Ignite Creation Date:
2024-05-06 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04722003
Status:
COMPLETED
Last Update Posted:
2023-11-28
First Post:
2021-01-21
Brief Title:
Mucosal Immunity Against Neisseria Gonorrhoeae After 4CMenB Vaccination
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Mucosal Immune Responses Against Neisseria Gonorrhoeae Following Meningococcal Immunization in Healthy Young Adults
Status:
COMPLETED
Status Verified Date:
2020-12-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 2 mechanistic clinical trial to assess the systemic and mucosal immunogenicity of the multicomponent meningococcal serogroup B vaccine 4CMenB or Bexsero R group 1 40 subjects against Neisseria gonorrhoeae using a placebo vaccine normal saline as a comparator group 2 10 subjects There will be approximately 50 participants ages 18-49 both male and non-pregnant female subjects enrolled at 1 site in the US The goal will be to ensure adequate representation of subjects by sex in both treatment groups The enrollment will be stratified by both sex and treatment arm During enrollment of the biopsy cohort male and non-pregnant female subjects will be randomized 41 to either 4CMenB or placebo up to a maximum of 10 male and 10 non-pregnant female subjects Group 1 approximate N40 will receive two doses of 4CMenB on Day 1 and Day 29 Group 2 approximate N10 will receive two placebo injections on Day 1 and Day 29 Both groups will receive a single-dose prefilled syringe that is administered intramuscularly 05-mililiter each The duration of each subjects participation is approximately 8 months from recruitment through the last study visit and the length of the study is estimated for 14 months The primary objective is to characterize the rectal mucosal Immunoglobulin G IgG antibody response to Neisseria gonorrhoeae GC elicited by the 4CMenB vaccine as compared with the placebo vaccine normal saline in healthy adult subjects
Detailed Description:
This is a Phase 2 mechanistic clinical trial to assess the systemic and mucosal immunogenicity of the multicomponent meningococcal serogroup B vaccine 4CMenB or Bexsero R group 1 40 subjects against Neisseria gonorrhoeae using a placebo vaccine normal saline as a comparator group 2 10 subjects There will be approximately 50 participants ages 18-49 both male and non-pregnant female subjects enrolled at 1 site in the US The goal will be to ensure adequate representation of subjects by sex in both treatment groups The enrollment will be stratified by both sex and treatment arm A subset of subjects in each treatment group N16 in Group 1 N4 in Group 2 will undergo rectal mucosal biopsy at two time points baseline and following the second vaccination for assessment of tissue Neisseria gonorrhoeae GC specific cellular responses During enrollment of the biopsy cohort male and non-pregnant female subjects will be randomized 41 to either 4CMenB or placebo up to a maximum of 10 male and 10 non-pregnant female subjects All subjects will undergo sampling of mucosal secretions for testing for antibodies against Neisseria gonorrhoeae GC Male subjects will undergo oropharyngeal and rectal mucosal sampling and female subjects will undergo oropharyngeal vaginal and rectal mucosal sampling Group 1 approximate N40 will receive two doses of 4CMenB on Day 1 and Day 29 Group 2 approximate N10 will receive two placebo injections on Day 1 and Day 29 Both groups will receive a single-dose prefilled syringe that is administered intramuscularly 05-mililter each The duration of each subjects participation is approximately 8 months from recruitment through the last study visit and the length of the study is estimated for 14 months The primary objective is to characterize the rectal mucosal Immunoglobulin G IgG antibody response to Neisseria gonorrhoeae GC elicited by the 4CMenB vaccine as compared with the placebo vaccine normal saline in healthy adult subjects The secondary objectives are 1 To characterize the serum IgG antibody response to Neisseria gonorrhoeae GC elicited by the 4CMenB vaccine as compared with the placebo vaccine in healthy adult subjects 2 To assess the safety and reactogenicity of 4CMenB in healthy adult subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None