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
1 other identifier
interventional
432
1 country
3
Brief Summary
The overall aim of this study is to evaluate the safety, immunogenicity and dose sparing effects of H7N9 influenza antigen formulated with 2 different adjuvants .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2018
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2017
CompletedFirst Posted
Study publicly available on registry
November 6, 2017
CompletedStudy Start
First participant enrolled
September 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2020
CompletedSeptember 30, 2020
September 1, 2020
1.4 years
October 30, 2017
September 28, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Number of participants with solicited local Adverse Events over the 7-day period post each study injection.
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.
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.
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 Outcomes (5)
Number of participants with unsolicited local and/or systemic Adverse Events over the 28-day period post each study injection.
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.
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
56-day period post the first study injection
Number of participants that presented seroprotection at day 28, 45 and 56 post first study injection
56-day period post the first study injection
Geometric mean of Hemagglutination-inhibition titre at day 28, 45 and 56 post first study injection
56-day period post the first study injection
Study Arms (8)
15 mcg H7N9 + adjuvant IB160
ACTIVE COMPARATORParticipants 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
7.5 mcg H7N9 + adjuvant IB160
ACTIVE COMPARATORParticipants 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
3.75 mcg H7N9 + adjuvant IB160
ACTIVE COMPARATORParticipants 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
15 mcg H7N9 + adjuvant SE
ACTIVE COMPARATORParticipants 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
7.5 mcg H7N9 + adjuvant SE
ACTIVE COMPARATORParticipants 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
3.75 mcg H7N9 + adjuvant SE
ACTIVE COMPARATORParticipants 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
15 mcg H7N9 without adjuvant
ACTIVE COMPARATORParticipants 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
Placebo (PBS)
PLACEBO COMPARATORParticipants in this arm will receive one dose of Placebo (PBS) at Day 0 and another dose at Day 28. Each dose = 0,5 ml
Interventions
H7N9 monovalent (fragmented and inactivated)
H7N9 monovalent (fragmented and inactivated)
H7N9 monovalent (fragmented and inactivated)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, 14015-069, Brazil
Centro de Pesquisas Clínicas do Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403 000, Brazil
Centro de Pesquisa Clínica do Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - ICr/HCFMUSP
São Paulo, São Paulo, 05415009, Brazil
Related Publications (1)
Vanni T, Thome BC, Sparrow E, Friede M, Fox CB, Beckmann AM, Huynh C, Mondini G, Silveira DH, Viscondi JYK, Braga PE, Silva AD, Salomao MDG, Piorelli RO, Santos JP, Gattas VL, Lucchesi MBB, Oliveira MMM, Koike ME, Kallas EG, Campos LMA, Coelho EB, Siqueira MAM, Garcia CC, Miranda MD, Paiva TM, Timenetsky MDCST, Adami EA, Akamatsu MA, Ho PL, Precioso AR. Dose-sparing effect of two adjuvant formulations with a pandemic influenza A/H7N9 vaccine: A randomized, double-blind, placebo-controlled, phase 1 clinical trial. PLoS One. 2022 Oct 18;17(10):e0274943. doi: 10.1371/journal.pone.0274943. eCollection 2022.
PMID: 36256646DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Esper Kallas, PhD
University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2017
First Posted
November 6, 2017
Study Start
September 24, 2018
Primary Completion
January 30, 2020
Study Completion
August 25, 2020
Last Updated
September 30, 2020
Record last verified: 2020-09