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Long-term immunogenicity and safety after a single dose of the quadrivalent meningococcal serogroups A, C, W, and Y tetanus toxoid conjugate vaccine in adolescents and adults: 5-year follow-up of an open, randomized trial.
BMC Infect Dis. 2015 Oct 06; 15:409.BI

Abstract

BACKGROUND

Long-term protection against meningococcal disease is associated with persistence of post-vaccination antibodies at protective levels. We evaluated the bactericidal antibody persistence and safety of the quadrivalent meningococcal serogroups A, C, W and Y tetanus-toxoid conjugate vaccine (MenACWY-TT) and the meningococcal polysaccharide serogroups A, C, W, and Y vaccine (MenACWY-PS) up to 5 years post-vaccination.

METHODS

This phase IIb, open, randomized, controlled study conducted in the Philippines and Saudi Arabia consisted of a vaccination phase and a long-term persistence phase. Healthy adolescents and adults aged 11-55 years were randomized (3:1) to receive a single dose of MenACWY-TT (ACWY-TT group) or MenACWY-PS (Men-PS group). Primary and persistence results up to 3 years post-vaccination have been previously reported. Antibody responses against meningococcal serogroups A, C, W, and Y were assessed by a serum bactericidal antibody assay using rabbit complement (rSBA, cut-off titers 1:8 and 1:128) at Year 4 and Year 5 post-vaccination. Vaccine-related serious adverse events (SAEs) and cases of meningococcal disease were assessed up to Year 5.

RESULTS

Of the 500 vaccinated participants, 404 returned for the Year 5 study visit (Total Cohort Year 5). For the Total Cohort Year 5, 71.6-90.0 and 64.9-86.3 % of MenACWY-TT recipients had rSBA titers ≥1:8 and ≥1:128, respectively, compared to 24.8-74.3 and 21.0-68.6 % of MenACWY-PS recipients. The rSBA geometric mean titers (GMTs) remained above the pre-vaccination levels in both treatment groups. Exploratory analyses suggested that both rSBA GMTs as well as the percentages of participants with rSBA titers above the cut-offs were higher in the ACWY-TT than in the Men-PS group for serogroups A, W and Y, with no apparent difference for MenC. No SAEs related to vaccination or cases of meningococcal disease were reported up to Year 5.

CONCLUSION

These results suggest that a single dose of MenACWY-TT could protect at least 72 % of vaccinated adolescents and adults against meningococcal disease at least 5 years post-vaccination.

TRIAL REGISTRATION

ClinicalTrials.gov NCT00356369.

Authors+Show Affiliations

Research Institute for Tropical Medicine, Corporate Ave, Muntinlupa City, 1781, Metro Manila, Philippines. cbtabora@yahoo.com.Philippine General Hospital Manila, Taft Avenue, Ermita, Manila, 1000, Metro Manila, Philippines. csmontalban@gmail.com.College of Medicine, Alfaisal University, Al Zahrawi Street, Al Maather, Al Takhassusi Rd, Riyadh, 11533, Saudi Arabia. zmemish@yahoo.com.GSK Vaccines, Avenue Fleming 20, B- 1300, Wavre, Belgium. dominique.boutriau@gsk.com.GSK Pharmaceuticals Limited, Embassy Links, #5, SRT Road, Bangalore, 560052, India. devayani.a.kolhe@gsk.com.GSK Vaccines, 2301 Renaissance Blvd, King of Prussia, PA, 19406, USA.GSK Vaccines, Avenue Fleming 20, B- 1300, Wavre, Belgium. jacqueline.m.miller@gsk.com.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26437712

Citation

Borja-Tabora, Charissa Fay Corazon, et al. "Long-term Immunogenicity and Safety After a Single Dose of the Quadrivalent Meningococcal Serogroups A, C, W, and Y Tetanus Toxoid Conjugate Vaccine in Adolescents and Adults: 5-year Follow-up of an Open, Randomized Trial." BMC Infectious Diseases, vol. 15, 2015, p. 409.
Borja-Tabora CF, Montalban C, Memish ZA, et al. Long-term immunogenicity and safety after a single dose of the quadrivalent meningococcal serogroups A, C, W, and Y tetanus toxoid conjugate vaccine in adolescents and adults: 5-year follow-up of an open, randomized trial. BMC Infect Dis. 2015;15:409.
Borja-Tabora, C. F., Montalban, C., Memish, Z. A., Boutriau, D., Kolhe, D., Miller, J. M., & Van der Wielen, M. (2015). Long-term immunogenicity and safety after a single dose of the quadrivalent meningococcal serogroups A, C, W, and Y tetanus toxoid conjugate vaccine in adolescents and adults: 5-year follow-up of an open, randomized trial. BMC Infectious Diseases, 15, 409. https://doi.org/10.1186/s12879-015-1138-y
Borja-Tabora CF, et al. Long-term Immunogenicity and Safety After a Single Dose of the Quadrivalent Meningococcal Serogroups A, C, W, and Y Tetanus Toxoid Conjugate Vaccine in Adolescents and Adults: 5-year Follow-up of an Open, Randomized Trial. BMC Infect Dis. 2015 Oct 6;15:409. PubMed PMID: 26437712.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term immunogenicity and safety after a single dose of the quadrivalent meningococcal serogroups A, C, W, and Y tetanus toxoid conjugate vaccine in adolescents and adults: 5-year follow-up of an open, randomized trial. AU - Borja-Tabora,Charissa Fay Corazon, AU - Montalban,Cecilia, AU - Memish,Ziad A, AU - Boutriau,Dominique, AU - Kolhe,Devayani, AU - Miller,Jacqueline M, AU - Van der Wielen,Marie, Y1 - 2015/10/06/ PY - 2015/02/12/received PY - 2015/09/21/accepted PY - 2015/10/7/entrez PY - 2015/10/7/pubmed PY - 2016/5/5/medline SP - 409 EP - 409 JF - BMC infectious diseases JO - BMC Infect Dis VL - 15 N2 - BACKGROUND: Long-term protection against meningococcal disease is associated with persistence of post-vaccination antibodies at protective levels. We evaluated the bactericidal antibody persistence and safety of the quadrivalent meningococcal serogroups A, C, W and Y tetanus-toxoid conjugate vaccine (MenACWY-TT) and the meningococcal polysaccharide serogroups A, C, W, and Y vaccine (MenACWY-PS) up to 5 years post-vaccination. METHODS: This phase IIb, open, randomized, controlled study conducted in the Philippines and Saudi Arabia consisted of a vaccination phase and a long-term persistence phase. Healthy adolescents and adults aged 11-55 years were randomized (3:1) to receive a single dose of MenACWY-TT (ACWY-TT group) or MenACWY-PS (Men-PS group). Primary and persistence results up to 3 years post-vaccination have been previously reported. Antibody responses against meningococcal serogroups A, C, W, and Y were assessed by a serum bactericidal antibody assay using rabbit complement (rSBA, cut-off titers 1:8 and 1:128) at Year 4 and Year 5 post-vaccination. Vaccine-related serious adverse events (SAEs) and cases of meningococcal disease were assessed up to Year 5. RESULTS: Of the 500 vaccinated participants, 404 returned for the Year 5 study visit (Total Cohort Year 5). For the Total Cohort Year 5, 71.6-90.0 and 64.9-86.3 % of MenACWY-TT recipients had rSBA titers ≥1:8 and ≥1:128, respectively, compared to 24.8-74.3 and 21.0-68.6 % of MenACWY-PS recipients. The rSBA geometric mean titers (GMTs) remained above the pre-vaccination levels in both treatment groups. Exploratory analyses suggested that both rSBA GMTs as well as the percentages of participants with rSBA titers above the cut-offs were higher in the ACWY-TT than in the Men-PS group for serogroups A, W and Y, with no apparent difference for MenC. No SAEs related to vaccination or cases of meningococcal disease were reported up to Year 5. CONCLUSION: These results suggest that a single dose of MenACWY-TT could protect at least 72 % of vaccinated adolescents and adults against meningococcal disease at least 5 years post-vaccination. TRIAL REGISTRATION: ClinicalTrials.gov NCT00356369. SN - 1471-2334 UR - https://www.unboundmedicine.com/medline/citation/26437712/Long_term_immunogenicity_and_safety_after_a_single_dose_of_the_quadrivalent_meningococcal_serogroups_A_C_W_and_Y_tetanus_toxoid_conjugate_vaccine_in_adolescents_and_adults:_5_year_follow_up_of_an_open_randomized_trial_ DB - PRIME DP - Unbound Medicine ER -