Clinical trial · Interventional
Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs
Evaluation of the Immunogenicity of Pneumococcal Conjugate Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Treated With Highly Active Antiretroviral Therapy (HAART)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatitis B | — | UNRESOLVED | — |
| HIV Infections | — | UNRESOLVED | — |
| Measles | — | UNRESOLVED | — |
| Pertussis | — | UNRESOLVED | — |
| Pneumococcal Infections | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed | Biological | — | UNRESOLVED |
| Hepatitis B Vaccine (Recombinant) | Biological | — | UNRESOLVED |
| Measles-Mumps-Rubella Vaccine (Live) | Biological | — | UNRESOLVED |
| Pneumococcal Conjugate Vaccine, Heptavalent | Biological | — | UNRESOLVED |
| Pneumococcal Vaccine, Polyvalent (23-valent) | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- DERIVEDAbzug MJ, Qin M, Levin MJ, Fenton T, Beeler JA, Bellini WJ, Audet S, Sowers SB, Borkowsky W, Nachman SA, Pelton SI, Rosenblatt HM; International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1024 and P1061s Protocol Teams. Immunogenicity, immunologic memory, and safety following measles revaccination in HIV-infected children receiving highly active antiretroviral therapy. J Infect Dis. 2012 Aug 15;206(4):512-22. doi: 10.1093/infdis/jis386. Epub 2012 Jun 12. PMID 22693229
- DERIVEDAbzug MJ, Warshaw M, Rosenblatt HM, Levin MJ, Nachman SA, Pelton SI, Borkowsky W, Fenton T; International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1024 and P1061s Protocol Teams. Immunogenicity and immunologic memory after hepatitis B virus booster vaccination in HIV-infected children receiving highly active antiretroviral therapy. J Infect Dis. 2009 Sep 15;200(6):935-46. doi: 10.1086/605448. PMID 19663708
- DERIVEDAbzug MJ, Song LY, Fenton T, Nachman SA, Levin MJ, Rosenblatt HM, Pelton SI, Borkowsky W, Edwards KM, Peters J; International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1024 Protocol Team. Pertussis booster vaccination in HIV-infected children receiving highly active antiretroviral therapy. Pediatrics. 2007 Nov;120(5):e1190-202. doi: 10.1542/peds.2007-0729. Epub 2007 Oct 15. PMID 17938165