Primary Immune DeficiencyPhase 4NCT00023504
Antibody Production in Immune Disorders
A Phase 4 study testing Pneumovax, Rabavert and Prevnar in people with Primary Immune Deficiency, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This study will evaluate immune function in people with a known or suspected immune disorder. It will determine participants immune response to vaccines by measuring blood antibody levels after vaccination. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Primary Immune Deficiency
- What is being tested?
- Pneumovax, Rabavert and Prevnar
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2002to 14 Oct 2021
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Individuals being evaluated by NIH investigators for known or suspected primary immune disorders.
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for at least 21 days prior to receipt of each vaccine and for the duration of study participation.
Who cannot join
- Documented HIV infection.
- Active malignancy.
- Immunosuppressive therapy, other than steroids.
- Symptomatic cardiac disease or ongoing treatment for it.
- Pregnant or lactating women (due to restrictions on use of vaccines).
- Surgery during the two weeks prior to entry.
Show all 18Show fewer
- Serious, ongoing, or uncontrolled infections.
- Platelet count less than 40,000/microL or other coagulation disorder.
- Any other major illness that, in the investigator's judgment, may substantially increase the risk associated with the patient's participation in this study.
- History of previous systemic reaction to the particular vaccine product being considered for administration.
- For RabAvert, persons known to be sensitive to:
- Processed bovine gelatin
- Chicken protein
- Neomycin
- Chlortetrycyline
- Amphotericin B
- For Prevnar, persons with know or possible latex sensitivity.
- The effects of the vaccines on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for at least 21 days prior to each vaccine and for the duration of study participation. Females of child bearing age will have a pregnancy test prior to each vaccination. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform study staff and her primary care physician immediately.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Evaluation of Immune Response to Vaccines in Primary Immune Disorders
This study will evaluate immune function in people with a known or suspected immune disorder. It will determine participants immune response to vaccines by measuring blood antibody levels after vaccination.
Patients enrolled in a NIH protocol involving immune reconstitution (bone marrow transplantation or gene therapy) for a known or suspected primary immune disorder may be eligible for this study.
Read more
Participants may be asked to have more than one vaccine, based on their age, use of IVIG, past immunization history and underlying immune problem. The possible vaccinations include:
Rabies vaccine
Diphtheria and tetanus booster
23 valent pneumococcal polysaccharide vaccine
Pneumococcal 7-valent conjugate vaccine
The diphtheria, tetanus, pneumococcus and rabies vaccines are approved by the Food and Drug Administration (FDA) and used routinely to protect against disease.
Study participants will have a blood sample drawn before vaccination. The number of additional samples collected will vary according to the vaccines administered; 1 for rabies; 1 for tetanus; and 1 to 2 for the pneumococcal vaccines. Each sample will be up to 5 teaspoonfuls. Participation in the study may last up to a year, depending on the blood sampling scheduling
Read the detailed description
The purpose of this study is to evaluate immune responses to vaccines in subjects (both children and adults) with known or suspected primary immune disorders. We intend to characterize immune responsiveness to standard, well characterized antigens (vaccines) in subjects with primary immune disorders, and/or in subjects who have received treatments to correct their primary immune disorders. This will be an open label, prospective study investigating the functional status of the adaptive immune system. Up to 50 subjects may be enrolled. It is anticipated that subjects will be referred by any investigators at NIH studying inherited disorders of the immune system under their own protocols.
After giving standard vaccines, we will test specific antibody. The vaccines include licensed and universally mandated diphtheria and tetanus toxoid, two licensed pneumococcal vaccine formulations recommended for protection of children from pneumonia, and rabies vaccine licensed in 1997 (not the formerly available reaction-prone formulation). We will obtain peripheral blood samples from subjects before vaccination and at a specific time intervals after vaccination. Measurement of specific antibody titers will be conducted by the immunology laboratory at the Department of Laboratory Medicin at the NIH. Subjects may be offered one or more of the vaccines based on available information about their exposure history and their immune status, and the vaccines may be offered sequentially or in combination to shorten study time.
While the vaccines used here are often medically indicated and given outside of research protocols both to provide protection and to assess immune responses, the investigators have elected to use a protocol for the following reasons:
- Enhancement of subject understanding of the use of vaccines for in vivo assessment of immune responses.
- Emphasis on the importance of obtaining pre- and post-immunization blood samples to monitor how well the body's immune system is working.
- Administration of rabies vaccine to subjects who would not ordinarily need it.
- Recognition that vaccine side effects have been widely publicized and may be of concern to potential enrollees.
- Conditions
- Primary Immune Deficiency
- Being tested
- Pneumovax, Rabavert, Prevnar, Tetanus diphtheria toxoid
- Keywords
- Antibody, Vaccination
- Medical subject headings
- Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PneumovaxBiological
To determine the function of T and B cells in vivo using immunizations in patients with known or suspected immune disorders.
RabavertBiological
To determine the function of T and B cells in vivo using immunizations in patients with known or suspected immune disorders.
PrevnarBiological
To determine the function of T and B cells in vivo using immunizations in patients with known or suspected immune disorders.
Tetanus diphtheria toxoidBiological
To determine the function of T and B cells in vivo using immunizations in patients with known or suspected immune disorders.
| Study group | Role | What they receive |
|---|---|---|
| Pneumococcal Vaccine | Active comparator | To determine the function of T and B cells in vivo using Pneumococcal vaccine immunization in patients with known or suspected immune disorders. Receives: Biological: Pneumovax; Biological: Prevnar; Biological: Tetanus diphtheria toxoid |
| Rabies Vaccine | Active comparator | To determine the function of T and B cells in vivo using Rabies vaccine immunization in patients with known or suspected immune disorders. Receives: Biological: Rabavert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post vaccine antibody level
To determine the function of T and B cells in vivo using immunizations in patients with known or suspected immune disorders.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2001 (estimated)
- Study start13 Jun 2002
- Primary completion22 May 2017
- Study completion14 Oct 2021
Why it stopped: Slow/Insufficient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune DeficiencyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Gulbu Uzel, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00023504
- Sponsor's protocol ID
- 010226
- Other IDs
- 01-I-0226
- Status last verified
- Oct 2021
- First submitted
- 7 Sep 2001
- Last updated
- 15 Oct 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immune Response to Vaccines in Primary Immune Disorders
- ClinicalTrials.gov ID
- NCT00023504
- Acronym / sponsor ID
- 010226
- Conditions
- Primary Immune Deficiency
- Keywords
- Antibody, Vaccination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow/Insufficient accrual
- Enrolment
- 21 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 13 Jun 2002 (actual)
- Primary completion
- 22 May 2017 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 10 Sep 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.
This study will evaluate immune function in people with a known or suspected immune disorder. It will determine participants immune response to vaccines by measuring blood antibody levels after vaccination.
Patients enrolled in a NIH protocol involving immune reconstitution (bone marrow transplantation or gene therapy) for a known or suspected primary immune disorder may be eligible for this study.
Participants may be asked to have more than one vaccine, based on their age, use of IVIG, past immunization history and underlying immune problem. The possible vaccinations include:
Rabies vaccine
Diphtheria and tetanus booster
23 valent pneumococcal polysaccharide vaccine
Pneumococcal 7-valent conjugate vaccine
The diphtheria, tetanus, pneumococcus and rabies vaccines are approved by the Food and Drug Administration (FDA) and used routinely to protect against disease.
Study participants will have a blood sample drawn before vaccination. The number of additional samples collected will vary according to the vaccines administered; 1 for rabies; 1 for tetanus; and 1 to 2 for the pneumococcal vaccines. Each sample will be up to 5 teaspoonfuls. Participation in the study may last up to a year, depending on the blood sampling scheduling
Detailed description
The purpose of this study is to evaluate immune responses to vaccines in subjects (both children and adults) with known or suspected primary immune disorders. We intend to characterize immune responsiveness to standard, well characterized antigens (vaccines) in subjects with primary immune disorders, and/or in subjects who have received treatments to correct their primary immune disorders. This will be an open label, prospective study investigating the functional status of the adaptive immune system. Up to 50 subjects may be enrolled. It is anticipated that subjects will be referred by any investigators at NIH studying inherited disorders of the immune system under their own protocols.
After giving standard vaccines, we will test specific antibody. The vaccines include licensed and universally mandated diphtheria and tetanus toxoid, two licensed pneumococcal vaccine formulations recommended for protection of children from pneumonia, and rabies vaccine licensed in 1997 (not the formerly available reaction-prone formulation). We will obtain peripheral blood samples from subjects before vaccination and at a specific time intervals after vaccination. Measurement of specific antibody titers will be conducted by the immunology laboratory at the Department of Laboratory Medicin at the NIH. Subjects may be offered one or more of the vaccines based on available information about their exposure history and their immune status, and the vaccines may be offered sequentially or in combination to shorten study time.
While the vaccines used here are often medically indicated and given outside of research protocols both to provide protection and to assess immune responses, the investigators have elected to use a protocol for the following reasons:
- Enhancement of subject understanding of the use of vaccines for in vivo assessment of immune responses.
- Emphasis on the importance of obtaining pre- and post-immunization blood samples to monitor how well the body's immune system is working.
- Administration of rabies vaccine to subjects who would not ordinarily need it.
- Recognition that vaccine side effects have been widely publicized and may be of concern to potential enrollees.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pneumococcal Vaccine | Active comparator | Biological: Pneumovax, Biological: Prevnar, Biological: Tetanus diphtheria toxoidTo determine the function of T and B cells in vivo using Pneumococcal vaccine immunization in patients with known or suspected immune disorders. |
| Rabies Vaccine | Active comparator | Biological: RabavertTo determine the function of T and B cells in vivo using Rabies vaccine immunization in patients with known or suspected immune disorders. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals being evaluated by NIH investigators for known or suspected primary immune disorders.
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for at least 21 days prior to receipt of each vaccine and for the duration of study participation.
Key exclusion criteria (18 listed)
- Documented HIV infection.
- Active malignancy.
- Immunosuppressive therapy, other than steroids.
- Symptomatic cardiac disease or ongoing treatment for it.
- Pregnant or lactating women (due to restrictions on use of vaccines).
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 |
|---|---|---|
| PneumovaxTo determine the function of T and B cells in vivo using immunizations in patients with known or suspected immune disorders. | Biological | Pneumococcal Vaccine |
| RabavertTo determine the function of T and B cells in vivo using immunizations in patients with known or suspected immune disorders. | Biological | Rabies Vaccine |
| PrevnarTo determine the function of T and B cells in vivo using immunizations in patients with known or suspected immune disorders. | Biological | Pneumococcal Vaccine |
| Tetanus diphtheria toxoidTo determine the function of T and B cells in vivo using immunizations in patients with known or suspected immune disorders. | Biological | Pneumococcal Vaccine |
Primary outcome
Post vaccine antibody level
Time frame: 28 days
To determine the function of T and B cells in vivo using immunizations in patients with known or suspected immune disorders.
Results and safety
The study was stopped early (reason given: Slow/Insufficient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- NIH Clinical Center Detailed Web PageLink 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.
Gulbu Uzel, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pneumovax, Rabavert and Prevnar in people with Primary Immune Deficiency, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 2 inclusion and 18 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: stopped early, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow/Insufficient accrual). Results are not available in the source record.
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?
Post vaccine antibody level (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2021.