HIV InfectionsNCT00257127
Immune System Function Following Vaccination in HIV Infected Children Taking Anti-HIV Drugs
A study testing Pneumococcal 7-valent conjugate vaccine, Pneumococcal polysaccharide vaccine and Hepatitis B vaccine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 26 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 6 to 23 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Pneumococcal 7-valent conjugate vaccine, Pneumococcal polysaccharide vaccine and Hepatitis B vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 26 sitesin 2 countries
- Study dates
- Feb 2006to Aug 2006
- 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 6 to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
United States24 sites
Usc La Nichd Crs
Alhambra, California, 91803
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, 80045
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
Chicago Children's CRS
Chicago, Illinois, 60614
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, 60637
South Florida CDTC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, 33316
Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
Gainesville, Florida, 32610-0296
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, 32209
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, 90806
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
New Haven, Connecticut, 06510
Children's Hosp.
New Orleans, Louisiana, 70118
Nyu Ny Nichd Crs
New York, New York, 10016
Metropolitan Hosp. Ctr.
New York, New York, 10029
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, 10037
Rutgers - New Jersey Medical School CRS
Newark, New Jersey, 07103
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, 19134
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, 14642
UCSD Mother-Child-Adolescent Program CRS
San Diego, California, 92103
SUNY Stony Brook NICHD CRS
Stony Brook, New York, 11794-8111
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, 10457
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, 01605
Puerto Rico2 sites
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, 00935
San Juan City Hosp. PR NICHD CRS
San Juan, 00936
About this study
Official title: Evaluation of Immunologic Memory Following Pneumococcal, Hepatitis B, and Measles Vaccination in HIV Infected Children Treated With Highly Active Antiretroviral Therapy (HAART)
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.
Read the detailed 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.
- Conditions
- HIV Infections
- Being tested
- Pneumococcal 7-valent conjugate vaccine, Pneumococcal polysaccharide vaccine, Hepatitis B vaccine, Measles, mumps, and rubella virus vaccine, live
- Keywords
- Vaccination
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumococcal 7-valent conjugate vaccineBiological
Also called PCV
0.5 mL administered intramuscularly
Pneumococcal polysaccharide vaccineBiological
Also called PPV
0.5 mL administered intramuscularly
Hepatitis B vaccineBiological
Also called HBV
0.5 mL administered intramuscularly
Measles, mumps, and rubella virus vaccine, liveBiological
Also called MMR
0.5 mL administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients will receive PCV, HBV, and MMR at study entry Receives: Biological: Pneumococcal 7-valent conjugate vaccine; Biological: Hepatitis B vaccine; Biological: Measles, mumps, and rubella virus vaccine, live |
| 2 | Experimental | Patients will receive PPV, HBV, and MMR at study entry Receives: Biological: Pneumococcal polysaccharide vaccine; Biological: Hepatitis B vaccine; Biological: Measles, mumps, and rubella virus vaccine, live |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 3 or greater hematologic and chemistry laboratory values, signs, or symptoms not present, as specified by the protocol
Measured: At study entry
Secondary outcomes (2)
Seropositivity, as determined by antibody levels
Measured: At study entry and Days 7 and 28
Immunologic memory, as determined by primary and secondary responses, antibody levels, and additional measures of immunologic memory
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2005 (estimated)
- Study startFeb 2006
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
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, MD, Study chair, The Children's Hospital, Denver, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00257127
- Sponsor's protocol ID
- P1061s
- Other IDs
- 10132, PACTG P1061s
- Status last verified
- Oct 2021
- First submitted
- 18 Nov 2005
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
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. doi: 10.1016/S1473-3099(04)01106-5.
PubMed 15288824Abzug MJ, Song LY, Levin MJ, Nachman SA, Borkowsky W, Pelton SI; International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1024 and P1061s Protocol Teams. Antibody persistence and immunologic memory after sequential pneumococcal conjugate and polysaccharide vaccination in HIV-infected children on highly active antiretroviral therapy. Vaccine. 2013 Oct 1;31(42):4782-90. doi: 10.1016/j.vaccine.2013.08.002. Epub 2013 Aug 14.
PubMed 23954381
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 Immunologic Memory Following Pneumococcal, Hepatitis B, and Measles Vaccination in HIV Infected Children Treated With Highly Active Antiretroviral Therapy (HAART)
- ClinicalTrials.gov ID
- NCT00257127
- Acronym / sponsor ID
- P1061s
- Conditions
- HIV Infections
- Keywords
- Vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- 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 start
- Feb 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 22 Nov 2005 (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 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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Pneumococcal 7-valent conjugate vaccine, Biological: Hepatitis B vaccine, Biological: Measles, mumps, and rubella virus vaccine, livePatients will receive PCV, HBV, and MMR at study entry |
| 2 | Experimental | Biological: Pneumococcal polysaccharide vaccine, Biological: Hepatitis B vaccine, Biological: Measles, mumps, and rubella virus vaccine, livePatients will receive PPV, HBV, and MMR at study entry |
Who may qualify
- Ages
- 6 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (23 listed)
- 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
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 |
|---|---|---|
| Pneumococcal 7-valent conjugate vaccineAlso: PCV0.5 mL administered intramuscularly | Biological | 1 |
| Pneumococcal polysaccharide vaccineAlso: PPV0.5 mL administered intramuscularly | Biological | 2 |
| Hepatitis B vaccineAlso: HBV0.5 mL administered intramuscularly | Biological | 1, 2 |
| Measles, mumps, and rubella virus vaccine, liveAlso: MMR0.5 mL administered subcutaneously | Biological | 1, 2 |
Primary outcome
Grade 3 or greater hematologic and chemistry laboratory values, signs, or symptoms not present, as specified by the protocol
Time frame: At study entry
2 secondary outcomes
Seropositivity, as determined by antibody levels
Time frame: At study entry and Days 7 and 28
Immunologic memory, as determined by primary and secondary responses, antibody levels, and additional measures of immunologic memory
Time frame: Throughout study
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.
- Background: PubMed 15288824Obaro 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. doi: 10.1016/S1473-3099(04)01106-5.
- Derived from this study: PubMed 23954381Abzug MJ, Song LY, Levin MJ, Nachman SA, Borkowsky W, Pelton SI; International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1024 and P1061s Protocol Teams. Antibody persistence and immunologic memory after sequential pneumococcal conjugate and polysaccharide vaccination in HIV-infected children on highly active antiretroviral therapy. Vaccine. 2013 Oct 1;31(42):4782-90. doi: 10.1016/j.vaccine.2013.08.002. Epub 2013 Aug 14.
- Click here for more information about PACTG P1024Link provided by the sponsor.
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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, MD study chair
The Children's Hospital, Denver, CO
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pneumococcal 7-valent conjugate vaccine, Pneumococcal polysaccharide vaccine and Hepatitis B vaccine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 26 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 7 inclusion and 23 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 26 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.
What does the primary outcome measure?
Grade 3 or greater hematologic and chemistry laboratory values, signs, or symptoms not present, as specified by the protocol (time frame: At study entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00257127, which also lists 2 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; AzTrials last refreshed its copy on 6 Nov 2026.