Trials Sponsors Conditions Drugs Pricing

Conditions

H7N9 Influenza Influenza

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.

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 COMPARATOR

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

Biological: H7N9 antigen + adjuvant IB160

7.5 mcg H7N9 + adjuvant IB160

ACTIVE COMPARATOR

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

Biological: H7N9 antigen + adjuvant IB160

3.75 mcg H7N9 + adjuvant IB160

ACTIVE COMPARATOR

Interventions

H7N9 antigen + adjuvant IB160Biological

H7N9 monovalent (fragmented and inactivated)

15 mcg H7N9 + adjuvant IB1603.75 mcg H7N9 + adjuvant IB1607.5 mcg H7N9 + adjuvant IB160

H7N9 antigen + adjuvant SEBiological

H7N9 monovalent (fragmented and inactivated)

Eligibility Criteria

Age18 Years - 59 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

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).

Sponsors & Collaborators

Butantan Institute
Governmentlead

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

Influenza, Human

Interventions

Adjuvants, Pharmaceutic

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutic AidsPharmaceutical PreparationsSpecialty Uses of ChemicalsChemical Actions and Uses

Study Officials

Esper Kallas, PhD
University of Sao Paulo
PRINCIPAL INVESTIGATOR

Enrollment

432 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (5)

Study Arms (8)

15 mcg H7N9 + adjuvant IB160

7.5 mcg H7N9 + adjuvant IB160

3.75 mcg H7N9 + adjuvant IB160

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

15 mcg H7N9 + adjuvant SE

7.5 mcg H7N9 + adjuvant SE

3.75 mcg H7N9 + adjuvant SE

15 mcg H7N9 without adjuvant

Placebo (PBS)

You may not qualify if:

Source record

Locations