Nathaly Samy

Münchner Arbeitsgemeinschaft für Psychoanalyse

Background Though Modified Vaccinia Ankara - Bavarian Nordic (MVA-BN®). vaccination is approved for smallpox and monkeypox prevention, immunological persistence and booster effects remain undescribed. Methods Participants naïve to smallpox vaccination were randomized to 1 dose MVA-BN (1×MVA, N = 181), 2 doses MVA-BN (2×MVA, N = 183), or placebo (N...

While the MVA-BN vaccine has been proven protective against smallpox and monkeypox, the long-term immunological persistence or booster effect has not been described. In this set of clinical studies, participants who had never been immunized against smallpox were randomized to receive, 4 weeks apart: 2 placebo vaccinations (PBO group, N =181); 1 MVA...

Background: Respiratory syncytial virus (RSV) is a major cause of severe respiratory disease in young children and the elderly. Protective immunity is not generated after repeated infections, but vaccination may hopefully prove effective. Methods: This phase 2 clinical study investigated a multivalent RSV vaccine (MVA-BN®-RSV) designed to induce...

Respiratory disease caused by RSV infection is recognized as a severe public health issue in infants, young children and elderly with no specific treatment option. Vaccination may be the most effective strategy to combat this highly infectious virus although no vaccine has been approved. The novel vaccine candidate MVA-BN-RSV encodes RSV surface pr...

Background: Many countries have stockpiled vaccines because of concerns about the reemergence of smallpox. Traditional smallpox vaccines are based on replicating vaccinia viruses; these vaccines have considerable side effects. Methods: To evaluate the efficacy of modified vaccinia Ankara (MVA) as a potential smallpox vaccine, we randomly assigne...

Background Modified Vaccinia Ankara (MVA) is a live, viral vaccine under advanced development as a non-replicating smallpox vaccine. A randomised, double-blind, placebo-controlled phase III clinical trial was conducted to demonstrate the humoral immunogenic equivalence of three consecutively manufactured MVA production lots, and to confirm the safe...

Clinical trial protocol. (PDF)

Patents by Paul Chaplin. (DOCX)

Background: Modified Vaccinia Ankara MVA-BN® is a live, highly attenuated, viral vaccine under advanced development as a non-replicating smallpox vaccine. In this Phase II trial, the safety and immunogenicity of Modified Vaccinia Ankara MVA-BN® (MVA) was assessed in a 56-80 years old population. Methods: MVA with a virus titer of 1 x 108 TCID50/...

Vaccinia-specific ELISA GMTs by Week (PPS, N = 102). Administrations at Week 0 (Group MM: first MVA vaccination; Group PM: Placebo) and at Week 4 (Group MM: second MVA vaccination; Group PM: first MVA vaccination). No samples were taken between week 8 and 32, therefore the graph was cut. PPS = Per Protocol Set, GMT = geometric mean titer, ELISA = e...

Vaccinia-specific PRNT GMTs by Week (PPS, N = 102). Administrations at Week 0 (Group MM: first MVA vaccination; Group PM: Placebo) and at Week 4 (Group MM: second MVA vaccination; Group PM: first MVA vaccination). No samples were taken between week 8 and 32, therefore the graph was cut. PPS = Per Protocol Analysis Set, GMT = geometric mean titer, P...

CONSORT Checklist. (DOCX)

Poster. (PDF)

Unsolicited related AEs after first vaccination. (DOCX)

Unsolicited AEs ≥ 3%. (DOCX)

Baseline Seropositivity Rates. (DOCX)

Overview of Immunogenicity Results. (DOCX)

Patents. (DOCX)

Initial Protocol for IRBs. (PDF)

Demographic Data PPS. (DOCX)

Immunogenicity Results PPS. (DOCX)

Grade and Relationship of Unsolicited AEs. (DOCX)

Unsolicited related AEs after second vaccination. (DOCX)

Background: Replicating smallpox vaccines can cause severe complications in individuals with atopic dermatitis (AD). Prior studies evaluating Modified Vaccinia Ankara virus (MVA), a non-replicating vaccine in humans, showed a favorable safety and immunogenicity profile in healthy volunteers. Objective: This Phase II study compared the safety and...

Background. First- and second-generation smallpox vaccines are contraindicated in individuals infected with human immunodeficiency virus (HIV). A new smallpox vaccine is needed to protect this population in the context of biodefense preparedness. The focus of this study was to compare the safety and immunogenicity of a replication-deficient, highly...

Background: Conventional smallpox vaccines based on replicating vaccinia virus (VV) strains (e.g. Lister Elstree, NYCBOH) are associated with a high incidence of myo-/pericarditis, a severe inflammatory cardiac complication. A new smallpox vaccine candidate based on a non-replicating Modified Vaccinia Ankara (MVA) poxvirus has been assessed for ca...

A randomised trial was conducted in 285 adults not immune to hepatitis B (HB) to compare the safety and immunogenicity of a commercial aluminium-adjuvanted HB vaccine with and without an additional new adjuvant (AgB/RC-210-04 or AgB study groups, respectively). The additional adjuvant RC-529 is a fully synthetic monosaccharide mimetic of monophosph...

A thiomersal-free (TF) formulation of the recombinant hepatitis B vaccine Hepavax-Gene has been developed. This study compared immunogenicity and safety of Hepavax-Gene, Hepavax-Gene TF and Engerix-B (containing trace amounts of thiomersal) in a large healthy adult population (N=770) using two vaccination schedules: the priming 0-1-2 months or the...

A Phase I trial was performed to investigate the safety and immunogenicity of the third generation smallpox vaccine MVA-BN (IMVAMUNE), a highly attenuated clone derived from the Modified Vaccinia Virus Ankara strain 571, in naive and pre-immunized subjects. A total of 86 healthy subjects received the vaccine in five groups using different doses and...

A significant percentage of patients with stage II melanomas suffer a relapse after surgery and therefore need the development of adjuvant therapies. In the study reported here, safety and immunological response were analyzed after vaccination in an adjuvant setting with recombinant modified vaccinia virus Ankara carrying the cDNA for human tyrosin...

Protocol title: Immunization of Patients with Malignant Melanoma with Autologous CD34+ Cell-Derived Dendritic Cells Transduced Ex Vivo with a Recombinant Nonreplicating Vaccinia Vector Encoding the Human Tyrosinase Gene: A Phase I Trial. Study Phase: Phase I. Study Design: Nonrandomized, noncontrolled, single center. Study Objectives: Primary objec...

Background: For more than ten years, a live, attenuated varicella vaccine is available. With the licensure of a temperature stable vaccine preparation in Germany in 1994, a cost reduction from DM 510,– to DM 99.50 was achieved with a general vaccine availability independent of special cooling requirements. In the United States, in Japan and in Sout...

Background: For more than ten years, a live, attenuated varicella vaccine is available. With the licensure of a temperature stable vaccine preparation in Germany in 1994, a cost reduction from DM 510,- to DM 99.50 was achieved with a general vaccine availability independent of special cooling requirements. In the United States, in Japan and in Sout...

The problem of hypercholesterolemia following heart transplantation (HTx) is often underestimated. Up to now there is no concept of therapy allowing an optimal adjustment of lipid parameters. Therapeutical trials using ion exchange resins, derivates of nicotinic acids and fibrates were not successful due to Cyclosporin A interaction, hepatotoxicity...

"Is there any safe and optimal treatment of hyperlipidemia following heart transplantation?" The problem of hypercholesterolemia following heart transplantation if often underestimated. Up to now there is no concept of therapy allowing an optimal adjustment of lipid parameters. Therapeutical trials using ion exchange resins, derivatives of nicotini...