CompletedPhase 1/2

Safety of and Immune Response to a Meningitis Vaccine in HIV-Infected Children and Youth

United States, Puerto Rico384 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 range

2 Years – 24 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Long-term Immunogenicity, as Assessed by Number of Participants With Protective Levels of Antibody at Week 72

Timeframe: Week 72

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

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

Number of Participants With Immunogenicity at Step 3 Entry

Timeframe: At 3.5 years (Step 3 entry)

Trial details

NCT IDNCT00459316

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2013-03

Results submitted2014-03-03

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