Pfizer Corporation

Wyeth

Lakshmi Khandke

Annaliesa Sybil Anderson

Kathrin Ute Jansen

Gary Warren Zlotnick

Leah Diane Fletcher

Thomas Richard Jones

John Erwin Farley

John Lance Perez

Shannon Lea Harris

Paul A Liberator

Cindy Xudong Yang

Avvari Krishna Prasad

Amardeep Singh Bhupender Bhalla

Rasappa Gounder Arumugham

Bounthon Loun

David Cooper

Lynn Marie Phelan

Johannes Frederik Beeslaar

Judith Absalon

Jose Miguel Aste-Amezaga

Isis Kanevsky

Miguel Angel Garcia

Leena Shriram Bagle

Lei Hu

Mark Edward Ruppen

Jianxin Gu

Jin-Hwan Kim

Rajesh Kumar Kainthan

Robert G K Donald

Ingrid Lea Scully

Suddham Singh

Robert C Seid, Jr

Ying Chen

Zhaowei Jin

Hanyoung Han

Ronald Malone

Susan Kay Hoiseth

Michael Hagen

Xudong Yang

Yury Vladimirovich Matsuka

Sandeep Nema

Joseph Perez

Thomas Newell Metcalf, Iii

Abbas Rashidbaigi

Tamara Shafer Hodge

Akihisa Nonoyama

Rasappa Arumugham

Robert Chancey Seid

The invention relates to immunogenic compositions comprising a capsular polysaccharide (CP) from, commonly referred to as group B streptococcus (GBS), conjugated to a carrier protein, and optionally including an aluminum-based adjuvant. The invention further relates to methods for inducing an immune response in subjects against GBS and/or for reducing or preventing invasive GBS disease in subjects using the compositions disclosed herein. The resulting antibodies can be used to treat or prevent GBS infection via passive immunotherapy.

Immunogenic compositions and uses thereof

In one aspect, the invention relates to a composition including a factor H binding protein (fHBP) and anon-serogroup B capsular polysaccharide. The invention further relates to uses of a composition that includes fHBP, such as, for example, uses to elicit an immune response againstserogroup B strains and non-serogroup B strains. The compositions and methods described herein are directed to administration in humans, including adults, adolescents, toddlers, and infants.

compositions and methods thereof

In one aspect, the invention relates to a composition including a first polypeptide having the sequence set forth in SEQ ID NO: 1 and a second polypeptide having the sequence set forth in SEQ ID NO: 2. In one embodiment, the composition includes about 120 &#x3bc;g/ml of a first polypeptide including the amino acid sequence set forth in SEQ ID NO: 1, 120 &#x3bc;g/ml of a second polypeptide including the amino acid sequence set forth in SEQ ID NO: 2, about 2.8 molar ratio polysorbate-80 to the first polypeptide, about 2.8 molar ratio polysorbate-80 to the second polypeptide, about 0.5 mg/ml aluminum, about 10 mM histidine, and about 150 mM sodium chloride. In one embodiment, a dose of the composition is about 0.5 ml in total volume. In one embodiment, two-doses of the composition induce a bactericidal titer against diverse heterologous subfamily A and subfamily B strains in a human.

The invention relates to immunogenic compositions comprising a capsular polysaccharide (CP) from, commonly referred to as group B(GBS), conjugated to a carrier protein, and optionally including an aluminum-based adjuvant. The invention further relates to methods for inducing an immune response in subjects against GBS and/or for reducing or preventing invasive GBS disease in subjects using the compositions disclosed herein. The resulting antibodies can be used to treat or prevent GBS infection via passive immunotherapy.

The invention relates to immunogenic polysaccharide-protein conjugates comprising a capsular polysaccharide (CP) from, commonly referred to as group B(GBS), and a carrier protein, wherein the CP is selected from the group consisting of serotypes Ia, Ib, II, III, IV, V, VI, VII, VIII, and IX, and wherein the CP has a sialic acid level of greater than about 60%. The invention also relates to methods of making the conjugates and immunogenic compositions comprising the conjugates. The invention also relates to immunogenic compositions comprising polysaccharide-protein conjugates, wherein the conjugates comprise a CP from GBS serotype IV and at least one additional serotype. The invention further relates to methods for inducing an immune response in subjects against GBS and/or for reducing or preventing invasive GBS disease in subjects using the compositions disclosed herein. The resulting antibodies can be used to treat or prevent GBS infection via passive immunotherapy.

Group Bpolysaccharide-protein conjugates, methods for producing conjugates, immunogenic compositions comprising conjugates, and uses thereof

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The present invention relates to stable formulations ofrLP2086 Subfamily B Antigens in immunogenic compositions. The present invention also relates to methods of preserving the conformation ofrLP2086 Antigens and methods for determining the potency ofrLP2086 antigens.

An immunogenic composition comprising a plurality of capsular polysaccharides fromserotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F conjugated to a carrier protein, and further comprising at least one preservative, preferably 2-phenoxyethanol (2-PE). The preservative-containing immunogenic compositions of the invention confer resistance to one or more micro-organisms and are useful for producing multi-dose vaccine formulations having advantageous properties with respect to long term stability of the different antigenic determinants in the immunogenic composition of choice. Related compositions and methods for measuring the efficacy of one or more preservatives in a vaccine formulation are also provided.

Vaccine formulations

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Nanuet, NY, United States of America

Lakshmi Khandke