Lars Jørgen Østergaard

A Bivalent Meningococcal B Vaccine in Adolescents and Young Adults

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaperJournal articleResearchpeer-review

DOI

  • Lars Ostergaard
  • Timo Vesikari, From Aarhus University Hospital, Aarhus, Denmark (L.O., N.B.S.); Vaccine Research Center, University of Tampere Medical School, Tampere, Finland (T.V.); Pfizer Vaccine Clinical Research and Development (J.A., J.J.E.) and Pfizer Vaccine Research and Development (K.U.J., A.S.A., T.R.J., S.L.H., R.O.), Pearl River, NY; Pfizer Vaccine Clinical Research and Development, Hurley, United Kingdom (J.B.); Research Institute of the McGill University Health Center, Montreal (B.J.W.); Senders Pediatrics, South Euclid, OH (S.S.); Pfizer Vaccine Medical Development, Scientific and Clinical Affairs (L.J.Y.) and Pfizer Vaccine Clinical Research and Development (D.R., R.M., J.G., J.L.P.), Collegeville, PA; and Pfizer Vaccine Clinical Research and Development, Brussels (J.-L.P.).
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  • Judith Absalon, From Aarhus University Hospital, Aarhus, Denmark (L.O., N.B.S.); Vaccine Research Center, University of Tampere Medical School, Tampere, Finland (T.V.); Pfizer Vaccine Clinical Research and Development (J.A., J.J.E.) and Pfizer Vaccine Research and Development (K.U.J., A.S.A., T.R.J., S.L.H., R.O.), Pearl River, NY; Pfizer Vaccine Clinical Research and Development, Hurley, United Kingdom (J.B.); Research Institute of the McGill University Health Center, Montreal (B.J.W.); Senders Pediatrics, South Euclid, OH (S.S.); Pfizer Vaccine Medical Development, Scientific and Clinical Affairs (L.J.Y.) and Pfizer Vaccine Clinical Research and Development (D.R., R.M., J.G., J.L.P.), Collegeville, PA; and Pfizer Vaccine Clinical Research and Development, Brussels (J.-L.P.).
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  • Johannes Beeslaar, From Aarhus University Hospital, Aarhus, Denmark (L.O., N.B.S.); Vaccine Research Center, University of Tampere Medical School, Tampere, Finland (T.V.); Pfizer Vaccine Clinical Research and Development (J.A., J.J.E.) and Pfizer Vaccine Research and Development (K.U.J., A.S.A., T.R.J., S.L.H., R.O.), Pearl River, NY; Pfizer Vaccine Clinical Research and Development, Hurley, United Kingdom (J.B.); Research Institute of the McGill University Health Center, Montreal (B.J.W.); Senders Pediatrics, South Euclid, OH (S.S.); Pfizer Vaccine Medical Development, Scientific and Clinical Affairs (L.J.Y.) and Pfizer Vaccine Clinical Research and Development (D.R., R.M., J.G., J.L.P.), Collegeville, PA; and Pfizer Vaccine Clinical Research and Development, Brussels (J.-L.P.).
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  • Brian J Ward, From Aarhus University Hospital, Aarhus, Denmark (L.O., N.B.S.); Vaccine Research Center, University of Tampere Medical School, Tampere, Finland (T.V.); Pfizer Vaccine Clinical Research and Development (J.A., J.J.E.) and Pfizer Vaccine Research and Development (K.U.J., A.S.A., T.R.J., S.L.H., R.O.), Pearl River, NY; Pfizer Vaccine Clinical Research and Development, Hurley, United Kingdom (J.B.); Research Institute of the McGill University Health Center, Montreal (B.J.W.); Senders Pediatrics, South Euclid, OH (S.S.); Pfizer Vaccine Medical Development, Scientific and Clinical Affairs (L.J.Y.) and Pfizer Vaccine Clinical Research and Development (D.R., R.M., J.G., J.L.P.), Collegeville, PA; and Pfizer Vaccine Clinical Research and Development, Brussels (J.-L.P.).
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  • Shelly Senders, From Aarhus University Hospital, Aarhus, Denmark (L.O., N.B.S.); Vaccine Research Center, University of Tampere Medical School, Tampere, Finland (T.V.); Pfizer Vaccine Clinical Research and Development (J.A., J.J.E.) and Pfizer Vaccine Research and Development (K.U.J., A.S.A., T.R.J., S.L.H., R.O.), Pearl River, NY; Pfizer Vaccine Clinical Research and Development, Hurley, United Kingdom (J.B.); Research Institute of the McGill University Health Center, Montreal (B.J.W.); Senders Pediatrics, South Euclid, OH (S.S.); Pfizer Vaccine Medical Development, Scientific and Clinical Affairs (L.J.Y.) and Pfizer Vaccine Clinical Research and Development (D.R., R.M., J.G., J.L.P.), Collegeville, PA; and Pfizer Vaccine Clinical Research and Development, Brussels (J.-L.P.).
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  • Joseph J Eiden, From Aarhus University Hospital, Aarhus, Denmark (L.O., N.B.S.); Vaccine Research Center, University of Tampere Medical School, Tampere, Finland (T.V.); Pfizer Vaccine Clinical Research and Development (J.A., J.J.E.) and Pfizer Vaccine Research and Development (K.U.J., A.S.A., T.R.J., S.L.H., R.O.), Pearl River, NY; Pfizer Vaccine Clinical Research and Development, Hurley, United Kingdom (J.B.); Research Institute of the McGill University Health Center, Montreal (B.J.W.); Senders Pediatrics, South Euclid, OH (S.S.); Pfizer Vaccine Medical Development, Scientific and Clinical Affairs (L.J.Y.) and Pfizer Vaccine Clinical Research and Development (D.R., R.M., J.G., J.L.P.), Collegeville, PA; and Pfizer Vaccine Clinical Research and Development, Brussels (J.-L.P.).
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  • Kathrin U Jansen, From Aarhus University Hospital, Aarhus, Denmark (L.O., N.B.S.); Vaccine Research Center, University of Tampere Medical School, Tampere, Finland (T.V.); Pfizer Vaccine Clinical Research and Development (J.A., J.J.E.) and Pfizer Vaccine Research and Development (K.U.J., A.S.A., T.R.J., S.L.H., R.O.), Pearl River, NY; Pfizer Vaccine Clinical Research and Development, Hurley, United Kingdom (J.B.); Research Institute of the McGill University Health Center, Montreal (B.J.W.); Senders Pediatrics, South Euclid, OH (S.S.); Pfizer Vaccine Medical Development, Scientific and Clinical Affairs (L.J.Y.) and Pfizer Vaccine Clinical Research and Development (D.R., R.M., J.G., J.L.P.), Collegeville, PA; and Pfizer Vaccine Clinical Research and Development, Brussels (J.-L.P.).
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  • Annaliesa S Anderson, From Aarhus University Hospital, Aarhus, Denmark (L.O., N.B.S.); Vaccine Research Center, University of Tampere Medical School, Tampere, Finland (T.V.); Pfizer Vaccine Clinical Research and Development (J.A., J.J.E.) and Pfizer Vaccine Research and Development (K.U.J., A.S.A., T.R.J., S.L.H., R.O.), Pearl River, NY; Pfizer Vaccine Clinical Research and Development, Hurley, United Kingdom (J.B.); Research Institute of the McGill University Health Center, Montreal (B.J.W.); Senders Pediatrics, South Euclid, OH (S.S.); Pfizer Vaccine Medical Development, Scientific and Clinical Affairs (L.J.Y.) and Pfizer Vaccine Clinical Research and Development (D.R., R.M., J.G., J.L.P.), Collegeville, PA; and Pfizer Vaccine Clinical Research and Development, Brussels (J.-L.P.).
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  • Laura J York, From Aarhus University Hospital, Aarhus, Denmark (L.O., N.B.S.); Vaccine Research Center, University of Tampere Medical School, Tampere, Finland (T.V.); Pfizer Vaccine Clinical Research and Development (J.A., J.J.E.) and Pfizer Vaccine Research and Development (K.U.J., A.S.A., T.R.J., S.L.H., R.O.), Pearl River, NY; Pfizer Vaccine Clinical Research and Development, Hurley, United Kingdom (J.B.); Research Institute of the McGill University Health Center, Montreal (B.J.W.); Senders Pediatrics, South Euclid, OH (S.S.); Pfizer Vaccine Medical Development, Scientific and Clinical Affairs (L.J.Y.) and Pfizer Vaccine Clinical Research and Development (D.R., R.M., J.G., J.L.P.), Collegeville, PA; and Pfizer Vaccine Clinical Research and Development, Brussels (J.-L.P.).
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  • Thomas R Jones, From Aarhus University Hospital, Aarhus, Denmark (L.O., N.B.S.); Vaccine Research Center, University of Tampere Medical School, Tampere, Finland (T.V.); Pfizer Vaccine Clinical Research and Development (J.A., J.J.E.) and Pfizer Vaccine Research and Development (K.U.J., A.S.A., T.R.J., S.L.H., R.O.), Pearl River, NY; Pfizer Vaccine Clinical Research and Development, Hurley, United Kingdom (J.B.); Research Institute of the McGill University Health Center, Montreal (B.J.W.); Senders Pediatrics, South Euclid, OH (S.S.); Pfizer Vaccine Medical Development, Scientific and Clinical Affairs (L.J.Y.) and Pfizer Vaccine Clinical Research and Development (D.R., R.M., J.G., J.L.P.), Collegeville, PA; and Pfizer Vaccine Clinical Research and Development, Brussels (J.-L.P.).
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  • Shannon L Harris, From Aarhus University Hospital, Aarhus, Denmark (L.O., N.B.S.); Vaccine Research Center, University of Tampere Medical School, Tampere, Finland (T.V.); Pfizer Vaccine Clinical Research and Development (J.A., J.J.E.) and Pfizer Vaccine Research and Development (K.U.J., A.S.A., T.R.J., S.L.H., R.O.), Pearl River, NY; Pfizer Vaccine Clinical Research and Development, Hurley, United Kingdom (J.B.); Research Institute of the McGill University Health Center, Montreal (B.J.W.); Senders Pediatrics, South Euclid, OH (S.S.); Pfizer Vaccine Medical Development, Scientific and Clinical Affairs (L.J.Y.) and Pfizer Vaccine Clinical Research and Development (D.R., R.M., J.G., J.L.P.), Collegeville, PA; and Pfizer Vaccine Clinical Research and Development, Brussels (J.-L.P.).
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  • Robert O'Neill, From Aarhus University Hospital, Aarhus, Denmark (L.O., N.B.S.); Vaccine Research Center, University of Tampere Medical School, Tampere, Finland (T.V.); Pfizer Vaccine Clinical Research and Development (J.A., J.J.E.) and Pfizer Vaccine Research and Development (K.U.J., A.S.A., T.R.J., S.L.H., R.O.), Pearl River, NY; Pfizer Vaccine Clinical Research and Development, Hurley, United Kingdom (J.B.); Research Institute of the McGill University Health Center, Montreal (B.J.W.); Senders Pediatrics, South Euclid, OH (S.S.); Pfizer Vaccine Medical Development, Scientific and Clinical Affairs (L.J.Y.) and Pfizer Vaccine Clinical Research and Development (D.R., R.M., J.G., J.L.P.), Collegeville, PA; and Pfizer Vaccine Clinical Research and Development, Brussels (J.-L.P.).
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  • David Radley, From Aarhus University Hospital, Aarhus, Denmark (L.O., N.B.S.); Vaccine Research Center, University of Tampere Medical School, Tampere, Finland (T.V.); Pfizer Vaccine Clinical Research and Development (J.A., J.J.E.) and Pfizer Vaccine Research and Development (K.U.J., A.S.A., T.R.J., S.L.H., R.O.), Pearl River, NY; Pfizer Vaccine Clinical Research and Development, Hurley, United Kingdom (J.B.); Research Institute of the McGill University Health Center, Montreal (B.J.W.); Senders Pediatrics, South Euclid, OH (S.S.); Pfizer Vaccine Medical Development, Scientific and Clinical Affairs (L.J.Y.) and Pfizer Vaccine Clinical Research and Development (D.R., R.M., J.G., J.L.P.), Collegeville, PA; and Pfizer Vaccine Clinical Research and Development, Brussels (J.-L.P.).
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  • Roger Maansson, From Aarhus University Hospital, Aarhus, Denmark (L.O., N.B.S.); Vaccine Research Center, University of Tampere Medical School, Tampere, Finland (T.V.); Pfizer Vaccine Clinical Research and Development (J.A., J.J.E.) and Pfizer Vaccine Research and Development (K.U.J., A.S.A., T.R.J., S.L.H., R.O.), Pearl River, NY; Pfizer Vaccine Clinical Research and Development, Hurley, United Kingdom (J.B.); Research Institute of the McGill University Health Center, Montreal (B.J.W.); Senders Pediatrics, South Euclid, OH (S.S.); Pfizer Vaccine Medical Development, Scientific and Clinical Affairs (L.J.Y.) and Pfizer Vaccine Clinical Research and Development (D.R., R.M., J.G., J.L.P.), Collegeville, PA; and Pfizer Vaccine Clinical Research and Development, Brussels (J.-L.P.).
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  • Jean-Louis Prégaldien, From Aarhus University Hospital, Aarhus, Denmark (L.O., N.B.S.); Vaccine Research Center, University of Tampere Medical School, Tampere, Finland (T.V.); Pfizer Vaccine Clinical Research and Development (J.A., J.J.E.) and Pfizer Vaccine Research and Development (K.U.J., A.S.A., T.R.J., S.L.H., R.O.), Pearl River, NY; Pfizer Vaccine Clinical Research and Development, Hurley, United Kingdom (J.B.); Research Institute of the McGill University Health Center, Montreal (B.J.W.); Senders Pediatrics, South Euclid, OH (S.S.); Pfizer Vaccine Medical Development, Scientific and Clinical Affairs (L.J.Y.) and Pfizer Vaccine Clinical Research and Development (D.R., R.M., J.G., J.L.P.), Collegeville, PA; and Pfizer Vaccine Clinical Research and Development, Brussels (J.-L.P.).
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  • John Ginis, From Aarhus University Hospital, Aarhus, Denmark (L.O., N.B.S.); Vaccine Research Center, University of Tampere Medical School, Tampere, Finland (T.V.); Pfizer Vaccine Clinical Research and Development (J.A., J.J.E.) and Pfizer Vaccine Research and Development (K.U.J., A.S.A., T.R.J., S.L.H., R.O.), Pearl River, NY; Pfizer Vaccine Clinical Research and Development, Hurley, United Kingdom (J.B.); Research Institute of the McGill University Health Center, Montreal (B.J.W.); Senders Pediatrics, South Euclid, OH (S.S.); Pfizer Vaccine Medical Development, Scientific and Clinical Affairs (L.J.Y.) and Pfizer Vaccine Clinical Research and Development (D.R., R.M., J.G., J.L.P.), Collegeville, PA; and Pfizer Vaccine Clinical Research and Development, Brussels (J.-L.P.).
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  • Nina B Staerke
  • John L Perez, From Aarhus University Hospital, Aarhus, Denmark (L.O., N.B.S.); Vaccine Research Center, University of Tampere Medical School, Tampere, Finland (T.V.); Pfizer Vaccine Clinical Research and Development (J.A., J.J.E.) and Pfizer Vaccine Research and Development (K.U.J., A.S.A., T.R.J., S.L.H., R.O.), Pearl River, NY; Pfizer Vaccine Clinical Research and Development, Hurley, United Kingdom (J.B.); Research Institute of the McGill University Health Center, Montreal (B.J.W.); Senders Pediatrics, South Euclid, OH (S.S.); Pfizer Vaccine Medical Development, Scientific and Clinical Affairs (L.J.Y.) and Pfizer Vaccine Clinical Research and Development (D.R., R.M., J.G., J.L.P.), Collegeville, PA; and Pfizer Vaccine Clinical Research and Development, Brussels (J.-L.P.).
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  • B1971009 and B1971016 Trial Investigators

BACKGROUND: MenB-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.

METHODS: We 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.

RESULTS: In 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.

CONCLUSIONS: MenB-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 ).

Original languageEnglish
JournalThe New England Journal of Medicine
Volume377
Issue24
Pages (from-to)2349-2362
Number of pages14
ISSN0028-4793
DOIs
Publication statusPublished - 14 Dec 2017

    Research areas

  • Adolescent, Adult, Antibodies, Bacterial, Antigens, Bacterial, Bacterial Proteins, Child, Female, Fever, Humans, Intention to Treat Analysis, Male, Meningococcal Infections, Meningococcal Vaccines, Neisseria meningitidis, Serogroup B, Phylogeny, Single-Blind Method, Young Adult, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial

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