Phase 1
N=60
Study of Meninigococcal Conjugate Vaccine Containing Serogroups A,C,Y,W and X (MCV5) in Healthy Adults
Meningococcal Vaccines
Bottom Line
View on ClinicalTrials.gov: NCT02810340 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Number and Percentage of Participants Experiencing Solicited Events — 12; 10; 7; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Adjuvanted MCV-5 (Biological); Non-Adjuvanted MCV-5 (Biological); Menactra® (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- PATH
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Percentage of Participants Experiencing Solicited Events |
12; 10; 7; 0; 1; 1 | — |
| PRIMARY Number and Percentage of Subjects Experiencing Unsolicited Adverse Events, by Severity |
1; 2; 5; 2; 1; 2 | — |
| PRIMARY Number of Subjects Experiencing Serious Adverse Events |
0; 0; 0 | — |
| SECONDARY Number and Percentage of Participants With Seroconversion for Meningococcal Polysaccharide A, C, Y, W and X Specific Antibodies |
17; 14; 16; 19; 20; 17 | — |
| SECONDARY Number and Percentage of Participants With Seroprotection for Meningococcal Polysaccharide A, C, Y, W and X (Antibody Titer ≥1:8), at Baseline and After 28 Days |
15; 17; 10; 20; 20; 20 | — |
| SECONDARY Number and Percentage of Participants With Seroprotection for Meningococcal Polysaccharide A, C, Y, W and X (Antibody Titer ≥1:128), at Baseline and After 28 Days |
15; 17; 10; 20; 20; 20 | — |
| SECONDARY Geometric Mean Titer (GMT) of Meningococcal Polysaccharide A, C, Y, W and X Specific Antibodies at Baseline and After 28 Days |
187; 350; 33.1; 6889; 5595; 3214 | — |
| SECONDARY Geometric Mean Fold Change in Meningococcal Polysaccharide A, C, Y, W and X Specific Antibody Titers |
36.8; 16.0; 97.0; 416; 1448; 68.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- age 18-45 years
- Written informed consent of volunteers
- Healthy as established by medical history, laboratory evaluation and screening evaluations
- Participants are able to understand and comply with planned study procedures and be available for all study visits
- Female subjects must be of non-childbearing potential (defined as surgically sterile or postmenopausal for more than 1 year), or if of childbearing potential must be practicing abstinence or using an effective licensed method of birth control
Exclusion Criteria
- Previous vaccination against Neisseria meningitidis.
- Known exposure to Neisseria meningitidis in the past.
- History of meningitis or seizures or any neurological or psychiatric disorder.
- Administration of any other vaccine within 30 days prior or after administration of study vaccines.
- Use of any investigational or non-registered drug or vaccine within 30 days prior to the administration of study vaccines or planned during the study.
- History of allergic disease or known hypersensitivity to any component of the three study vaccines.
- History of Serious Adverse Reactions following administration of Tetanus Toxoid, Diphtheria Toxoid or CRM containing vaccines.
- History of Guillan-Barré syndrome.
- Confirmed or suspected immunosuppressive or immune-deficient condition. 10. A family history of congenital or hereditary immunodeficiency.
- Chronic administration (defined as more than 14 days) of immune-suppressants or other immune-modifying agents within six months prior to administration of study vaccine.
- 12. Laboratory confirmed infection of either hepatitis B virus (HBs Ag positive on ELISA), hepatitis C virus (anti-HCV positive on ELISA as well as PCR) or human immunodeficiency virus (HIV on ELISA).
- Major congenital defects or serious chronic illness.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history, physical examination or laboratory screening tests.
- Known bleeding disorders.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of study vaccines or planned administration during the vaccine period.
- History (within the past year) or signs of alcohol or substance abuse.
- Pregnancy or lactation.
- A Body Mass Index (BMI) equal to or above 30.
- Any other condition, which in the opinion of the investigator, might interfere with the study objectives, jeopardize the safety or rights of the participant or making it unlikely the participant could complete the protocol.
Data sourced from ClinicalTrials.gov (NCT02810340). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.