Immunogenicity, Tolerability and Safety in Adolescents of Bivalent rLP2086, a Meningococcal Serogroup B Vaccine, Coadministered with Quadrivalent Human Papilloma Virus Vaccine

Senders, Shelly; Bhuyan, Prakash; Jiang, Qin; Absalon, Judith; Eiden, Joseph; Jones, Thomas R.; York, Laura J.; Jansen, Kathrin U.; O’Neill, Robert E.; Harris, Shannon L.; Ginis, John; Perez, John L.

doi:10.1097/inf.0000000000001072

Cited by 41 publications

(26 citation statements)

References 20 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…This small study not only confirmed that clinical isolates tended to be more resistant to the bactericidal antibody elicited by immunization with Bexsero but that SBA activity also declined significantly within 4 to 6 months of the administration of the second dose of vaccine. Trumenba also proved to be highly immunogenic in this age group, with titers exceeding the lower limit of quantitation against its panel of reference isolates in 80% to 100% of vaccinees receiving three doses of vaccine (49–51). Data from a small study of individual sera from young adults, using an antigenically diverse panel of isolates to determine SBA activity, suggest that this vaccine has the potential to offer broad protection, but this remains to be confirmed by surveillance once the vaccine is more widely used.…”

Section: Vaccine Antigen Coverage Antibody Persistence and Agementioning

confidence: 98%

Recent Progress in the Prevention of Serogroup B Meningococcal Disease

Feavers

Maiden

2017

Clin Vaccine Immunol

View full text Add to dashboard Cite

The widespread use of meningococcal polysaccharide conjugate vaccines has highlighted the challenge of providing protection against serogroup B disease. Over a period of 4 decades, vaccine development has focused on subcapsular protein antigens, first with outer membrane vesicle (OMV) vaccines against epidemic outbreaks, and more recently on new multicomponent vaccines designed to offer better cross-protection against the antigenically diverse strains responsible for endemic disease. Because of the low incidence of meningococcal disease, the protective efficacy of these vaccines has not been determined in clinical studies, and their licensure has been based on serological data; however, the serological assays used to predict protective coverage have limitations. As a result, evidence of the effectiveness of these vaccines against different strains and the contribution of specific antigens to protection can only be provided by epidemiological analyses following their implementation in sufficiently large populations. The recent inclusion of the four-component meningococcal serogroup B (4CMenB) vaccine, Bexsero, in the infant immunization program in the UK has provided preliminary evidence that the vaccine is effective. Ongoing surveillance will provide valuable data on its longer-term impact and antigenic coverage. Further development of protein-based vaccines against meningococcal disease is anticipated to improve antigenic coverage and adjust to changes in circulating strains. At the same time, alternative immunization strategies may be explored to improve overall vaccine effectiveness by, for example, protecting the youngest infants or providing herd protection.

show abstract

Section: Vaccine Antigen Coverage Antibody Persistence and Agementioning

confidence: 98%

Recent Progress in the Prevention of Serogroup B Meningococcal Disease

Feavers

Maiden

2017

Clin Vaccine Immunol

View full text Add to dashboard Cite

show abstract

“…For the adolescent study, individuals aged 10‐18 years enrolled at sites across North America and Europe were randomly assigned to receive MenB‐FHbp (n = 2693) or control vaccine (hepatitis A virus vaccine [HAV]/saline; n = 897) at months 0, 2 and 6 (Table ). In a similar study performed in young adults, individuals aged 18‐25 years enrolled at sites across North America and Europe were randomly assigned to receive MenB‐FHbp (n = 2471) or saline (n = 822) at months 0, 2 and 6 .…”

Section: Resultsmentioning

confidence: 99%

“…Several phase 2 studies have assessed the immunogenicity, safety and tolerability of concomitant administration of MenB‐FHbp with quadrivalent human papillomavirus vaccine (HPV4) and with MenACWY administered concomitantly with Tdap (Table ) . The HPV4 study was performed prior to availability of the non‐avalent HPV vaccine.…”

Section: Resultsmentioning

confidence: 99%

A review of the immunogenicity, safety and current recommendations for the meningococcal serogroup B vaccine, MenB‐FHbp

Alderfer

Snow

2019

J Clin Pharm Ther

View full text Add to dashboard Cite

What is known and objective This review describes invasive meningococcal disease (IMD) epidemiology in the United States, provides a brief overview of available meningococcal vaccines and discusses meningococcal serogroup B (MenB) vaccine development. Particular focus is given to the recombinant protein MenB vaccine, MenB‐FHbp (Trumenba®, bivalent rLP2086) in light of recent publication of phase 3 data; the other MenB vaccine (Bexsero®, MenB‐4C) has been recently reviewed. Current recommendations of the US Advisory Committee on Immunization Practices (ACIP) for MenB vaccination and potential barriers to immunization are also discussed. Methods Using the published literature, this article reviews the development and use of MenB‐FHbp to date, with a focus on the United States. Results and discussion Despite the availability of medical treatment, IMD is associated with significant mortality and frequently occurring serious permanent sequelae in surviving individuals. Worldwide, most IMD is caused by six serogroups (A, B, C, W, X and Y). MenB is the most common disease‐causing meningococcal serogroup in the United States and has caused several recent university‐based IMD outbreaks. MenB vaccines, including MenB‐FHbp, are available in the United States. ACIP recommends that all individuals ≥10 years of age at increased risk for meningococcal disease receive MenB vaccination; healthy individuals 16‐23 years of age are recommended MenB vaccines based on individual clinical decision‐making. MenB‐FHbp is used on a 2‐dose schedule (0, 6 months) when vaccinating healthy individuals and on a tailored 3‐dose schedule (0, 1‒2, 6 months) in cases of increased risk. What is new and conclusion Because vaccination provides the most effective protection against IMD, pharmacists are in an excellent position to offer evidence‐based vaccine information, as well as to encourage and provide meningococcal immunizations to adolescents and young adults.

show abstract

“…For HPV-18, noninferiority criteria (lower bound of the 95% confidence interval of geometric mean titer [GMT] ratio >0.67) were not met for the GMT ratio at 1 month after the third quadrivalent HPV vaccination (lower bound of 95% confidence interval for GMT ratio was 0.62); however, for each HPV vaccine type, more than 99% of subjects achieved seroconversion. 16 In clinical trials, both MenB vaccines were safe, with few serious adverse events (all resolved without sequelae). 7 -16 There were no deaths considered to be related to either vaccine.…”

Section: Introductionmentioning

confidence: 99%

“…1 College students have a lower risk of serogroup B meningococcal disease than the general population of a similar age (college students compared with 18-through 23-year-olds: 0.09 per 100 000 and 0.14 per 100 000, respectively). 16 and for MenACWY and tetanus, diphtheria, and pertussis antigens (unpublished data) when MenB-FHbp was administered concomitantly. For HPV-18, noninferiority criteria (lower bound of the 95% confidence interval of geometric mean titer [GMT] ratio >0.67) were not met for the GMT ratio at 1 month after the third quadrivalent HPV vaccination (lower bound of 95% confidence interval for GMT ratio was 0.62); however, for each HPV vaccine type, more than 99% of subjects achieved seroconversion.…”

Section: Introductionmentioning

confidence: 99%

Recommendations for Serogroup B Meningococcal Vaccine for Persons 10 Years and Older

Byington¹,

Maldonado²,

Barnett³

et al. 2016

Pediatrics

View full text Add to dashboard Cite

This policy statement provides recommendations for the prevention of serogroup B meningococcal disease through the use of 2 newly licensed serogroup B meningococcal vaccines: MenB-FHbp (Trumenba; Wyeth Pharmaceuticals, a subsidiary of Pfizer, Philadelphia, PA) and MenB-4C (Bexsero; Novartis Vaccines, Siena, Italy). Both vaccines are approved for use in persons 10 through 25 years of age. MenB-FHbp is licensed as a 2- or 3-dose series, and MenB-4C is licensed as a 2-dose series for all groups. Either vaccine is recommended for routine use in persons 10 years and older who are at increased risk of serogroup B meningococcal disease (category A recommendation). Persons at increased risk of meningococcal serogroup B disease include the following: (1) persons with persistent complement component diseases, including inherited or chronic deficiencies in C3, C5–C9, properdin, factor D, or factor H or persons receiving eculizumab (Soliris; Alexion Pharmaceuticals, Cheshire, CT), a monoclonal antibody that acts as a terminal complement inhibitor by binding C5 and inhibiting cleavage of C5 to C5A; (2) persons with anatomic or functional asplenia, including sickle cell disease; and (3) healthy persons at increased risk because of a serogroup B meningococcal disease outbreak. Both serogroup B meningococcal vaccines have been shown to be safe and immunogenic and are licensed by the US Food and Drug Administration for individuals between the ages of 10 and 25 years. On the basis of epidemiologic and antibody persistence data, the American Academy of Pediatrics agrees with the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention that either vaccine may be administered to healthy adolescents and young adults 16 through 23 years of age (preferred ages are 16 through 18 years) to provide short-term protection against most strains of serogroup B meningococcal disease (category B recommendation).

show abstract

Immunogenicity, Tolerability and Safety in Adolescents of Bivalent rLP2086, a Meningococcal Serogroup B Vaccine, Coadministered with Quadrivalent Human Papilloma Virus Vaccine

Abstract: Concomitant administration of bivalent rLP2086 and HPV-4 elicits robust immune responses to both vaccines without increasing reactogenicity compared with bivalent rLP2086 alone. Concurrent administration may increase compliance with both vaccine schedules.

Cited by 41 publications

References 20 publications

Recent Progress in the Prevention of Serogroup B Meningococcal Disease

Recent Progress in the Prevention of Serogroup B Meningococcal Disease

A review of the immunogenicity, safety and current recommendations for the meningococcal serogroup B vaccine, MenB‐FHbp

Recommendations for Serogroup B Meningococcal Vaccine for Persons 10 Years and Older

Contact Info

Product

Resources

About