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

This study has been completed.
Sponsor:
Collaborator:
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00459316
First received: April 10, 2007
Last updated: September 3, 2014
Last verified: September 2014
Results First Received: March 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: HIV Infections
Meningitis
Intervention: Biological: Quadrivalent meningococcal conjugate vaccine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Group 1: CD4%≥15, Age ≤11 to <25

Participants ≤11 to <25 years of age with CD4% at screening ≥15%; All receiving Quadrivalent meningococcal conjugate vaccine at entry, those who were eligible/randomized receiving Quadrivalent meningococcal conjugate vaccine at week 24, and 3 years.

Quadrivalent meningococcal conjugate vaccine: MCV4 vaccine (4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 µg of diphtheria toxoid protein carrier ) was given by injection intramuscularly at least once and no more than two times for each participant, depending on adverse reactions.

Group 2: CD4%<15, Age ≤11 to <25

Participants ≤11 to <25 years of age with CD4% at screening <15%; All receiving Quadrivalent meningococcal conjugate vaccine at entry, those who were eligible receiving Quadrivalent meningococcal conjugate vaccine at week 24.

Quadrivalent meningococcal conjugate vaccine: MCV4 vaccine (4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 µg of diphtheria toxoid protein carrier ) was given by injection intramuscularly at least once and no more than two times for each participant, depending on adverse reactions.

Group 3: Age ≥2 to <11, CD4%≥25

Participants ≥2 to <11 years of age with CD4% at screening ≥ 25%; All receiving Quadrivalent meningococcal conjugate vaccine at entry, those who were eligible receiving Quadrivalent meningococcal conjugate vaccine at week 24, and 3 years.

Quadrivalent meningococcal conjugate vaccine: MCV4 vaccine (4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 µg of diphtheria toxoid protein carrier ) was given by injection intramuscularly at least once and no more than two times for each participant, depending on adverse reactions.


Participant Flow for 2 periods

Period 1:   Steps 1 & 2
    Group 1: CD4%≥15, Age ≤11 to <25     Group 2: CD4%<15, Age ≤11 to <25     Group 3: Age ≥2 to <11, CD4%≥25  
STARTED     280     39     59  
COMPLETED     259     32     57  
NOT COMPLETED     21     7     2  
Other eligibility failure                 1                 1                 0  
Death                 1                 1                 0  
Not able to get to clinic                 7                 4                 0  
Withdrawal by Subject                 6                 1                 0  
Not willing to adhere to regulations                 1                 0                 0  
Lost to Follow-up                 5                 0                 2  

Period 2:   Step 3
    Group 1: CD4%≥15, Age ≤11 to <25     Group 2: CD4%<15, Age ≤11 to <25     Group 3: Age ≥2 to <11, CD4%≥25  
STARTED     152 [1]   0 [2]   40 [1]
COMPLETED     149     0     39  
NOT COMPLETED     3     0     1  
Withdrawal by Subject                 3                 0                 1  
[1] Not all participants from Steps 1/2 were eligible for Step 3
[2] Group 2 participants were not eligible for Step 3



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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.   [ Time Frame: Study entry and Week 28 ]

2.  Primary:   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)   [ Time Frame: At Study entry, Week 4 ]

3.  Primary:   Long-term Immunogenicity, as Assessed by Number of Participants With Protective Levels of Antibody at Week 72   [ Time Frame: Week 72 ]

4.  Primary:   Number of Participants With Grade 3 or Higher Adverse Events Within 42 Days Following Dose 1 of the Vaccine.   [ Time Frame: From administration of Dose 1 at week 0 to 42 days post-vaccination ]

5.  Primary:   Number of Participants With Reactions and Grade 3 or Higher Adverse Events Within 42 Days Following Dose 2 of the Vaccine.   [ Time Frame: From administration of Dose 2 at week 24 to 6 weeks post-vaccination ]

6.  Primary:   Number of Participants With Immunogenicity at Step 3 Entry   [ Time Frame: At 3.5 years (Step 3 entry) ]

7.  Primary:   Number of Participants With 4-fold Memory Response in Step 3   [ Time Frame: Step 3 entry and Week 1 post-booster vaccine ]

8.  Primary:   Number of Participants With Seropositive Memory Response (in Step 3)   [ Time Frame: Step 3 entry and Week 1 post-booster vaccine ]

9.  Primary:   Number of Participants With Primary Response (in Step 3)   [ Time Frame: Step 3 entry and Week 4 post-booster vaccine ]

10.  Primary:   Number of Participants With Immunogenicity at Step 3 Weeks 4 and 24   [ Time Frame: At Step 3 Weeks 4 and 24 post-booster vaccine ]

11.  Secondary:   Safety, as Assessed by Number of Participants With Reactions and Grade 3 or Higher Adverse Events Within 42 Days Following Step 3 Dose of the Vaccine.   [ Time Frame: From administration of vaccination at Step 3 entry through 6 weeks post-vaccination ]

12.  Secondary:   To Examine Whether the Immunogenicity of the MCV4 in HIV-1 Infected Youth Varies as a Function of the Study Subjects’ Immune Status at the Time of Vaccination;   [ Time Frame: Week 4 ]
Results not yet reported.   Anticipated Reporting Date:   09/2014   Safety Issue:   No

13.  Secondary:   To Compare the Long-term Immunogenicity, as Assessed by Number of Participants With Protective Antibody Titers (>= 1:128), Between the 1-dose Versus 2-dose Arms for Those in Group 1   [ Time Frame: At Week 72 ]
Results not yet reported.   Anticipated Reporting Date:   09/2014   Safety Issue:   No

14.  Secondary:   Immunogenic Response as Assessed by Number of Participants With Protective Antibody Titers (>= 1:128) to Serogroup C in Group 2   [ Time Frame: At Weeks 4, 28, and 72 ]
Results not yet reported.   Anticipated Reporting Date:   09/2014   Safety Issue:   No

15.  Secondary:   Comparison of Responders and Non-responders by Genetic Determinants   [ Time Frame: At Weeks 4, 24, 28, and 72 ]
Results not yet reported.   Anticipated Reporting Date:   09/2014   Safety Issue:   No

16.  Secondary:   Comparison of the Number of Participants With Protective Antibody Titers for Serogroup C Between Treatment Arms (1 vs. 2 Doses) of Group 1 (Step 3)   [ Time Frame: At 3.5 years ]
Results not yet reported.   Anticipated Reporting Date:   09/2014   Safety Issue:   No

17.  Secondary:   Comparison of Memory Response for Serogroup C Between Treatment Arms (1 vs. 2 Doses) of Group 1 (Step 3)   [ Time Frame: At Week 1 post-booster vaccination ]
Results not yet reported.   Anticipated Reporting Date:   09/2014   Safety Issue:   No

18.  Secondary:   Comparison of Response (Memory or Primary) for Serogroup C Between Treatment Arms (1 vs. 2 Doses) of Group 1 (Step 3)   [ Time Frame: At Week 4 post-booster vaccination ]
Results not yet reported.   Anticipated Reporting Date:   09/2014   Safety Issue:   No

19.  Secondary:   Comparison of Immunogenicity, as Assessed by Number of Participants With Protective Levels of Antibody (Titers Great Than or Equal to 1:128), Between Treatment Arms (1 vs. 2 Doses) of Group 1 (Step 3)   [ Time Frame: At Weeks 4 and 24 post-booster vaccination ]
Results not yet reported.   Anticipated Reporting Date:   09/2014   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinicaltrals.gov Coordinator
Organization: Center for Biostatistics in AIDS Research, Harvard School of Public Health
phone: (617) 432-2829
e-mail: CBAR.ClinicalTrials.Gov@sdac.harvard.edu


Publications of Results:

Other Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00459316     History of Changes
Other Study ID Numbers: P1065, 10396, IMPAACT P1065, PACTG P1065
Study First Received: April 10, 2007
Results First Received: March 3, 2014
Last Updated: September 3, 2014
Health Authority: United States: Food and Drug Administration