HIV InfectionsNCT00013871
Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs
A study testing Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed, Measles-Mumps-Rubella Vaccine (Live) and Pneumococcal Vaccine, Polyvalent (23-valent) in people with HIV Infections and Hepatitis B, run by National Institute of Allergy and Infectious Diseases (NIAID) at 40 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- HIV Infections, Hepatitis B, Measles
- What is being tested?
- Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed, Measles-Mumps-Rubella Vaccine (Live) and Pneumococcal Vaccine, Polyvalent (23-valent)
- Type of treatment
- Vaccines
- How many people
- 300 participants
- Where
- 40 sitesin 2 countries
- Study dates
- Start not givento Nov 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.)
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
40 sites in 2 countries.
40 sites in 2 countries
United States38 sites
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, 80218
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, 21201
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, 21287
UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, 35233
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, 02115
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts, 02118
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
Brooklyn, New York, 11203
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, 60614
Chicago Children's CRS
Chicago, Illinois, 60637
Columbus Regional HealthCare System, The Med. Ctr.
Columbus, Georgia, 31901
South Florida CDTC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida
Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
Gainesville, Florida, 32610
Connecticut Children's Med. Ctr.
Hartford, Connecticut
Texas Children's Hosp. CRS
Houston, Texas, 77030
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, 32209
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, 90801
Usc La Nichd Crs
Los Angeles, California, 90033
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, 33161
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
New Haven, Connecticut, 06504
Schneider Children's Hosp., Div. of Infectious Diseases
New Hyde Park, New York, 11040
Nyu Ny Nichd Crs
New York, New York, 10016
Columbia IMPAACT CRS
New York, New York, 10032
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, 10037
Cornell Univ., Div. of Ped. Infectious Diseases & Immunology
New York, New York
Metropolitan Hosp. Ctr.
New York, New York
St. Luke's-Roosevelt Hosp. Ctr.
New York, New York
Rutgers - New Jersey Medical School CRS
Newark, New Jersey, 07103
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, 94609
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, 14642
UCSD Mother-Child-Adolescent Program CRS
San Diego, California, 92103
UCSF Pediatric AIDS CRS
San Francisco, California, 94143
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, 01199
SUNY Stony Brook NICHD CRS
Stony Brook, New York, 11794
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, 10457
Montefiore Med. Ctr. - AECOM
The Bronx, New York, 19461
Children's National Med. Ctr. Washington DC NICHD CRS
Washington D.C., District of Columbia
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, 01655
Puerto Rico2 sites
San Juan City Hosp. PR NICHD CRS
San Juan
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan
About this study
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)
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.
Read the 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.
- Conditions
- HIV Infections, Hepatitis B, Measles, Pneumococcal Infections, Pertussis
- Being tested
- Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed, Measles-Mumps-Rubella Vaccine (Live), Pneumococcal Vaccine, Polyvalent (23-valent), Pneumococcal Conjugate Vaccine, Heptavalent, Hepatitis B Vaccine (Recombinant)
- Keywords
- Measles-Mumps-Rubella Vaccine, Antibodies, Viral, Hepatitis B Vaccines, Immunization, Secondary, Pneumococcal Vaccines, Antiretroviral Therapy, Highly Active, Diphtheria-Tetanus-acellular Pertussis Vaccines
- Medical subject headings
- HIV Infections, Hepatitis B, Measles, Pneumococcal Infections, Whooping Cough, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine AdsorbedBiological
Measles-Mumps-Rubella Vaccine (Live)Biological
Pneumococcal Vaccine, Polyvalent (23-valent)Biological
Pneumococcal Conjugate Vaccine, HeptavalentBiological
Hepatitis B Vaccine (Recombinant)Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Enrolment
- 300 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Mark Abzug, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00013871
- Sponsor's protocol ID
- P1024
- Other IDs
- PACTG 1024, 10609, ACTG P1024
- Status last verified
- Oct 2021
- First submitted
- 31 Mar 2001
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
Abzug 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.
PubMed 22693229Abzug 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.
PubMed 19663708Abzug 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.
PubMed 17938165
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00013871
- Acronym / sponsor ID
- P1024
- Conditions
- HIV Infections, Hepatitis B, Measles, Pneumococcal Infections, Pertussis
- Keywords
- Measles-Mumps-Rubella Vaccine, Antibodies, Viral, Hepatitis B Vaccines, Immunization, Secondary, Pneumococcal Vaccines, Antiretroviral Therapy, Highly Active, Diphtheria-Tetanus-acellular Pertussis Vaccines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study completion
- Nov 2004 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Derived from this study: PubMed 22693229Abzug 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.
- Derived from this study: PubMed 19663708Abzug 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.
- Derived from this study: PubMed 17938165Abzug 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Abzug study chair
40 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed, Measles-Mumps-Rubella Vaccine (Live) and Pneumococcal Vaccine, Polyvalent (23-valent) in people with HIV Infections and Hepatitis B, run by National Institute of Allergy and Infectious Diseases (NIAID) at 40 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00013871, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.