InfluenzaPhase 1/2NCT00133471
Inactivated Influenza A/H9N2 Vaccine With and Without MF59 Adjuvant in Ambulatory Adults
A Phase 1/2 study testing Influenza A/H9N2 vaccine and MF59 adjuvant in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this study is to compare the body's reactions and immune responses after receiving different strengths of a H9N2 influenza virus vaccine with and without an adjuvant given into the arm muscle. Study participants will include up to 96 healthy adults, ages 18-34. Read more about this study
- Who is it for?
- Ages 18 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza A/H9N2 vaccine and MF59 adjuvant
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Dec 2005
- 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 34 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ambulatory, healthy males and non-pregnant female adults 18-34 years of age.
- Able to give informed consent and available for all study visits.
- Able to understand and comply with planned study procedures.
- Women capable of bearing children must utilize an acceptable means of birth control (abstinence, oral contraceptives ("the pill"), intrauterine devices (IUDs), contraceptive implants under the skin, or contraceptive injections, or condoms with foam).
- On no concomitant medications except contraceptive medications.
- Normal screening laboratory values.
Who cannot join
- Known allergy to eggs or other components of vaccine.
- Prior receipt of an influenza A/H9N2 vaccine.
- Abnormal screening laboratory values (laboratory values must be within normal limits).
- Pregnancy, desire to become pregnant in the next 3 months, or lactation.
- Immunosuppression as a result of underlying illness or treatment.
- Use of oral or parenteral steroids, high-dose inhaled steroids (>800 mcg per day of beclomethasone dipropionate or equivalent), other immunosuppressive or cytotoxic drugs.
Show all 15Show fewer
- Active neoplastic disease or history of any hematologic malignancy.
- Acute or chronic condition that (in the opinion of the investigator) would render vaccination unsafe or would interfere with the evaluation of responses (including but not limited to the following: known chronic liver disease, significant renal disease, unstable or progressive neurologic disorder, diabetes mellitus, transplant recipient).
- Use of experimental vaccines or medications within the month prior to study entry, or expected use of experimental or licensed vaccines or blood/blood products during the 1 month period after each inoculation with study vaccine.
- Receipt of immunoglobulin or other blood product within 3 months prior to enrollment.
- Receipt of other licensed vaccines within the preceding 2 weeks (inactivated vaccines) or 4 weeks (live vaccines).
- History of a severe reaction following vaccination with a contemporary influenza vaccine.
- Subject is enrolled in another clinical trial.
- Study personnel (those persons identified on study personnel logs).
- Any condition that in the opinion of the investigator would interfere with the interpretation or evaluation of the vaccine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Reactogenicity and Immunogenicity of Four Dosage Levels of Intramuscular Monovalent Inactivated Influenza A/H9N2 Vaccine With and Without MF59 Adjuvant in Ambulatory Adults
The purpose of this study is to compare the body's reactions and immune responses after receiving different strengths of a H9N2 influenza virus vaccine with and without an adjuvant given into the arm muscle. Study participants will include up to 96 healthy adults, ages 18-34. The 4 dosages of the experimental H9N2 vaccine to be tested in this study are the following: 3.75, 7.5, 15, and 30-mcg (with and without MF59 adjuvant). Participants will be vaccinated on Days 0 and 28. Participants will record any vaccine side effects in a diary for 7 days following each vaccination. Participants will return to the clinic on days 2 and 7 after vaccination. Blood samples will be collected 7 days following each vaccination. Serum and nasal wash specimens will be collected before each vaccination and 4 weeks after injections (0, 4, and 8 weeks). Participants will be involved in study related procedures for up to 8 months.
Read the detailed description
The primary goal of this study is to assess the safety of 4 different dosages of purified monovalent surface antigen (SA) influenza A/H9N2 virus vaccine with or without MF59 adjuvant and administered intramuscularly to ambulatory adults. The hypothesis is that all dosage levels of adjuvanted and nonadjuvanted vaccine will be well tolerated. The primary objective of this project is to evaluate the safety of 4 dosage levels of monovalent surface antigen (SA) influenza A/H9N2 virus vaccine given with or without MF59 adjuvant. The primary endpoint is the frequency and severity of solicited local and systemic adverse events in each vaccine dosage level group. The secondary objective of this project is to determine the immunogenicity of 4 dosage levels of monovalent surface antigen (SA) influenza A/H9N2 virus vaccine given with or without MF59 adjuvant. The secondary endpoints include the following: the proportions of subjects in each vaccine dosage group that achieve a serum HAI titer of at least 1:32 one month after the second vaccination; the geometric mean titer (GMT) of serum HAI antibody against the influenza A/H9N2 virus one month after the second vaccination; the rates of significant increases in titer between pre- and post-immunization serum samples (defined as seroconversion-i.e., increase in titer from <1:4 pre-immunization to at least 1:8 after vaccination, or 4-fold or greater increase in titer between pre- and post-immunization samples) 28 days after each vaccination (days 28 and 56); and the proportion of subjects with a 4-fold or greater increase in percent HA-specific antibody in nasal wash specimens for each vaccine group. The study will be a double-blind evaluation of 4 dosage levels of study vaccine. The 4 dosage levels to be tested are 3.75-, 7.5-, 15-, and 30-mcg of HA of the vaccine strain with and without MF59 adjuvant. Because all dosage levels are lower than the total hemagglutinin content of the FLUAD® vaccine used in Europe, subjects will be enrolled into all dosage and adjuvant groups concurrently using a randomized, double-blind study design. Ninety-six persons 18-34 years of age will be enrolled. A single lot of monovalent inactivated SA influenza A/H9N2 vaccine will be used throughout the trial. All injections will be administered in a 0.5-mL volume into the deltoid muscle. Screening and safety laboratory examinations will be assessed before the first dose and 7 days after each vaccination. Assessments for reactogenicity will be done for at least 20 minutes after each vaccination, in the clinic 2 and 7 days after each inoculation, via diary card for seven days after each vaccination, and via phone or other contact at 7 months after the first vaccination for any serious adverse events during the entire study period. Serum and nasal wash samples collected on days 0, 28, and 56 will be used to measure immunogenicity of the vaccine preparation. Participants will be involved in study related procedures for up to 8 months.
- Conditions
- Influenza
- Being tested
- Influenza A/H9N2 vaccine, MF59 adjuvant
- Keywords
- Influenza, vaccine, A/H9N2, MF59, adjuvant
- 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/H9N2 vaccineBiological
A single lot of monovalent inactivated SA influenza A/H9N2 vaccine. All injections will be administered in a 0.5-mL volume into the deltoid muscle. Dosage levels are: 3.75-, 7.5-, 15-, and 30-mcg of HA of the vaccine strain with and without MF59 adjuvant.
MF59 adjuvantDrug
MF59 adjuvant is an oil-in-water emulsion.
| Study group | Role | What they receive |
|---|---|---|
| Group 1A: 3.75 mcg A/H9N2 no adjuvant | Experimental | 12 subjects to receive 3.75 mcg A/H9N2 with no adjuvant. Receives: Biological: Influenza A/H9N2 vaccine |
| Group 2B: 7.5 mcg A/H9N2 plus MF59 adjuvant | Experimental | 12 subjects to receive 7.5 mcg A/H9N2 plus MF59 adjuvant. Receives: Biological: Influenza A/H9N2 vaccine; Drug: MF59 adjuvant |
| Group 3A: 15 mcg A/H9N2 no adjuvant | Experimental | 12 subjects to receive 15 mcg A/H9N2 with no adjuvant. Receives: Biological: Influenza A/H9N2 vaccine |
| Group 3B: 15 mcg A/H9N2 plus MF59 adjuvant | Experimental | 12 subjects to receive 15 mcg A/H9N2 plus MF59 adjuvant. Receives: Biological: Influenza A/H9N2 vaccine; Drug: MF59 adjuvant |
| Group 4B: 30 mcg A/H9N2 plus MF59 adjuvant | Experimental | 12 subjects to receive 30 mcg A/H9N2 plus MF59 adjuvant. Receives: Biological: Influenza A/H9N2 vaccine; Drug: MF59 adjuvant |
| Group 4A: 30 mcg A/H9N2 no adjuvant | Experimental | 12 subjects to receive 30 mcg A/H9N2 with no adjuvant. Receives: Biological: Influenza A/H9N2 vaccine |
| Group 2A: 7.5 mcg A/H9N2 no adjuvant | Experimental | 12 subjects to receive 7.5 mcg A/H9N2 with no adjuvant. Receives: Biological: Influenza A/H9N2 vaccine |
| Group 1B: 3.75 mcg A/H9N2 plus MF59 adjuvant | Experimental | 12 subjects to receive 3.75 mcg A/H9N2 plus MF59 adjuvant. Receives: Biological: Influenza A/H9N2 vaccine; Drug: MF59 adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency and severity of solicited local and systemic adverse events in each vaccine dosage level group.
Measured: Duration of study.
Secondary outcomes (4)
The proportions of subjects in each vaccine dosage group that achieve a serum HAI titer of at least 1:32.
Measured: One month after the second vaccination.
Rates of significant increases in titer between pre- and post-immunization serum samples 28 days after each vaccination.
Measured: Days 28 and 56.
The geometric mean titer (GMT) of serum HAI antibody against the influenza A/H9N2 virus.
Measured: One month after the second vaccination.
The proportion of subjects with a 4-fold or greater increase in percent HA-specific antibody in nasal wash specimens for each vaccine group.
Measured: Nasal wash samples collected on Days 0, 28, and 56.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2005 (estimated)
- Study startMar 2005
- Primary completionDec 2005
- Study completionDec 2005
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
- 96 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133471
- Sponsor's protocol ID
- 04-019
- Status last verified
- Jan 2009
- First submitted
- 19 Aug 2005
- Last updated
- 27 Aug 2010
- Results posted
- No
Publications
Atmar RL, Keitel WA, Patel SM, Katz JM, She D, El Sahly H, Pompey J, Cate TR, Couch RB. Safety and immunogenicity of nonadjuvanted and MF59-adjuvanted influenza A/H9N2 vaccine preparations. Clin Infect Dis. 2006 Nov 1;43(9):1135-42. doi: 10.1086/508174. Epub 2006 Sep 25.
PubMed 17029131
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
- Evaluation of the Reactogenicity and Immunogenicity of Four Dosage Levels of Intramuscular Monovalent Inactivated Influenza A/H9N2 Vaccine With and Without MF59 Adjuvant in Ambulatory Adults
- ClinicalTrials.gov ID
- NCT00133471
- Acronym / sponsor ID
- 04-019
- Conditions
- Influenza
- Keywords
- Influenza, vaccine, A/H9N2, MF59, adjuvant
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Mar 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 23 Aug 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 compare the body's reactions and immune responses after receiving different strengths of a H9N2 influenza virus vaccine with and without an adjuvant given into the arm muscle. Study participants will include up to 96 healthy adults, ages 18-34. The 4 dosages of the experimental H9N2 vaccine to be tested in this study are the following: 3.75, 7.5, 15, and 30-mcg (with and without MF59 adjuvant). Participants will be vaccinated on Days 0 and 28. Participants will record any vaccine side effects in a diary for 7 days following each vaccination. Participants will return to the clinic on days 2 and 7 after vaccination. Blood samples will be collected 7 days following each vaccination. Serum and nasal wash specimens will be collected before each vaccination and 4 weeks after injections (0, 4, and 8 weeks). Participants will be involved in study related procedures for up to 8 months.
Detailed description
The primary goal of this study is to assess the safety of 4 different dosages of purified monovalent surface antigen (SA) influenza A/H9N2 virus vaccine with or without MF59 adjuvant and administered intramuscularly to ambulatory adults. The hypothesis is that all dosage levels of adjuvanted and nonadjuvanted vaccine will be well tolerated. The primary objective of this project is to evaluate the safety of 4 dosage levels of monovalent surface antigen (SA) influenza A/H9N2 virus vaccine given with or without MF59 adjuvant. The primary endpoint is the frequency and severity of solicited local and systemic adverse events in each vaccine dosage level group. The secondary objective of this project is to determine the immunogenicity of 4 dosage levels of monovalent surface antigen (SA) influenza A/H9N2 virus vaccine given with or without MF59 adjuvant. The secondary endpoints include the following: the proportions of subjects in each vaccine dosage group that achieve a serum HAI titer of at least 1:32 one month after the second vaccination; the geometric mean titer (GMT) of serum HAI antibody against the influenza A/H9N2 virus one month after the second vaccination; the rates of significant increases in titer between pre- and post-immunization serum samples (defined as seroconversion-i.e., increase in titer from <1:4 pre-immunization to at least 1:8 after vaccination, or 4-fold or greater increase in titer between pre- and post-immunization samples) 28 days after each vaccination (days 28 and 56); and the proportion of subjects with a 4-fold or greater increase in percent HA-specific antibody in nasal wash specimens for each vaccine group. The study will be a double-blind evaluation of 4 dosage levels of study vaccine. The 4 dosage levels to be tested are 3.75-, 7.5-, 15-, and 30-mcg of HA of the vaccine strain with and without MF59 adjuvant. Because all dosage levels are lower than the total hemagglutinin content of the FLUAD® vaccine used in Europe, subjects will be enrolled into all dosage and adjuvant groups concurrently using a randomized, double-blind study design. Ninety-six persons 18-34 years of age will be enrolled. A single lot of monovalent inactivated SA influenza A/H9N2 vaccine will be used throughout the trial. All injections will be administered in a 0.5-mL volume into the deltoid muscle. Screening and safety laboratory examinations will be assessed before the first dose and 7 days after each vaccination. Assessments for reactogenicity will be done for at least 20 minutes after each vaccination, in the clinic 2 and 7 days after each inoculation, via diary card for seven days after each vaccination, and via phone or other contact at 7 months after the first vaccination for any serious adverse events during the entire study period. Serum and nasal wash samples collected on days 0, 28, and 56 will be used to measure immunogenicity of the vaccine preparation. Participants will be involved in study related procedures for up to 8 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group 1A: 3.75 mcg A/H9N2 no adjuvant | Experimental | Biological: Influenza A/H9N2 vaccine12 subjects to receive 3.75 mcg A/H9N2 with no adjuvant. |
| Group 2B: 7.5 mcg A/H9N2 plus MF59 adjuvant | Experimental | Biological: Influenza A/H9N2 vaccine, Drug: MF59 adjuvant12 subjects to receive 7.5 mcg A/H9N2 plus MF59 adjuvant. |
| Group 3A: 15 mcg A/H9N2 no adjuvant | Experimental | Biological: Influenza A/H9N2 vaccine12 subjects to receive 15 mcg A/H9N2 with no adjuvant. |
| Group 3B: 15 mcg A/H9N2 plus MF59 adjuvant | Experimental | Biological: Influenza A/H9N2 vaccine, Drug: MF59 adjuvant12 subjects to receive 15 mcg A/H9N2 plus MF59 adjuvant. |
| Group 4B: 30 mcg A/H9N2 plus MF59 adjuvant | Experimental | Biological: Influenza A/H9N2 vaccine, Drug: MF59 adjuvant12 subjects to receive 30 mcg A/H9N2 plus MF59 adjuvant. |
| Group 4A: 30 mcg A/H9N2 no adjuvant | Experimental | Biological: Influenza A/H9N2 vaccine12 subjects to receive 30 mcg A/H9N2 with no adjuvant. |
| Group 2A: 7.5 mcg A/H9N2 no adjuvant | Experimental | Biological: Influenza A/H9N2 vaccine12 subjects to receive 7.5 mcg A/H9N2 with no adjuvant. |
| Group 1B: 3.75 mcg A/H9N2 plus MF59 adjuvant | Experimental | Biological: Influenza A/H9N2 vaccine, Drug: MF59 adjuvant12 subjects to receive 3.75 mcg A/H9N2 plus MF59 adjuvant. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Ambulatory, healthy males and non-pregnant female adults 18-34 years of age.
- Able to give informed consent and available for all study visits.
- Able to understand and comply with planned study procedures.
- Women capable of bearing children must utilize an acceptable means of birth control (abstinence, oral contraceptives ("the pill"), intrauterine devices (IUDs), contraceptive implants under the skin, or contraceptive injections, or condoms with foam).
- On no concomitant medications except contraceptive medications.
Key exclusion criteria (15 listed)
- Known allergy to eggs or other components of vaccine.
- Prior receipt of an influenza A/H9N2 vaccine.
- Abnormal screening laboratory values (laboratory values must be within normal limits).
- Pregnancy, desire to become pregnant in the next 3 months, or lactation.
- Immunosuppression as a result of underlying illness or treatment.
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/H9N2 vaccineA single lot of monovalent inactivated SA influenza A/H9N2 vaccine. All injections will be administered in a 0.5-mL volume into the deltoid muscle. Dosage levels are: 3.75-, 7.5-, 15-, and 30-mcg of HA of the vaccine strain with and without MF59 adjuvant. | Biological | Group 1A: 3.75 mcg A/H9N2 no adjuvant, Group 1B: 3.75 mcg A/H9N2 plus MF59 adjuvant, Group 2A: 7.5 mcg A/H9N2 no adjuvant, Group 2B: 7.5 mcg A/H9N2 plus MF59 adjuvant, Group 3A: 15 mcg A/H9N2 no adjuvant, Group 3B: 15 mcg A/H9N2 plus MF59 adjuvant, Group 4A: 30 mcg A/H9N2 no adjuvant, Group 4B: 30 mcg A/H9N2 plus MF59 adjuvant |
| MF59 adjuvantMF59 adjuvant is an oil-in-water emulsion. | Drug | Group 1B: 3.75 mcg A/H9N2 plus MF59 adjuvant, Group 2B: 7.5 mcg A/H9N2 plus MF59 adjuvant, Group 3B: 15 mcg A/H9N2 plus MF59 adjuvant, Group 4B: 30 mcg A/H9N2 plus MF59 adjuvant |
Primary outcome
The frequency and severity of solicited local and systemic adverse events in each vaccine dosage level group.
Time frame: Duration of study.
4 secondary outcomes
The proportions of subjects in each vaccine dosage group that achieve a serum HAI titer of at least 1:32.
Time frame: One month after the second vaccination.
Rates of significant increases in titer between pre- and post-immunization serum samples 28 days after each vaccination.
Time frame: Days 28 and 56.
The geometric mean titer (GMT) of serum HAI antibody against the influenza A/H9N2 virus.
Time frame: One month after the second vaccination.
The proportion of subjects with a 4-fold or greater increase in percent HA-specific antibody in nasal wash specimens for each vaccine group.
Time frame: Nasal wash samples collected on Days 0, 28, and 56.
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.
- Results publication: PubMed 17029131Atmar RL, Keitel WA, Patel SM, Katz JM, She D, El Sahly H, Pompey J, Cate TR, Couch RB. Safety and immunogenicity of nonadjuvanted and MF59-adjuvanted influenza A/H9N2 vaccine preparations. Clin Infect Dis. 2006 Nov 1;43(9):1135-42. doi: 10.1086/508174. Epub 2006 Sep 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.
1 site 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 Influenza A/H9N2 vaccine and MF59 adjuvant in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 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 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The frequency and severity of solicited local and systemic adverse events in each vaccine dosage level group. (time frame: Duration of study.). 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 NCT00133471, 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.