InfluenzaPhase 1NCT00382980
Dose-Escalating Trial Using Vero Cell-culture Derived H5N1 +/- Aluminum in Adults
A Phase 1 study testing Aluminum hydroxide and Inactivated Vero cell based whole virus influenza A/H5N1 in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.
Trial summary
The purpose of this research study is to compare how the body reacts to different strengths of an experimental cell culture-grown whole virus A/H5N1 flu vaccine when given with or without the addition of aluminum hydroxide adjuvant. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Aluminum hydroxide and Inactivated Vero cell based whole virus influenza A/H5N1
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 308 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2006to Sep 2007
- Phase
- Phase 1
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Stage 1 Cohort
- Healthy males and females aged 18 to 40 years, inclusive;
- Females of childbearing potential must agree to practice adequate contraception for the duration of the study (not surgically sterile or Aftermenopausal for at least 1 year);
- Good health as determined by screening medical history and physical examination;
- On no medications with the exception of licensed hormonal contraceptives and vitamins;
- Willingness to comply with study procedures;
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- Ability to provide informed consent;
- Availability for follow-up for 6 months after second vaccination;
- Normal screening laboratory values for total WBC, platelet count, hemoglobin, creatinine, and alanine aminotransferase (Stage 1 only).
- Stage 2 Cohort
- Healthy males and non-pregnant females aged 18 to 40 years, inclusive.
- Females of childbearing potential must agree to practice adequate contraception for the duration of the study.
- Good health as determined by screening medical history and physical examination.
- Willingness to comply with study procedures.
- Ability to provide informed consent.
- Availability for follow-up for 6 months after second vaccination.
Who cannot join
- Stage 1 Cohort
- Have a positive urine or serum pregnancy test in the 24 hours prior to vaccination (if female of childbearing potential) or are women who are breastfeeding.
- Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.
- Have an active neoplastic disease or a history of any hematologic malignancy.
- Have long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. (Nasal and topical steroids are allowed.)
- Have a diagnosis of schizophrenia, Bi-polar disease or other major psychiatric diagnosis.
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- Have been hospitalized for psychiatric illness, history of suicide attempt or confinement for danger to self or others.
- Have a history of receiving immunoglobulin or other blood product within the 3 months prior to vaccination in this study.
- Have received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to vaccination in this study.
- Have 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.)
- Have a history of severe reactions following immunization with contemporary influenza virus vaccines.
- Have 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 expect to receive an experimental agent during the 7-month study period.
- Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol.
- Participated in an influenza A/H5 vaccine study in the past in a group receiving vaccine (but does not exclude documented placebo recipients).
- Have a known active human immunodeficiency virus, hepatitis B, or hepatitis C infection.
- Have a history of alcohol or drug abuse in the last 5 years.
- Have a history of Guillain Barre Syndrome.
- Have any condition that the investigator believes may interfere with successful completion of the study.
- Stage 2 Cohort
- Have a positive urine or serum pregnancy test prior to vaccination (if female of childbearing potential) or are women who are breastfeeding.
- Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.
- Have an active neoplastic disease or a history of any hematologic malignancy. Have long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (Nasal and topical steroids are allowed.)
- Have a diagnosis of schizophrenia, Bi-polar disease or other major psychiatric diagnosis.
- Have been hospitalized for psychiatric illness, history of suicide attempt or confinement for danger to self or others.
- Are receiving psychiatric drugs*. Subjects who are receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without de-compensating symptoms will be allowed to be enrolled in the study.
- aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, molindone, thiothixene, pimozide, fluphenazine, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, chlorprothixene, chlorpromazine, perphenazine, trifluopromazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate.
- Have a history of receiving immunoglobulin or other blood product within the 3 months prior to vaccination in this study.
- Have received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to vaccination in this study.
- Have 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.)
- Have a history of severe reactions following immunization with contemporary influenza virus vaccines.
- Have 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 expect to receive an experimental agent during the 7-month study period.
- Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol.
- Participated in an influenza A/H5 vaccine study in the past in a group receiving vaccine (but does not exclude documented placebo recipients).
- Have a known active human immunodeficiency virus, hepatitis B, or hepatitis C infection.
- Have a history of alcohol or drug abuse in the last 5 years.
- Have a history of Guillain Barre Syndrome.
- Have any condition that the investigator believes may interfere with successful completion of the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Maryland School of Medicine
Baltimore, Maryland, 21201
Baylor College of Medicine
Houston, Texas, 77030
Vanderbilt University
Nashville, Tennessee, 37232
Stanford University
Stanford, California, 94305
UCLA Center For Vaccine Research
Torrance, California, 90502
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Clinical Trial of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Immunization With Inactivated, Vero Cell-Culture Derived Influenza A/H5N1 Vaccine Given Alone or With Aluminum Hydroxide to Healthy Young Adults
The purpose of this research study is to compare how the body reacts to different strengths of an experimental cell culture-grown whole virus A/H5N1 flu vaccine when given with or without the addition of aluminum hydroxide adjuvant. Researchers will also look at how much antibody is made to the influenza virus hemagglutinin (HA) after subjects receive the H5N1 vaccine. Three hundred healthy adults aged 18-40 years will participate for approximately 9 months, which includes screening. Participants will receive 2 doses of vaccine or placebo injected 28 days apart. Participants will have blood samples taken up to 7 times and have 8 scheduled study visits.
Read the detailed description
This is a phase I, randomized, double-blind, placebo-controlled, dose-ranging clinical trial of the safety, reactogenicity, and immunogenicity of intramuscular immunization with inactivated, Vero cell-culture derived influenza A/H5N1 vaccine given alone or with aluminum hydroxide to healthy young adults. The primary objectives are to determine the dose-related safety of an inactivated, cell-culture grown whole virus influenza A/H5N1 vaccine with or without aluminum hydroxide adjuvant in healthy adults; to determine the potential for aluminum hydroxide to enhance the immune response to inactivated whole virus H5N1 vaccine in healthy adults approximately 1 month following receipt of 2 doses of vaccine; and to provide information for the selection of the best dosage level for further studies. The secondary objective is to evaluate dose-related immunogenicity and the percent of subjects responding approximately 1 and 7 months after the first vaccination. The primary endpoints are adverse event (AE) or serious adverse event (SAE) information (solicited in the clinic and via memory aids, concomitant medications, periodic targeted physical assessment, and laboratory safety evaluations in a subset of subjects); proportion of subjects in each dose group achieving a serum neutralizing antibody titer of greater than or equal to 40 against the influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine (approximately Day 56); proportion of subjects in each dose group achieving a serum hemagglutination inhibition (HAI) antibody titer of greater than or equal to 40 against the influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine (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; and GMT 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 (approximately Day 56). 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; and GMT 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. Approximately 300 healthy adults, 18-40 years old inclusive, will be enrolled at up to 5 sites in the United States for up to 9 months, including the screening period. Two doses of vaccine or placebo will be injected into the deltoid muscle approximately 28 days apart. The study will be conducted in 2 stages. During Stage 1, 90 subjects will be randomized to receive saline placebo or 7.5 micrograms (with or without aluminum hydroxide), 15 micrograms (with or without aluminum hydroxide), or 45 micrograms (without aluminum hydroxide) (6 groups; N=15 per group). Blood for safety evaluations will be obtained from all subjects in the Stage 1 cohort at screening, and before and 1 week after each vaccination. Subjects in Stage 1 will receive their second vaccinations following review of available clinical and laboratory safety data by the Safety Monitoring Committee (SMC). If no dose-limiting toxicity or safety-related issues are noted during the week after administration of the first dose of vaccine during Stage 1 (based on review of clinical and laboratory safety data by the SMC), then Stage 1 subjects will receive a second vaccination. A complete Stage 1 safety report will be reviewed by the SMC prior to the enrollment of the 210 additional subjects in Stage 2 (N=50 per formulation group total). Sera for immune assessment of antigen-specific immune responses will be collected from all subjects at baseline (Day 0), 1 month after each vaccine dose, and 6 months after the second vaccine dose. This study is linked to DMID protocol 07-0022.
- Conditions
- Influenza
- Being tested
- Aluminum hydroxide, Inactivated Vero cell based whole virus influenza A/H5N1, Placebo
- Keywords
- influenza, vaccine, A/H5N1, aluminum hydroxide, Vero cell
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aluminum hydroxideBiological
Adjuvant administered with A/H5N1 vaccine dosages 7.5 mcg and 15 mcg.
Inactivated Vero cell based whole virus influenza A/H5N1Biological
Inactivated Vero cell-grown, whole virus, influenza A/H5N1 vaccine at dosages 7.5 mcg and 15 mcg of hemagglutinin (HA) per 0.5 mL, each dosage with and without aluminum hydroxide adjuvant; 45 mcg HA/0.5 mL without adjuvant.
PlaceboDrug
Saline injected into the deltoid muscle. 2 identical dosages will be given approximately 28 days apart.
| Study group | Role | What they receive |
|---|---|---|
| 7.5- | Experimental | 7.5 mcg of vaccine without adjuvant administered on Days 0 and 28. Receives: Biological: Inactivated Vero cell based whole virus influenza A/H5N1 |
| 45- | Experimental | 45 mcg of vaccine without adjuvant administered on Days 0 and 28. Receives: Biological: Inactivated Vero cell based whole virus influenza A/H5N1 |
| Placebo | Placebo comparator | Placebo administered on Days 0 and 28. Receives: Drug: Placebo |
| 15+ | Experimental | 15 mcg of vaccine with aluminum hydroxide adjuvant administered on Days 0 and 28. Receives: Biological: Aluminum hydroxide; Biological: Inactivated Vero cell based whole virus influenza A/H5N1 |
| 7.5+ | Experimental | 7.5 mcg of vaccine with aluminum hydroxide adjuvant administered on Days 0 and 28. Receives: Biological: Aluminum hydroxide; Biological: Inactivated Vero cell based whole virus influenza A/H5N1 |
| 15- | Experimental | 15 mcg of vaccine without adjuvant administered on Days 0 and 28. Receives: Biological: Inactivated Vero cell based whole virus influenza A/H5N1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event (AE) or serious adverse event (SAE) information (solicited in the clinic and via memory aids, concomitant medications, periodic targeted physical assessment, and laboratory safety evaluations for a subset of subjects.
Measured: Duration of study.
Proportion of subjects in each dose group achieving a serum neutralizing antibody titer of greater than or equal to 40 against the influenza A/H5N1 virus.
Measured: 28 days after receipt of the 2nd dose of vaccine, approximately Day 56.
Proportion of subjects in each dose group achieving a serum hemagglutination inhibition (HAI) antibody titer of greater than or equal to 40 against the influenza A/H5N1 virus.
Measured: 28 days after receipt of the 2nd dose of vaccine, approximately Day 56.
Geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers in each group.
Measured: 28 days after receipt of the 2nd dose of vaccine, approximately Day 56.
Geometric mean titer (GMT) and frequency of 4-fold or greater increases in serum HAI antibody titers in each group.
Measured: 28 days after receipt of the 2nd dose of vaccine, approximately Day 56.
Secondary outcomes (2)
GMT and frequency of 4-fold or greater increases in neutralizing antibody titers in each group.
Measured: 1 month and 7 months after receipt of the 1st dose of vaccine.
GMT and frequency of 4-fold or greater increases in serum HAI antibody titers in each group.
Measured: 1 month and 7 months after receipt of the 1st dose of vaccine.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionSep 2007
- Study completionSep 2007
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382980
- Sponsor's protocol ID
- 06-0052
- Status last verified
- Sep 2008
- First submitted
- 28 Sep 2006
- Last updated
- 27 Aug 2010
- Results posted
- No
Publications
Keitel WA, Dekker CL, Mink C, Campbell JD, Edwards KM, Patel SM, Ho DY, Talbot HK, Guo K, Noah DL, Hill H. Safety and immunogenicity of inactivated, Vero cell culture-derived whole virus influenza A/H5N1 vaccine given alone or with aluminum hydroxide adjuvant in healthy adults. Vaccine. 2009 Nov 5;27(47):6642-8. doi: 10.1016/j.vaccine.2009.03.015. Epub 2009 Mar 25.
PubMed 19773098
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Clinical Trial of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Immunization With Inactivated, Vero Cell-Culture Derived Influenza A/H5N1 Vaccine Given Alone or With Aluminum Hydroxide to Healthy Young Adults
- ClinicalTrials.gov ID
- NCT00382980
- Acronym / sponsor ID
- 06-0052
- Conditions
- Influenza
- Keywords
- influenza, vaccine, A/H5N1, aluminum hydroxide, Vero cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Oct 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 2 Oct 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.
The purpose of this research study is to compare how the body reacts to different strengths of an experimental cell culture-grown whole virus A/H5N1 flu vaccine when given with or without the addition of aluminum hydroxide adjuvant. Researchers will also look at how much antibody is made to the influenza virus hemagglutinin (HA) after subjects receive the H5N1 vaccine. Three hundred healthy adults aged 18-40 years will participate for approximately 9 months, which includes screening. Participants will receive 2 doses of vaccine or placebo injected 28 days apart. Participants will have blood samples taken up to 7 times and have 8 scheduled study visits.
Detailed description
This is a phase I, randomized, double-blind, placebo-controlled, dose-ranging clinical trial of the safety, reactogenicity, and immunogenicity of intramuscular immunization with inactivated, Vero cell-culture derived influenza A/H5N1 vaccine given alone or with aluminum hydroxide to healthy young adults. The primary objectives are to determine the dose-related safety of an inactivated, cell-culture grown whole virus influenza A/H5N1 vaccine with or without aluminum hydroxide adjuvant in healthy adults; to determine the potential for aluminum hydroxide to enhance the immune response to inactivated whole virus H5N1 vaccine in healthy adults approximately 1 month following receipt of 2 doses of vaccine; and to provide information for the selection of the best dosage level for further studies. The secondary objective is to evaluate dose-related immunogenicity and the percent of subjects responding approximately 1 and 7 months after the first vaccination. The primary endpoints are adverse event (AE) or serious adverse event (SAE) information (solicited in the clinic and via memory aids, concomitant medications, periodic targeted physical assessment, and laboratory safety evaluations in a subset of subjects); proportion of subjects in each dose group achieving a serum neutralizing antibody titer of greater than or equal to 40 against the influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine (approximately Day 56); proportion of subjects in each dose group achieving a serum hemagglutination inhibition (HAI) antibody titer of greater than or equal to 40 against the influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine (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; and GMT 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 (approximately Day 56). 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; and GMT 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. Approximately 300 healthy adults, 18-40 years old inclusive, will be enrolled at up to 5 sites in the United States for up to 9 months, including the screening period. Two doses of vaccine or placebo will be injected into the deltoid muscle approximately 28 days apart. The study will be conducted in 2 stages. During Stage 1, 90 subjects will be randomized to receive saline placebo or 7.5 micrograms (with or without aluminum hydroxide), 15 micrograms (with or without aluminum hydroxide), or 45 micrograms (without aluminum hydroxide) (6 groups; N=15 per group). Blood for safety evaluations will be obtained from all subjects in the Stage 1 cohort at screening, and before and 1 week after each vaccination. Subjects in Stage 1 will receive their second vaccinations following review of available clinical and laboratory safety data by the Safety Monitoring Committee (SMC). If no dose-limiting toxicity or safety-related issues are noted during the week after administration of the first dose of vaccine during Stage 1 (based on review of clinical and laboratory safety data by the SMC), then Stage 1 subjects will receive a second vaccination. A complete Stage 1 safety report will be reviewed by the SMC prior to the enrollment of the 210 additional subjects in Stage 2 (N=50 per formulation group total). Sera for immune assessment of antigen-specific immune responses will be collected from all subjects at baseline (Day 0), 1 month after each vaccine dose, and 6 months after the second vaccine dose. This study is linked to DMID protocol 07-0022.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 7.5- | Experimental | Biological: Inactivated Vero cell based whole virus influenza A/H5N17.5 mcg of vaccine without adjuvant administered on Days 0 and 28. |
| 45- | Experimental | Biological: Inactivated Vero cell based whole virus influenza A/H5N145 mcg of vaccine without adjuvant administered on Days 0 and 28. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered on Days 0 and 28. |
| 15+ | Experimental | Biological: Aluminum hydroxide, Biological: Inactivated Vero cell based whole virus influenza A/H5N115 mcg of vaccine with aluminum hydroxide adjuvant administered on Days 0 and 28. |
| 7.5+ | Experimental | Biological: Aluminum hydroxide, Biological: Inactivated Vero cell based whole virus influenza A/H5N17.5 mcg of vaccine with aluminum hydroxide adjuvant administered on Days 0 and 28. |
| 15- | Experimental | Biological: Inactivated Vero cell based whole virus influenza A/H5N115 mcg of vaccine without adjuvant administered on Days 0 and 28. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Stage 1 Cohort
- Healthy males and females aged 18 to 40 years, inclusive;
- Females of childbearing potential must agree to practice adequate contraception for the duration of the study (not surgically sterile or Aftermenopausal for at least 1 year);
- Good health as determined by screening medical history and physical examination;
- On no medications with the exception of licensed hormonal contraceptives and vitamins;
Key exclusion criteria (39 listed)
- Stage 1 Cohort
- Have a positive urine or serum pregnancy test in the 24 hours prior to vaccination (if female of childbearing potential) or are women who are breastfeeding.
- Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.
- Have an active neoplastic disease or a history of any hematologic malignancy.
- Have long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. (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 hydroxideAdjuvant administered with A/H5N1 vaccine dosages 7.5 mcg and 15 mcg. | Biological | 15+, 7.5+ |
| Inactivated Vero cell based whole virus influenza A/H5N1Inactivated Vero cell-grown, whole virus, influenza A/H5N1 vaccine at dosages 7.5 mcg and 15 mcg of hemagglutinin (HA) per 0.5 mL, each dosage with and without aluminum hydroxide adjuvant; 45 mcg HA/0.5 mL without adjuvant. | Biological | 15+, 15-, 45-, 7.5+, 7.5- |
| PlaceboSaline injected into the deltoid muscle. 2 identical dosages will be given approximately 28 days apart. | Drug | Placebo |
Primary outcome
Adverse event (AE) or serious adverse event (SAE) information (solicited in the clinic and via memory aids, concomitant medications, periodic targeted physical assessment, and laboratory safety evaluations for a subset of subjects.
Time frame: Duration of study.
Proportion of subjects in each dose group achieving a serum neutralizing antibody titer of greater than or equal to 40 against the influenza A/H5N1 virus.
Time frame: 28 days after receipt of the 2nd dose of vaccine, approximately Day 56.
Proportion of subjects in each dose group achieving a serum hemagglutination inhibition (HAI) antibody titer of greater than or equal to 40 against the influenza A/H5N1 virus.
Time frame: 28 days after receipt of the 2nd dose of vaccine, approximately Day 56.
Geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers in each group.
Time frame: 28 days after receipt of the 2nd dose of vaccine, approximately Day 56.
Geometric mean titer (GMT) and frequency of 4-fold or greater increases in serum HAI antibody titers in each group.
Time frame: 28 days after receipt of the 2nd dose of vaccine, approximately Day 56.
2 secondary outcomes
GMT and frequency of 4-fold or greater increases in neutralizing antibody titers in each group.
Time frame: 1 month and 7 months after receipt of the 1st dose of vaccine.
GMT and frequency of 4-fold or greater increases in serum HAI antibody titers in each group.
Time frame: 1 month and 7 months after receipt of the 1st dose of vaccine.
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 27 Aug 2010.
- Derived from this study: PubMed 19773098Keitel WA, Dekker CL, Mink C, Campbell JD, Edwards KM, Patel SM, Ho DY, Talbot HK, Guo K, Noah DL, Hill H. Safety and immunogenicity of inactivated, Vero cell culture-derived whole virus influenza A/H5N1 vaccine given alone or with aluminum hydroxide adjuvant in healthy adults. Vaccine. 2009 Nov 5;27(47):6642-8. doi: 10.1016/j.vaccine.2009.03.015. Epub 2009 Mar 25.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aluminum hydroxide and Inactivated Vero cell based whole virus influenza A/H5N1 in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 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 16 inclusion and 39 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 27 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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.
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?
Adverse event (AE) or serious adverse event (SAE) information (solicited in the clinic and via memory aids, concomitant medications, periodic targeted physical assessment, and laboratory safety evaluations for a subset of subjects. (time frame: Duration of study.). 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 NCT00382980, 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 27 Aug 2010.