Active ImmunityNCT00005907
Comparison of Immune Response to Booster Vaccines in Blood Transplant Patients and Healthy Volunteers
An observational study of Active Immunity and Healthy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This study will compare the immune system response to booster vaccines for tetanus/diphtheria and hepatitis B in healthy volunteers with that of patients who have had a blood transplant. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Active Immunity, Healthy, Stem Cell Transplantation
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2000to May 2002
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
HEALTHY VOLUNTEERS:
Male or female subjects who are at least 18 years of age, but no older than 60 years of age.
Received complete hepatitis B and/or tetanus/diphtheria vaccination series.
If female, have a negative urine or serum pregnancy test within two weeks prior to entry into this study, and agree to avoid pregnancy during entire participation through the use of effective birth control or abstinence.
Volunteers reporting good general health and denying any illness that can adversely affect an immune response to a vaccine.
No history of a serious adverse event associated with any previous vaccination.
Not participating in another experimental vaccine study.
Serum hemoglobin greater than or equal to 11 g/dL.
No history of hepatitis B.
Must not have received a tetanus/diphtheria or hepatitis B booster in the last 6 months.
HSCT VOLUNTEERS:
Male or female subjects who are at least 5 years of age, but no older than 60 years of age.
Be enrolled in a HSCT protocol at NIH.
Be greater than or equal to 3 months post-HSCT.
Received tetanus/diphtheria vaccination series.
If female, have a negative urine or serum pregnancy test within two weeks prior to entry into this study, and agree to avoid pregnancy during entire participation through the use of effective birth control or abstinence.
No history of a serious adverse event associated with any previous vaccination.
Not participating in another experimental vaccine study.
Serum hemoglobin greater than or equal to 9 g/dL.
No history of hepatitis B.
Not receiving any more than replacement glucocorticoid therapy.
Not receiving any dose of cyclosporine.
No acute graft-versus-host disease grade II or higher, at time of consideration for study.
No chronic graft-versus-host disease more involved than localized skin lesions and/or liver dysfunction, at time of consideration for study.
Must not have received a tetanus/diphtheria or hepatitis B booster in the last 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892
About this study
Official title: Evaluation of Hepatitis B Surface Antigen-Specific and Tetanus Toxoid-Specific Lymphocytes
This study will compare the immune system response to booster vaccines for tetanus/diphtheria and hepatitis B in healthy volunteers with that of patients who have had a blood transplant. (A blood transplant is an infusion of donated stem cells-i.e., cells that mature into white blood cells, red blood cells and platelets). The study will also look at how age of the blood cell donor and recipient, the type of blood transplant, the amount of certain types of white cells in donor blood, and other variables may influence the vaccine response among the transplant patients.
This study includes normal volunteers and patients who have had a blood transplant. Healthy volunteers between the ages of 18 and 60 who have previously been vaccinated with the hepatitis B or tetanus/diphtheria vaccine and have not had hepatitis B may be eligible for this study. Patients enrolled in a blood cell transplant study at NIH who are between 5 and 60 years old, have been vaccinated against tetanus/diphtheria, and have not had hepatitis B may be eligible. Candidates will be screened with a medical history and blood tests.
Those enrolled in the study will have about 2 tablespoons of blood drawn before vaccination with a standard tetanus/diphtheria booster shot. Volunteers who have previously been vaccinated with the hepatitis B vaccine and all blood transplant patients will also receive a hepatitis B vaccination. Participants will have blood drawn (from 1 to 5 tablespoons) up to once a week after vaccination for no more than 8 weeks to evaluate the immune response to vaccination.
Read the detailed description
This study will compare booster vaccine responses in patients undergoing hematopoietic stem cell transplant (HSCT) to a group of healthy volunteers. Responses among different types of HSCT will be compared to each other as well. Serum antibody titers to vaccine antigens and quantification of antigen specific lymphocytes will be followed. Approximately 15 healthy subjects and 40 patients will be enrolled.
- Conditions
- Active Immunity, Healthy, Stem Cell Transplantation
- Keywords
- B Cell, Reconstitution, T Cell, Transplant, Vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2000 (estimated)
- Study startJun 2000
- Study completionMay 2002
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 Active ImmunityStudies 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
- Observational
- Enrolment
- 55 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005907
- Sponsor's protocol ID
- 000144
- Other IDs
- 00-I-0144
- Status last verified
- May 2002
- First submitted
- 9 Jun 2000
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Li Volti S, Mauro L, Di Gregorio F, Romeo MA, Lupo L, Pizzarelli G, Mangiagli A, Giammanco G, Russo G. Immune status and immune response to diphtheria-tetanus and polio vaccines in allogeneic bone marrow-transplanted thalassemic patients. Bone Marrow Transplant. 1994 Aug;14(2):225-7.
PubMed 7994236Ljungman P, Cordonnier C, de Bock R, Einsele H, Engelhard D, Grundy J, Link H, Locasciulli A, Prentice G, Reusser P, et al. Immunisations after bone marrow transplantation: results of a European survey and recommendations from the infectious diseases working party of the European Group for Blood and Marrow Transplantation. Bone Marrow Transplant. 1995 Mar;15(3):455-60.
PubMed 7599572Singhal S, Mehta J. Reimmunization after blood or marrow stem cell transplantation. Bone Marrow Transplant. 1999 Apr;23(7):637-46. doi: 10.1038/sj.bmt.1701640.
PubMed 10218839
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hepatitis B Surface Antigen-Specific and Tetanus Toxoid-Specific Lymphocytes
- ClinicalTrials.gov ID
- NCT00005907
- Acronym / sponsor ID
- 000144
- Conditions
- Active Immunity, Healthy, Stem Cell Transplantation
- Keywords
- B Cell, Reconstitution, T Cell, Transplant, Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jun 2000
- Study completion
- May 2002
- First posted
- 12 Jun 2000 (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 compare the immune system response to booster vaccines for tetanus/diphtheria and hepatitis B in healthy volunteers with that of patients who have had a blood transplant. (A blood transplant is an infusion of donated stem cells-i.e., cells that mature into white blood cells, red blood cells and platelets). The study will also look at how age of the blood cell donor and recipient, the type of blood transplant, the amount of certain types of white cells in donor blood, and other variables may influence the vaccine response among the transplant patients.
This study includes normal volunteers and patients who have had a blood transplant. Healthy volunteers between the ages of 18 and 60 who have previously been vaccinated with the hepatitis B or tetanus/diphtheria vaccine and have not had hepatitis B may be eligible for this study. Patients enrolled in a blood cell transplant study at NIH who are between 5 and 60 years old, have been vaccinated against tetanus/diphtheria, and have not had hepatitis B may be eligible. Candidates will be screened with a medical history and blood tests.
Those enrolled in the study will have about 2 tablespoons of blood drawn before vaccination with a standard tetanus/diphtheria booster shot. Volunteers who have previously been vaccinated with the hepatitis B vaccine and all blood transplant patients will also receive a hepatitis B vaccination. Participants will have blood drawn (from 1 to 5 tablespoons) up to once a week after vaccination for no more than 8 weeks to evaluate the immune response to vaccination.
Detailed description
This study will compare booster vaccine responses in patients undergoing hematopoietic stem cell transplant (HSCT) to a group of healthy volunteers. Responses among different types of HSCT will be compared to each other as well. Serum antibody titers to vaccine antigens and quantification of antigen specific lymphocytes will be followed. Approximately 15 healthy subjects and 40 patients will be enrolled.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 4 Mar 2008.
- Background: PubMed 7994236Li Volti S, Mauro L, Di Gregorio F, Romeo MA, Lupo L, Pizzarelli G, Mangiagli A, Giammanco G, Russo G. Immune status and immune response to diphtheria-tetanus and polio vaccines in allogeneic bone marrow-transplanted thalassemic patients. Bone Marrow Transplant. 1994 Aug;14(2):225-7.
- Background: PubMed 7599572Ljungman P, Cordonnier C, de Bock R, Einsele H, Engelhard D, Grundy J, Link H, Locasciulli A, Prentice G, Reusser P, et al. Immunisations after bone marrow transplantation: results of a European survey and recommendations from the infectious diseases working party of the European Group for Blood and Marrow Transplantation. Bone Marrow Transplant. 1995 Mar;15(3):455-60.
- Background: PubMed 10218839Singhal S, Mehta J. Reimmunization after blood or marrow stem cell transplantation. Bone Marrow Transplant. 1999 Apr;23(7):637-46. doi: 10.1038/sj.bmt.1701640.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Active Immunity and Healthy, 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.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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.
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 NCT00005907, 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 4 Mar 2008.