Study of Meninigococcal Conjugate Vaccine Containing Serogroups A,C,Y,W and X (MCV5) in Healthy Adults
Condition: Meningococcal Vaccines
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety of adjuvanted and
      non-adjuvanted formulations of MCV-5 vaccine. The secondary objective is to assess the immune
      response of adjuvanted and non-adjuvanted formulations of MCV-5 vaccine.
    

Detailed description: 
      Prior to the study, there was no vaccine available against serogroup X of N. meningitidis.
      This bacterium has caused many outbreaks in Africa and Europe in recent past. It has been
      responsible for outbreaks between 2006 and 2010 in Kenya, Niger, Togo, Uganda, and Burkina
      Faso, the latter with at least 1,300 cases of serogroup X meningitis among the 6,732 reported
      annual cases. The WHO has expressed concerns over the lack of a serogroup X vaccine and has
      encouraged more research into it. As a result, Serum Institute of India Private Limited
      (SIIPL) has developed the candidate vaccine MCV-5 (currently renamed NmCV-5), which is a
      polyvalent conjugate vaccine composed of serogroups A, C, Y, W, and X of Neisseria
      meningitidis capsular polysaccharides, conjugated to protein carriers, CRM and tetanus
      toxoid, with aluminum phosphate as an adjuvant. It is intended for the prevention of
      meningitis and/or septicemia caused by serogroups A, C, Y, W, and X of N. meningitidis in
      countries where the disease is endemic and causes large epidemics, such as the countries in
      the African meningitis belt.

      The three-group design of the study will allow safety evaluation of the adjuvanted and
      nonadjuvanted MCV-5 formulations. Menactra® has been chosen as the control vaccine, because
      of the large safety database accumulated since the vaccine has been introduced in the USA in
      2005 and progressively in other countries
    

Intervention name(s): Adjuvanted MCV-5; Non-Adjuvanted MCV-5; Menactra®
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM), and 125 μg Al3+adjuvant.; Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, and 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM).; Menactra® vaccine was a clear to slightly turbid solution supplied in a 0.5 mL single dose vial. Each 0.5 mL dose of vaccine was formulated in sodium phosphate buffered isotonic sodium chloride solution to contain four mcg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 μg of diphtheria toxoid protein carrier and residual amounts of formaldehyde of less than 2.66 μg (0.000532%), by calculation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention