A Bivalent Meningococcal B Vaccine in Adolescents and Young Adults
BackgroundMenB-FHbp is a licensed meningococcal B vaccine targeting factor H-binding protein. Two phase 3 studies assessed the safety of the vaccine and its immunogenicity against diverse strains of group B meningococcus.MethodsWe randomly assigned 3596 adolescents (10 to 18 years of age) to receive MenB-FHbp or hepatitis A virus vaccine and saline and assigned 3304 young adults (18 to 25 years of age) to receive MenB-FHbp or saline at baseline, 2 months, and 6 months. Immunogenicity was assessed in serum bactericidal assays that included human complement (hSBAs). We used 14 meningococcal B test strains that expressed vaccine-heterologous factor H-binding proteins representative of meningococcal B epidemiologic diversity; an hSBA titer of at least 1:4 is the accepted correlate of protection. The five primary end points were the proportion of participants who had an increase in their hSBA titer for each of 4 primary strains by a factor of 4 or more and the proportion of those who had an hSBA titer at least as high as the lower limit of quantitation (1:8 or 1:16) for all 4 strains combined after dose 3. We also assessed the hSBA responses to the primary strains after dose 2; hSBA responses to the 10 additional strains after doses 2 and 3 were assessed in a subgroup of participants only. Safety was assessed in participants who received at least one dose.ResultsIn the modified intention-to-treat population, the percentage of adolescents who had an increase in the hSBA titer by a factor of 4 or more against each primary strain ranged from 56.0 to 85.3% after dose 2 and from 78.8 to 90.2% after dose 3; the percentages of young adults ranged from 54.6 to 85.6% and 78.9 to 89.7%, after doses 2 and 3, respectively. Composite responses after doses 2 and 3 in adolescents were 53.7% and 82.7%, respectively, and those in young adults were 63.3% and 84.5%, respectively. Responses to the 4 primary strains were predictive of responses to the 10 additional strains. Most of those who received MenB-FHbp reported mild or moderate pain at the vaccination site.ConclusionsMenB-FHbp elicited bactericidal responses against diverse meningococcal B strains after doses 2 and 3 and was associated with more reactions at the injection site than the hepatitis A virus vaccine and saline. (Funded by Pfizer; ClinicalTrials.gov numbers, NCT01830855 and NCT01352845)..
Medienart: |
Artikel |
---|
Erscheinungsjahr: |
2017 |
---|---|
Erschienen: |
2017 |
Enthalten in: |
Zur Gesamtaufnahme - volume:377 |
---|---|
Enthalten in: |
The New England journal of medicine - 377(2017), 24, Seite 2349 |
Sprache: |
Englisch |
---|
Beteiligte Personen: |
Lars Ostergaard [VerfasserIn] |
---|
Links: |
---|
RVK: |
---|
doi: |
10.1056/NEJMoa1614474 |
---|
funding: |
|
---|---|
Förderinstitution / Projekttitel: |
|
PPN (Katalog-ID): |
OLC1999417860 |
---|
LEADER | 01000caa a2200265 4500 | ||
---|---|---|---|
001 | OLC1999417860 | ||
003 | DE-627 | ||
005 | 20230514101201.0 | ||
007 | tu | ||
008 | 171228s2017 xx ||||| 00| ||eng c | ||
024 | 7 | |a 10.1056/NEJMoa1614474 |2 doi | |
028 | 5 | 2 | |a PQ20171228 |
035 | |a (DE-627)OLC1999417860 | ||
035 | |a (DE-599)GBVOLC1999417860 | ||
035 | |a (PRQ)proquest_journals_19766316400 | ||
035 | |a (KEY)0171808820170000377002402349bivalentmeningococcalbvaccineinadolescentsandyoung | ||
040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
041 | |a eng | ||
082 | 0 | 4 | |a 610 |q DE-101 |
084 | |a XA 10000 |q AVZ |2 rvk | ||
084 | |a 44.60 |2 bkl | ||
084 | |a 44.00 |2 bkl | ||
100 | 0 | |a Lars Ostergaard |e verfasserin |4 aut | |
245 | 1 | 2 | |a A Bivalent Meningococcal B Vaccine in Adolescents and Young Adults |
264 | 1 | |c 2017 | |
336 | |a Text |b txt |2 rdacontent | ||
337 | |a ohne Hilfsmittel zu benutzen |b n |2 rdamedia | ||
338 | |a Band |b nc |2 rdacarrier | ||
520 | |a BackgroundMenB-FHbp is a licensed meningococcal B vaccine targeting factor H-binding protein. Two phase 3 studies assessed the safety of the vaccine and its immunogenicity against diverse strains of group B meningococcus.MethodsWe randomly assigned 3596 adolescents (10 to 18 years of age) to receive MenB-FHbp or hepatitis A virus vaccine and saline and assigned 3304 young adults (18 to 25 years of age) to receive MenB-FHbp or saline at baseline, 2 months, and 6 months. Immunogenicity was assessed in serum bactericidal assays that included human complement (hSBAs). We used 14 meningococcal B test strains that expressed vaccine-heterologous factor H-binding proteins representative of meningococcal B epidemiologic diversity; an hSBA titer of at least 1:4 is the accepted correlate of protection. The five primary end points were the proportion of participants who had an increase in their hSBA titer for each of 4 primary strains by a factor of 4 or more and the proportion of those who had an hSBA titer at least as high as the lower limit of quantitation (1:8 or 1:16) for all 4 strains combined after dose 3. We also assessed the hSBA responses to the primary strains after dose 2; hSBA responses to the 10 additional strains after doses 2 and 3 were assessed in a subgroup of participants only. Safety was assessed in participants who received at least one dose.ResultsIn the modified intention-to-treat population, the percentage of adolescents who had an increase in the hSBA titer by a factor of 4 or more against each primary strain ranged from 56.0 to 85.3% after dose 2 and from 78.8 to 90.2% after dose 3; the percentages of young adults ranged from 54.6 to 85.6% and 78.9 to 89.7%, after doses 2 and 3, respectively. Composite responses after doses 2 and 3 in adolescents were 53.7% and 82.7%, respectively, and those in young adults were 63.3% and 84.5%, respectively. Responses to the 4 primary strains were predictive of responses to the 10 additional strains. Most of those who received MenB-FHbp reported mild or moderate pain at the vaccination site.ConclusionsMenB-FHbp elicited bactericidal responses against diverse meningococcal B strains after doses 2 and 3 and was associated with more reactions at the injection site than the hepatitis A virus vaccine and saline. (Funded by Pfizer; ClinicalTrials.gov numbers, NCT01830855 and NCT01352845). | ||
650 | 4 | |a Strains (organisms) | |
650 | 4 | |a Research & development--R&D | |
650 | 4 | |a Adolescence | |
650 | 4 | |a Complement factor H | |
650 | 4 | |a Pain | |
650 | 4 | |a Factor H-binding protein | |
650 | 4 | |a Vaccination | |
650 | 4 | |a Immunization | |
650 | 4 | |a Teenagers | |
650 | 4 | |a Meningitis | |
650 | 4 | |a Antigens | |
650 | 4 | |a Immunogenicity | |
650 | 4 | |a Proteins | |
650 | 4 | |a Hepatitis A | |
650 | 4 | |a Young adults | |
650 | 4 | |a Vaccines | |
650 | 4 | |a Immunoglobulins | |
700 | 0 | |a Timo Vesikari |4 oth | |
700 | 0 | |a Judith Absalon |4 oth | |
700 | 0 | |a Johannes Beeslaar |4 oth | |
700 | 0 | |a Brian J Ward |4 oth | |
700 | 0 | |a Shelly Senders |4 oth | |
700 | 0 | |a Joseph J Eiden |4 oth | |
700 | 0 | |a Kathrin U Jansen |4 oth | |
700 | 0 | |a Annaliesa S Anderson |4 oth | |
700 | 0 | |a Laura J York |4 oth | |
700 | 0 | |a Thomas R Jones |4 oth | |
700 | 0 | |a Shannon L Harris |4 oth | |
700 | 0 | |a Robert O'Neill |4 oth | |
700 | 0 | |a David Radley |4 oth | |
700 | 0 | |a Roger Maansson |4 oth | |
700 | 0 | |a Jean-Louis Prégaldien |4 oth | |
700 | 0 | |a John Ginis |4 oth | |
700 | 0 | |a Nina B Staerke |4 oth | |
700 | 0 | |a John L Perez |4 oth | |
773 | 0 | 8 | |i Enthalten in |t The New England journal of medicine |d Waltham, Mass. : MMS, 1928 |g 377(2017), 24, Seite 2349 |w (DE-627)129495220 |w (DE-600)207154-X |w (DE-576)014893169 |x 0028-4793 |7 nnns |
773 | 1 | 8 | |g volume:377 |g year:2017 |g number:24 |g pages:2349 |
856 | 4 | 1 | |u http://dx.doi.org/10.1056/NEJMoa1614474 |3 Volltext |
856 | 4 | 2 | |u https://search.proquest.com/docview/1976631640 |
912 | |a GBV_USEFLAG_A | ||
912 | |a SYSFLAG_A | ||
912 | |a GBV_OLC | ||
912 | |a SSG-OLC-PHA | ||
912 | |a SSG-OLC-DE-84 | ||
912 | |a GBV_ILN_20 | ||
912 | |a GBV_ILN_40 | ||
912 | |a GBV_ILN_105 | ||
912 | |a GBV_ILN_168 | ||
912 | |a GBV_ILN_183 | ||
912 | |a GBV_ILN_290 | ||
912 | |a GBV_ILN_2004 | ||
912 | |a GBV_ILN_2006 | ||
912 | |a GBV_ILN_2008 | ||
912 | |a GBV_ILN_2021 | ||
912 | |a GBV_ILN_2219 | ||
912 | |a GBV_ILN_2414 | ||
912 | |a GBV_ILN_2424 | ||
912 | |a GBV_ILN_4012 | ||
912 | |a GBV_ILN_4112 | ||
912 | |a GBV_ILN_4125 | ||
912 | |a GBV_ILN_4126 | ||
912 | |a GBV_ILN_4219 | ||
912 | |a GBV_ILN_4256 | ||
912 | |a GBV_ILN_4305 | ||
912 | |a GBV_ILN_4306 | ||
912 | |a GBV_ILN_4310 | ||
912 | |a GBV_ILN_4315 | ||
912 | |a GBV_ILN_4320 | ||
912 | |a GBV_ILN_4323 | ||
936 | r | v | |a XA 10000 |
936 | b | k | |a 44.60 |q AVZ |
936 | b | k | |a 44.00 |q AVZ |
951 | |a AR | ||
952 | |d 377 |j 2017 |e 24 |h 2349 |