Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00013871

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

300

Enrollment

Locations

7.5

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Hepatitis B Measles Pneumococcal Infections Pertussis	Biological: Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed Biological: Measles-Mumps-Rubella Vaccine (Live) Biological: Pneumococcal Vaccine, Polyvalent (23-valent) Biological: Pneumococcal Conjugate Vaccine, Heptavalent Biological: Hepatitis B Vaccine (Recombinant)	N/A

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 Design

Study Type:

Interventional

Primary Purpose:

Prevention

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)

Actual Study Completion Date :

Nov 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAB, Dept. of Ped., Div. of Infectious Diseases	Birmingham	Alabama	United States	35233
2	Long Beach Memorial Med. Ctr., Miller Children's Hosp.	Long Beach	California	United States	90801
3	Usc La Nichd Crs	Los Angeles	California	United States	90033
4	Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.	Oakland	California	United States	94609
5	UCSD Mother-Child-Adolescent Program CRS	San Diego	California	United States	92103
6	UCSF Pediatric AIDS CRS	San Francisco	California	United States	94143
7	Univ. of Colorado Denver NICHD CRS	Aurora	Colorado	United States	80218
8	Connecticut Children's Med. Ctr.	Hartford	Connecticut	United States
9	Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease	New Haven	Connecticut	United States	06504
10	Children's National Med. Ctr. Washington DC NICHD CRS	Washington	District of Columbia	United States
11	South Florida CDTC Ft Lauderdale NICHD CRS	Fort Lauderdale	Florida	United States
12	Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy	Gainesville	Florida	United States	32610
13	Univ. of Florida Jacksonville NICHD CRS	Jacksonville	Florida	United States	32209
14	Univ. of Miami Ped. Perinatal HIV/AIDS CRS	Miami	Florida	United States	33161
15	Columbus Regional HealthCare System, The Med. Ctr.	Columbus	Georgia	United States	31901
16	Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease	Chicago	Illinois	United States	60614
17	Chicago Children's CRS	Chicago	Illinois	United States	60637
18	Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology	Baltimore	Maryland	United States	21201
19	Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases	Baltimore	Maryland	United States	21287
20	HMS - Children's Hosp. Boston, Div. of Infectious Diseases	Boston	Massachusetts	United States	02115
21	BMC, Div. of Ped Infectious Diseases	Boston	Massachusetts	United States	02118
22	Baystate Health, Baystate Med. Ctr.	Springfield	Massachusetts	United States	01199
23	WNE Maternal Pediatric Adolescent AIDS CRS	Worcester	Massachusetts	United States	01655
24	Rutgers - New Jersey Medical School CRS	Newark	New Jersey	United States	07103
25	Bronx-Lebanon Hosp. IMPAACT CRS	Bronx	New York	United States	10457
26	Montefiore Med. Ctr. - AECOM	Bronx	New York	United States	19461
27	SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS	Brooklyn	New York	United States	11203
28	Schneider Children's Hosp., Div. of Infectious Diseases	New Hyde Park	New York	United States	11040
29	Nyu Ny Nichd Crs	New York	New York	United States	10016
30	Columbia IMPAACT CRS	New York	New York	United States	10032
31	Harlem Hosp. Ctr. NY NICHD CRS	New York	New York	United States	10037
32	Cornell Univ., Div. of Ped. Infectious Diseases & Immunology	New York	New York	United States
33	Metropolitan Hosp. Ctr.	New York	New York	United States
34	St. Luke's-Roosevelt Hosp. Ctr.	New York	New York	United States
35	Strong Memorial Hospital Rochester NY NICHD CRS	Rochester	New York	United States	14642
36	SUNY Stony Brook NICHD CRS	Stony Brook	New York	United States	11794
37	St. Christopher's Hosp. for Children	Philadelphia	Pennsylvania	United States
38	Texas Children's Hosp. CRS	Houston	Texas	United States	77030
39	San Juan City Hosp. PR NICHD CRS	San Juan		Puerto Rico
40	Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS	San Juan		Puerto Rico