Brief Title
Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs
Official Title
Evaluation of the Immunogenicity of Pneumococcal Conjugate Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Treated With Highly Active Antiretroviral Therapy (HAART)
Brief Summary
The purpose of this study is to determine if 2 doses of Pneumococcal Conjugate Vaccine (PCV)
followed by 1 dose of Pneumococcal Polysaccharide Vaccine (PPV) in HIV-infected children on
anti-HIV therapy is helpful and safe in fighting pneumococcal infections in this group of
children. This study will also look at the protection provided by childhood vaccination
against measles, pertussis, and hepatitis B virus.
Pneumococcal infections are the most common AIDS-related infection in HIV-infected children.
PCV may help reduce the chances of HIV-infected children getting pneumococcal infections.
This study will look at whether pneumococcal vaccines are safe and effective in HIV-infected
children receiving HAART. It will look at whether HIV-infected children are protected by
childhood vaccines received previously and if more doses are safe and improve protection.
Detailed Description
Infection by Streptococcus pneumoniae is the most frequent opportunistic infection observed
in HIV-infected children. PCVs are immunogenic and efficacious in normal children and offer
hope of reducing pneumococcal infections in HIV-infected children. The degree to which
children on HAART are protected by prior immunizations and are responsive to new
immunizations is still largely undefined. This study is designed to answer whether PCV
immunizations are safe and effective. The immune responses to prior immunizations and
responsiveness to booster doses of vaccines against measles, pertussis, and hepatitis B virus
of children on HAART will also be examined. Answers to these questions will determine whether
these children are likely to be protected against these clinically relevant pathogens and
whether they should routinely receive booster doses of these vaccines after a period of
HAART.
Patients are stratified on the basis of CD4 percentage and age. Patients that previously
received a primary hepatitis B vaccine (HBV) series receive an HBV immunization at entry.
Other vaccinations may be given (based on age and/or CD4 cell measurement, and immunization
status) for PCV at entry and 2 months, and measles-mumps-rubella (MMR) vaccine and PPV at 4
months. Some patients may be administered DTaP at a 6-month visit on the basis of age,
previous immunization history, and negative tetanus antibody status. Follow-up visits are
done at 8, 12, and 24 months. Blood samples are collected at all clinic visits for assessment
of HIV RNA, immune responses against pneumococcus, measles, pertussis, and hepatitis B virus,
as well as for laboratory evaluations.
Study Type
Interventional
Condition
HIV Infections
Intervention
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
300
Completion Date
November 2004
Eligibility Criteria
Inclusion Criteria
Patients may be eligible for this study if they:
- Are 2 to 18 years of age.
- Are HIV-infected.
- Have a viral load (amount of HIV in the blood) under 60,000 copies/ml within 30 days
of study entry.
- Have been on their current anti-HIV drugs for at least 3 months.
- Have received 4 or more doses of a pertussis vaccine.
- Have received 1 or more doses of measles vaccine unless a CD4 percent or CD4 number
ruled out taking the vaccine. (This reflects a change in the CD4 requirement.)
- Expect to be able to complete all study injections and follow-up.
- Have a negative pregnancy test if able to have children and use effective methods of
birth control.
- Have parent or guardian's consent if under 18 years of age.
- Have received an approved hepatitis B vaccine series. Not required for study entry,
but children who have received this vaccine will be studied.
- (This study was changed to allow patients who became HIV infected after birth, have a
viral load between 30,000 and 60,000 copies/ml, and who have been on their current
anti-HIV drugs for 3 to 6 months.)
Exclusion Criteria
Patients will not be eligible for this study if they:
- Had a certain CD4 level before beginning anti-HIV drugs and at screening.
- Have received any killed vaccine within 4 weeks, or any live vaccine within 6 weeks,
of entering the study.
- Have received pneumococcal vaccines or had a reaction to PPV.
- Have had an allergic reaction to any measles or hepatitis B vaccines, or to other
routine childhood immunizations if 13 years of age or less.
- Have any other condition that would make receiving study vaccines inadvisable.
- Are currently on medications that affect the immune system, except for G-CSF and
erythropoietin. This includes the equivalent to more than 1 mg/kg/day of prednisone in
the 2 weeks preceding study screening. Nonsteroidal anti-inflammatory agents and
inhaled corticosteroids are not excluded.
- Have received certain blood products within the previous 6 months.
- Have other diseases of the immune system.
- Have had cancer within 3 months of study screening or are being treated or have been
treated for cancer within 3 months of study entry.
- Are pregnant.
- Have any other disease or previous surgery that would interfere with study treatment.
- Are likely to have bleeding disorders.
- Show certain side effects to vaccines at screening.
Gender
All
Ages
2 Years - 18 Years
Accepts Healthy Volunteers
No
Contacts
Mark Abzug, ,
Location Countries
Puerto Rico
Location Countries
Puerto Rico
Administrative Informations
NCT ID
NCT00013871
Organization ID
P1024
Secondary IDs
PACTG 1024
Responsible Party
Sponsor
Study Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Sponsor
Mark Abzug, Study Chair,
Verification Date
November 2013