Prospective, Multi-country, Non-interventional, Case-control with Test- negative Controls to Estimate the Effectiveness of the Ad26.ZEBOV, MVA-BN-Filo Vaccine Regimen Against Ebola Virus Disease in Real-world Setting (v2.0, 23 January 2024)

Start Date05 Jan 2025

Sponsor / Collaborator

Janssen Research & Development LLC

NCT06549530

/ RecruitingPhase 2

Open-label, Multicenter Immunogenicity and Safety Study of MVA-BN Vaccine in Children from 2 Years to Less Than 12 Years of Age Compared to Adults for the Prevention of Smallpox, Mpox, and Related Orthopoxvirus Infections

All participants will receive 2 vaccinations of the same dose of Modified Vaccinia Ankara Virus (MVA-BN) vaccine 4 weeks apart (standard regimen).
Serum samples for assessment of immune response will be collected at baseline (visit of first vaccination) and at 2 weeks (week 6), 6 months (week 30), and 1 year after the second (last) vaccination.

Start Date21 Oct 2024

Sponsor / Collaborator

Bavarian Nordic A/S

[+1]

PACTR202306534727467

/ RecruitingPhase 2IIT

A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral-Vectored Marburg Virus Vaccine in Healthy Adults

Start Date26 Sep 2023

Sponsor / Collaborator-

100 Clinical Results associated with MVA-BN-Filo(Bavarian Nordic, Crucell)

100 Translational Medicine associated with MVA-BN-Filo(Bavarian Nordic, Crucell)

100 Patents (Medical) associated with MVA-BN-Filo(Bavarian Nordic, Crucell)

Literatures (Medical) associated with MVA-BN-Filo(Bavarian Nordic, Crucell)

31 Dec 2025·Emerging Microbes & Infections

Evaluation of waning of IgG antibody responses after rVSVΔG-ZEBOV-GP and Ad26.ZEBOV, MVA-BN-Filo Ebola virus disease vaccines: a modelling study from the PREVAC randomized trial

Article

rVSVΔG-ZEBOV-GP and Ad26.ZEBOV, MVA-BN-Filo are WHO-prequalified vaccination regimens against Ebola virus disease (EVD). Challenges associated with measuring long-term clinical protection warrant the evaluation of immune response kinetics after vaccination. Data from a large phase 2 randomized double-blind clinical trial (PREVAC) were used to evaluate waning of anti-Ebola virus (EBOV) glycoprotein (GP_1,2) antibody concentrations after rVSVΔG-ZEBOV-GP or Ad26.ZEBOV, MVA-BN-Filo vaccination with linear mixed-effect regression models. After a post-vaccination peak, each vaccination strategy was associated with a decrease of anti-EBOV GP_1,2 antibody concentrations with distinct kinetics, highlighting a less-rapid decline in antibody levels after vaccination by rVSVΔG-ZEBOV-GP. One year after administration of the vaccine, antibody concentrations were higher in children compared to adults for both vaccines, although with different effect sizes: 1.74-fold higher concentrations (95% confidence interval [CI] [1.48; 2.02]) for children 12-17 years old to 3.10-fold higher concentrations (95% CI [2.58; 3.69]) for those 1-4 years old compared to adults for Ad26.ZEBOV, MVA-BN-Filo versus 1.36-fold (95% CI [1.12; 1.61]) to 1.41-fold (95% CI [1.21; 1.62]) higher than these values for adults, with relatively small changes from one age category of children to another, for rVSVΔG-ZEBOV-GP. Antibody concentrations also differed according to geographical location, pre-vaccination antibody concentration, and sex. In combination with knowledge on memory response, characterization of the major determinants of immune response durability of both vaccinations may guide future EVD control protocols.Trial registration: ClinicalTrials.gov identifier: NCT02876328.

02 Apr 2025·Science Translational Medicine

Ebola virus vaccination elicits Ebola virus–specific immune responses without substantial cross-reactivity to other filoviruses

Article

Author: Dearlove, Bethany L. ; Merbah, Mélanie ; Thapa, Pallavi ; Mwakisisile, Joel ; Paquin-Proulx, Dominic ; Mwesigwa, Betty ; Paolino, Kristopher ; Eller, Michael A. ; Akintunde, Akindiran ; Iroezindu, Michael ; Rolland, Morgane ; Ward, Lucy ; Ntinginya, Nyanda ; Kosgei, Josphat ; Robinson, Cynthia ; Luhn, Kerstin ; Shubin, Zhanna ; Barrera, Michael D. ; Hooper, Jay W. ; Mdluli, Thembi ; Costanzo, Margaret C. ; Kibuuka, Hannah ; Alrubayyi, Aljawharah ; Bai, Hongjun ; Wollen-Roberts, Suzanne ; Duncan, Shayla ; Boeckelman, Jacob ; Ake, Julie A. ; Eller, Leigh Anne ; Oyieko, Janet ; Jani, Ilesh ; Kim, Dohoon ; Li, Yifan ; McLean, Chelsea ; Viegas, Edna ; Beckman, Bradley ; Robb, Merlin L. ; Kwilas, Steven A. ; Sawe, Fredrick ; Curtis, Daniel J.

The Janssen Ebola virus (EBOV) vaccine consists of the adenovirus type 26 vector encoding the EBOV glycoprotein (GP) (Ad26.ZEBOV) and the modified vaccinia Ankara (MVA) vector encoding GP from EBOV, Sudan virus, and Marburg virus and nucleoprotein from Tai Forest virus (MVA-BN-Filo) administered 8 weeks later. We conducted a systems immunology analysis of antibody-mediated and cellular immune responses induced after two immunizations with either vaccine used first. The response to vaccination was EBOV GP specific and defined by high antibody binding, Fc effector, and neutralizing responses with CD4 T cell responses also contributing. The vaccine-induced antibody profile did not distinguish people living with or without HIV-1. Samples from 48 survivors and 121 contacts from the 2007 Ugandan Bundibugyo virus epidemic also showed minimal cross-reactivity to other filovirus proteins after infection and exposure. The lack of cross-reactivity suggests that different multivalent vaccine candidates are required to provide broad protection across filoviruses.

04 Feb 2025·JOURNAL OF INFECTIOUS DISEASES

Innate and Cellular Immune Response to the Ebola Vaccine Ad26.ZEBOV, MVA-BN-Filo: An Ancillary Study of the EBL2001 Phase 2 Trial

Article

Author: Surénaud, Mathieu ; Luhn, Kerstin ; Durand, Mélany ; Richert, Laura ; Wiedemann, Aurélie ; Foucat, Emile ; Guillaumat, Lydia ; Robinson, Cynthia ; Thiébaut, Rodolphe ; Bockstal, Viki ; Krief, Corinne ; Lacabaratz, Christine ; Lévy, Yves

Abstract:

Background:

The EBL2001 phase 2 trial tested the 2-dose Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine in Europe. Safety and humoral immunogenicity assessments led to European Union market authorization in 2020. Complementary analyses of immune responses are warranted to better characterize vaccine effects.

Methods:

We conducted an ancillary study to analyze changes in the serum and cellular responses. Serum biomarkers of activation/inflammation were evaluated using a Luminex assay. Vaccine-elicited T-cell responses and functions were evaluated by assessing their phenotype, cytokine production, proliferation, and cytotoxic potential. Integrated data analysis was performed through correlation and principal component analysis of serum biomarkers and cellular immune responses.

Results:

Forty-eight volunteers were included. The Ad26.ZEBOV, MVA-BN-Filo vaccine elicited (1) serum increase of inflammatory/activation markers mainly at 1 day after the Ad26.ZEBOV vaccine; and (2) durable EBOV-specific T-cell proliferation and CD8+ T cells exhibiting a cytotoxic phenotype after Ad26.ZEBOV prime, after MVA-BN-Filo boost, and 6 months postvaccination. Integrated analysis revealed correlations between (1) EBOV-specific CD8+ T-cell proliferation and cytotoxic phenotype; and (2) high EBOV-specific CD8+ T-cell cytotoxic phenotype and low inflammatory marker IL-8 at day 1 postvaccination.

Discussion:

This study provides unique insights into the in vivo contribution of proliferation/cytotoxic CD8+ T cells and inflammation to the Ad26.ZEBOV, MVA-BN-Filo vaccine-induced potency.Clinical Trials Registration. NCT02416453.

News (Medical) associated with MVA-BN-Filo(Bavarian Nordic, Crucell)

29 Oct 2024

·www.globenewswire.com

First Children Vaccinated in New Clinical Study Seeking to Expand the Indication for Bavarian Nordic’s Mpox Vaccine

Clinical study in children 2-11 years of age follows the recent EMA and WHO approvals of the MVA-BN mpox vaccine for adolescents 12-17 of age. COPENHAGEN, Denmark, October 29, 2024 – Bavarian Nordic A/S (OMX: BAVA) announced today the initiation of a clinical study of the MVA-BN® mpox/smallpox vaccine in children 2 to 11 years of age. The first children have now been vaccinated in the study, which is currently enrolling in the Democratic Republic of Congo (DRC) with plans also to include sites in Uganda. A total of 460 individuals are expected to participate in the study, which will compare the safety and immunogenicity of the vaccine between children aged 2 to 11 years of age to adults. The study (NCT06549530) is partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI). Results from this study could support an extension of the current approval of MVA-BN to include children from 2 years of age and older. Last month, the WHO prequalified the vaccine for adolescents 12 to 17 years of age, adopting the recent approval from the European Medicines Agency (EMA) for this age group. Paul Chaplin, President & CEO of Bavarian Nordic, said: “Children remain highly vulnerable to mpox infections in the ongoing outbreak in Africa, highlighting the importance and urgency to broaden the access to effective vaccines that can be safely administered to this young population. Following the recent approval of MVA-BN for adolescents, we are pleased to initiate this study, which could provide additional data to further extend the indication to also include children, and we thank CEPI and our partners in Africa for their support of this important work.” Dr Nicole Lurie, Executive Director of Preparedness and Response at CEPI, said: “The findings of this study will be crucial in shaping mpox vaccine strategies that could protect children and bring an end to this devastating and widespread outbreak, while also providing pivotal vaccine guidance in local endemic populations to tackle mpox outbreaks that could strike in the future.” While this study represents the first investigation of MVA-BN as an mpox/smallpox vaccine for younger children, a recombinant version of MVA-BN (Mvabea®) was approved by EMA in 2020 as part of a prime-boost vaccine regimen1 for the prevention of disease caused by Ebola virus in individuals 1 year of age and older. Clinical studies supporting this approval encompassed more than 3,300 individuals across Europe, USA, and Africa including over 800 children and adolescents 1 to 17 years of age in Africa2. The safety profile of Mvabea in children 1 to 17 years of age was generally similar to that observed in adults. About the mpox vaccineMVA-BN or Modified Vaccinia Ankara-Bavarian Nordic is the only non-replicating mpox vaccine approved in the U.S., Switzerland, Singapore and Mexico (marketed as JYNNEOS®), Canada (marketed as IMVAMUNE®), and the EU/EAA and United Kingdom (marketed as IMVANEX®). Originally developed as a smallpox vaccine in collaboration with the U.S. government to ensure the supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines, MVA-BN has been indicated for use in the general population (from 12 years old) in individuals considered at risk for smallpox or mpox infection. 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. ContactsEurope: 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 1 Mvabea® was licensed in 2014 to Johnson & Johnson as part of a prime-boost vaccine regimen. 2 https://www.ema.europa.eu/en/documents/assessment-report/mvabea-epar-public-assessment-report_en.pdf Attachment 2024-10-29-en

Drug ApprovalVaccineClinical Study

14 Dec 2022

·www.reuters.com

J&J and Merck Ebola vaccines produce lasting antibodies in children and adults -studies

Dec 14 (Reuters) - Ebola vaccines developed by Johnson & Johnson and Merck & Co (MRK.N) produced virus-fighting antibodies and appear to be safe in children and adults, according to data from two studies published on Wednesday. Both companies' vaccines produced antibodies 14 days after the first of two shots and were detectable at varying levels in both children and adults for one year, data from the studies conducted in Western Africa showed. The vaccines are designed to target the Zaire strain of the virus, not the Sudan strain of Ebola that recently caused an outbreak and at least 56 deaths in Uganda. One regimen tested a dose of J&J's vaccine, followed by a booster shot of a vaccine from Danish drugmaker Bavarian Nordic (BAVA.CO) , while another tested two doses of Merck's vaccine with eight weeks in between. A third option followed the first Merck dose with a placebo. "I think the study shows that both the vaccines elicit good antibody responses," said Dr. H. Clifford Lane, one of the researchers and a clinical director at the U.S. National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH). Only Merck's shot can potentially be given as a single dose while J&J's vaccine may need to continue as a two-dose regimen, Lane added. The NIH researchers noted that they were unable to assess the actual level of protection against the disease from the vaccines as no participants contracted Ebola during the trial, which began enrollment in 2017. But they said the vaccines were found to be safe for children and adults. "Long-term follow up of the participants in this trial is taking place to determine if and when booster doses might be needed," said Brian Greenwood, a study co-author from the London School of Hygiene & Tropical Medicine. A total of 1,400 adults and 1,401 children aged 1 to 17 years old participated in the trials conducted in collaboration with Liberia Ministry of Health and with the University Clinical Research Center and the Center for Vaccine Development-Mali. The results were published in The New England Journal of Medicine. Merck's vaccine Ervebo was approved by the European regulator and prequalified by the World Health Organization in 2019. J&J's Zabdeno got European and WHO clearances in 2020 and 2021, respectively. Bavarian Nordic's Mvabea, used in the J&J regimen, also received European approval in 2020 and WHO prequalification in 2021. Our Standards: The Thomson Reuters Trust Principles.

Drug ApprovalVaccineClinical ResultPhase 3

14 Dec 2022

·www.sciencedaily.com

Ebola vaccine regimens safe, immunogenic in adults and children

Two randomized, placebo-controlled trials evaluating three Ebola vaccine administration strategies in adults and children found that all the regimens were safe in both age groups, according to new results. Antibodies were produced in response to the vaccine regimens beginning at 14 days after the first vaccination and continued to be detectable at varying levels -- depending on the vaccine and regimen used -- in both children and adults for one year. The study enrolled volunteers at sites in Guinea, Liberia, Sierra Leone and Mali to identify optimal vaccination strategies to curtail outbreaks of Ebola virus disease. Two randomized, placebo-controlled trials evaluating three Ebola vaccine administration strategies in adults and children found that all the regimens were safe in both age groups, according to results published today in the New England Journal of Medicine. Antibodies were produced in response to the vaccine regimens beginning at 14 days after the first vaccination and continued to be detectable at varying levels -- depending on the vaccine and regimen used -- in both children and adults for one year. The study enrolled volunteers at sites in Guinea, Liberia, Sierra Leone and Mali to identify optimal vaccination strategies to curtail outbreaks of Ebola virus disease. The trials were conducted under the Partnership for Research on Ebola Vaccination (PREVAC) international consortium. PREVAC's partner organizations include the U.S. National Institutes of Health (NIH), the French National Institute of Health and Medical Research and the London School of Hygiene & Tropical Medicine. The National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, sponsored the trial in Liberia and Mali. In Liberia, the study was done in collaboration with the Liberia Ministry of Health through the Partnership for Research on Ebola Virus in Liberia program. In Mali, it was conducted in collaboration with the University Clinical Research Center and the Center for Vaccine Development-Mali. The trials began enrollment in 2017, were conducted simultaneously and shared a placebo arm. A total of 1,400 adults and 1,401 children aged 1 year to 17 years old were randomized to receive two injections of either placebo or Ebola vaccine in one of three regimens. The Ebola vaccine regimens were Ad26.ZEBOV (supplied by Johnson & Johnson) followed eight weeks later with a booster dose of MVA-BN-Filo vaccine (supplied by manufacturer Bavarian Nordic); two doses of rVSVΔG-ZEBOV-GP (manufactured by Merck Sharp & Dohme Corp) separated by eight weeks; or one dose of the Merck vaccine followed eight weeks later by a placebo injection. Antibody responses were observed by day 14 after the first injection of either Ad26.ZEBOV or rVSVΔG-ZEBOV-GP vaccine. The researchers say this finding is notable because vaccines against Ebola virus disease are typically administered during an outbreak and so information about how rapidly a vaccine produces an antibody effect is of potential use in efforts to protect at-risk populations. However, it is not currently known what level of antibody response reliably correlates with vaccine-induced protection against Ebola virus infection or disease. As no participants contracted Ebola virus disease during the trial, the investigators were not able to assess protection from disease. The researchers cite several strengths of the trials, including outstanding retention of volunteers throughout the course of trial, achieved with continuing community engagement and ongoing trust-building efforts.

VaccineClinical ResultClinical Study

100 Deals associated with MVA-BN-Filo(Bavarian Nordic, Crucell)

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hemorrhagic Fever, Ebola	European Union	Janssen-Cilag International NV	01 Jul 2020
Hemorrhagic Fever, Ebola	Iceland	Janssen-Cilag International NV	01 Jul 2020
Hemorrhagic Fever, Ebola	Liechtenstein	Janssen-Cilag International NV	01 Jul 2020
Hemorrhagic Fever, Ebola	Norway	Janssen-Cilag International NV	01 Jul 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Monkeypox	Phase 2	United States	Bavarian Nordic A/S	21 Oct 2024
Monkeypox	Phase 2	Uganda	Bavarian Nordic A/S	21 Oct 2024
Orthopoxvirus infection	Phase 2	United States	Bavarian Nordic A/S	21 Oct 2024
Orthopoxvirus infection	Phase 2	Uganda	Bavarian Nordic A/S	21 Oct 2024
Smallpox	Phase 2	United States	Bavarian Nordic A/S	21 Oct 2024
Smallpox	Phase 2	Uganda	Bavarian Nordic A/S	21 Oct 2024
HIV Infections	Phase 2	Burkina Faso	Janssen Vaccines & Prevention BV	06 Nov 2015
HIV Infections	Phase 2	Côte d'Ivoire	Janssen Vaccines & Prevention BV	06 Nov 2015
HIV Infections	Phase 2	Kenya	Janssen Vaccines & Prevention BV	06 Nov 2015
HIV Infections	Phase 2	Uganda	Janssen Vaccines & Prevention BV	06 Nov 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02661464 (CTgov)	Phase 3	Hemorrhagic Fever, Ebola	677	MVA-BN-Filo+Ad26.ZEBOV (Cohort 1: Ad26.ZEBOV + MVA-BN-Filo)	zedhbmkdet = ewkiqhojhz pptotkmjvi (pbnxhoqolb, ljxwivbigf - uiqzwzqxgw) View more	-	02 Jan 2024
				placebo+MVA-BN-Filo+Ad26.ZEBOV (Cohort 1: Placebo)	zedhbmkdet = eptjjjluye pptotkmjvi (pbnxhoqolb, wkgwyvmbgg - igvrgnifid) View more
NCT03929757 (PACTR201905827924069 \| ###DELETE, CTgov)	Phase 2	Hemorrhagic Fever, Ebola	108	MVA-BN-Filo+Ad26.ZEBOV (Main Study: Ad26.ZEBOV + MVA-BN-Filo + MenACWY)	agkfwtbyeq = sunluaofkh nhtxmujwtt (mwovgjjiwe, jphwwcxquj - yzvtkzpnui) View more	-	22 Jun 2023
				MenACWY vaccine (Main Study: MenACWY (Control Arm))	agkfwtbyeq = peekikrrkl nhtxmujwtt (mwovgjjiwe, kpljsrgynu - invrfazrrv) View more
NCT04228783 (CTgov)	Phase 3	Hemorrhagic Fever, Ebola	974	MVA-BN-Filo+Ad26.ZEBOV (Ad26.ZEBOV(Lot A), MVA-BN-Filo (Lot 1) (Group 1))	gzvvgueymt(klzzhneynn) = qnqrekbqwh iymiixdlwu (brhkknavmb, fxvjdvjcbq - getztbxxzs) View more	-	17 May 2023
				MVA-BN-Filo+Ad26.ZEBOV (Ad26.ZEBOV(Lot B), MVA-BN-Filo (Lot 2) (Group 2))	gzvvgueymt(klzzhneynn) = xiqghgcpmq iymiixdlwu (brhkknavmb, kudxqhpbtm - qvmmejgwtp) View more
NCT02876328 (PREVAC, Pubmed \| N Engl J Med)	Phase 2	Hemorrhagic Fever, Ebola	4,789	Vaccines (Ad26.ZEBOV followed by MVA-BN-Filo)	xaiihamobh(nnshhfwnww) = sxefpkzily ifwjxyveze (jaqhvtfdei, 401)	Positive	14 Dec 2022
				Vaccines (rVSVΔG-ZEBOV-GP followed by placebo)	xaiihamobh(nnshhfwnww) = fziogxrwol ifwjxyveze (jaqhvtfdei, 992)
NCT02509494 (EBOVAC-Salone, CTgov)	Phase 3	Hemorrhagic Fever, Ebola	1,023	MVA-BN-Filo (Ad26.ZEBOV)+Ad26.ZEBOV (Stage 1 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo (Ad26.ZEBOV))	cjpqcikslq = ghjwfmfhnh yfbhleijsp (dmnmficvzd, cceldhcmeo - mmqrzfajyr) View more	-	18 Jul 2022
				MVA-BN-Filo+Ad26.ZEBOV (Stage 2 (>=18 Years): Ad26.ZEBOV, MVA-BN-Filo)	cjpqcikslq = ffpufpcgdj yfbhleijsp (dmnmficvzd, gbnwlhqiog - dgtihxfwbs) View more
NCT03583606 (CTgov)	Phase 1	Hemorrhagic Fever, Ebola	61	Placebo+ChAd3-EBO-Z (ChAd3-EBO-Z + Placebo)	uqxbzrcknf = bqsgqulmvs sdrknbhbag (yylledkevq, zyguavxfiw - lgjymbrydi) View more	-	02 Jun 2021
				ChAd3-EBO-Z (ChAd3-EBO-Z + ChAd3-EBO-Z)	uqxbzrcknf = ntxuyyieuw sdrknbhbag (yylledkevq, twjbhxsulf - sspjsmxdrq) View more
NCT02852005 (CTgov)	Phase 1	HIV Infections	27	MVA (Group 1: Boost)	yxlsvrbxif(sslxjfgfkz) = hgfkdmrrpm vymsrkdbtf (iyxoxfdhsl, sasvejmpjl - ucednjoxso) View more	-	01 Apr 2021
				AIDSVAX B/E+MVA/HIV62B (Group 2: Boost)	yxlsvrbxif(sslxjfgfkz) = tyvklzozsd vymsrkdbtf (iyxoxfdhsl, kvqjkgzmyt - jdiddnvgku) View more

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