Co-administration of a meningococcal glycoconjugate ACWY vaccine with travel vaccines: A randomized, open-label, multi-center study

• Published in: Travel medicine and infectious disease Vol. 12; no. 5; pp. 485 - 493
• Main Authors: Alberer, Martin, Burchard, Gerd, Jelinek, Tomas, Reisinger, Emil, Beran, Jiri, Meyer, Seetha, Forleo-Neto, Eduardo, Gniel, Dieter, Dagnew, Alemnew F., Kumar Arora, Ashwani
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 01.09.2014; Elsevier Limited
• Subjects: Adult; Antimalarials - administration & dosage; Co-administration; Communicable Disease Control - statistics & numerical data; Communicable Diseases - epidemiology; Cross-Sectional Studies; Encephalitis; Female; Humans; Immunogenicity; Infectious Disease; Japanese encephalitis; Male; Meningitis; Meningococcal disease; Meningococcal Infections - prevention & control; Meningococcal Vaccines - administration & dosage; Middle Aged; Mortality; Neisseria meningitidis; Neutralization; Rabies; Safety; Travel; Travel - statistics & numerical data; Travel Medicine; Vaccination - statistics & numerical data; Vaccine; Vaccines; Vaccines - administration & dosage; Vaccines, Conjugate - administration & dosage; Vector-borne diseases; Young Adult; Asia; LL; PP; Co-administration; PCECV; AE; CI; Vaccine; GMT; Rabies; SAE; MITT; hSBA; JEV; JE; GMC; Meningococcal disease; Japanese encephalitis; geometric mean concentration; serum bactericidal activities with human complement; modified intent to treat population; geometric mean titer; Lower limit; serious adverse event; per-protocol set; adverse event; Japanese encephalitis vaccine; purified chick embryo cell culture derived rabies vaccine; confidence interval
• DOI: 10.1016/j.tmaid.2014.04.011
• ISSN: 1477-8939; 1873-0442

Potential interactions between vaccines may compromise the immunogenicity and/or safety of individual vaccines so must be assessed before concomitant administration is recommended. In this study, the immunogenicity and safety of travel vaccines against Japanese encephalitis (JEV) and rabies (PCECV) administered together with or without a quadrivalent meningococcal glycoconjugate ACWY-CRM vaccine were evaluated (NCT01466387). Healthy adults aged 18 to ≤60 years were randomized to one of four vaccine regimens: JEV + PCECV + MenACWY-CRM, JEV + PCECV, PCECV or MenACWY-CRM. Immunogenicity at baseline and 28 days post-complete vaccination was assessed by serum bactericidal assay using human complement or neutralization tests. Adverse events (AEs) were collected throughout the study period. JEV + PCECV + MenACWY-CRM was non-inferior to JEV + PCECV. Post-vaccination seroprotective neutralizing titers or concentrations were achieved in 98–99% (JE) and 100% (rabies) of subjects across the vaccine groups. Antibody responses to vaccine meningococcal serogroups were in the same range for MenACWY-CRM and JEV + PCECV + MenACWY-CRM. Rates of reporting of AEs were similar for JEV + PCECV and JEV + PCECV + MenACWY-CRM. MenACWY-CRM was administered with an inactivated adjuvanted JE and a purified chick embryo cell-culture rabies vaccine without compromising immunogenicity or safety of the individual vaccines. These data provide evidence that MenACWY-CRM could be effectively incorporated into travel vaccination programs. Trial number: NCT01466387.