Safety of and Immune Response to a Meningitis Vaccine in HIV-Infected Children and Youth (NCT00459316) | Clinical Trial Compass
CompletedPhase 1/2
Safety of and Immune Response to a Meningitis Vaccine in HIV-Infected Children and Youth
United States384 participantsStarted 2007-06
Plain-language summary
Bacterial meningitis infection is common in youth 2 to 24 years of age in the United States. This disease can be treated by antibiotics, but mortality rates associated with meningitis of up to 53% have been estimated. Vaccination against meningitis may be effective in preventing this disease, especially for HIV-infected youth who have weakened immune systems. The purpose of this study was to determine the safety of and immune response to a preventive meningitis vaccine in HIV-infected youth.
Who can participate
Age range2 Years – 24 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for Steps 1, 2, and 3:
* HIV-infected
* Age greater than or equal to 2 and less than 25 years (Steps 1 and 2 only)
* CD4% documented within 120 days of study entry
* Participants on antiretroviral therapy (ART) must have been on stable ART regimen for at least 90 days prior to study entry
* Able and willing to complete all study immunizations and evaluations
* Parent or guardian willing to provide informed consent, if applicable
* Participants and/or their partners who are sexually active had to agree to use at least one of the following methods of contraception as long as they are on the study: hormonal birth control drugs (oral, injectable or transdermal); male or female condoms with or without a spermicide; diaphragm/cervical cap with spermicide; intrauterine device (IUD)
Inclusion Criteria specific to Step 3:
* Participants must have been enrolled in Groups 1 or 3 of previous versions of P1065
* Participants did not have to be less than 25 years of age
* Participants must have had serology data from Weeks 0, 4, and 28 from their previous participation in P1065
* Participants must have been within 3.5 years +/- 6 months from the first MCV4 dose received in a previous version of P1065
Exclusion Criteria for Step 1:
* Any nonstudy vaccine on study entry day
* Any inactive vaccine within 2 weeks prior to study entry
* Plans to receive any vaccine 2 weeks after the first injection
* Receipt of any live nonstudy vaccine within 4 weeks prior to study entr…
What they're measuring
1
Number of Immunogenic Responders, With Response Defined as a 4-fold or Greater Increase in Serum Bactericidal Antibody Titers From Study Entry to Week 28 After 2 Doses of MCV-4.
Timeframe: Study entry and Week 28
2
Number of Participants With Short-term Immunogenicity, Defined as Number of Seroconverters at Week 4 (Those With at Least a 4-fold Rise in Meningococcal Serum Bactericidal Titers From Baseline)
Timeframe: At Study entry, Week 4
3
Long-term Immunogenicity, as Assessed by Number of Participants With Protective Levels of Antibody at Week 72
Timeframe: Week 72
4
Number of Participants With Grade 3 or Higher Adverse Events Within 42 Days Following Dose 1 of the Vaccine.
Timeframe: From administration of Dose 1 at week 0 to 42 days post-vaccination
5
Number of Participants With Reactions and Grade 3 or Higher Adverse Events Within 42 Days Following Dose 2 of the Vaccine.
Timeframe: From administration of Dose 2 at week 24 to 6 weeks post-vaccination
6
Number of Participants With Immunogenicity at Step 3 Entry
Timeframe: At 3.5 years (Step 3 entry)
7
Number of Participants With 4-fold Memory Response in Step 3
Trial details
NCT IDNCT00459316
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)