Safety and Immunogenicity of Intradermal, and Low-dose Subcutaneous vs Subcutaneous Administration of Menomune® - A/C/Y/W-135
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers
Study Overview
Brief Summary
The objective of this trial is to study the administration of the Menomune vaccine given intradermally and low-dose subcutaneously versus standard subcutaneously. This study will describe the immunogenicity of Menomune® - A/C/Y/W-135 administered subcutaneously (standard dose) versus intradermally over a dose range (1/10th, 2/10th, and 3/10th of standard dose) and a low dose (2/10th of standard dose) subcutaneously.
The secondary objective is to describe the safety of the subcutaneous (SC) and intradermal (ID) routes at different dosages
Detailed Description
This trial will provide a proof of concept that a dose range of Menomune given ID can induce an immune response that is comparable to standard dosing by the SC route, and is equivalent or superior to a low dose given SC.
Subjects will be randomized according to a computer-generated randomization schedule to receive the vaccine by SC injection or by ID injection at different dosages.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18 to 55 years of age.
- •Willing to return for 3 follow-up visits and comply with a 30 day follow-up period.
- •Signed an informed consent form.
Exclusion Criteria
- •Allergy to any component of the vaccine and latex.
- •Known or suspected immunodeficiency or receipt of immunosuppressive therapy or blood products within the previous two months.
- •History of serious chronic diseases (such as cardiac or renal disease).
- •Acute febrile illness at the time of visit.
- •Pregnancy.
- •Receipt of any vaccine within the 28 days prior to enrollment.
- •Receipt of meningococcal vaccine (example in Military) within the past 5 years or history of meningococcal disease.
Arms & Interventions
Group 1
0.5 mL Subcutaneous arm (Menomune® )
Intervention: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined (Biological)
Group 2
0.1 mL Subcutaneous arm (Menomune®)
Intervention: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined (Biological)
Group 3
0.05 mL Intradermal arm (Menomune®)
Intervention: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined (Biological)
Group 4
0.1 mL Intradermal arm (Menomune®)
Intervention: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined (Biological)
Group 5
0.15 mL Intradermal arm (Menomune®)
Intervention: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined (Biological)
Outcomes
Primary Outcomes
Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers
Time Frame: Baseline to 28 days post vaccination
Percentage of participants with a 4-fold rise in Serum bactericidal assay using baby rabbit complement (SBA-BR) antibody titers to each meningococcal serogroup from baseline to Day 28 post-vaccination.
Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination.
Time Frame: Baseline (Day 0) and Day 28 post-vaccination
GMTs and their 95% confidence interval to the vaccine meningococcal serogroups at Day 0 and Day 28 post-vaccination.
Secondary Outcomes
- Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.(Day 0 to 7 days post-vaccination)