Influenza VaccinesPhase 1/2CCTA #0005NCT01623232
MAS-1 Adjuvanted Compared to Unadjuvanted Influenza Vaccines in the Elderly
A Phase 1/2 study testing MAS-1 adjuvant and influenza HA antigen and standard dose, inactivated trivalent influenza vaccine (TIV) in people with Influenza Vaccines and Aged, run by US Department of Veterans Affairs at 4 sites in United States.
Trial summary
This is a Phase 1,2 randomized, double-blind, multi-center, clinical trial, in participants aged 65 years and older, evaluating the immunogenicity and safety of a water-in-oil emulsion adjuvant (MAS-1 adjuvant, Mercia Pharma, Inc, Scarsdale, NY) combined with each of the three reduced HA antigen dose levels of… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza Vaccines, Aged
- What is being tested?
- MAS-1 adjuvant and influenza HA antigen and standard dose, inactivated trivalent influenza vaccine (TIV)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2012to Jun 2014
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Participants must meet all of the following inclusion criteria at Screening/Baseline to participate in this study:
- Ambulatory persons aged at least 65 years or older on the day of enrollment. Participants will be considered ambulatory if they are not institutionalized, bedridden, or homebound.
- Written informed consent form and Authorization to Obtain and Release Protected Health Information (HIPAA) form signed.
- Medically stable. Participants may have clinically stable underlying chronic conditions such as, but not limited to hypertension, diabetes, congestive heart failure, ischemic heart disease, or chronic lung disease, but their symptoms/signs must be controlled, as judged by the investigator, based on physical examination and medical history. Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 4 weeks before receipt of the test article, are eligible.
- Body Mass Index (BMI)<40
- Normal ranges for safety labs including:
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- WBC count 3,600 - 11,200 cells/mm3
- Platelets: 150,000-450,000/mm3
- Hemoglobin >sex-specific institutional lower limit of normal (Female 11 g/dL and Male 12.5 g/dL).
- Chemistry Panel: ALT, AST, total bilirubin <1.1 times and CPK <1.25 times the upper limit of normal for the study; glucose 65 to 100 mg/dL; creatinine 0.40 to 1.40 mg/dL
- Absolute neutrophil, lymphocyte and eosinophil counts are within the study normal range.
- Normal urine dipstick: negative or trace urine protein, negative or trace urine blood.
- Able to attend all scheduled visits and to comply with all trial procedures.
Who cannot join
- Participants who meet any of the exclusion criteria at Screening/Baseline will be excluded from study participation. Participants will not be able to participate if they have:
- Systemic hypersensitivity to eggs, chicken proteins, or any of the other vaccine components, or a history of a life-threatening reaction to TIV or a vaccine containing any of the same substances.
- History of congenital or acquired immunodeficiency, Human Immunodeficiency Virus infection, hepatitis C or B virus infection, or autoimmune disease, or immunosuppressive therapy or radiation therapy in the preceding six months.
- Systemic corticosteroid therapy, as follows:
- Continuous use with a dosage equivalent to >15 mg per day of oral prednisone for 90 days preceding vaccination.
- Sporadic use with a dosage equivalent to >40 mg per day of oral prednisone for >14 consecutive days in the 90 days preceding vaccination.
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- Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, and history of neoplastic disease but disease-free for 5 years).
- Current alcohol abuse or drug addiction that may interfere with trial procedures.
- Receipt of blood or blood-derived products in the past three months.
- Receipt of influenza vaccine in the past six months.
- Receipt of any other vaccine in the past four weeks.
- Planned receipt of another vaccine in the four weeks following the trial vaccination.
- Planned participation in another clinical trial during the present trial period. Concomitant participation in an observational trial (not involving drugs, vaccines, or medical devices) is acceptable.
- Thrombocytopenia or bleeding disorder contraindicating IM vaccination. Anticoagulation is only a relative contraindication to IM vaccine injections (39). Exclusion from participation on this basis is at the discretion of the participant and the investigator after full discussion of the risks.
- History of Guillain-Barr syndrome.
- An acute febrile illness within 24 hours prior to vaccination. Vaccination will be deferred until the participant has been afebrile for at least 24 hours.
- Signs and symptoms of an acute infectious respiratory ill
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, 52246-2208
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
St Louis, Missouri, 63106
About this study
This is a Phase 1,2 randomized, double-blind, multi-center, clinical trial, in participants aged 65 years and older, evaluating the immunogenicity and safety of a water-in-oil emulsion adjuvant (MAS-1 adjuvant, Mercia Pharma, Inc, Scarsdale, NY) combined with each of the three reduced HA antigen dose levels of trivalent influenza virus vaccine compared with licensed, unadjuvanted, standard dose trivalent virus (TIV). Immunogenicity for each of the three viral strains (A/H1N1, A/H3N2, and B virus) in the concurrent influenza seasonal vaccine will be assessed.
Read the detailed description
Many VA patients are at-risk for complications from influenza because of advanced age and underlying chronic diseases. A more effective influenza virus vaccine is needed in older patient populations and high antibody levels are correlated with protection. Vaccine dose-sparing to maximize the number of doses available is a public health goal. The combination of influenza vaccine antigens with an adjuvant could help improve the vaccine. This study will be a phase 1, 2 randomized, observer-blind, multi-center, clinical trial, in patients aged 65 years and older, evaluating the immunogenicity and safety of a water-in-oil emulsion adjuvant (MAS-1) combined with each of three reduced influenza hemagglutinin (HA) antigen dose levels of trivalent influenza virus vaccine compared to unadjuvanted, standard dose trivalent influenza virus vaccine (TIV). Immunogenicity for each of the three viral strains (A/H1N1, A/H3N2, and B virus) in the concurrent seasonal influenza vaccine will be assessed. The hypothesis is that adjuvanted influenza virus vaccine (using reduced doses of influenza HA antigen containing 1 g, 3 g and 5 g of HA) has superior immunogenicity compared to unadjuvanted, standard dose trivalent influenza virus vaccine (containing 15 g HA antigen) for each of three viral strains, and the adjuvanted vaccine has an acceptable safety profile. The primary objectives are to demonstrate 1) acceptable safety for influenza virus vaccine, adjuvanted with MAS-1 compared to unadjuvanted, standard dose TIV, and 2) improved immunogenicity of the adjuvanted influenza virus vaccine compared to unadjuvanted, standard dose TIV for each of the three viral strains. Immunogenicity will be measured by hemagglutination inhibition (HAI) antibody titers. The primary measure of immunogenicity is the seroconversion rate at 1 month post-vaccination for each viral strain. Secondary and exploratory immunogenicity objectives include the seroprotection rate (defined as the proportion of subjects with a post-vaccination HAI antibody titer > 1:40 for a viral strain) at 1, 3 and 6 months post-vaccination for each viral strain; the geometric mean titers (GMTs) of HAI antibody and ratio of GMTs pre-vaccination and at 1, 3 and 6 months post-vaccination between the four vaccine groups for each viral strain; and the geometric mean fold increase (GMFI) at 1, 3 and 6 months post-vaccination compared to pre-vaccination (i.e., GMT of the post-vaccination values divided by the GMT of the pre-vaccination value) for each virus strain within each of the four vaccine groups. The study population of 160 subjects (40 per vaccine group) who provide informed consent and meet eligibility criteria will be enrolled at four clinical sites. Subjects who meet the entry criteria for the study will be randomly assigned to receive one of the three adjuvanted influenza virus vaccine dose levels or unadjuvanted, standard dose TIV. Randomization will be stratified by clinical site (4 sites) and age (65-74 years old or 75 years old). Vaccine preparation will be performed at point-of-use by the site pharmacists according to a standardized procedure. Administration of vaccine will be performed by an unblinded vaccine administrator. Study assessments will be performed by blinded study personnel. Subjects will also be blinded to treatment assignment. Study subjects will each participate for a total of 12 months post-vaccination. The whole study duration of 32 - 32.5 months is expected to include 6 months of startup, 8 - 10 weeks of enrollment, 12 months of follow-up post-vaccination and 12 months of study closure and data analysis. If the objectives of this study are achieved and the hypothesis is correct, the adjuvanted influenza virus vaccine at one or more of the reduced HA antigen doses will induce an improved HAI antibody response compared to unadjuvanted, standard dose TIV with an acceptable safety profile. Results of this trial will inform the design of future clinical trials studying adjuvanted influenza virus vaccines utilizing this novel water-in-oil adjuvant emulsion that could include dose-finding studies for the optimal amount of adjuvant combined with one HA antigen dose, and larger phase 2 and 3 clinical trials.
- Conditions
- Influenza Vaccines, Aged
- Being tested
- MAS-1 adjuvant and influenza HA antigen, standard dose, inactivated trivalent influenza vaccine (TIV)
- Keywords
- vaccine, influenzavirus A, influenzavirus B, 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.
MAS-1 adjuvant and influenza HA antigenBiological
Also called MER4101
Vaccines will be administered IM in the deltoid muscle. HA antigen of each of three viral strains at doses of 1 micrograms, 3 micrograms, or 5 micrograms per viral strain adjuvanted with MAS-1 adjuvant and as nonadjuvanted standard dose TIV will be tested.
- Treatment Group 1:each 0.3 mL dose will be administered as an emulsion containing 0.186 grams of MAS-1 oil vehicle and 1 micrograms HA of each of three viral strains in 0.08 mL sterile phosphate buffered saline (PBS).
- Treatment Group 2:each 0.3 mL dose will be administered as an emulsion containing 0.186 grams of MAS-1 oil vehicle and 3 micrograms HA of each of three viral strains in 0.08 mL sterile PBS.
- Treatment Group 3:each 0.3 mL dose will be administered as an emulsion containing 0.186 grams of MAS-1 oil vehicle and 5 micrograms HA of each of three viral strains in 0.08 mL sterile PBS.
standard dose, inactivated trivalent influenza vaccine (TIV)Biological
Vaccine will be administered IM in the deltoid muscle. HA antigen of each of three viral strains as nonadjuvanted standard dose TIV will be tested.
- Treatment Group 4:0.5 mL dose of licensed, unadjuvanted, standard dose influenza virus vaccine with 15 micrograms HA of each of 3 viral strains.
| Study group | Role | What they receive |
|---|---|---|
| adjuvant plus 1 �g of HA antigen | Experimental | MAS-1-adjuvant-formulated influenza vaccine, at three HA antigen dose levels containing 1 �g of HA antigen Receives: Biological: MAS-1 adjuvant and influenza HA antigen |
| adjuvant plus 3 �g of HA antigen | Experimental | MAS-1-adjuvant-formulated influenza vaccine, at three HA antigen dose levels containing 3 �g of HA antigen Receives: Biological: MAS-1 adjuvant and influenza HA antigen |
| adjuvant plus 5 �g of HA antigen | Experimental | MAS-1-adjuvant-formulated influenza vaccine, at three HA antigen dose levels containing 5 �g of HA antigen Receives: Biological: MAS-1 adjuvant and influenza HA antigen |
| licensed influenza vaccine | Active comparator | licensed, inactivated, standard dose influenza vaccine without adjuvant Receives: Biological: standard dose, inactivated trivalent influenza vaccine (TIV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety
Participants with at least one vaccine-related adverse event (AE) from the following four categories: solicited AEs, unsolicited AEs, serious AEs, and abnormal safety labs for severity grade 2 or higher, grade 3 only, and grade 4 or 5.
Measured: 12 months
Secondary outcomes (8)
immunogenicity
The primary immunogenicity outcome is the seroconversion rate at 1 month (day 28) post-vaccination for each of the three virus strains in each vaccine group. Seroconversion rate at 1 month is defined as the proportion of participants with either a pre-vaccination HAI antibody titer <1:10 and a post-vaccination antibody titer = 1:40, or a pre-vaccination HAI antibody titer = 1:10 and a minimum four-fold rise in post-vaccination antibody titer.
Measured: 6 months
immunogenicity
The seroprotection rate at 1 month (day 28) post-vaccination for each of the three virus strains in each vaccine group. Seroprotection is defined as the proportion of participants with post-vaccination antibody titer of 1:40 or greater.
Measured: 1 month
immunogenicity
The geometric mean titers of antibody and ratios of geometric mean antibody titers at 1 month (28 days) post-vaccination for each virus strain and vaccine group.
Measured: 1 month
immunogenicity
The seroprotection rates up to 6 months post-vaccination for each virus strain and vaccine group.
Measured: 6 months
immunogenicity
The rates of antibody titers at serum dilutions of at least 1:80, at least 1:160, and at least 1:320.
Measured: 6 months
immunogenicity
The geometric mean antibody titers and ratios of geometric mean antibody titers up to 6 months post-vaccination for each virus strain and vaccine group.
Measured: 6 months
safety
Participants in each vaccine group experiencing an individual adverse event (AE) by severity grade, relatedness to vaccine, for solicited AEs, unsolicited AEs, serious AEs and abnormal safety labs.
Measured: 12 months
safety
Participants in each vaccine group experiencing at least one abnormal symptom with any severity grade, grade 2 or higher, grade 3 or higher, and grades 4 and 5, by relatedness to vaccine, for solicited adverse events (AE), serious AEs and safety labs.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2013 (estimated)
- Study completionJun 2014 (estimated)
Why it stopped: FDA hold on the project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza VaccinesStudies of the same condition, open and under way.
- 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- St. Louis University
- Responsible party
- Sponsor
- Investigators
- Geoffrey J. Gorse, MD, Principal investigator, St. Louis VA Medical Center John Cochran Division, St. Louis, MO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623232
- Sponsor's protocol ID
- CLIN-07-11S
- Other IDs
- 1 I01 CX000633-01
- Acronym
- CCTA #0005
- Status last verified
- Sep 2012
- First submitted
- 15 Jun 2012
- Last updated
- 26 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAS-1 Adjuvanted Compared to Unadjuvanted Influenza Vaccines in the Elderly
- ClinicalTrials.gov ID
- NCT01623232
- Acronym / sponsor ID
- CCTA #0005 / CLIN-07-11S
- Conditions
- Influenza Vaccines, Aged
- Keywords
- vaccine, influenzavirus A, influenzavirus B, adjuvant
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: FDA hold on the project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- St. Louis University
- Study start
- Oct 2012
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 19 Jun 2012 (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 is a Phase 1,2 randomized, double-blind, multi-center, clinical trial, in participants aged 65 years and older, evaluating the immunogenicity and safety of a water-in-oil emulsion adjuvant (MAS-1 adjuvant, Mercia Pharma, Inc, Scarsdale, NY) combined with each of the three reduced HA antigen dose levels of trivalent influenza virus vaccine compared with licensed, unadjuvanted, standard dose trivalent virus (TIV). Immunogenicity for each of the three viral strains (A/H1N1, A/H3N2, and B virus) in the concurrent influenza seasonal vaccine will be assessed.
Detailed description
Many VA patients are at-risk for complications from influenza because of advanced age and underlying chronic diseases. A more effective influenza virus vaccine is needed in older patient populations and high antibody levels are correlated with protection. Vaccine dose-sparing to maximize the number of doses available is a public health goal. The combination of influenza vaccine antigens with an adjuvant could help improve the vaccine. This study will be a phase 1, 2 randomized, observer-blind, multi-center, clinical trial, in patients aged 65 years and older, evaluating the immunogenicity and safety of a water-in-oil emulsion adjuvant (MAS-1) combined with each of three reduced influenza hemagglutinin (HA) antigen dose levels of trivalent influenza virus vaccine compared to unadjuvanted, standard dose trivalent influenza virus vaccine (TIV). Immunogenicity for each of the three viral strains (A/H1N1, A/H3N2, and B virus) in the concurrent seasonal influenza vaccine will be assessed. The hypothesis is that adjuvanted influenza virus vaccine (using reduced doses of influenza HA antigen containing 1 g, 3 g and 5 g of HA) has superior immunogenicity compared to unadjuvanted, standard dose trivalent influenza virus vaccine (containing 15 g HA antigen) for each of three viral strains, and the adjuvanted vaccine has an acceptable safety profile. The primary objectives are to demonstrate 1) acceptable safety for influenza virus vaccine, adjuvanted with MAS-1 compared to unadjuvanted, standard dose TIV, and 2) improved immunogenicity of the adjuvanted influenza virus vaccine compared to unadjuvanted, standard dose TIV for each of the three viral strains. Immunogenicity will be measured by hemagglutination inhibition (HAI) antibody titers. The primary measure of immunogenicity is the seroconversion rate at 1 month post-vaccination for each viral strain. Secondary and exploratory immunogenicity objectives include the seroprotection rate (defined as the proportion of subjects with a post-vaccination HAI antibody titer > 1:40 for a viral strain) at 1, 3 and 6 months post-vaccination for each viral strain; the geometric mean titers (GMTs) of HAI antibody and ratio of GMTs pre-vaccination and at 1, 3 and 6 months post-vaccination between the four vaccine groups for each viral strain; and the geometric mean fold increase (GMFI) at 1, 3 and 6 months post-vaccination compared to pre-vaccination (i.e., GMT of the post-vaccination values divided by the GMT of the pre-vaccination value) for each virus strain within each of the four vaccine groups. The study population of 160 subjects (40 per vaccine group) who provide informed consent and meet eligibility criteria will be enrolled at four clinical sites. Subjects who meet the entry criteria for the study will be randomly assigned to receive one of the three adjuvanted influenza virus vaccine dose levels or unadjuvanted, standard dose TIV. Randomization will be stratified by clinical site (4 sites) and age (65-74 years old or 75 years old). Vaccine preparation will be performed at point-of-use by the site pharmacists according to a standardized procedure. Administration of vaccine will be performed by an unblinded vaccine administrator. Study assessments will be performed by blinded study personnel. Subjects will also be blinded to treatment assignment. Study subjects will each participate for a total of 12 months post-vaccination. The whole study duration of 32 - 32.5 months is expected to include 6 months of startup, 8 - 10 weeks of enrollment, 12 months of follow-up post-vaccination and 12 months of study closure and data analysis. If the objectives of this study are achieved and the hypothesis is correct, the adjuvanted influenza virus vaccine at one or more of the reduced HA antigen doses will induce an improved HAI antibody response compared to unadjuvanted, standard dose TIV with an acceptable safety profile. Results of this trial will inform the design of future clinical trials studying adjuvanted influenza virus vaccines utilizing this novel water-in-oil adjuvant emulsion that could include dose-finding studies for the optimal amount of adjuvant combined with one HA antigen dose, and larger phase 2 and 3 clinical trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| adjuvant plus 1 �g of HA antigen | Experimental | Biological: MAS-1 adjuvant and influenza HA antigenMAS-1-adjuvant-formulated influenza vaccine, at three HA antigen dose levels containing 1 �g of HA antigen |
| adjuvant plus 3 �g of HA antigen | Experimental | Biological: MAS-1 adjuvant and influenza HA antigenMAS-1-adjuvant-formulated influenza vaccine, at three HA antigen dose levels containing 3 �g of HA antigen |
| adjuvant plus 5 �g of HA antigen | Experimental | Biological: MAS-1 adjuvant and influenza HA antigenMAS-1-adjuvant-formulated influenza vaccine, at three HA antigen dose levels containing 5 �g of HA antigen |
| licensed influenza vaccine | Active comparator | Biological: standard dose, inactivated trivalent influenza vaccine (TIV)licensed, inactivated, standard dose influenza vaccine without adjuvant |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- Participants must meet all of the following inclusion criteria at Screening/Baseline to participate in this study:
- Ambulatory persons aged at least 65 years or older on the day of enrollment. Participants will be considered ambulatory if they are not institutionalized, bedridden, or homebound.
- Written informed consent form and Authorization to Obtain and Release Protected Health Information (HIPAA) form signed.
- Medically stable. Participants may have clinically stable underlying chronic conditions such as, but not limited to hypertension, diabetes, congestive heart failure, ischemic heart disease, or chronic lung disease, but their symptoms/signs must be controlled, as judged by the investigator, based on physical examination and medical history. Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 4 weeks before receipt of the test article, are eligible.
- Body Mass Index (BMI)<40
Key exclusion criteria (17 listed)
- Participants who meet any of the exclusion criteria at Screening/Baseline will be excluded from study participation. Participants will not be able to participate if they have:
- Systemic hypersensitivity to eggs, chicken proteins, or any of the other vaccine components, or a history of a life-threatening reaction to TIV or a vaccine containing any of the same substances.
- History of congenital or acquired immunodeficiency, Human Immunodeficiency Virus infection, hepatitis C or B virus infection, or autoimmune disease, or immunosuppressive therapy or radiation therapy in the preceding six months.
- Systemic corticosteroid therapy, as follows:
- Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, and history of neoplastic disease but disease-free for 5 years).
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 |
|---|---|---|
| MAS-1 adjuvant and influenza HA antigenAlso: MER4101Vaccines will be administered IM in the deltoid muscle. HA antigen of each of three viral strains at doses of 1 micrograms, 3 micrograms, or 5 micrograms per viral strain adjuvanted with MAS-1 adjuvant and as nonadjuvanted standard dose TIV will be tested. 1. Treatment Group 1:each 0.3 mL dose will be administered as an emulsion containing 0.186 grams of MAS-1 oil vehicle and 1 micrograms HA of each of three viral strains in 0.08 mL sterile phosphate buffered saline (PBS). 2. Treatment Group 2:each 0.3 mL dose will be administered as an emulsion containing 0.186 grams of MAS-1 oil vehicle and 3 micrograms HA of each of three viral strains in 0.08 mL sterile PBS. 3. Treatment Group 3:each 0.3 mL dose will be administered as an emulsion containing 0.186 grams of MAS-1 oil vehicle and 5 micrograms HA of each of three viral strains in 0.08 mL sterile PBS. | Biological | adjuvant plus 1 �g of HA antigen, adjuvant plus 3 �g of HA antigen, adjuvant plus 5 �g of HA antigen |
| standard dose, inactivated trivalent influenza vaccine (TIV)Vaccine will be administered IM in the deltoid muscle. HA antigen of each of three viral strains as nonadjuvanted standard dose TIV will be tested. 4. Treatment Group 4:0.5 mL dose of licensed, unadjuvanted, standard dose influenza virus vaccine with 15 micrograms HA of each of 3 viral strains. | Biological | licensed influenza vaccine |
Primary outcome
safety
Time frame: 12 months
Participants with at least one vaccine-related adverse event (AE) from the following four categories: solicited AEs, unsolicited AEs, serious AEs, and abnormal safety labs for severity grade 2 or higher, grade 3 only, and grade 4 or 5.
8 secondary outcomes
immunogenicity
Time frame: 6 months
immunogenicity
Time frame: 1 month
immunogenicity
Time frame: 1 month
immunogenicity
Time frame: 6 months
immunogenicity
Time frame: 6 months
immunogenicity
Time frame: 6 months
safety
Time frame: 12 months
safety
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2012.
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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.
Geoffrey J. Gorse, MD principal investigator
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
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 MAS-1 adjuvant and influenza HA antigen and standard dose, inactivated trivalent influenza vaccine (TIV) in people with Influenza Vaccines and Aged, run by US Department of Veterans Affairs 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 13 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: withdrawn, as of the sponsor's last update on 26 Sep 2012. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
safety (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2012.