InfluenzaPhase 2NCT00240968
H5 Booster After a Two Dose Schedule
A Phase 2 study testing Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial summary
The purpose of this study is to determine whether a third dose of vaccines containing A/Vietnam/1203/04 provides more immunity than two doses. Subjects who participate in this study will have participated in DMID protocol 04-063 involving the A/Vietnam/1203/04. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 337 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2005to Jul 2006
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Previous recipient of inactivated Influenza A/H5N1 vaccine in study DMID 04-063.
- Male or nonpregnant female (as indicated by a negative urine pregnancy test immediately prior to vaccine administration) between the ages of 18 and 65 years, inclusive.
- Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (i.e., barrier method, abstinence, and licensed hormonal methods) for the entire study period.
- Is in good health, as determined by vital signs (heart rate, blood pressure, oral temperature), medical history and a targeted physical examination based on medical history.
- Able to understand and comply with planned study procedures.
- Provides informed consent prior to any study procedures and is available for all study visits.
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- In order to be eligible to participate in the blood specimen collection substudy, subjects must also meet the following additional inclusion criteria:
- Previously achieved a 4-fold or greater increase from baseline in GMT following the second immunization with A/H5N1 approximately 28 days after dose 2 of study DMID 04-063 (approximately Day 56).
- Agrees to the storage of clinical specimens for an indefinite period of time at a central laboratory for use in future research.
Who cannot join
- Received placebo in DMID Study 04-063.
- Known allergy to eggs or other components of the vaccine or latex.
- Has a positive urine pregnancy test prior to vaccination (if female of childbearing potential) or women who are breastfeeding.
- Is undergoing immunosuppression as a result of an underlying illness or treatment.
- Has or had a neoplastic disease diagnosed or treated within the last 5 years or any lifetime history of hematologic malignancy. Those participants with any history of benign basal cell carcinoma of the skin may participate.
- Is using oral or parenteral steroids, high-dose inhaled steroids (>800 micrograms/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs.
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- Has a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
- Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
- Has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses (this includes, but is not limited to: known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients).
- Has a history of severe reactions following immunization with contemporary influenza virus vaccines.
- Has an acute illness, including an isolated oral temperature greater than 100.4 degrees F, within 1 week of vaccination.
- Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to enrollment in this study other than DMID 04-063, or expects to receive an experimental agent during the 7-month study period.
- Has a history of alcohol abuse or drug abuse (including chronic pain medication) in the last 5 years.
- Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Maryland Baltimore
Baltimore, Maryland, 21201
University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases
Rochester, New York, 14642-0001
UCLA Center For Vaccine Research
Torrance, California, 90502
About this study
Official title: Evaluation of a Booster Dose of A/Vietnam/1203/04 (H5N1) Vaccine Administered at 6 Months to Healthy Adult Subjects After a Two Dose Schedule at 0 and 1 Months
The purpose of this study is to determine whether a third dose of vaccines containing A/Vietnam/1203/04 provides more immunity than two doses. Subjects who participate in this study will have participated in DMID protocol 04-063 involving the A/Vietnam/1203/04. In this study, each subject will be asked to receive a third dose of the H5 vaccine at the same level administered in protocol 04-063. Subjects will be asked to record oral temperature and any experienced side effects for 7 days following the vaccine. Study procedures will include up to 3 blood sample collections. Participants will be involved in study related procedures for up to 6 months.
Read the detailed description
This study is linked to DMID protocols 04-063, 07-0022 and 08-0059. DMID Study 05-0090 is an extension study to DMID Study 04-063. Between March and May 2005, DMID Study 04-063 enrolled approximately 450 subjects at three study sites. Subjects were stratified by age and history of prior influenza vaccination for the 2004-2005 season, and randomly assigned to receive 2 doses of saline placebo (N=50) or 7.5, 15, 45, or 90 mcg of the influenza A/H5N1 virus vaccine (N=100/dose group) by IM injection. Approximately 6 months after receiving their second vaccination, subjects enrolled in DMID Study 04-063 will return to the clinic for their final study visit (Visit 6). After completing this visit, which includes collection of safety data and a 30-mL blood draw, the unblinded vaccine administrator will determine if the study subject received placebo or the influenza A/H5N1 vaccine. In the proposed extension study (DMID Study 05-0090), subjects who received the influenza A/H5N1 vaccine will be provided with information about DMID Study 05-0090 and asked if they are willing to receive a third dose of vaccine at the same dose level originally administered (i.e., those subjects originally receiving two doses of 7.5 mcg will receive a single booster dose of 7.5 mcg, those receiving two doses of 15 mcg will receive a single booster of 15 mcg, etc.). Subjects that provide informed consent and are eligible for DMID Study 05-0090 will be given a third dose of the vaccine at the same dose level they previously received by the unblinded vaccine administrator. Symptoms and signs will be assessed in the clinic for 15 to 30 minutes after inoculation, and the subjects will maintain a memory aid to record oral temperature and systemic and local adverse events (AEs) for 7 days after each immunization. Subjects will be encouraged to take their temperature around the same time each day. All subjects will receive a safety follow-up telephone call at 1 to 3 days to elicit any AE information and between 13 to 19 days after the vaccination to elicit any AE information and review the memory aid. Subjects will return to the clinic 28 (+/- 3) days after vaccination for assessment of AEs and concomitant medications, targeted physical examination (if indicated) and blood sample collection. During this follow-up visit, subjects who have been identified as "high responders" to the vaccine in the DMID 04-063 study will also be solicited to participate in a blood specimen collection substudy. Subjects will be provided with information about the substudy and asked if they would consent to have an additional 100 mL of blood drawn after the blood sample is collected for serum antibody assays. Refusal to consent for this substudy does not preclude subjects from continuing in the booster vaccine trial. At approximately Day 180 (6 months after booster vaccination), subjects will return to the clinic for a final immunogenicity blood sample collection and for follow-up, which may include a targeted physical examination (if indicated). The duration of the study treatment for each subject in this study will be about 6 months.
- Conditions
- Influenza
- Being tested
- Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)
- Keywords
- Avian influenza, vaccine, A/H5N1, sub-study
- Medical subject headings
- Influenza, Human, Influenza in Birds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)Biological
A monovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in unit¿¿dose vials containing either 30-mcg/mL A/H5N1 HA or 90-mcg/mL A/H5N1 HA. Subjects will receive 1 of 4 dose levels of vaccine (7.5, 15, 45, or 90 mcg) administered intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| 3 | Experimental | Subjects will receive a single 45 mcg IM dose of the influenza A/H5N1 virus vaccine. Receives: Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) |
| 4 | Experimental | Subjects will receive a single 90 mcg IM dose of the influenza A/H5N1 virus vaccine. Receives: Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) |
| 1 | Experimental | Subjects will receive a single 7.5 mcg IM dose of the influenza A/H5N1 virus vaccine. Receives: Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) |
| 2 | Experimental | Subjects will receive a single 15 mcg IM dose of the influenza A/H5N1 virus vaccine. Receives: Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects in each dose group achieving a serum neutralizing antibody titer of 1:40 against the influenza A/H5N1 virus.
Measured: Day 28 following booster immunization.
Adverse event (AE) or serious adverse event (SAE) information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessments).
Measured: Adverse Events will be collected through day 28. Serious Adverse Events will be collected throughout the study through day 180.
Secondary outcomes (2)
Proportion of subjects in each group achieving a day 28 post boost titer that is a 4-fold or greater increase compared to the peak titer achieved after the first two doses of vaccine.
Measured: Day 28.
Geometric mean titer of serum neutralizing and HAI antibodies at 28 and 180 days following booster immunization.
Measured: Day 28 and 180.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240968
- Sponsor's protocol ID
- 05-0090
- Status last verified
- Jul 2008
- First submitted
- 14 Oct 2005
- Last updated
- 16 Aug 2013
- Results posted
- No
Publications
Zangwill KM, Treanor JJ, Campbell JD, Noah DL, Ryea J. Evaluation of the safety and immunogenicity of a booster (third) dose of inactivated subvirion H5N1 influenza vaccine in humans. J Infect Dis. 2008 Feb 15;197(4):580-3. doi: 10.1086/526537.
PubMed 18237269
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
- Evaluation of a Booster Dose of A/Vietnam/1203/04 (H5N1) Vaccine Administered at 6 Months to Healthy Adult Subjects After a Two Dose Schedule at 0 and 1 Months
- ClinicalTrials.gov ID
- NCT00240968
- Acronym / sponsor ID
- 05-0090
- Conditions
- Influenza
- Keywords
- Avian influenza, vaccine, A/H5N1, sub-study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Oct 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 18 Oct 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 whether a third dose of vaccines containing A/Vietnam/1203/04 provides more immunity than two doses. Subjects who participate in this study will have participated in DMID protocol 04-063 involving the A/Vietnam/1203/04. In this study, each subject will be asked to receive a third dose of the H5 vaccine at the same level administered in protocol 04-063. Subjects will be asked to record oral temperature and any experienced side effects for 7 days following the vaccine. Study procedures will include up to 3 blood sample collections. Participants will be involved in study related procedures for up to 6 months.
Detailed description
This study is linked to DMID protocols 04-063, 07-0022 and 08-0059. DMID Study 05-0090 is an extension study to DMID Study 04-063. Between March and May 2005, DMID Study 04-063 enrolled approximately 450 subjects at three study sites. Subjects were stratified by age and history of prior influenza vaccination for the 2004-2005 season, and randomly assigned to receive 2 doses of saline placebo (N=50) or 7.5, 15, 45, or 90 mcg of the influenza A/H5N1 virus vaccine (N=100/dose group) by IM injection. Approximately 6 months after receiving their second vaccination, subjects enrolled in DMID Study 04-063 will return to the clinic for their final study visit (Visit 6). After completing this visit, which includes collection of safety data and a 30-mL blood draw, the unblinded vaccine administrator will determine if the study subject received placebo or the influenza A/H5N1 vaccine. In the proposed extension study (DMID Study 05-0090), subjects who received the influenza A/H5N1 vaccine will be provided with information about DMID Study 05-0090 and asked if they are willing to receive a third dose of vaccine at the same dose level originally administered (i.e., those subjects originally receiving two doses of 7.5 mcg will receive a single booster dose of 7.5 mcg, those receiving two doses of 15 mcg will receive a single booster of 15 mcg, etc.). Subjects that provide informed consent and are eligible for DMID Study 05-0090 will be given a third dose of the vaccine at the same dose level they previously received by the unblinded vaccine administrator. Symptoms and signs will be assessed in the clinic for 15 to 30 minutes after inoculation, and the subjects will maintain a memory aid to record oral temperature and systemic and local adverse events (AEs) for 7 days after each immunization. Subjects will be encouraged to take their temperature around the same time each day. All subjects will receive a safety follow-up telephone call at 1 to 3 days to elicit any AE information and between 13 to 19 days after the vaccination to elicit any AE information and review the memory aid. Subjects will return to the clinic 28 (+/- 3) days after vaccination for assessment of AEs and concomitant medications, targeted physical examination (if indicated) and blood sample collection. During this follow-up visit, subjects who have been identified as "high responders" to the vaccine in the DMID 04-063 study will also be solicited to participate in a blood specimen collection substudy. Subjects will be provided with information about the substudy and asked if they would consent to have an additional 100 mL of blood drawn after the blood sample is collected for serum antibody assays. Refusal to consent for this substudy does not preclude subjects from continuing in the booster vaccine trial. At approximately Day 180 (6 months after booster vaccination), subjects will return to the clinic for a final immunogenicity blood sample collection and for follow-up, which may include a targeted physical examination (if indicated). The duration of the study treatment for each subject in this study will be about 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 3 | Experimental | Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)Subjects will receive a single 45 mcg IM dose of the influenza A/H5N1 virus vaccine. |
| 4 | Experimental | Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)Subjects will receive a single 90 mcg IM dose of the influenza A/H5N1 virus vaccine. |
| 1 | Experimental | Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)Subjects will receive a single 7.5 mcg IM dose of the influenza A/H5N1 virus vaccine. |
| 2 | Experimental | Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)Subjects will receive a single 15 mcg IM dose of the influenza A/H5N1 virus vaccine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Previous recipient of inactivated Influenza A/H5N1 vaccine in study DMID 04-063.
- Male or nonpregnant female (as indicated by a negative urine pregnancy test immediately prior to vaccine administration) between the ages of 18 and 65 years, inclusive.
- Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (i.e., barrier method, abstinence, and licensed hormonal methods) for the entire study period.
- Is in good health, as determined by vital signs (heart rate, blood pressure, oral temperature), medical history and a targeted physical examination based on medical history.
- Able to understand and comply with planned study procedures.
Key exclusion criteria (14 listed)
- Received placebo in DMID Study 04-063.
- Known allergy to eggs or other components of the vaccine or latex.
- Has a positive urine pregnancy test prior to vaccination (if female of childbearing potential) or women who are breastfeeding.
- Is undergoing immunosuppression as a result of an underlying illness or treatment.
- Has or had a neoplastic disease diagnosed or treated within the last 5 years or any lifetime history of hematologic malignancy. Those participants with any history of benign basal cell carcinoma of the skin may participate.
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 |
|---|---|---|
| Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)A monovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in unit¿¿dose vials containing either 30-mcg/mL A/H5N1 HA or 90-mcg/mL A/H5N1 HA. Subjects will receive 1 of 4 dose levels of vaccine (7.5, 15, 45, or 90 mcg) administered intramuscularly. | Biological | 1, 2, 3, 4 |
Primary outcome
Proportion of subjects in each dose group achieving a serum neutralizing antibody titer of 1:40 against the influenza A/H5N1 virus.
Time frame: Day 28 following booster immunization.
Adverse event (AE) or serious adverse event (SAE) information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessments).
Time frame: Adverse Events will be collected through day 28. Serious Adverse Events will be collected throughout the study through day 180.
2 secondary outcomes
Proportion of subjects in each group achieving a day 28 post boost titer that is a 4-fold or greater increase compared to the peak titer achieved after the first two doses of vaccine.
Time frame: Day 28.
Geometric mean titer of serum neutralizing and HAI antibodies at 28 and 180 days following booster immunization.
Time frame: Day 28 and 180.
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.
- Results publication: PubMed 18237269Zangwill KM, Treanor JJ, Campbell JD, Noah DL, Ryea J. Evaluation of the safety and immunogenicity of a booster (third) dose of inactivated subvirion H5N1 influenza vaccine in humans. J Infect Dis. 2008 Feb 15;197(4):580-3. doi: 10.1086/526537.
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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 Phase 2 study testing Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) 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 9 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Proportion of subjects in each dose group achieving a serum neutralizing antibody titer of 1:40 against the influenza A/H5N1 virus. (time frame: Day 28 following booster immunization.). The study lists 2 primary outcomes in all. 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 NCT00240968, which also lists 1 linked publication.
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.