Development of a human papillomavirus competitive luminex immunoassay for 9 HPV types.

In the clinical trials of the quadrivalent human papillomavirus (qHPV) vaccine, antibodies were measured by a competitive Luminex immunoassay (HPV-4 cLIA). A nine-valent HPV (9vHPV) vaccine targeting the types in the qHPV vaccine (HPV6/11/16/18), as well as 5 of the next most frequent HPV types found in cervical cancers worldwide (HPV31/33/45/52/58) is under development. To support the 9vHPV vaccine program, a nine-multiplexed cLIA (HPV-9 cLIA) was developed.

Development of neutralizing monoclonal antibodies for oncogenic human papillomavirus types 31, 33, 45, 52, and 58.

Human papillomavirus (HPV) is the etiological agent for all cervical cancers, a significant number of other anogenital cancers, and a growing number of head and neck cancers. Two licensed vaccines offer protection against the most prevalent oncogenic types, 16 and 18, responsible for approximately 70% of cervical cancer cases worldwide and one of these also offers protection against types 6 and 11, responsible for 90% of genital warts. The vaccines are comprised of recombinantly expressed major capsid proteins that self-assemble into virus-like particles (VLPs) and prevent infection by eliciting neutralizing antibodies.

Evolution of type-specific immunoassays to evaluate the functional immune response to Gardasil: a vaccine for human papillomavirus types 16, 18, 6 and 11.

Epidemiological studies and clinical trials of vaccines depend on the accurate measurement of antibodies within the polyclonal response to infection or vaccination. The assay currently used to measure the antibody response to vaccination with GARDASIL [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine]--a quadrivalent vaccine used against human papillomavirus (HPV) types 6, 11, 16, and 18--is a competitive Luminex assay (cLIA) that uses multiplex technology to detect type-specific neutralizing antibodies against all four HPV types in a single serum sample. Here we describe how the cLIA was developed, as well as how the monoclonal antibodies (mAbs), used as competitors in the assay, were characterized.

A novel Staphylococcus aureus vaccine: iron surface determinant B induces rapid antibody responses in rhesus macaques and specific increased survival in a murine S. aureus sepsis model.

Staphylococcus aureus is a major cause of nosocomial infections worldwide, and the rate of resistance to clinically relevant antibiotics, such as methicillin, is increasing; furthermore, there has been an increase in the number of methicillin-resistant S. aureus community-acquired infections. Effective treatment and prevention strategies are urgently needed.

Safety of a modified-live combination vaccine against respiratory and reproductive diseases in pregnant cows.

A combination vaccine (Bovi-Shield FP4 + L5, Pfizer Animal Health) containing modified-live virus (MLV) components against bovine herpesvirus-1 (BHV-1), bovine viral diarrhea virus BVDV), parainfluenza virus-3 (PI3), bovine respiratory syncytial virus (BRSV), and inactivated cultures of Leptospira canicola, grippotyphosa, hardjo, icterohaemorrhagiae, and pomona was evaluated for safety in pregnant beef and dairy animals. Heifers vaccinated prebreeding with the minimum immunizing dose (lowest antigen level initiating immunizing effects) of the vaccine's MLV BHV-1 or BVDV components and during pregnancy (approximately 200 days of gestation) with vaccine containing 10x doses of the same BHV-1 and BVDV components delivered live, healthy calves that were determined to be serologically negative (titer less than 1:2) for neutralizing antibodies to BHV-1 and BVDV prior to nursing. Additionally, in three field safety studies, previously vaccinated cows and heifers that received a field dose (vaccine containing antigen levels required for commercial sale of the MLV combination vaccine during either the first, second, or third trimester of pregnancy had abortion rates similar to those of pregnant cows and heifers vaccinated during the same stage of pregnancy with sterile water diluent.