InfluenzaNCT00311727
Cell-Mediated Immune Responses to Influenza A/H5N1 Vaccine
A study testing Influenza A/H5N1 in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial summary
This study may determine whether laboratory studies of people's blood cells, who have received vaccines against H5 influenza, or "bird flu," will help to decide if the vaccines are going to be prevent disease effectively. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza A/H5N1
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2005to Mar 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects who are eligible and enrolled in the main monovalent subvirion H5 vaccine trials [Division of Microbiology and Infectious Diseases (DMID) studies 04-063 and 04-076] and have agreed to the extra blood draws for the cell-mediated immunity (CMI) sub-study will be enrolled.
- Subjects will not be recruited outside the main vaccine trials or future DMID sponsored influenza A/H5N1 studies.
- Subjects who understand and sign the consent form for this study.
- Subjects who meet pre-screening qualifications for the DMID study will be eligible for the initial pre-vaccination blood draw.
- Subjects who meet all inclusion criteria for the DMID study and who are vaccinated will be allowed to participate in the remaining portions of this study.
Who cannot join
- 1. All subjects who are ineligible for the main monovalent subvirion H5 vaccine trials will not be eligible for the cell-mediated immunity (CMI) sub-study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Maryland Baltimore
Baltimore, Maryland, 21201
Vanderbilt University
Nashville, Tennessee, 37232-2581
University of Rochester
Rochester, New York, 14642
About this study
This study may determine whether laboratory studies of people's blood cells, who have received vaccines against H5 influenza, or "bird flu," will help to decide if the vaccines are going to be prevent disease effectively. About 232 people, 18 years and older, enrolled in the studies "A Randomized, Double-Blinded, Placebo-Controlled, Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine in Healthy Adults" and "in Healthy Elderly Adults" will participate. Participants may be involved in this study for about 14 months. Procedures may include blood draws, physical exams, and medical history reviews.
Read the detailed description
This study is linked to DMID protocol 04-063 and 04-076, "A Randomized, Double Blinded, Placebo-ontrolled, Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine in Healthy Adults (04-063)" and also "in Healthy Elderly Adults" (04-076). All adult subjects enrolled in the main vaccine trials at Vanderbilt (04-076), Maryland (04-063), and Rochester (04-063) will be eligible for enrollment in the cell-mediated immune response sub-study. A maximum of 232 healthy ambulatory male and female subjects; 180 subjects 18 to 64 years old and 64 subjects aged 65 years and older, in the United States, could be enrolled. The primary objectives are: to establish a reproducible, functional cell-mediated immune response assay to evaluate the magnitude and functional capacity of T cells responding to monovalent subvirion H5 influenza vaccine and to evaluate the percent of subjects demonstrating a CD4+ and/or CD8+ response approximately 14 days after the first vaccination and 14 days and 6 months after the second vaccination (04-063), and 14 days after the first and second vaccination and 14 days and 6 months after the third vaccination (04-076). The secondary objectives are: to evaluate dose-related and age-related humoral immunogenicity compared to the cellular immune responses approximately 14 days after the first vaccination and 14 days and 6 months after the second vaccination (04-063), and 14 days after the first and second vaccination and 14 days and 6 months after the third vaccination (04-076) and to establish CMI assays that can be applied to future avian vaccine immunogenicity evaluation, such as the Chiron H9N2 avian influenza vaccine, future H7 vaccines, or vaccines with other avian HA molecules. The study outcome measure, immunogenicity will be based on H5 strain-specific cell-mediated immunity measured 14 days after the first, second, and third (04-076 only) dose, and month 6 after the last dose of vaccine.
- Conditions
- Influenza
- Being tested
- Influenza A/H5N1
- Keywords
- Cell-Mediated Immune Responses, Influenza, A/H5N1, Vaccine, sub-study
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza A/H5N1Biological
232 subjects receive Influenza A/H5N1 vaccine as part of DMID protocols 04-063 and 04-076.
| Study group | Role | What they receive |
|---|---|---|
| Influenza A/H5N1 | Experimental | 232 subjects receiving Influenza A/H5N1 vaccine. Receives: Biological: Influenza A/H5N1 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2006 (estimated)
- Study startOct 2005
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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
- Allocation
- Non-randomised
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311727
- Sponsor's protocol ID
- 05-0006
- Status last verified
- May 2007
- First submitted
- 5 Apr 2006
- Last updated
- 16 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell-Mediated Immune Responses to Influenza A/H5N1 Vaccine
- ClinicalTrials.gov ID
- NCT00311727
- Acronym / sponsor ID
- 05-0006
- Conditions
- Influenza
- Keywords
- Cell-Mediated Immune Responses, Influenza, A/H5N1, Vaccine, sub-study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Oct 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 6 Apr 2006 (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 may determine whether laboratory studies of people's blood cells, who have received vaccines against H5 influenza, or "bird flu," will help to decide if the vaccines are going to be prevent disease effectively. About 232 people, 18 years and older, enrolled in the studies "A Randomized, Double-Blinded, Placebo-Controlled, Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine in Healthy Adults" and "in Healthy Elderly Adults" will participate. Participants may be involved in this study for about 14 months. Procedures may include blood draws, physical exams, and medical history reviews.
Detailed description
This study is linked to DMID protocol 04-063 and 04-076, "A Randomized, Double Blinded, Placebo-ontrolled, Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine in Healthy Adults (04-063)" and also "in Healthy Elderly Adults" (04-076). All adult subjects enrolled in the main vaccine trials at Vanderbilt (04-076), Maryland (04-063), and Rochester (04-063) will be eligible for enrollment in the cell-mediated immune response sub-study. A maximum of 232 healthy ambulatory male and female subjects; 180 subjects 18 to 64 years old and 64 subjects aged 65 years and older, in the United States, could be enrolled. The primary objectives are: to establish a reproducible, functional cell-mediated immune response assay to evaluate the magnitude and functional capacity of T cells responding to monovalent subvirion H5 influenza vaccine and to evaluate the percent of subjects demonstrating a CD4+ and/or CD8+ response approximately 14 days after the first vaccination and 14 days and 6 months after the second vaccination (04-063), and 14 days after the first and second vaccination and 14 days and 6 months after the third vaccination (04-076). The secondary objectives are: to evaluate dose-related and age-related humoral immunogenicity compared to the cellular immune responses approximately 14 days after the first vaccination and 14 days and 6 months after the second vaccination (04-063), and 14 days after the first and second vaccination and 14 days and 6 months after the third vaccination (04-076) and to establish CMI assays that can be applied to future avian vaccine immunogenicity evaluation, such as the Chiron H9N2 avian influenza vaccine, future H7 vaccines, or vaccines with other avian HA molecules. The study outcome measure, immunogenicity will be based on H5 strain-specific cell-mediated immunity measured 14 days after the first, second, and third (04-076 only) dose, and month 6 after the last dose of vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Influenza A/H5N1 | Experimental | Biological: Influenza A/H5N1232 subjects receiving Influenza A/H5N1 vaccine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All subjects who are eligible and enrolled in the main monovalent subvirion H5 vaccine trials [Division of Microbiology and Infectious Diseases (DMID) studies 04-063 and 04-076] and have agreed to the extra blood draws for the cell-mediated immunity (CMI) sub-study will be enrolled.
- Subjects will not be recruited outside the main vaccine trials or future DMID sponsored influenza A/H5N1 studies.
- Subjects who understand and sign the consent form for this study.
- Subjects who meet pre-screening qualifications for the DMID study will be eligible for the initial pre-vaccination blood draw.
- Subjects who meet all inclusion criteria for the DMID study and who are vaccinated will be allowed to participate in the remaining portions of this study.
Key exclusion criteria (1 listed)
- 1. All subjects who are ineligible for the main monovalent subvirion H5 vaccine trials will not be eligible for the cell-mediated immunity (CMI) sub-study.
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 |
|---|---|---|
| Influenza A/H5N1232 subjects receive Influenza A/H5N1 vaccine as part of DMID protocols 04-063 and 04-076. | Biological | Influenza A/H5N1 |
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 16 Aug 2013.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Influenza A/H5N1 in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites 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 5 inclusion and 1 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 16 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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 16 Aug 2013.