InfluenzaPhase 1/2NCT00680069
H5N1 (Clade 2) Vaccination of Adults and Elderly
A Phase 1/2 study testing Influenza Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005 in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.
Trial summary
The purpose of this research study is to study the safety and effectiveness of vaccinating individuals who have previously received an avian influenza vaccine derived from one type of H5N1 virus with a vaccine derived from a different type of avian influenza virus. Read more about this study
- Who is it for?
- Ages 19 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 517 participants
- Where
- 8 sitesUnited States
- Study dates
- Nov 2008to Nov 2009
- 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 19 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -The subject must have previously received at least 2 doses via the intramuscular route of placebo or vaccine derived from A/H5N1/VN/1203/04 as part of one of the following DMID Protocol Nos.: 04-062, 04-063 (and 05-0090), 04-076, 05-0015, 05-0127, 05-0141, or 06-0089; or the subject must have received placebo intramuscularly as part of DMID Protocol No. 06-0052. -The subject must be 19 years old or older. -Women of childbearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for greater than or equal to 1 year) must agree to practice adequate contraception, including, but not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, birth control pills, patches or hormonal shots or hormonal implants, NuvaRing and IUDs (intrauterine devices), during the study period between enrollment and 30 days following receipt of the last dose of vaccine. -For a female subject of childbearing potential, she must have a negative pregnancy test (urine or serum) within 24 hours prior to vaccination. -The subject is in good health, as determined by vital signs (heart rate less than 100 bpm; blood pressure: systolic greater than or equal to 90 mm Hg and less than or equal to 140 mm Hg; diastolic less than or equal to 90 mm Hg; oral temperature less than 100.0 degrees Fahrenheit), medical history to ensure stable medical condition, and a targeted physical examination, when necessary, based on medical history. A systolic blood pressure of less than or equal to 160 and a diastolic blood pressure of less than or equal to 90 is acceptable in subjects greater than 65 years of age. -The subject is able to understand and comply with the planned study procedures, including being available for all study visits. -The subject has provided informed consent prior to any study procedures.
Who cannot join
- -The subject is allergic to eggs, egg products, chicken or egg proteins or other components of the vaccine (including gelatin, formaldehyde, octoxinol and thimerosal). -The subject is a woman who is breastfeeding or intends to become pregnant during the study period between enrollment and 30 days following receipt of the last dose of vaccine. -The subject is immunosuppressed as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months. -The subject has an active neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematologic malignancy. An active neoplastic disease is defined as treatment for neoplastic disease within the past 5 years. -The subject has long-term (greater than 2 weeks) use of oral or parenteral glucocorticoids, or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed). -The subject received immunoglobulin or another blood product within the 3 months prior to enrollment in this study. -The subject has received an inactivated vaccine within the 2 weeks or a live vaccine within the 4 weeks prior to enrollment in this study or plans to receive another vaccine within the next 28 days (or 56 days for prior placebo recipients). -The subject has an acute or chronic medical condition that would render vaccination unsafe or would interfere with the evaluation of responses. These conditions include, but are not limited to: solicited reactogenicity symptoms, history of significant renal impairment (dialysis and treatment for kidney disease, including diabetic and hypertensive kidney disease); subjects with diabetes mellitus, well-controlled with oral agents may enroll as long as there has been no dose adjustment with the past 6 months; insulin-dependent diabetes is excluded; cardiac insufficiency, if heart failure is present (New York Association Functional Class III or IV); an arteriosclerotic event during the 6 months prior to enrollment (e.g., history of myocardial infarction, stroke, recanalization of femoral arteries or transient ischemic attack). -The subject has a history of a severe reaction following receipt of an influenza virus vaccine. -The subject has an acute illness or an oral temperature greater than 99.9 degrees Fahrenheit (37.7 degrees Celsius) within 3 days prior to enrollment or vaccination. -The subject is currently participating in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication) or has received an experimental agent within 1 month prior to enrollment in this study, or expects to receive another experimental agent during participation in this study. -The subject 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. -The subject has a diagnosis of schizophrenia, bi-polar disease, or other severe (disabling) chronic psychiatric diagnosis. -The subject has been hospitalized within the past 5 years prior to enrollment for psychiatric illness, history of suicide attempt or confinement for danger to self or others. -The subject is receiving psychiatric drugs. Subjects who are receiving a single antidepressant drug and are stable for at least 3 months prior to enrollment without decompensating are allowed enrollment into the study. -The subject has a history of alcohol or drug abuse in the 5 years prior to enrollment. -The subject has a known human immunodeficiency virus, hepatitis B, or hepatitis C infection. -The subject has a history of Guillain-Barré syndrome. -The subject has any condition that the investigator believes may interfere with successful completion of the study. The subject plans to enroll in another clinical trial that has a study intervention such as a drug, biologic, or device that could interfere with safety assessment of the investigational product at any time during the study period.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
Baltimore, Maryland, 21201-1509
Cincinnati Children's Hospital Medical Center - Infectious Diseases
Cincinnati, Ohio, 45229-3039
Duke Translational Medicine Institute - Clinical Vaccine Unit
Durham, North Carolina, 27704-2120
Baylor College of Medicine - Molecular Virology and Microbiology
Houston, Texas, 77030-3411
University of Iowa - Vaccine Research and Education Unit
Iowa City, Iowa, 52242-2600
Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center
Nashville, Tennessee, 37232-2573
Saint Louis University - Center for Vaccine Development
St Louis, Missouri, 63104-1015
Stanford University - Stanford Hospital and Clinics - Pediatrics - Infectious Diseases
Stanford, California, 94305-2200
About this study
Official title: A Randomized, Double-Blinded, Phase I/II Study of the Safety, Reactogenicity, and Immunogenicity of an Inactivated Influenza Vaccine Derived From A/H5N1/Indonesia/05/05 (Clade 2) in Healthy Adults and Elderly Who Participated in a Previous A/H5N1/Vietnam/1203/2004 (Clade 1) Vaccine Study
The purpose of this research study is to study the safety and effectiveness of vaccinating individuals who have previously received an avian influenza vaccine derived from one type of H5N1 virus with a vaccine derived from a different type of avian influenza virus. A second reason for this study is to compare responses in people who have received two different but similar types of H5N1 vaccine to the responses in subjects who receive 2 doses of only the H5N1 vaccine used in this study. The information obtained may provide important information into the usefulness of a pre-pandemic vaccination. Participants will include 600 healthy adult volunteers, ages 19 and older, in the United States. Study procedures include: physical exams, vaccination with either a low dose (15 micrograms) or high dose (90 micrograms) of vaccine, blood samples, and maintaining a memory aid to record oral temperatures and side effects. Study participation will be approximately 7 months.
Read the detailed description
The goals of this study are to investigate the safety, reactogenicity, and immunogenicity of a single dose of monovalent subvirion influenza vaccine produced from a clade 2 A/H5N1 vaccine administered by intramuscular injection to healthy adults and the elderly who have previously received at least 2 doses of clade 1 A/H5N1 vaccine. In addition, this study will compare these results to individuals who are receiving 2 doses of the clade 2 A/H5N1 vaccine for the first time. The primary objective of the study is to compare the immune response following a single low-dose (15 mcg) to a single high-dose (90 mcg) of influenza vaccine derived from the clade 2 virus A/H5N1/Indonesia/05/05 in individuals who have previously received at least 2 doses of an influenza vaccine derived from the clade 1 virus A/H5N1/Vietnam/1203/2004 (A/VN/1203/04). The secondary objectives will: compare the immune response following a single low-dose (15 mcg) or single high-dose (90 mcg) of influenza vaccine derived from the clade 2 virus A/H5N1/Indonesia/05/05 in individuals who have previously received at least 2 doses of an influenza vaccine derived from the clade 1 virus A/H5N1/Vietnam/1203/2004 (A/VN/1203/04) to a group that has not received any previous A/H5N1 vaccine but who will receive 2 doses of an influenza vaccine derived from the clade 2 virus A/H5N1/Indonesia/05/05; evaluate the factors associated with immunologic response to a single dose of a vaccine derived from a clade 2 virus among individuals who have previously received at least 2 doses of vaccine derived from a clade 1 virus; evaluate the safety of a single dose of subvirion inactivated vaccine derived from the clade 2 virus A/H5N1/Indonesia/05/05 in individuals who have previously received at least 2 doses of an influenza vaccine derived from the clade 1 virus A/H5N1/Vietnam/1203/2004 (A/VN/1203/04); explore immunologic responses following vaccination with a clade 2 vaccine from A/H5N1/Indonesia/05/05 to influenza strains other than A/H5N1/Indonesia/05/05, including A/VN/1203/04; evaluate the immune responses of previously unvaccinated individuals after 1 or 2 doses of clade 2 virus A/H5N1/Indonesia/05/05 vaccine; and evaluate the duration of antibody responses following 1 or 2 doses of vaccine derived from the clade 2 virus A/H5N1/Indonesia/05/05. This study will recruit 600 healthy volunteers aged 19 years or older, in the United States, who have previously participated in a linked DMID-sponsored study. This study is linked to DMID protocols 04-063, 05-0090, 04-076, 05-0015, 05-0127, 05-0141, 06-0089, 04-062, 06-0052, and 08-0030. The study will be conducted at up to 7 vaccine centers. Subjects who previously received at least 2 doses of the clade 1 vaccine derived from the A/H5N1/Vietnam/1203/2004 virus will be randomized to receive a single dose of either 15 mcg or 90 mcg of a clade 2 vaccine derived from the A/H5N1/Indonesia/05/05 virus in a 1:1 ratio. H5 naïve subjects who previously received at least 2 doses of a placebo will be randomized to receive 2 doses of either the 15 mcg or 90 mcg of a clade 2 vaccine derived from the A/H5N1/Indonesia/05/05 virus in a 1:1 ratio. Volunteers will be observed in the clinic for 15 minutes after inoculation, and will maintain a memory aid to record oral temperature and systemic and local adverse events (AEs) for 8 days following each vaccination. Volunteers will be contacted by telephone 1 to 3 days after each vaccination to assess for the occurrence of AEs, and they will return to the clinic 8-10 days after each vaccination for AE and concomitant medication assessment, a targeted physical examination (if indicated), and review of the memory aid. T
- Conditions
- Influenza
- Being tested
- Influenza Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005
- Keywords
- avian influenza,H5N1,Influenza,parent protocol
- 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 Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005Biological
Inactivated monovalent subvirion influenza A/H5N1/Indonesia/05/05 (clade 2) vaccine administered via intramuscular injection. Low Dose Group will receive 15 mcg intramuscularly (IM), High Dose Group will receive 90 mcg IM. Subjects who received previous clade 1 vaccine will receive 1 dose, clade 1 vaccine-naive subjects will receive 2 doses 28 days apart.
| Study group | Role | What they receive |
|---|---|---|
| High Dose Group | Experimental | Volunteers will receive 90 mcg IM. Subjects who received previous clade 1 vaccine will get 1 dose, clade 1 vaccine-naive subjects receive 2 doses 28 days apart Receives: Biological: Influenza Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005 |
| Low Dose Group | Experimental | Volunteers will receive 15 mcg intramuscularly (IM). Subjects who received previous clade 1 vaccine will get 1 dose, clade 1 vaccine-naive subjects receive 2 doses 28 days apart. Receives: Biological: Influenza Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune responses approximately 28 days after one dose of an H5N1 clade 2 vaccine.
Measured: Approximately Day 28.
Secondary outcomes (2)
Immunologic outcomes include antibodies generated against strains other than A/Indonesia/05/05.
Measured: Blood samples taken prior to vaccination on Day 0, and 28 days and 6 months after receipt of last vaccination testing.
Safety outcomes include frequencies and severities of adverse events (AEs) in the high- and low-dose groups in aggregate, and in other strata previously identified.
Measured: Duration of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2008 (estimated)
- Study startNov 2008
- Primary completionMay 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 517 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680069
- Sponsor's protocol ID
- 07-0022
- Status last verified
- Aug 2015
- First submitted
- 15 May 2008
- Last updated
- 30 Dec 2016
- Results posted
- No
Publications
Winokur PL, Patel SM, Brady R, Chen WH, El-Kamary SS, Edwards K, Creech CB, Frey S, Keitel WA, Belshe R, Walter E, Bellamy A, Hill H. Safety and Immunogenicity of a Single Low Dose or High Dose of Clade 2 Influenza A(H5N1) Inactivated Vaccine in Adults Previously Primed With Clade 1 Influenza A(H5N1) Vaccine. J Infect Dis. 2015 Aug 15;212(4):525-30. doi: 10.1093/infdis/jiv087. Epub 2015 Feb 23.
PubMed 25712967Belshe RB, Frey SE, Graham IL, Anderson EL, Jackson LA, Spearman P, Edupuganti S, Mulligan MJ, Rouphael N, Winokur P, Dolor RJ, Woods CW, Walter EB, Chen WH, Turley C, Edwards KM, Creech CB, Hill H, Bellamy AR; National Institute of Allergy and Infectious Diseases-Funded Vaccine and Treatment Evaluation Units. Immunogenicity of avian influenza A/Anhui/01/2005(H5N1) vaccine with MF59 adjuvant: a randomized clinical trial. JAMA. 2014 Oct 8;312(14):1420-8. doi: 10.1001/jama.2014.12609.
PubMed 25291578
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Phase I/II Study of the Safety, Reactogenicity, and Immunogenicity of an Inactivated Influenza Vaccine Derived From A/H5N1/Indonesia/05/05 (Clade 2) in Healthy Adults and Elderly Who Participated in a Previous A/H5N1/Vietnam/1203/2004 (Clade 1) Vaccine Study
- ClinicalTrials.gov ID
- NCT00680069
- Acronym / sponsor ID
- 07-0022
- Conditions
- Influenza
- Keywords
- avian influenza,H5N1,Influenza,parent protocol
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 517 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Nov 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 19 May 2008 (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 study the safety and effectiveness of vaccinating individuals who have previously received an avian influenza vaccine derived from one type of H5N1 virus with a vaccine derived from a different type of avian influenza virus. A second reason for this study is to compare responses in people who have received two different but similar types of H5N1 vaccine to the responses in subjects who receive 2 doses of only the H5N1 vaccine used in this study. The information obtained may provide important information into the usefulness of a pre-pandemic vaccination. Participants will include 600 healthy adult volunteers, ages 19 and older, in the United States. Study procedures include: physical exams, vaccination with either a low dose (15 micrograms) or high dose (90 micrograms) of vaccine, blood samples, and maintaining a memory aid to record oral temperatures and side effects. Study participation will be approximately 7 months.
Detailed description
The goals of this study are to investigate the safety, reactogenicity, and immunogenicity of a single dose of monovalent subvirion influenza vaccine produced from a clade 2 A/H5N1 vaccine administered by intramuscular injection to healthy adults and the elderly who have previously received at least 2 doses of clade 1 A/H5N1 vaccine. In addition, this study will compare these results to individuals who are receiving 2 doses of the clade 2 A/H5N1 vaccine for the first time. The primary objective of the study is to compare the immune response following a single low-dose (15 mcg) to a single high-dose (90 mcg) of influenza vaccine derived from the clade 2 virus A/H5N1/Indonesia/05/05 in individuals who have previously received at least 2 doses of an influenza vaccine derived from the clade 1 virus A/H5N1/Vietnam/1203/2004 (A/VN/1203/04). The secondary objectives will: compare the immune response following a single low-dose (15 mcg) or single high-dose (90 mcg) of influenza vaccine derived from the clade 2 virus A/H5N1/Indonesia/05/05 in individuals who have previously received at least 2 doses of an influenza vaccine derived from the clade 1 virus A/H5N1/Vietnam/1203/2004 (A/VN/1203/04) to a group that has not received any previous A/H5N1 vaccine but who will receive 2 doses of an influenza vaccine derived from the clade 2 virus A/H5N1/Indonesia/05/05; evaluate the factors associated with immunologic response to a single dose of a vaccine derived from a clade 2 virus among individuals who have previously received at least 2 doses of vaccine derived from a clade 1 virus; evaluate the safety of a single dose of subvirion inactivated vaccine derived from the clade 2 virus A/H5N1/Indonesia/05/05 in individuals who have previously received at least 2 doses of an influenza vaccine derived from the clade 1 virus A/H5N1/Vietnam/1203/2004 (A/VN/1203/04); explore immunologic responses following vaccination with a clade 2 vaccine from A/H5N1/Indonesia/05/05 to influenza strains other than A/H5N1/Indonesia/05/05, including A/VN/1203/04; evaluate the immune responses of previously unvaccinated individuals after 1 or 2 doses of clade 2 virus A/H5N1/Indonesia/05/05 vaccine; and evaluate the duration of antibody responses following 1 or 2 doses of vaccine derived from the clade 2 virus A/H5N1/Indonesia/05/05. This study will recruit 600 healthy volunteers aged 19 years or older, in the United States, who have previously participated in a linked DMID-sponsored study. This study is linked to DMID protocols 04-063, 05-0090, 04-076, 05-0015, 05-0127, 05-0141, 06-0089, 04-062, 06-0052, and 08-0030. The study will be conducted at up to 7 vaccine centers. Subjects who previously received at least 2 doses of the clade 1 vaccine derived from the A/H5N1/Vietnam/1203/2004 virus will be randomized to receive a single dose of either 15 mcg or 90 mcg of a clade 2 vaccine derived from the A/H5N1/Indonesia/05/05 virus in a 1:1 ratio. H5 naïve subjects who previously received at least 2 doses of a placebo will be randomized to receive 2 doses of either the 15 mcg or 90 mcg of a clade 2 vaccine derived from the A/H5N1/Indonesia/05/05 virus in a 1:1 ratio. Volunteers will be observed in the clinic for 15 minutes after inoculation, and will maintain a memory aid to record oral temperature and systemic and local adverse events (AEs) for 8 days following each vaccination. Volunteers will be contacted by telephone 1 to 3 days after each vaccination to assess for the occurrence of AEs, and they will return to the clinic 8-10 days after each vaccination for AE and concomitant medication assessment, a targeted physical examination (if indicated), and review of the memory aid. T
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Dose Group | Experimental | Biological: Influenza Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005Volunteers will receive 90 mcg IM. Subjects who received previous clade 1 vaccine will get 1 dose, clade 1 vaccine-naive subjects receive 2 doses 28 days apart |
| Low Dose Group | Experimental | Biological: Influenza Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005Volunteers will receive 15 mcg intramuscularly (IM). Subjects who received previous clade 1 vaccine will get 1 dose, clade 1 vaccine-naive subjects receive 2 doses 28 days apart. |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -The subject must have previously received at least 2 doses via the intramuscular route of placebo or vaccine derived from A/H5N1/VN/1203/04 as part of one of the following DMID Protocol Nos.: 04-062, 04-063 (and 05-0090), 04-076, 05-0015, 05-0127, 05-0141, or 06-0089; or the subject must have received placebo intramuscularly as part of DMID Protocol No. 06-0052. -The subject must be 19 years old or older. -Women of childbearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for greater than or equal to 1 year) must agree to practice adequate contraception, including, but not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, birth control pills, patches or hormonal shots or hormonal implants, NuvaRing and IUDs (intrauterine devices), during the study period between enrollment and 30 days following receipt of the last dose of vaccine. -For a female subject of childbearing potential, she must have a negative pregnancy test (urine or serum) within 24 hours prior to vaccination. -The subject is in good health, as determined by vital signs (heart rate less than 100 bpm; blood pressure: systolic greater than or equal to 90 mm Hg and less than or equal to 140 mm Hg; diastolic less than or equal to 90 mm Hg; oral temperature less than 100.0 degrees Fahrenheit), medical history to ensure stable medical condition, and a targeted physical examination, when necessary, based on medical history. A systolic blood pressure of less than or equal to 160 and a diastolic blood pressure of less than or equal to 90 is acceptable in subjects greater than 65 years of age. -The subject is able to understand and comply with the planned study procedures, including being available for all study visits. -The subject has provided informed consent prior to any study procedures.
Key exclusion criteria (1 listed)
- -The subject is allergic to eggs, egg products, chicken or egg proteins or other components of the vaccine (including gelatin, formaldehyde, octoxinol and thimerosal). -The subject is a woman who is breastfeeding or intends to become pregnant during the study period between enrollment and 30 days following receipt of the last dose of vaccine. -The subject is immunosuppressed as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months. -The subject has an active neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematologic malignancy. An active neoplastic disease is defined as treatment for neoplastic disease within the past 5 years. -The subject has long-term (greater than 2 weeks) use of oral or parenteral glucocorticoids, or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed). -The subject received immunoglobulin or another blood product within the 3 months prior to enrollment in this study. -The subject has received an inactivated vaccine within the 2 weeks or a live vaccine within the 4 weeks prior to enrollment in this study or plans to receive another vaccine within the next 28 days (or 56 days for prior placebo recipients). -The subject has an acute or chronic medical condition that would render vaccination unsafe or would interfere with the evaluation of responses. These conditions include, but are not limited to: solicited reactogenicity symptoms, history of significant renal impairment (dialysis and treatment for kidney disease, including diabetic and hypertensive kidney disease); subjects with diabetes mellitus, well-controlled with oral agents may enroll as long as there has been no dose adjustment with the past 6 months; insulin-dependent diabetes is excluded; cardiac insufficiency, if heart failure is present (New York Association Functional Class III or IV); an arteriosclerotic event during the 6 months prior to enrollment (e.g., history of myocardial infarction, stroke, recanalization of femoral arteries or transient ischemic attack). -The subject has a history of a severe reaction following receipt of an influenza virus vaccine. -The subject has an acute illness or an oral temperature greater than 99.9 degrees Fahrenheit (37.7 degrees Celsius) within 3 days prior to enrollment or vaccination. -The subject is currently participating in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication) or has received an experimental agent within 1 month prior to enrollment in this study, or expects to receive another experimental agent during participation in this study. -The subject 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. -The subject has a diagnosis of schizophrenia, bi-polar disease, or other severe (disabling) chronic psychiatric diagnosis. -The subject has been hospitalized within the past 5 years prior to enrollment for psychiatric illness, history of suicide attempt or confinement for danger to self or others. -The subject is receiving psychiatric drugs. Subjects who are receiving a single antidepressant drug and are stable for at least 3 months prior to enrollment without decompensating are allowed enrollment into the study. -The subject has a history of alcohol or drug abuse in the 5 years prior to enrollment. -The subject has a known human immunodeficiency virus, hepatitis B, or hepatitis C infection. -The subject has a history of Guillain-Barré syndrome. -The subject has any condition that the investigator believes may interfere with successful completion of the study. The subject plans to enroll in another clinical trial that has a study intervention such as a drug, biologic, or device that could interfere with safety assessment of the investigational product at any time during the study period.
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 Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005Inactivated monovalent subvirion influenza A/H5N1/Indonesia/05/05 (clade 2) vaccine administered via intramuscular injection. Low Dose Group will receive 15 mcg intramuscularly (IM), High Dose Group will receive 90 mcg IM. Subjects who received previous clade 1 vaccine will receive 1 dose, clade 1 vaccine-naive subjects will receive 2 doses 28 days apart. | Biological | High Dose Group, Low Dose Group |
Primary outcome
Immune responses approximately 28 days after one dose of an H5N1 clade 2 vaccine.
Time frame: Approximately Day 28.
2 secondary outcomes
Immunologic outcomes include antibodies generated against strains other than A/Indonesia/05/05.
Time frame: Blood samples taken prior to vaccination on Day 0, and 28 days and 6 months after receipt of last vaccination testing.
Safety outcomes include frequencies and severities of adverse events (AEs) in the high- and low-dose groups in aggregate, and in other strata previously identified.
Time frame: Duration of Study
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 30 Dec 2016.
- Results publication: PubMed 25712967Winokur PL, Patel SM, Brady R, Chen WH, El-Kamary SS, Edwards K, Creech CB, Frey S, Keitel WA, Belshe R, Walter E, Bellamy A, Hill H. Safety and Immunogenicity of a Single Low Dose or High Dose of Clade 2 Influenza A(H5N1) Inactivated Vaccine in Adults Previously Primed With Clade 1 Influenza A(H5N1) Vaccine. J Infect Dis. 2015 Aug 15;212(4):525-30. doi: 10.1093/infdis/jiv087. Epub 2015 Feb 23.
- Derived from this study: PubMed 25291578Belshe RB, Frey SE, Graham IL, Anderson EL, Jackson LA, Spearman P, Edupuganti S, Mulligan MJ, Rouphael N, Winokur P, Dolor RJ, Woods CW, Walter EB, Chen WH, Turley C, Edwards KM, Creech CB, Hill H, Bellamy AR; National Institute of Allergy and Infectious Diseases-Funded Vaccine and Treatment Evaluation Units. Immunogenicity of avian influenza A/Anhui/01/2005(H5N1) vaccine with MF59 adjuvant: a randomized clinical trial. JAMA. 2014 Oct 8;312(14):1420-8. doi: 10.1001/jama.2014.12609.
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Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
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.
8 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 Influenza Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005 in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 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 1 inclusion and 1 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 30 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 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?
Immune responses approximately 28 days after one dose of an H5N1 clade 2 vaccine. (time frame: Approximately Day 28.). 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 NCT00680069, which also lists 2 linked publications.
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 30 Dec 2016.