- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03330899
Safety and Immunogencity of H7N9 Influenza Antigen With 2 Adjuvant Formulations in Healthy Adults in Brazil
A Phase I Randomized, Double-blind, Placebo-controlled, Dose Finding Clinical Trial to Evaluate the Safety and Immunogencity of H7N9 Influenza Antigen Adjuvanted With 2 Different Adjuvant Formulations in Healthy Adult Volunteers in Brazil
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
SP
-
Ribeirao Preto, SP, Brazil, 14015-069
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
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Sao Paulo, SP, Brazil, 05403 000
- Centro de Pesquisas Clínicas do Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
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Sao Paulo, SP, Brazil, 05415009
- Centro de Pesquisa Clínica do Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - ICr/HCFMUSP
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy male or female (non-pregnant) adults 18 through 59 years of age at the enrollment visit.
- To be available to participate in the study throughout its duration (approximately seven months).
- Healthy, as established by the medical history, physical examination, and screening laboratory evaluations.
- Capable and willing to complete Participant Diaries and willing to return for all follow-up visits.
- To demonstrate intention to participate in the study, as documented by signature in the study´s informed consent form.
- For females of child-bearing potential, willing to utilize reliable birth control measures from Day 0 through at least 60 days following the last study vaccination.
Exclusion Criteria:
- Participation in another clinical trial involving any experimental therapy within the previous three months or planned enrollment in such a trial during the period of this study.
- Evidence of active neurological, cardiac, pulmonary, hepatic or renal disease as clinical history and/or physical examination (except hypertension under control).
- Compromised immune system diseases including: HIV, Hepattis B and C, diabetes mellitus, cancer (except basal cell carcinoma) and autoimmune diseases.
- Behavioral, cognitive or psychiatric disease that in the opinion of the principal investigator or his representative physician, affects the participant ability to understand and cooperate with all study protocol requirements.
- Abusive usage of alcohol or drugs in the past 12 months that has caused medical, professional or family problems, indicated by clinical history.
- Known systemic hypersensitivity to eggs or to any component of the vaccine.
- History of severe adverse reaction after previous administration of an Influenza vaccine within 6 weeks following vaccination.
- History of Guillain-Barre Syndrome or other demyelinating disease.
- Have a history of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines.
- Diagnosis of asthma with a history of hospitalization related to this condition in the last six months due to illness.
- Suspected or confirmed fever in the 3 days prior to vaccination or axillary temperature greater than 37.8 ° C on the day of vaccination.
- Use of corticosteroids (except topical or nasal) or other immunosuppressive drugs within 42 days before study initiation/baseline. It will be considered immunosuppressive dose of corticosteroids the equivalent to a dose ≥10 mg of prednisone per day for over 14 days.
- Impaired coagulation due to chronic disease or due to use anticoagulant medication (warfarin or heparin) in the 7 days preceding vaccination.
- Have received live virus vaccine within 28 days or killed virus vaccine in the last 14 days prior to vaccination, or have a scheduled immunization from the first study vaccination until 21 days after the second vaccination.
- Have received any influenza A/H7 vaccine.
- History of asplenia.
- Have received blood products in the past 6 months, including transfusions or immunoglobulin, or scheduled administration of blood products or immunoglobulin for the first 21 days after vaccination.
- Any other condition that might put at risk the safety/rights of a potential participant or his/her compliance with this protocol in investigator's opinion or his representative physician.
- Laboratory values at screening equal to or greater than Grade 2 will be considered to be exclusionary. Vital signs may be performed up to three times to allow for transient conditions to resolve. Screening laboratory values that are out of range, but are considered to be due to an acute illness or process may be repeated once. Grade 1 laboratory values will be reviewed by a licensed study clinician and the clinician will determine whether the laboratory abnormality is clinically significant and should be considered exclusionary. If determined to be clinically insignificant, the study team is not required to follow the laboratory until resolution or the value is determined to be clinically stable.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 15 mcg H7N9 + adjuvant IB160
Participants in this arm will receive one dose of the combination (15 mcg H7N9 antigen + adjuvant IB160) at Day 0 and another dose at Day 28. Each dose after combination = 0,5 ml 15 mcg of the monovalent H7N9 antigen per dose |
H7N9 monovalent (fragmented and inactivated)
|
ACTIVE_COMPARATOR: 7.5 mcg H7N9 + adjuvant IB160
Participants in this arm will receive one dose of the combination (7.5 mcg H7N9 antigen + adjuvant IB160) at Day 0 and another dose at Day 28. Each dose after combination = 0,5 ml 7.5 mcg of the monovalent H7N9 antigen per dose |
H7N9 monovalent (fragmented and inactivated)
|
ACTIVE_COMPARATOR: 3.75 mcg H7N9 + adjuvant IB160
Participants in this arm will receive one dose of the combination (3.75 mcg H7N9 antigen + adjuvant IB160) at Day 0 and another dose at Day 28. Each dose after combination = 0,5 ml 3.75 mcg of the monovalent H7N9 antigen per dose |
H7N9 monovalent (fragmented and inactivated)
|
ACTIVE_COMPARATOR: 15 mcg H7N9 + adjuvant SE
Participants in this arm will receive one dose of the combination (15 mcg H7N9 antigen + adjuvant SE) at Day 0 and another dose at Day 28. Each dose after combination = 0,5 ml 15 mcg of the monovalent H7N9 antigen per dose |
H7N9 monovalent (fragmented and inactivated)
|
ACTIVE_COMPARATOR: 7.5 mcg H7N9 + adjuvant SE
Participants in this arm will receive one dose of the combination (7.5 mcg H7N9 antigen + adjuvant SE) at Day 0 and another dose at Day 28. Each dose after combination = 0,5 ml 7.5 mcg of the monovalent H7N9 antigen per dose |
H7N9 monovalent (fragmented and inactivated)
|
ACTIVE_COMPARATOR: 3.75 mcg H7N9 + adjuvant SE
Participants in this arm will receive one dose of the combination (3.75 mcg H7N9 antigen + adjuvant SE) at Day 0 and another dose at Day 28. Each dose after combination = 0,5 ml 3.75 mcg of the monovalent H7N9 antigen per dose |
H7N9 monovalent (fragmented and inactivated)
|
ACTIVE_COMPARATOR: 15 mcg H7N9 without adjuvant
Participants in this arm will receive one dose of the 15 mcg H7N9 antigen without adjuvant at Day 0 and another dose at Day 28. Each dose = 0,5 ml |
H7N9 monovalent (fragmented and inactivated)
|
PLACEBO_COMPARATOR: Placebo (PBS)
Participants in this arm will receive one dose of Placebo (PBS) at Day 0 and another dose at Day 28. Each dose = 0,5 ml |
Placebo (Phosphate Buffered Saline -PBS)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with solicited local Adverse Events over the 7-day period post each study injection.
Time Frame: 7-day period post each study injection (Days 0-6)
|
Solicited local Adverse Events (AE) include erythema, swelling/induration, pain/tenderness, ecchymosis, pruritis. The participant will be given a Participant Diary, a digital thermometer and ruler in which the participant will be asked to record any local and/or systemic reactions. The participant will have been instructed that if he/she experiences an AE requiring medical care, the participant should inform the study staff as soon as possible and seek medical care as appropriate. A visit will be schedule to occur 7 days after each study injection. Study staff will review the Participant Diary and interim history with the participant and inquire about new medical events, which will be recorded in the appropriate Clinical Research Forms. |
7-day period post each study injection (Days 0-6)
|
Number of participants with solicited systemic Adverse Effects over the 7-day period post each study injection.
Time Frame: 7-day period post each study injection (Days 0-6)
|
Solicited systemic Adverse Events (AE) include fever, fatigue/malaise, myalgia, arthralgia, chills, nausea/vomiting, and headache. The participant will be given a Participant Diary, a digital thermometer and ruler in which the participant will be asked to record any local and/or systemic reactions. The participant will have been instructed that if he/she experiences an AE requiring medical care, the participant should inform the study staff as soon as possible and seek medical care as appropriate. A visit will be schedule to occur 7 days after each study injection. Study staff will review the Participant Diary and interim history with the participant and inquire about new medical events, which will be recorded in the appropriate Clinical Research Forms. |
7-day period post each study injection (Days 0-6)
|
Number of participants with unsolicited local and/or systemic Adverse Events over the 7-day period post each study injection.
Time Frame: 7-day period post each study injection (Days 0-6)
|
Unsolicited local and/or systemic Adverse Events include any AE not include in the description of solicited AE, as described in Outcome 1 and 2. The participant will be given a Participant Diary, a digital thermometer and ruler in which the participant will be asked to record any local and/or systemic reactions. The participant will have been instructed that if he/she experiences an AE requiring medical care, the participant should inform the study staff as soon as possible and seek medical care as appropriate. A visit will be schedule to occur 7 days after each study injection. Study staff will review the Participant Diary and interim history with the participant and inquire about new medical events, which will be recorded in the appropriate Clinical Research Forms. |
7-day period post each study injection (Days 0-6)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with unsolicited local and/or systemic Adverse Events over the 28-day period post each study injection.
Time Frame: 28-day period post each study injection (Days 0-27)
|
Unsolicited local and/or systemic Adverse Events include any AE not include in the description of solicited AE, as described in Outcome 1 and 2. A visit will be schedule to occur 28 days after each study injection. Study staff will review the Participant Diary and interim history with the participant and inquire about new medical events, which will be recorded in the appropriate Clinical Research Forms. |
28-day period post each study injection (Days 0-27)
|
Number of participants with Serious Adverse Events over the 222-day period post second study injection.
Time Frame: 222-day period post the second study injection (Days 0-221)
|
Serious Adverse Event (SAE) is defined as an adverse event that meets one of the following conditions:
Participants will be contacted by phone on Day 222 after administration of second dose of study product for (a) closure of any ongoing AEs and concomitant medications; and (b) collection of any SAEs and new concomitant medications, if associated with the SAE reported. |
222-day period post the second study injection (Days 0-221)
|
Number of participants that presented seroconversion at day 28, 45 and 56 post first study injection
Time Frame: 56-day period post the first study injection
|
Seroconvertion is defined as: prevaccination Hemagglutination-inhibition test (HI) antibody titer ≤1:10 and postvaccination HI antibody titer ≥1:40, or prevaccination HI antibody titer ≥1:10 and a postvaccination increase by a factor of four or more). Participants will be invited to return on days 28, 45 and 56 post first study injection, when blood samples will be taken for HI testing. |
56-day period post the first study injection
|
Number of participants that presented seroprotection at day 28, 45 and 56 post first study injection
Time Frame: 56-day period post the first study injection
|
Seroprotection is defined as postvaccination Hemagglutination-inhibition test (HI) antibody titer ≥ 1:40. Participants will be invited to return on days 28, 45 and 56 post first study injection, when blood samples will be taken for HI testing. |
56-day period post the first study injection
|
Geometric mean of Hemagglutination-inhibition titre at day 28, 45 and 56 post first study injection
Time Frame: 56-day period post the first study injection
|
Geometric mean of Hemagglutination-inhibition test titre will be calculated for the different groups of participants at day 28, 45 and 56 post first study injection. Participants will be invited to return on days 28, 45 and 56 post first study injection, when blood samples will be taken for HI testing. |
56-day period post the first study injection
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Esper Kallas, PhD, University of Sao Paulo
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FLP-01-IB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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