Immune System Function Following Vaccination in HIV Infected Children Taking Anti-HIV Drugs

HIV Infections Clinical Trial

Official title:

Evaluation of Immunologic Memory Following Pneumococcal, Hepatitis B, and Measles Vaccination in HIV Infected Children Treated With Highly Active Antiretroviral Therapy (HAART)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00257127
• Other study ID #: P1061s
• Secondary ID: 10132PACTG P1061
• Status: Completed
• Phase: N/A
• Start date: February 2006
• Est. completion date: August 2006

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine immune system function following vaccination in HIV-infected children currently taking anti-HIV drugs. To test the effectiveness of prior vaccination, patients in this study will receive booster shots of one of two pneumococcal vaccines, a hepatitis B vaccine, and a measles vaccine.

Description:

With their immunocompromised status, HIV-infected children are at especially high risk for opportunistic infections, including infection by Streptococcus pneumoniae, hepatitis B, and measles. In PACTG P1024, HIV-infected children taking highly active antiretroviral therapy (HAART) received 2 doses of the pneumococcal conjugate vaccine (PCV), 1 dose of the pneumococcal polysaccharide vaccine (PPV), and booster shots of the hepatitis B vaccine (HBV) and measles, mumps, and rubella vaccine (MMR). Early responses to these vaccinations were favorable, but with declining antibody responses within the 18 months after vaccination. It is unknown if additional booster vaccinations in these children will result in a protective immunologic memory upon re-exposure to these pathogens. This study will determine whether HIV-infected children on HAART have evidence of specific immunologic memory 3 to 4 years after vaccination in PACTG P1024.

Patients will be randomly assigned to receive PCV or PPV at study entry. All eligible patients will also receive HBV and MMR at study entry. Patients will be monitored in the clinic for 1 hour after vaccination for any adverse effects. Study staff will contact patients by phone around Day 3 after study entry to ask patients if they have experienced any adverse effects to the vaccinations; patients who received MMR at study entry will be contacted again around Day 21. Some patients may be asked to return to the clinic for further evaluation if they experience side effects.

There will be study visits at study entry and Days 7 and 28. Medical history, a physical exam, blood collection, and an assessment of HIV-related symptoms will occur at all visits. HAART will not be provided by this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 23 Years

Eligibility

Inclusion Criteria:

• Completed the 96-week initial study period of PACTG P1024 and had enrolled into that study between June 1, 2001 and March 31, 2002

• Fulfilled PACTG P1024's definition of HAART (taking 3 or more antiretrovirals [ARVs] from at least 2 of the available therapeutic drug classes) during PACTG P1024's vaccination period (Weeks 0 to 24). Patients who were taking 3 nucleoside reverse transcriptase inhibitors during that period without a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor (PI) are not eligible for this study. Nontherapeutic boosting doses of ritonavir used in ritonavir-boosted PI regimens are not counted as separate ARVs.

• Stable ARV regimen in the 4 weeks prior to study entry

• No changes anticipated to current ARV regimen during this study

• Willing to complete all study vaccinations and evaluations

• Willing to use acceptable forms of contraception, if applicable

• Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

• Abnormal blood or chemistry values on most recent laboratory tests. More information on this criterion can be found in the protocol.

• Received PCV, HBV, PPV, or MMR vaccines during PACTG P1024 in a sequence other than specified in PACTG P1024

• Received one or more doses of each of PCV, PPV, MMR, or HBV vaccines since the end of PACTG P1024's vaccination period

• Previous Grade 3 or higher adverse events or allergic reactions judged to be possibly or definitely related to the PCV, PPV, MMR, or HBV vaccines

• Received any killed vaccine within the 4 weeks prior to study entry

• Received any live vaccine within the 6 weeks prior to study entry

• Planning to receive any killed or live vaccine other than study vaccines between the first and third study visits

• Presence of an underlying condition that contraindicates use of any of the study vaccines. Patients who have a CD4% less than 15% will not be given the MMR vaccine, but such patients will not be excluded from this study.

• Current immunomodulatory therapy, including IL-2, any interferon product, GM-CSF, or thalidomide. Patients taking G-CSF or erythropoietin are not excluded.

• Anticipated need for immunomodulatory treatment during this study

• Any intramuscular immune globulin product within the 6 months prior to study entry

• Intravenous immune globulin within the 11 months prior to study entry

• Platelets or plasma products within the 7 months prior to study entry

• Anticipated need for immune globulin products during this study

• Current systemic immunosuppressive therapy, including the equivalent of 1 mg/kg/day or greater of prednisone in the 2 weeks prior to study entry. Patients using inhaled corticosteroids only are not excluded from this study. More information on this criterion can be found in the protocol.

• Anticipated need for systemic immunosuppressive therapy during this study

• Other known or suspected diseases of the immune system

• Cancer in the 3 months prior to study entry or treatment for cancer within the 3 months prior to study entry

• Other acute or chronic medical or surgical conditions or contraindications that, in the opinion of the investigator, may interfere with the study

• Known bleeding disorder

• Any Grade 2 or higher clinical toxicity at study screening. More information on this criterion can be found in the protocol.

• Require certain medications

• Pregnancy

Related Conditions & MeSH terms

• HIV Infections

Intervention

Biological:
• Pneumococcal 7-valent conjugate vaccine
0.5 mL administered intramuscularly
• Pneumococcal polysaccharide vaccine
0.5 mL administered intramuscularly
• Hepatitis B vaccine
0.5 mL administered intramuscularly
• Measles, mumps, and rubella virus vaccine, live
0.5 mL administered subcutaneously

Locations

Country	Name	City	State
Puerto Rico	San Juan City Hosp. PR NICHD CRS	San Juan
Puerto Rico	Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS	San Juan
United States	Usc La Nichd Crs	Alhambra	California
United States	Univ. of Colorado Denver NICHD CRS	Aurora	Colorado
United States	UAB, Dept. of Ped., Div. of Infectious Diseases	Birmingham	Alabama
United States	BMC, Div. of Ped Infectious Diseases	Boston	Massachusetts
United States	HMS - Children's Hosp. Boston, Div. of Infectious Diseases	Boston	Massachusetts
United States	Bronx-Lebanon Hosp. IMPAACT CRS	Bronx	New York
United States	SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS	Brooklyn	New York
United States	Chicago Children's CRS	Chicago	Illinois
United States	Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease	Chicago	Illinois
United States	South Florida CDTC Ft Lauderdale NICHD CRS	Fort Lauderdale	Florida
United States	Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy	Gainesville	Florida
United States	Univ. of Florida Jacksonville NICHD CRS	Jacksonville	Florida
United States	Long Beach Memorial Med. Ctr., Miller Children's Hosp.	Long Beach	California
United States	Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease	New Haven	Connecticut
United States	Children's Hosp.	New Orleans	Louisiana
United States	Harlem Hosp. Ctr. NY NICHD CRS	New York	New York
United States	Metropolitan Hosp. Ctr.	New York	New York
United States	Nyu Ny Nichd Crs	New York	New York
United States	Rutgers - New Jersey Medical School CRS	Newark	New Jersey
United States	St. Christopher's Hosp. for Children	Philadelphia	Pennsylvania
United States	Strong Memorial Hospital Rochester NY NICHD CRS	Rochester	New York
United States	UCSD Mother-Child-Adolescent Program CRS	San Diego	California
United States	SUNY Stony Brook NICHD CRS	Stony Brook	New York
United States	WNE Maternal Pediatric Adolescent AIDS CRS	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (1)

Obaro SK, Pugatch D, Luzuriaga K. Immunogenicity and efficacy of childhood vaccines in HIV-1-infected children. Lancet Infect Dis. 2004 Aug;4(8):510-8. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grade 3 or greater hematologic and chemistry laboratory values, signs, or symptoms not present, as specified by the protocol		At study entry
Secondary	Seropositivity, as determined by antibody levels		At study entry and Days 7 and 28
Secondary	Immunologic memory, as determined by primary and secondary responses, antibody levels, and additional measures of immunologic memory		Throughout study

External Links

•   Click here for more information about PACTG P1024
•   Haga clic aquí para ver información sobre este ensayo clínico en español