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MenACWY-CRM conjugate vaccine booster dose given 4-6 years after priming: Results from a phase IIIb, multicenter, open label study in adolescents and adults.
Vaccine. 2019 09 30; 37(42):6171-6179.V

Abstract

BACKGROUND

Vaccination strategies against bacterial meningitis vary across countries. In the United States, a single dose of quadrivalent meningococcal conjugate vaccine (MenACWY) is recommended at 11-12 years of age, with a booster dose approximately 5 years later. We assessed immune responses to a booster dose of MenACWY-CRM vaccine after priming with MenACWY-CRM or MenACWY-D vaccines in adolescents and adults.

METHODS

In this phase IIIb, multicenter, open-label study, healthy 15-55-year-olds, who received MenACWY-CRM (N = 301) or MenACWY-D (N = 300) 4-6 years earlier or were meningococcal vaccine-naïve (N = 100), received one MenACWY-CRM vaccine dose. Immunogenicity was evaluated pre-vaccination, 3 or 5 days post-vaccination (sampling subgroups), and 28 days post-vaccination by serum bactericidal activity assay using human complement (hSBA). After vaccination, participants were monitored for 7 days for reactogenicity, 29 days for unsolicited adverse events (AEs), and 181 days for serious AEs and medically-attended AEs.

RESULTS

Sufficiency of the immune response to a MenACWY-CRM booster dose was demonstrated; the lower limit of the 1-sided 97.5% confidence interval for percentages of participants with hSBA seroresponse at 28 days post-vaccination was >75% for each serogroup in those primed with either the MenACWY-CRM or MenACWY-D vaccine. Seroresponse was observed in ≥93.24% of primed participants and ≥35.87% of naïve participants 28 days post-vaccination. At 5 days post-booster, among primed participants, hSBA titers ≥1:8 were achieved in ≥47.14% of participants for MenA and in ≥85.52% of participants for MenC, MenW and MenY, and 3.25- to 8.59-fold increases in hSBA geometric mean titers against each vaccine serogroup were observed. No safety concerns were raised throughout the 6-month follow-up period.

CONCLUSIONS

A booster dose of the MenACWY-CRM vaccine induced a robust and rapid anamnestic response in adolescents and adults, irrespectively of either MenACWY-CRM or MenACWY-D vaccine administered 4-6 years earlier, with an acceptable clinical safety profile. ClinicalTrials.gov registration: NCT02986854.

Authors+Show Affiliations

CopperView Medical Center, South Jordan, UT, United States. Electronic address: tipton@rx-research.com.Brownsboro Park Pediatrics, Louisville, KY, United States.Senders Pediatrics, Cleveland, OH, United States. Electronic address: ssenders@senderspediatrics.com.Kentucky Pediatric/Adult Research, Bardstown, KY, United States.GSK, Siena, Italy. Electronic address: maria.x.lattanzi@gsk.com.GSK, Amsterdam, the Netherlands. Electronic address: thembile.x.mzolo@gsk.com.GSK, Amsterdam, the Netherlands. Electronic address: silvia.x.barbi@gsk.com.GSK, Siena, Italy. Electronic address: michele.x.pellegrini@gsk.com.GSK, Siena, Italy. Electronic address: pavitra.x.keshavan@gsk.com.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31495595

Citation

Tipton, Mary, et al. "MenACWY-CRM Conjugate Vaccine Booster Dose Given 4-6 Years After Priming: Results From a Phase IIIb, Multicenter, Open Label Study in Adolescents and Adults." Vaccine, vol. 37, no. 42, 2019, pp. 6171-6179.
Tipton M, Daly W, Senders S, et al. MenACWY-CRM conjugate vaccine booster dose given 4-6 years after priming: Results from a phase IIIb, multicenter, open label study in adolescents and adults. Vaccine. 2019;37(42):6171-6179.
Tipton, M., Daly, W., Senders, S., Block, S. L., Lattanzi, M., Mzolo, T., Barbi, S., Pellegrini, M., & Keshavan, P. (2019). MenACWY-CRM conjugate vaccine booster dose given 4-6 years after priming: Results from a phase IIIb, multicenter, open label study in adolescents and adults. Vaccine, 37(42), 6171-6179. https://doi.org/10.1016/j.vaccine.2019.08.065
Tipton M, et al. MenACWY-CRM Conjugate Vaccine Booster Dose Given 4-6 Years After Priming: Results From a Phase IIIb, Multicenter, Open Label Study in Adolescents and Adults. Vaccine. 2019 09 30;37(42):6171-6179. PubMed PMID: 31495595.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - MenACWY-CRM conjugate vaccine booster dose given 4-6 years after priming: Results from a phase IIIb, multicenter, open label study in adolescents and adults. AU - Tipton,Mary, AU - Daly,Wendy, AU - Senders,Shelly, AU - Block,Stanley L, AU - Lattanzi,Maria, AU - Mzolo,Thembile, AU - Barbi,Silvia, AU - Pellegrini,Michele, AU - Keshavan,Pavitra, Y1 - 2019/09/05/ PY - 2019/01/31/received PY - 2019/08/25/revised PY - 2019/08/26/accepted PY - 2019/9/10/pubmed PY - 2020/9/8/medline PY - 2019/9/10/entrez KW - Adolescents KW - Adults KW - Booster response KW - Early immune response KW - Quadrivalent meningococcal conjugate vaccine KW - Safety SP - 6171 EP - 6179 JF - Vaccine JO - Vaccine VL - 37 IS - 42 N2 - BACKGROUND: Vaccination strategies against bacterial meningitis vary across countries. In the United States, a single dose of quadrivalent meningococcal conjugate vaccine (MenACWY) is recommended at 11-12 years of age, with a booster dose approximately 5 years later. We assessed immune responses to a booster dose of MenACWY-CRM vaccine after priming with MenACWY-CRM or MenACWY-D vaccines in adolescents and adults. METHODS: In this phase IIIb, multicenter, open-label study, healthy 15-55-year-olds, who received MenACWY-CRM (N = 301) or MenACWY-D (N = 300) 4-6 years earlier or were meningococcal vaccine-naïve (N = 100), received one MenACWY-CRM vaccine dose. Immunogenicity was evaluated pre-vaccination, 3 or 5 days post-vaccination (sampling subgroups), and 28 days post-vaccination by serum bactericidal activity assay using human complement (hSBA). After vaccination, participants were monitored for 7 days for reactogenicity, 29 days for unsolicited adverse events (AEs), and 181 days for serious AEs and medically-attended AEs. RESULTS: Sufficiency of the immune response to a MenACWY-CRM booster dose was demonstrated; the lower limit of the 1-sided 97.5% confidence interval for percentages of participants with hSBA seroresponse at 28 days post-vaccination was >75% for each serogroup in those primed with either the MenACWY-CRM or MenACWY-D vaccine. Seroresponse was observed in ≥93.24% of primed participants and ≥35.87% of naïve participants 28 days post-vaccination. At 5 days post-booster, among primed participants, hSBA titers ≥1:8 were achieved in ≥47.14% of participants for MenA and in ≥85.52% of participants for MenC, MenW and MenY, and 3.25- to 8.59-fold increases in hSBA geometric mean titers against each vaccine serogroup were observed. No safety concerns were raised throughout the 6-month follow-up period. CONCLUSIONS: A booster dose of the MenACWY-CRM vaccine induced a robust and rapid anamnestic response in adolescents and adults, irrespectively of either MenACWY-CRM or MenACWY-D vaccine administered 4-6 years earlier, with an acceptable clinical safety profile. ClinicalTrials.gov registration: NCT02986854. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/31495595/MenACWY_CRM_conjugate_vaccine_booster_dose_given_4_6_years_after_priming:_Results_from_a_phase_IIIb_multicenter_open_label_study_in_adolescents_and_adults_ DB - PRIME DP - Unbound Medicine ER -