Meningitis Clinical Trial
Official title:
A Phase 3 Trial to Evaluate the Safety, Immunogenicity, and Non-Interference With Concomitant Routine Vaccines, of a Meningococcal Serogroup ACYWX Conjugate Vaccine (NmCV-5) in Comparison With MenACWY-TT Conjugate Vaccine in Healthy Malian Infants
Verified date | May 2023 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Infants aged 9 months will be randomized to receive a meningococcal vaccine at 9 months or 15 months. Infants randomized to the 9-month age group will be further randomized in a 2:1 ratio to receive a single dose of the experimental meningococcal vaccine (NmCV-5) or a single dose of the comparator meningococcal vaccine (MenACWY-TT). Prospectively identified and consented infants randomized to the 15-month age group will return when aged 15 months and will be randomized in a 2:1 ratio to receive a single dose of NmCV-5 or a single dose of MenACWY-TT.
Status | Active, not recruiting |
Enrollment | 1200 |
Est. completion date | July 2025 |
Est. primary completion date | March 6, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 9 Months to 11 Months |
Eligibility | Inclusion Criteria: 1. Male and female children between 9 months and 11 months old inclusive. 2. Parent(s)/legal guardian(s) have provided written informed consent, after the nature of the study has been explained according to local regulatory requirements. 3. The investigator believes that their parent(s)/guardian(s) will be available for all the subjects visits and will comply with the requirements of the protocol (e.g., timely reporting of adverse events). 4. Individual is in good health as determined by medical history, physical examination, and clinical judgement of the investigator. 5. Individual has completed their local infant EPI vaccines, not including 9-month EPI vaccines (at the 9-month visit) or 15- month EPI vaccines (at the 15-month visit). A birth dose of oral polio vaccine is not required. Exclusion Criteria: 1. History of receipt of any meningococcal vaccine. 2. Has received a measles-containing vaccine. 3. Current or previous, confirm or suspected disease caused by N. meningitidis. 4. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrolment or study vaccination (for the 15-month age group). 5. History of severe allergic reactions after previous vaccinations or hypersensitivity to any study vaccine component including tetanus, diphtheria and mutant diphtheria toxoid (CRM197). 6. Acute or chronic, clinically significant pulmonary, cardiovascular, metabolic, neurological, hepatic, or renal functional abnormality, as determined by medical history or physical examination. 7. Any confirmed or suspected condition with impaired or altered function of the immune system (e.g., immunodeficiency, autoimmune conditions, malnutrition). 8. Have any bleeding disorder which is considered a contraindication to intramuscular injection or blood draw. 9. Severe acute malnutrition. Note: a weight-for-length Z-score of less than -3 satisfies this exclusion criteria. 10. History of either hepatitis B or hepatitis C virus infection, human immunodeficiency virus infection, or hereditary immunodeficiency. 11. Presence of major and clinically significant congenital defects. 12. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the study vaccination or planned use throughout the study period (for corticosteroids, this means prednisone, or equivalent, = 0.5 mg/kg per day. Inhaled, intranasal, and topical steroids are allowed). 13. Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months or planned use throughout the study period. 14. Administration of any vaccine within 14 days prior to enrolment in the study or planned administration of any vaccine within 14 days before or after study vaccination. 15. Use of any investigational or non-registered drug or vaccine within 28 days prior to the administration of study vaccine or planned during the study. 16. Malaria infection as confirmed by a Rapid Diagnostic Test. Note: subjects positive at screening may be treated for malaria as per national guidelines outside of the study, and if the subject remains eligible, vaccinated no earlier than 5 days after completing treatment. 17. Individuals who are close family member* of individuals conducting this study. *defined as a child with direct genetic relationship to a member of the study team. 18. Have experienced a moderate or severe acute infection and/or fever (defined as temperature = 37.5°C) within 3 days prior to enrolment or study vaccination. 19. Have received systemic antibiotic treatment within 3 days prior to enrolment or study vaccination. 20. Non-residence in the study area or intent to move out within six months. 21. Any condition which, in the opinion of the investigator, might post additional risk to the subject due to participation in the study. |
Country | Name | City | State |
---|---|---|---|
Mali | Centre pour le Developpement des Vaccins du Mali | Bamako |
Lead Sponsor | Collaborator |
---|---|
Emory University | National Institute of Allergy and Infectious Diseases (NIAID) |
Mali,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Serious Adverse Events | The number of serious adverse events, reported through 2 years of follow-up or during the entire study period, will be compared between study arms. | Up to 2 years | |
Other | Change in Proportion of Participants with rSBA Titers = 8 | The number and proportion of participants with rSBA titers = 8 will be compared between study arms. | 6 months and 2 years following meningococcal vaccination | |
Other | Change in Proportion of Participants with rSBA Titers = 128 | The number and proportion of participants with rSBA titers = 128 will be compared between study arms. | 6 months and 2 years following meningococcal vaccination | |
Other | Change in Calculated rSBA Titers | The calculated rSBA GMTs against each of the five meningococcal serogroups will be compared between study arms. | 6 months and 2 years following meningococcal vaccination | |
Other | Seroprotective Response Rates by Age at Vaccination | The comparison of the 9-month and 15-month group proportions of seroprotective response rates will be examined as an exploratory endpoint. | 28 days after meningococcal vaccination | |
Other | rSBA GMTs by Age at Vaccination | The comparison of the 9-month and 15-month group proportions of rSBA GMTs against each of the five meningococcal serogroups will be examined as an exploratory endpoint. | 28 days after meningococcal vaccination | |
Primary | Percentage of Participants with Seroprotective Response | The percentage of participants with seroprotective response (defined as rabbit serum bactericidal antibody (rSBA) titers = 8) against each meningococcal serogroup A, C, W, X and Y, 28 days after a single dose of meningococcal vaccine, will be compared between study arms, among participants vaccinated at either 9 months or 15 months of age. | 28 days after meningococcal vaccination | |
Primary | Percentage of Participants with Seroprotective Response to Serogroup X after NmCV-5 | The percentage of participants with seroprotective response to serogroup X in the NmCV-5 arm, to be compared to the percentage of participants with the lowest seroprotective response among serogroups A, C, W and Y in the MenACWY-TT arm. | 28 days after meningococcal vaccination | |
Secondary | Percentage of Participants with Seroprotective Response to Serogroup X | The percentage of participants with seroprotective response (rSBA antibody titers = 8) to serogroup X in the NmCV-5 arm compared to the percentage of participants with seroprotective response to serogroup X MenACWY-TT arm, 28 days after a single dose of meningococcal vaccine. | 28 days after meningococcal vaccination | |
Secondary | rSBA Titers | Level of rSBA titers (evaluated as geometric mean titers (GMTs)) against meningococcal serogroups A, C, W, X and Y, 28 days after meningococcal vaccine at either 9-11 or 15-17 months of age. | 28 days after meningococcal vaccination | |
Secondary | Percentage of Participants with Seroresponse in rSBA Titers | For a subset of participants, the percentage of participants with seroresponse in rSBA titers to meningococcal serogroups A, C, W, X and Y at 28 days after a single dose of meningococcal vaccine at either 9 months or 15 months of age will be examined. Seroresponse is defined as a post-immunization rSBA titer of 32 or greater if the participant's preimmunization (Baseline) rSBA titer was < 8; or a = four-fold increase over baseline at Day 29 post-immunization if the participant's pre-immunization rSBA titer was = 8. | 28 days after meningococcal vaccination | |
Secondary | Proportion of Participants with rSBA titers = 128 | The proportion of participants with rSBA titers = 128 at 28 days after a single dose of meningococcal vaccine will be examined. | 28 days after meningococcal vaccination | |
Secondary | Number of Serious Adverse Events | The number of serious adverse events reported after meningococcal vaccination will be compared between study arms. | 6 months after meningococcal vaccination | |
Secondary | Number of Solicited Adverse Events | The number of solicited adverse events reported after meningococcal vaccination will be compared between study arms. Solicited adverse events following meningococcal vaccination include injection site tenderness, swelling/induration, erythema, irritability, drowsiness, anorexia, and fever. | 7 days after meningococcal vaccination | |
Secondary | Number of Unsolicited Adverse Events | The number of unsolicited adverse events following meningococcal vaccination will be compared between study arms. | 28 days after meningococcal vaccination | |
Secondary | Proportion of Participants with Seropositive Response for Measles | Proportion of participants with seropositive response for measles vaccine will be compared between study arms. The seropositive response to measles vaccine is defined as achieving anti-measles immunoglobulin G (IgG) concentration = 150 milli-international units per milliliter (mIU/mL). | 28 days after meningococcal vaccination | |
Secondary | Proportion of Participants with Seropositive Response for Rubella | Proportion of participants with seropositive response for rubella vaccine will be compared between study arms. The seropositive response to rubella vaccine is defined as achieving anti-rubella IgG concentration = 4 IU/mL. | 28 days after meningococcal vaccination | |
Secondary | Proportion of Participants with Seroprotective Titers for Yellow Fever Vaccine | Proportion of participants with seroprotective titers for yellow fever vaccine will be compared between study arms. The seroprotective response to yellow fever vaccine is defined as yellow fever neutralizing antibody titers = 1:8. | 28 days after meningococcal vaccination |
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