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

Butantan Institute

Status and phase

Completed

Phase 1

Conditions

H7N9 Influenza

Influenza

Treatments

Biological: H7N9 antigen + adjuvant SE

Biological: Placebo (PBS)

Biological: H7N9 antigen + adjuvant IB160

Biological: H7N9 antigen without adjuvant

Study type

Interventional

Funder types

Other

Identifiers

NCT03330899

FLP-01-IB

Details and patient eligibility

About

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 .

Full 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.

Enrollment

432 patients

Sex

All

Ages

18 to 59 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

432 participants in 8 patient groups, including a placebo group

15 mcg H7N9 + adjuvant IB160

Active Comparator group

Description:

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

Treatment:

Biological: H7N9 antigen + adjuvant IB160

7.5 mcg H7N9 + adjuvant IB160

Active Comparator group

Description:

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

Treatment:

Biological: H7N9 antigen + adjuvant IB160

3.75 mcg H7N9 + adjuvant IB160

Active Comparator group

Description:

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

Treatment:

Biological: H7N9 antigen + adjuvant IB160

15 mcg H7N9 + adjuvant SE

Active Comparator group

Description:

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

Treatment:

Biological: H7N9 antigen + adjuvant SE

7.5 mcg H7N9 + adjuvant SE

Active Comparator group

Description:

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

Treatment:

Biological: H7N9 antigen + adjuvant SE

3.75 mcg H7N9 + adjuvant SE

Active Comparator group

Description:

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

Treatment:

Biological: H7N9 antigen + adjuvant SE

15 mcg H7N9 without adjuvant

Active Comparator group

Description:

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

Treatment:

Biological: H7N9 antigen without adjuvant

Placebo (PBS)

Placebo Comparator group

Description:

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