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Immunogenicity and safety of concomitant administration of a combined hepatitis A/B vaccine and a quadrivalent meningococcal conjugate vaccine in healthy adults.
J Travel Med. 2015 Mar-Apr; 22(2):105-14.JT

Abstract

BACKGROUND

This phase 3b randomized, open-label study evaluated the immunogenicity and safety of coadministration of a hepatitis A and/or B vaccine with a quadrivalent oligosaccharide meningococcal CRM197 -conjugate vaccine (MenACWY-CRM), in the context of an accelerated hepatitis A and/or B immunization schedule.

METHODS

A total of 252 healthy adult subjects were randomized to three groups to receive hepatitis A/B only (HepA/B), hepatitis A/B coadministered with MenACWY-CRM (HepA/B+MenACWY-CRM), or MenACWY-CRM only (MenACWY-CRM). Hepatitis A and/or B vaccination was administered in the form of a single booster dose or a primary three-dose series, depending on the hepatitis A and/or B vaccination history of subjects. Antibody responses to hepatitis A/B vaccination were assessed 1 month following the last hepatitis A and/or B dose. Serum bactericidal activity with human complement (hSBA) against meningococcal serogroups A, C, W-135, and Y was assessed 1 month post-MenACWY-CRM vaccination. Safety was monitored throughout the study.

RESULTS

At 1 month following the final hepatitis A and/or B vaccination, concomitant administration of hepatitis A/B and MenACWY-CRM was non-inferior to administration of hepatitis A/B alone in terms of geometric mean concentrations of antibodies against the hepatitis A and B antigens. One month post-MenACWY-CRM vaccination, the percentages of subjects achieving hSBA titers ≥8 for serogroups A, C, W-135, and Y in the HepA/B+MenACWY-CRM group (76, 87, 99, and 94%, respectively) were comparable to those in the MenACWY-CRM group (67, 82, 96, and 88%, respectively). The percentages of subjects reporting adverse events (AEs) were similar across study groups and a majority of the reported AEs were mild to moderate in nature. There were no study vaccine-related serious AEs.

CONCLUSIONS

MenACWY-CRM can be administered concomitantly with a hepatitis A and/or B vaccine in the context of an accelerated hepatitis A and/or B immunization schedule without increasing safety concerns or compromising the immune responses to any of the vaccine antigens. [NCT01453348].

Authors+Show Affiliations

Department of Infectious Diseases and Tropical Medicine, University of Munich, Munich, Germany.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

25483566

Citation

Alberer, Martin, et al. "Immunogenicity and Safety of Concomitant Administration of a Combined Hepatitis A/B Vaccine and a Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adults." Journal of Travel Medicine, vol. 22, no. 2, 2015, pp. 105-14.
Alberer M, Burchard G, Jelinek T, et al. Immunogenicity and safety of concomitant administration of a combined hepatitis A/B vaccine and a quadrivalent meningococcal conjugate vaccine in healthy adults. J Travel Med. 2015;22(2):105-14.
Alberer, M., Burchard, G., Jelinek, T., Reisinger, E. C., Meyer, S., Forleo-Neto, E., Dagnew, A. F., & Arora, A. K. (2015). Immunogenicity and safety of concomitant administration of a combined hepatitis A/B vaccine and a quadrivalent meningococcal conjugate vaccine in healthy adults. Journal of Travel Medicine, 22(2), 105-14. https://doi.org/10.1111/jtm.12180
Alberer M, et al. Immunogenicity and Safety of Concomitant Administration of a Combined Hepatitis A/B Vaccine and a Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adults. J Travel Med. 2015 Mar-Apr;22(2):105-14. PubMed PMID: 25483566.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and safety of concomitant administration of a combined hepatitis A/B vaccine and a quadrivalent meningococcal conjugate vaccine in healthy adults. AU - Alberer,Martin, AU - Burchard,Gerd, AU - Jelinek,Tomas, AU - Reisinger,Emil C, AU - Meyer,Seetha, AU - Forleo-Neto,Eduardo, AU - Dagnew,Alemnew F, AU - Arora,Ashwani Kumar, Y1 - 2014/12/07/ PY - 2014/05/14/received PY - 2014/10/02/revised PY - 2014/10/03/accepted PY - 2014/12/9/entrez PY - 2014/12/9/pubmed PY - 2015/12/15/medline SP - 105 EP - 14 JF - Journal of travel medicine JO - J Travel Med VL - 22 IS - 2 N2 - BACKGROUND: This phase 3b randomized, open-label study evaluated the immunogenicity and safety of coadministration of a hepatitis A and/or B vaccine with a quadrivalent oligosaccharide meningococcal CRM197 -conjugate vaccine (MenACWY-CRM), in the context of an accelerated hepatitis A and/or B immunization schedule. METHODS: A total of 252 healthy adult subjects were randomized to three groups to receive hepatitis A/B only (HepA/B), hepatitis A/B coadministered with MenACWY-CRM (HepA/B+MenACWY-CRM), or MenACWY-CRM only (MenACWY-CRM). Hepatitis A and/or B vaccination was administered in the form of a single booster dose or a primary three-dose series, depending on the hepatitis A and/or B vaccination history of subjects. Antibody responses to hepatitis A/B vaccination were assessed 1 month following the last hepatitis A and/or B dose. Serum bactericidal activity with human complement (hSBA) against meningococcal serogroups A, C, W-135, and Y was assessed 1 month post-MenACWY-CRM vaccination. Safety was monitored throughout the study. RESULTS: At 1 month following the final hepatitis A and/or B vaccination, concomitant administration of hepatitis A/B and MenACWY-CRM was non-inferior to administration of hepatitis A/B alone in terms of geometric mean concentrations of antibodies against the hepatitis A and B antigens. One month post-MenACWY-CRM vaccination, the percentages of subjects achieving hSBA titers ≥8 for serogroups A, C, W-135, and Y in the HepA/B+MenACWY-CRM group (76, 87, 99, and 94%, respectively) were comparable to those in the MenACWY-CRM group (67, 82, 96, and 88%, respectively). The percentages of subjects reporting adverse events (AEs) were similar across study groups and a majority of the reported AEs were mild to moderate in nature. There were no study vaccine-related serious AEs. CONCLUSIONS: MenACWY-CRM can be administered concomitantly with a hepatitis A and/or B vaccine in the context of an accelerated hepatitis A and/or B immunization schedule without increasing safety concerns or compromising the immune responses to any of the vaccine antigens. [NCT01453348]. SN - 1708-8305 UR - https://www.unboundmedicine.com/medline/citation/25483566/Immunogenicity_and_safety_of_concomitant_administration_of_a_combined_hepatitis_A/B_vaccine_and_a_quadrivalent_meningococcal_conjugate_vaccine_in_healthy_adults_ DB - PRIME DP - Unbound Medicine ER -