InfluenzaPhase 1/2NCT00280033
H5 Adult - Chiron Study of Bird Flu Vaccine
A Phase 1/2 study testing Aluminum hydroxide, Inactivated Influenza A/H5N1 Vaccine (Chiron) and MF-59 in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial summary
This study is will gather critical information on the safety, tolerability, and the immunogenicity (capability of causing an immune response) of A/H5N1 (Bird flu) virus vaccine in healthy adults. Up to 400 healthy adults, aged 18 to 64, will participate. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Aluminum hydroxide, Inactivated Influenza A/H5N1 Vaccine (Chiron) and MF-59
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 394 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2006to Nov 2006
- Phase
- Phase 1/2
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or nonpregnant female (as indicated by a negative urine pregnancy test immediately prior to vaccine administration) between the ages of 18 and 64 years, inclusive.
- Women of childbearing potential (not surgically sterile or post menopausal for greater than or equal to one year) 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.
- Subjects should have normal safety laboratory values (Hgb, WBC, Plt, ALT, and creatinine) prior to the first immunization.
- Able to understand and comply with planned study procedures.
- Provides written informed consent prior to initiation of any study procedures.
Who cannot join
- Has a 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 an active neoplastic disease or a history of any hematologic malignancy.
- Is using oral or parenteral steroids, high-dose inhaled steroids (greater than 800 micrograms/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs (nasal and topical steroids are allowed).
- Has a history of receiving immunoglobulin or other blood products within the 3 months prior to vaccination in this study.
Show all 17Show fewer
- Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to vaccination 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 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 vaccination in this study, or expects to receive an experimental agent during the 7-month study period.
- 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.
- Participated in H5 vaccine study in the past.
- Known current HIV, hepatitis B (HBsAg) or hepatitis C infection.
- History of alcohol or drug abuse in the last 5 years.
- Planned travel outside the US between vaccination and the second study visit.
- History of Guillain-Barre.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Vanderbilt University
Nashville, Tennessee, 37232
Saint Louis University
St Louis, Missouri, 63110
Stanford University
Stanford, California, 94305-5208
About this study
Official title: A Randomized, Placebo-Controlled, Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine Given Alone or Combined With Adjuvants in Healthy Adults
This study is will gather critical information on the safety, tolerability, and the immunogenicity (capability of causing an immune response) of A/H5N1 (Bird flu) virus vaccine in healthy adults. Up to 400 healthy adults, aged 18 to 64, will participate. Each subject will participate for about 7 months and will be randomly placed in one of several different study groups receiving a different dose of vaccine or placebo. All subjects will receive two injections of their assigned study product, about 28 days apart, in the muscle. Subjects will keep a journal of their temperature and any adverse effects between study visits. A small amount of blood will also be drawn before the first injection, 7 days after each injection, 1 month after the first injection, and 1 and 6 months after the second injection.
Read the detailed description
The emergence of novel influenza A virus strains in humans (including subtype A/H5N1, H7N7 H9N2 viruses) has added urgency to ongoing efforts to develop plans for responding to potential pandemic situations. This study compares the safety, reactogenicity, and immunogenicity of increasing doses of monovalent subvirion influenza A/H5N1 virus vaccine administered by intramuscular (IM) injection to healthy adults alone or combined with the adjuvants aluminum hydroxide or MF59. The primary objectives are to determine: the dose-related safety of subvirion inactivated H5N1vaccine with and without adjuvants in healthy adults; the dose-related immunogenicity of subvirion inactivated H5N1vaccine with and without adjuvants in healthy adults approximately 1 month following receipt of 2 vaccine doses; to provide information for the selection of the best dosage level for further studies. The secondary objectives are to evaluate dose-related immunogenicity and the percent of subjects responding about 1 and 7 months after the first vaccination. The primary endpoints are: adverse event (AE) or serious adverse event (SAE) information; proportion of subjects in each dose group achieving a serum neutralizing antibody titer of 1:40 against the influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine; proportion of subjects in each dose group achieving a serum hemagglutination (HAI) antibody titer of 1:40 against the influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine; geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers in each group 28 days after receipt of the second dose of vaccine; geometric mean titer and frequency of 4-fold or greater increases in serum HAI antibody titers in each group 28 days after receipt of the second dose of vaccine. The secondary endpoints are: GMT and frequency of 4-fold or greater increases in neutralizing antibody titers in each group 1 month and 7 months after receipt of the first dose of vaccine; geometric mean titer and frequency of 4-fold or greater increases in serum HAI antibody titers in each group 1 month and 7 months after receipt of the first dose of vaccine; development of serum antibody responses against antigenically drifted variants of H5N1 influenza virus. The primary outcome measures will be the frequencies and severities of AEs in each group and the proportions of subjects who achieve a serum neutralizing antibody titer of 1:40 against the influenza A/H5N1 virus on Day 56. About 390 healthy adults, 18 to 64 years old, inclusive, will be enrolled into this multicenter, randomized, placebo-controlled, dose-ranging clinical trial. Nine groups of randomized subjects will receive two doses of saline placebo or influenza A/H5N1 vaccine at 45, 30, or 15 micrograms; or influenza A/H5N1 vaccine at 15 or 7.5 micrograms with MF59; or influenza A/H5N1 vaccine with aluminum hydroxide at 30, 15, or 7.5 micrograms (N=30, 60 or 90/vaccine dose group total 390). Laboratory safety profile blood will be drawn prior to the first immunization. Subjects will receive 2 doses approximately 28 days apart. Subjects will be observed after inoculation and maintain a memory aid for 7 days afterwards. Subjects will be telephoned 1 to 3 days after vaccination for AE assessment, and they will return to the clinic on Day 7 for AE and concomitant medication assessment, targeted physical examination, safety laboratory tests and a review of the memory aid. Telephone calls assessing AEs will be performed after each vaccination. Serum for safety laboratory tests will be obtained prior to and approximately 7 days after first and second immunizations. I
- Conditions
- Influenza
- Being tested
- Aluminum hydroxide, Inactivated Influenza A/H5N1 Vaccine (Chiron), MF-59, Placebo
- Keywords
- H5N1, Influenza, vaccine, parent protocol
- 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.
Aluminum hydroxideBiological
Provided in vials that contain 0.8 mL volume per vial.
Inactivated Influenza A/H5N1 Vaccine (Chiron)Biological
Monovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in unit-dose vials containing 60 mcg/mL A/H5N1 HA as determined by single radial immunodiffusion. It may be formulated with MF59 or aluminum hydroxide. Dosages: 7.5 mcg, 15 mcg, 30 mcg, or 45 mcg.
MF-59Biological
Proprietary experimental adjuvant. Provided in vials that contain 0.7 mL volume per vial.
PlaceboDrug
Saline placebo.
| Study group | Role | What they receive |
|---|---|---|
| 9 | Placebo comparator | Saline administered on days 0 and 28. Receives: Drug: Placebo |
| 8 | Experimental | 45 mcg alone administered on days 0 and 28. Receives: Biological: Inactivated Influenza A/H5N1 Vaccine (Chiron) |
| 7 | Experimental | 30 mcg plus aluminum hydroxide administered on days 0 and 28. Receives: Biological: Aluminum hydroxide; Biological: Inactivated Influenza A/H5N1 Vaccine (Chiron) |
| 6 | Experimental | 30 mcg alone administered on days 0 and 28. Receives: Biological: Inactivated Influenza A/H5N1 Vaccine (Chiron) |
| 5 | Experimental | 15 mcg plus aluminum hydroxide administered on days 0 and 28. Receives: Biological: Aluminum hydroxide; Biological: Inactivated Influenza A/H5N1 Vaccine (Chiron) |
| 4 | Experimental | 15 mcg plus MF59 administered on days 0 and 28. Receives: Biological: Inactivated Influenza A/H5N1 Vaccine (Chiron); Biological: MF-59 |
| 3 | Experimental | 15 mcg alone administered on days 0 and 28. Receives: Biological: Inactivated Influenza A/H5N1 Vaccine (Chiron) |
| 2 | Experimental | 7.5 mcg plus aluminum hydroxide administered on days 0 and 28. Receives: Biological: Aluminum hydroxide; Biological: Inactivated Influenza A/H5N1 Vaccine (Chiron) |
| 1 | Experimental | 7.5 mcg plus MF59 administered on days 0 and 28. Receives: Biological: Inactivated Influenza A/H5N1 Vaccine (Chiron); Biological: MF-59 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titer and frequency of 4-fold or greater increases in serum hemagglutination inhibition (HAI) antibody titers in each group 28 days after receipt of the second dose of vaccine.
Measured: Approximately Day 56.
Adverse event or SAE information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessments).
Measured: Adverse events will be collected through 28 days following the second dose of vaccine (approximately Day 56). Serious adverse events will be collected throughout the study through Day 208.
Proportion of subjects in each group achieving a serum neutralizing antibody titer ratio of 1:40 against the influenza A/H5N1 virus 28 days following second dose of vaccine.
Measured: Approximately Day 56.
Proportion of subjects in each dose group achieving a serum hemagglutination (HAI) antibody titer of 1:40 against the influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine.
Measured: Approximately Day 56.
Geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers in each group 28 days after receipt of the second dose of vaccine.
Measured: Approximately Day 56.
Secondary outcomes (3)
Geometric mean titer and the frequency of 4-fold or greater increases in neutralizing antibody titers in each group 1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine.
Measured: Blood samples for serum assays will be collected at Day 0 and at Days 28, 56, and 208 after the first immunization.
Geometric mean titer and the frequency of 4-fold or greater increases in serum HAI antibody titers 1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine.
Measured: Blood samples for serum assays will be collected at Day 0 and at Days 28, 56, and 208 after the first immunization.
Development of serum antibody responses against antigenically drifted variants of H5N1influenza virus.
Measured: Blood samples for serum assays will be collected at Day 0 and at Days 28, 56, and 208 after the first immunization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2006 (estimated)
- Study startFeb 2006
- Primary completionNov 2006
- Study completionNov 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00280033
- Sponsor's protocol ID
- 04-062
- Status last verified
- Jan 2009
- First submitted
- 19 Jan 2006
- Last updated
- 13 Sep 2013
- Results posted
- No
Publications
Bernstein DI, Edwards KM, Dekker CL, Belshe R, Talbot HK, Graham IL, Noah DL, He F, Hill H. Effects of adjuvants on the safety and immunogenicity of an avian influenza H5N1 vaccine in adults. J Infect Dis. 2008 Mar 1;197(5):667-75. doi: 10.1086/527489.
PubMed 18260764
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine Given Alone or Combined With Adjuvants in Healthy Adults
- ClinicalTrials.gov ID
- NCT00280033
- Acronym / sponsor ID
- 04-062
- Conditions
- Influenza
- Keywords
- H5N1, Influenza, vaccine, parent protocol
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Feb 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 20 Jan 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 is will gather critical information on the safety, tolerability, and the immunogenicity (capability of causing an immune response) of A/H5N1 (Bird flu) virus vaccine in healthy adults. Up to 400 healthy adults, aged 18 to 64, will participate. Each subject will participate for about 7 months and will be randomly placed in one of several different study groups receiving a different dose of vaccine or placebo. All subjects will receive two injections of their assigned study product, about 28 days apart, in the muscle. Subjects will keep a journal of their temperature and any adverse effects between study visits. A small amount of blood will also be drawn before the first injection, 7 days after each injection, 1 month after the first injection, and 1 and 6 months after the second injection.
Detailed description
The emergence of novel influenza A virus strains in humans (including subtype A/H5N1, H7N7 H9N2 viruses) has added urgency to ongoing efforts to develop plans for responding to potential pandemic situations. This study compares the safety, reactogenicity, and immunogenicity of increasing doses of monovalent subvirion influenza A/H5N1 virus vaccine administered by intramuscular (IM) injection to healthy adults alone or combined with the adjuvants aluminum hydroxide or MF59. The primary objectives are to determine: the dose-related safety of subvirion inactivated H5N1vaccine with and without adjuvants in healthy adults; the dose-related immunogenicity of subvirion inactivated H5N1vaccine with and without adjuvants in healthy adults approximately 1 month following receipt of 2 vaccine doses; to provide information for the selection of the best dosage level for further studies. The secondary objectives are to evaluate dose-related immunogenicity and the percent of subjects responding about 1 and 7 months after the first vaccination. The primary endpoints are: adverse event (AE) or serious adverse event (SAE) information; proportion of subjects in each dose group achieving a serum neutralizing antibody titer of 1:40 against the influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine; proportion of subjects in each dose group achieving a serum hemagglutination (HAI) antibody titer of 1:40 against the influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine; geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers in each group 28 days after receipt of the second dose of vaccine; geometric mean titer and frequency of 4-fold or greater increases in serum HAI antibody titers in each group 28 days after receipt of the second dose of vaccine. The secondary endpoints are: GMT and frequency of 4-fold or greater increases in neutralizing antibody titers in each group 1 month and 7 months after receipt of the first dose of vaccine; geometric mean titer and frequency of 4-fold or greater increases in serum HAI antibody titers in each group 1 month and 7 months after receipt of the first dose of vaccine; development of serum antibody responses against antigenically drifted variants of H5N1 influenza virus. The primary outcome measures will be the frequencies and severities of AEs in each group and the proportions of subjects who achieve a serum neutralizing antibody titer of 1:40 against the influenza A/H5N1 virus on Day 56. About 390 healthy adults, 18 to 64 years old, inclusive, will be enrolled into this multicenter, randomized, placebo-controlled, dose-ranging clinical trial. Nine groups of randomized subjects will receive two doses of saline placebo or influenza A/H5N1 vaccine at 45, 30, or 15 micrograms; or influenza A/H5N1 vaccine at 15 or 7.5 micrograms with MF59; or influenza A/H5N1 vaccine with aluminum hydroxide at 30, 15, or 7.5 micrograms (N=30, 60 or 90/vaccine dose group total 390). Laboratory safety profile blood will be drawn prior to the first immunization. Subjects will receive 2 doses approximately 28 days apart. Subjects will be observed after inoculation and maintain a memory aid for 7 days afterwards. Subjects will be telephoned 1 to 3 days after vaccination for AE assessment, and they will return to the clinic on Day 7 for AE and concomitant medication assessment, targeted physical examination, safety laboratory tests and a review of the memory aid. Telephone calls assessing AEs will be performed after each vaccination. Serum for safety laboratory tests will be obtained prior to and approximately 7 days after first and second immunizations. I
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 9 | Placebo comparator | Drug: PlaceboSaline administered on days 0 and 28. |
| 8 | Experimental | Biological: Inactivated Influenza A/H5N1 Vaccine (Chiron)45 mcg alone administered on days 0 and 28. |
| 7 | Experimental | Biological: Aluminum hydroxide, Biological: Inactivated Influenza A/H5N1 Vaccine (Chiron)30 mcg plus aluminum hydroxide administered on days 0 and 28. |
| 6 | Experimental | Biological: Inactivated Influenza A/H5N1 Vaccine (Chiron)30 mcg alone administered on days 0 and 28. |
| 5 | Experimental | Biological: Aluminum hydroxide, Biological: Inactivated Influenza A/H5N1 Vaccine (Chiron)15 mcg plus aluminum hydroxide administered on days 0 and 28. |
| 4 | Experimental | Biological: Inactivated Influenza A/H5N1 Vaccine (Chiron), Biological: MF-5915 mcg plus MF59 administered on days 0 and 28. |
| 3 | Experimental | Biological: Inactivated Influenza A/H5N1 Vaccine (Chiron)15 mcg alone administered on days 0 and 28. |
| 2 | Experimental | Biological: Aluminum hydroxide, Biological: Inactivated Influenza A/H5N1 Vaccine (Chiron)7.5 mcg plus aluminum hydroxide administered on days 0 and 28. |
| 1 | Experimental | Biological: Inactivated Influenza A/H5N1 Vaccine (Chiron), Biological: MF-597.5 mcg plus MF59 administered on days 0 and 28. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male or nonpregnant female (as indicated by a negative urine pregnancy test immediately prior to vaccine administration) between the ages of 18 and 64 years, inclusive.
- Women of childbearing potential (not surgically sterile or post menopausal for greater than or equal to one year) 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.
- Subjects should have normal safety laboratory values (Hgb, WBC, Plt, ALT, and creatinine) prior to the first immunization.
- Able to understand and comply with planned study procedures.
Key exclusion criteria (17 listed)
- Has a 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 an active neoplastic disease or a history of any hematologic malignancy.
- Is using oral or parenteral steroids, high-dose inhaled steroids (greater than 800 micrograms/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs (nasal and topical steroids are allowed).
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 |
|---|---|---|
| Aluminum hydroxideProvided in vials that contain 0.8 mL volume per vial. | Biological | 2, 5, 7 |
| Inactivated Influenza A/H5N1 Vaccine (Chiron)Monovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in unit-dose vials containing 60 mcg/mL A/H5N1 HA as determined by single radial immunodiffusion. It may be formulated with MF59 or aluminum hydroxide. Dosages: 7.5 mcg, 15 mcg, 30 mcg, or 45 mcg. | Biological | 1, 2, 3, 4, 5, 6, 7, 8 |
| MF-59Proprietary experimental adjuvant. Provided in vials that contain 0.7 mL volume per vial. | Biological | 1, 4 |
| PlaceboSaline placebo. | Drug | 9 |
Primary outcome
Geometric mean titer and frequency of 4-fold or greater increases in serum hemagglutination inhibition (HAI) antibody titers in each group 28 days after receipt of the second dose of vaccine.
Time frame: Approximately Day 56.
Adverse event or SAE information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessments).
Time frame: Adverse events will be collected through 28 days following the second dose of vaccine (approximately Day 56). Serious adverse events will be collected throughout the study through Day 208.
Proportion of subjects in each group achieving a serum neutralizing antibody titer ratio of 1:40 against the influenza A/H5N1 virus 28 days following second dose of vaccine.
Time frame: Approximately Day 56.
Proportion of subjects in each dose group achieving a serum hemagglutination (HAI) antibody titer of 1:40 against the influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine.
Time frame: Approximately Day 56.
Geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers in each group 28 days after receipt of the second dose of vaccine.
Time frame: Approximately Day 56.
3 secondary outcomes
Geometric mean titer and the frequency of 4-fold or greater increases in neutralizing antibody titers in each group 1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine.
Time frame: Blood samples for serum assays will be collected at Day 0 and at Days 28, 56, and 208 after the first immunization.
Geometric mean titer and the frequency of 4-fold or greater increases in serum HAI antibody titers 1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine.
Time frame: Blood samples for serum assays will be collected at Day 0 and at Days 28, 56, and 208 after the first immunization.
Development of serum antibody responses against antigenically drifted variants of H5N1influenza virus.
Time frame: Blood samples for serum assays will be collected at Day 0 and at Days 28, 56, and 208 after the first immunization.
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 13 Sep 2013.
- Results publication: PubMed 18260764Bernstein DI, Edwards KM, Dekker CL, Belshe R, Talbot HK, Graham IL, Noah DL, He F, Hill H. Effects of adjuvants on the safety and immunogenicity of an avian influenza H5N1 vaccine in adults. J Infect Dis. 2008 Mar 1;197(5):667-75. doi: 10.1086/527489.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Aluminum hydroxide, Inactivated Influenza A/H5N1 Vaccine (Chiron) and MF-59 in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 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 6 inclusion and 17 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 13 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Geometric mean titer and frequency of 4-fold or greater increases in serum hemagglutination inhibition (HAI) antibody titers in each group 28 days after receipt of the second dose of vaccine. (time frame: Approximately Day 56.). The study lists 5 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 NCT00280033, 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 13 Sep 2013.