InfluenzaPhase 1NCT03330899

Safety and Immunogencity of H7N9 Influenza Antigen With 2 Adjuvant Formulations in Healthy Adults in Brazil

A Phase 1 study testing H7N9 antigen + adjuvant IB160, H7N9 antigen + adjuvant SE and H7N9 antigen without adjuvant in people with Influenza and H7N9 Influenza, run by Butantan Institute at 3 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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 . Read more about this study

Who is it for?: Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for: Influenza, H7N9 Influenza
What is being tested?: H7N9 antigen + adjuvant IB160, H7N9 antigen + adjuvant SE and H7N9 antigen without adjuvant
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 432 participants
Where: 3 sitesBrazil
Study dates: 24 Sep 2018to 25 Aug 2020
Phase: Phase 1
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 18 to 59 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 19Show fewer

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.

Trial locations and contacts

3 sites in 1 country.

Brazil3 sites

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, 14015-069
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
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

Other trials in Brazil

About this study

Official title: 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

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 .

Read the detailed description

Following the emergence of avian influenza A/H7N9 influenza virus in humans in China in March 2013, the WHO Essential Regulatory Laboratories prepared candidate vaccine viruses and reagents for further development and several manufacturers have developed various inactivated influenza vaccines with and without adjuvant against A/H7N9 and tested these candidates in trials in healthy adults. The overall aim of this study is to evaluate the safety, immunogenicity and dose sparing effects of H7N9 influenza antigen produced by Butantan Institute in combination with 2 different adjuvants.

Conditions: Influenza, H7N9 Influenza
Being tested: H7N9 antigen + adjuvant IB160, H7N9 antigen + adjuvant SE, H7N9 antigen without adjuvant, Placebo (PBS)
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

H7N9 antigen + adjuvant IB160Biological
H7N9 monovalent (fragmented and inactivated)
H7N9 antigen + adjuvant SEBiological
H7N9 monovalent (fragmented and inactivated)
H7N9 antigen without adjuvantBiological
H7N9 monovalent (fragmented and inactivated)
Placebo (PBS)Biological
Placebo (Phosphate Buffered Saline -PBS)

Study groups in NCT03330899
Study group	Role	What they receive
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 Receives: 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 Receives: Biological: H7N9 antigen + adjuvant IB160
3.75 mcg H7N9 + adjuvant IB160	Active comparator	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 Receives: Biological: H7N9 antigen + adjuvant IB160
15 mcg H7N9 + adjuvant SE	Active comparator	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 Receives: Biological: H7N9 antigen + adjuvant SE
7.5 mcg H7N9 + adjuvant SE	Active comparator	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 Receives: Biological: H7N9 antigen + adjuvant SE
3.75 mcg H7N9 + adjuvant SE	Active comparator	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 Receives: Biological: H7N9 antigen + adjuvant SE
15 mcg H7N9 without adjuvant	Active comparator	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 Receives: Biological: H7N9 antigen without adjuvant
Placebo (PBS)	Placebo comparator	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 Receives: Biological: Placebo (PBS)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: 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.
Serious Adverse Event (SAE) is defined as an adverse event that meets one of the following conditions:
- Death.
- Life-threatening.
- Requires inpatient hospitalization or prolongation of existing hospitalization.
- Results in congenital anomaly/birth defect.
- Results in a persistent or significant disability or incapacity.
- Important medical events that might not result in death, be life-threatening, or require hospitalization might be considered SAEs when, based upon appropriate medical judgment, the event might jeopardize the well-being of the participant and require medical or surgical intervention to prevent one of the outcomes listed above.
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.
Measured: 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
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.
Measured: 56-day period post the first study injection
Number of participants that presented seroprotection at day 28, 45 and 56 post 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.
Measured: 56-day period post the first study injection
Geometric mean of Hemagglutination-inhibition titre at day 28, 45 and 56 post 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.
Measured: 56-day period post the first study injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Sep 201825 Aug 2020

First posted6 Nov 2017
Study start24 Sep 2018
Primary completion30 Jan 2020
Study completion25 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for InfluenzaStudies 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
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 432 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03330899
Sponsor's protocol ID: FLP-01-IB
Status last verified: Sep 2020
First submitted: 30 Oct 2017
Last updated: 30 Sep 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 36256646

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
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

All Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03330899
Acronym / sponsor ID: FLP-01-IB
Conditions: Influenza, H7N9 Influenza
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 432 participants (actual)
Lead sponsor: Butantan InstituteOther government
Study start: 24 Sep 2018 (actual)
Primary completion: 30 Jan 2020 (actual)
Study completion: 25 Aug 2020 (actual)
First posted: 6 Nov 2017 (actual)
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 overall aim of this study is to evaluate the safety, immunogenicity and dose sparing effects of H7N9 influenza antigen formulated with 2 different adjuvants .

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
15 mcg H7N9 + adjuvant IB160	Active comparator	Biological: H7N9 antigen + adjuvant IB160Participants 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 comparator	Biological: H7N9 antigen + adjuvant IB160Participants 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 comparator	Biological: H7N9 antigen + adjuvant IB160Participants 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 comparator	Biological: H7N9 antigen + adjuvant SEParticipants 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 comparator	Biological: H7N9 antigen + adjuvant SEParticipants 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 comparator	Biological: H7N9 antigen + adjuvant SEParticipants 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 comparator	Biological: H7N9 antigen without adjuvantParticipants 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 comparator	Biological: 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

Who may qualify

Ages: 18 to 59 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (19 listed)

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.

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
H7N9 antigen + adjuvant IB160H7N9 monovalent (fragmented and inactivated)	Biological	15 mcg H7N9 + adjuvant IB160, 3.75 mcg H7N9 + adjuvant IB160, 7.5 mcg H7N9 + adjuvant IB160
H7N9 antigen + adjuvant SEH7N9 monovalent (fragmented and inactivated)	Biological	15 mcg H7N9 + adjuvant SE, 3.75 mcg H7N9 + adjuvant SE, 7.5 mcg H7N9 + adjuvant SE
H7N9 antigen without adjuvantH7N9 monovalent (fragmented and inactivated)	Biological	15 mcg H7N9 without adjuvant
Placebo (PBS)Placebo (Phosphate Buffered Saline -PBS)	Biological	Placebo (PBS)

Primary outcome

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.
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.
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.

5 secondary outcomes

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)
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)
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
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
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

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 Sep 2020.
Derived from this study: PubMed 36256646Vanni 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.

Related trials for Influenza

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
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.

Esper Kallas, PhD principal investigator

University of Sao Paulo

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 19 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 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

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?

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)). The study lists 3 primary outcomes in all. 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 NCT03330899, which also lists 1 linked publication.

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 Sep 2020.