 weeks, but 30-40% of those affected may develop chronic arthritis that can last for months or even years5. In 2024, 620,000 cases of chikungunya and over 200 deaths were reported worldwide6. Recent data suggest that chikungunya is severely underreported and often misdiagnosed as dengue fever due to a similar symptom profile7. About VIMKUNYA® Chikungunya vaccine (recombinant, adsorbed)VIMKUNYA is a single dose, prefilled, adjuvanted VLP recombinant protein vaccine for active immunization for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 12 years and older. The US, EU and UK approvals of VIMKUNYA (CHIKV VLP vaccine) were all based on results from two phase 3 clinical trials which enrolled more than 3,500 healthy individuals 12 years of age and older. The studies met their primary endpoints, with results showing that 21 days after vaccination, the vaccine induced neutralizing antibodies in up to 97.8% of the vaccinated individuals, (97.8% in individuals 12 years to 64 and 87.3% in over 65 year olds). The key secondary endpoint of seroresponse rate at day 8 post vaccination was 46.6% and 96.8% at day 15 in the 12-64 year old population and 82.3% at day 15 for the over 65 population. The vaccine was well-tolerated and vaccine-related adverse events were mainly mild or moderate in nature. The most common side effects were pain at the injection site, fatigue, headache, and muscle pain. About Bavarian NordicBavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. 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. Contact investors:Europe: Rolf Sass Sørensen, Vice President Investor Relations, rss@bavarian-nordic.com, Tel: +45 61 77 47 43US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600 Contact media:Nicole Seroff, Vice President Corporate Communications, nise@bavarian-nordic.com, Tel: +45 53 88 06 03 1 European Centre for Disease Prevention and Control. Increasing risk of mosquito-borne diseases in EU/EEA following spread of Aedes species. https://www.ecdc.europa.eu/en/news-events/increasing-risk-mosquito-borne-diseases-eueea-following-spread-aedes-species 2 Bavarian Nordic Receives U.S. FDA Approval of Chikungunya Vaccine for Persons Aged 12 and Older. https://www.bavarian-nordic.com/media/media/news.aspx?news=7053 3 Bavarian Nordic Receives Marketing Authorization in Europe for Chikungunya Vaccine for Persons Aged 12 and Older. https://www.bavarian-nordic.com/media/media/news.aspx?news=7056 4 Centers for Disease Control and Prevention. Areas at Risk for Chikungunya. https://www-cdc-gov.libproxy1.nus.edu.sg/chikungunya/data-maps/index.html. 5 European Centre for Disease Prevention and Control. Chikungunya virus disease. https://www.ecdc.europa.eu/en/chikungunya-virus-disease. 6 European Centre for Disease Prevention and Control. Chikungunya virus disease case notification rate per 100 000 population, January 2024-December 2024. https://www.ecdc.europa.eu/en/publications-data/chikungunya-virus-disease-case-notification-rate-100-000-population-january-2024. 7 Ribas Freitas AR, Pinheiro Chagas AA, Siqueira AM, Pamplona de Góes Cavalcanti L. How much of the current serious arbovirus epidemic in Brazil is dengue and how much is chikungunya? Lancet Reg Health Am. 2024 Apr 30;34:100753. doi: 10.1016/j.lana.2024.100753. PMID: 38711542; PMCID: PMC11070701. Attachment 2025-05-02-en

Clinical ResultDrug ApprovalPhase 3Vaccine

04 Apr 2025

·endpts.com

Novavax’s held-up approval package may signal warning for Covid vaccine makers

On the precipice of FDA approval, Novavax’s Covid vaccine is now in limbo while a decision to approve or reject it is held up. The delay reinforces a fear from other vaccine makers about how their own applications might fare in the new administration. Novavax had expected to receive FDA approval of its vaccine on Tuesday, the PDUFA date assigned by the agency. The company has had its shot on the market under emergency use authorization and said it responded to all information requests from the agency in the lead-up to a decision. But the review deadline came and went. Politico reported that Principal Deputy Commissioner Sara Brenner personally stepped in to halt the approval process, an extremely unusual step for a political appointee. Ousted CBER chief Peter Marks said in an interview with the Wall Street Journal that “the politicals shouldn’t have been involved in this.” “There was no controversy. The review staff agreed it was an approval,” Marks said. A source familiar with the application told Endpoints News on Friday that no new information requests came on the day of the PDUFA and that the company had been having conversations with the agency about label language, usually a final step in the review process. No official communication has been provided to Novavax since, the source added. An HHS official familiar with the situation told Endpoints that “any delays to the FDA’s independent review process for the Novavax are a result of scientific review to ensure safety and efficacy.” The delay for Novavax throws other upcoming regulatory decisions into question, specifically for Moderna, which recently filed three vaccines for approval, including two new Covid products: a next-generation candidate and a combination vaccine with flu. The PDUFA for the next-generation Covid vaccine is May 31. “For those new vaccines, even including the combination, I think they will end up [under] much greater scrutiny in terms of the pathway,” Roger Song, an analyst at Jefferies, told Endpoints. “In the combination vaccine, you never had any prior data to support this.” The FDA has approved other vaccines since HHS Secretary Robert F. Kennedy Jr. took over US health agencies, including a new formulation of an existing smallpox vaccine and a chikungunya vaccine for kids and adults 12 and older, both made by Bavarian Nordic. But makers of Covid shots in particular may face a hurdle. Kennedy and his allies have been hypercritical of those vaccines’ use, their safety and the regulatory decisions that opened the market to them. Song said Covid vaccine makers could be at risk because it’s a market that’s accumulated less long-term data in an environment where the data is more polarizing. Still, Novavax’s vaccine, which is based on a protein subunit platform rather than mRNA, has shown promising durability that could garner regulators’ support, Song noted. Vaccine makers have been operating under guidance that Phase 3 combo vaccine data should show adequate safety and immunogenicity but not efficacy, so long as each individual vaccine in the combination showed good efficacy in a standalone Phase 3 study. Moderna said in February that it “may require vaccine efficacy data” from its seasonal flu shot before the FDA makes a decision. A spokesperson for Moderna declined to comment on the status of ongoing reviews. As for Novavax, the company seemed to previously get the endorsement of now-FDA Commissioner Marty Makary. He wrote in a June 2021 tweet that “Novavax may be the best COVID-19 Vaccine to date.” Now, under his leadership, the product application is stalled. Editor’s note: This story was updated with a response from an HHS official.

VaccinePhase 3Emergency Use AuthorizationClinical Result

100 Deals associated with Smallpox vaccine(Bavarian Nordic A/S)

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KEGG	Wiki	ATC	Drug Bank
-	Smallpox vaccine(Bavarian Nordic A/S)	J07BX	DB15483

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Monkeypox	Liechtenstein	Bavarian Nordic A/S	31 Jul 2013
Monkeypox	European Union	Bavarian Nordic A/S	31 Jul 2013
Monkeypox	Norway	Bavarian Nordic A/S	31 Jul 2013
Monkeypox	Iceland	Bavarian Nordic A/S	31 Jul 2013
Smallpox	Liechtenstein	Bavarian Nordic A/S	31 Jul 2013
Smallpox	Iceland	Bavarian Nordic A/S	31 Jul 2013
Smallpox	Norway	Bavarian Nordic A/S	31 Jul 2013
Smallpox	European Union	Bavarian Nordic A/S	31 Jul 2013
Vaccinia	Liechtenstein	Bavarian Nordic A/S	31 Jul 2013
Vaccinia	Norway	Bavarian Nordic A/S	31 Jul 2013
Vaccinia	Iceland	Bavarian Nordic A/S	31 Jul 2013
Vaccinia	European Union	Bavarian Nordic A/S	31 Jul 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pregnancy	Phase 3	United States	Bavarian Nordic A/S	31 Mar 2025
Vaccinia	Preclinical	United States	Bavarian Nordic A/S	01 Mar 2015
Dermatitis, Atopic	Preclinical	Mexico	Bavarian Nordic A/S	01 Jul 2006
Dermatitis, Atopic	Preclinical	United States	Bavarian Nordic A/S	01 Jul 2006
HIV Infections	Preclinical	United States	Bavarian Nordic A/S	01 Jun 2006
HIV Infections	Preclinical	Puerto Rico	Bavarian Nordic A/S	01 Jun 2006
Rhinitis, Allergic, Seasonal	Preclinical	Germany	Bavarian Nordic A/S	01 Apr 2004

Clinical Result

Indication

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05512949 (NEWS) Manual	Phase 2	Monkeypox	229	MVA-BN (aged between 12 and 17 years)	ghcpyldvdi(lccszozwru) = After two doses, antibody levels were found to be equivalent at day 43 to those in adults aged 18 to 50 years. rvcwauqdgc (xziketylzj ) View more	Positive	17 Oct 2024
Literature Manual	Not Applicable	Monkeypox	45	MVA-BN 2 doses	pnhjosmoml(icgjyaanya) = 2 doses: mpox M1R, B6R, A35R, A29L, and H3L antigens peaked at 112, 384, 85, 29, and 76 at week 3 after vaccination but then declined to 38, 82, 32, 25, and 31 at 12 months; 1 dose: the median binding antibody ELISA titers to mpox M1R, B6R, A35R, A29L, and H3L antigens peaked at 45, 90, 32, 31, and 28 at week 3 but then declined to 33, 43, 30, 25, and 28 at 12 months ctpnpssrcn (cpdnpgoxra )	Negative	03 Oct 2024
				MVA-BN 1 doses
NCT05740982 (NEWS) Manual	Phase 2	Hemorrhagic Fever, Ebola	526	IMVANEX (adolescents 12-17 years of age)	(lbnzbzhzgl) = a similar safety profile between both age groups qhnachupkb (xeyqsxycge ) View more	Positive	19 Sep 2024
				IMVANEX (adults aged 18 years and older)
NCT03699124 (Pubmed) Manual	Phase 3	-	1,129	MVA-BN	(pubgfajgel) = bqnnbbjtuy sdekjhmojn (awiotzbacj ) View more	Positive	29 Nov 2022
NCT03699124 (CTgov)	Phase 3	Smallpox	1,129	FD MVA-BN (GP 1: Two Doses of FD MVA-BN--Lot 1)	jdmunodhzm(oluveyqiod) = saxbyofbhk eejncnbfsi (urxzjoudor, dszngqfbup - rojavbtawe) View more	-	27 May 2021
				FD MVA-BN (GP 2: Two Doses of FD MVA-BN--Lot 2)	jdmunodhzm(oluveyqiod) = egtlaznizp eejncnbfsi (urxzjoudor, iqlbjdmbyu - dczhydvjvs) View more
NCT01668537 (CTgov)	Phase 2	Smallpox	651	LF (LF Formulation)	jmatpetpyt(yvqbxxyblz) = vkyfyyqjbv bpgdygvcql (rumbatfwag, hoyyqmwqbu - dqtqkyxeyk) View more	-	12 Oct 2020
				MVA-BN (FD Formulation)	jmatpetpyt(yvqbxxyblz) = lbjzrwznrg bpgdygvcql (rumbatfwag, nlntdfqgwl - xbynczxdog) View more
NCT03472014 (CTgov)	Phase 4	-	22	MVA-BN	yxmcxgkwbb(fckmqthgrh) = bbrwrzbuxb ynwlnizuvc (wizlogvylr, aitqznvxad - eornzeglup) View more	-	19 Aug 2020
NCT01913353 (Pubmed \| Br Dent J \| N Engl J Med) Manual	Phase 3	Smallpox	433	modified vaccinia Ankara+ACAM2000	ryjkiyzgvp(vapallrzuj): RO = 97.9 (95% CI, 96.6 - 98.3) View more	Superior	14 Nov 2019
				ACAM2000
NCT00686582 (CTgov)	Phase 2	Smallpox	304	IMVAMUNE (Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose)	arrbylihsx(piswguckco) = rbqbzvsiks gyhwjeykuk (lcbruukpqx, rhfddjmpkk - siqrsfospx) View more	-	18 Feb 2019
				IMVAMUNE (Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose)	arrbylihsx(piswguckco) = krvakpeyjx gyhwjeykuk (lcbruukpqx, hnfabrgtmx - czihwxukex) View more
NCT00857493 (CTgov)	Phase 2	Smallpox	120	IMVAMUNE (Group 1)	pteyvxxuxw(ggmyuuubyn) = vssjxtbpfm jcdehnmuvf (kqgbynnwpq, yqconhgrln - updndkonll) View more	-	10 Jan 2019
				IMVAMUNE (Group 2)	pteyvxxuxw(ggmyuuubyn) = myhjlihqrb jcdehnmuvf (kqgbynnwpq, ycoskhdphw - qpnbdeocts) View more

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Smallpox vaccine(Bavarian Nordic A/S)

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