Clinical trial NCT05091307: A Study of Ad26.COV2.S and Influenza Vaccines in Healthy Adults
Official title: A Randomized, Double-blind, Phase 3 Study to Evaluate Safety, Reactogenicity, and Immunogenicity of Co-administration of Ad26.COV2.S and Influenza Vaccines in Healthy Adults 18 Years of Age and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19 Prevention
Lead sponsor: Janssen Vaccines & Prevention B.V.
Sponsor class: INDUSTRY
First posted: 2021-10-25
Enrollment: 861
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to demonstrate the non-inferiority (NI) of the humoral immune response of the 4 influenza vaccine strains after concomitant administration of the Ad26.COV2.S vaccine and a seasonal quadrivalent standard-dose influenza vaccine versus the administration of a seasonal quadrivalent standard-dose influenza vaccine administered alone; and to demonstrate the NI of the binding antibody response after concomitant administration of Ad26.COV2.S vaccine and a seasonal quadrivalent standard-dose influenza vaccine versus the administration of Ad26.COV2.S vaccine administered alone.

Detailed description: Severe acute respiratory syndrome coronavirus(-2) (SARS CoV-2) is a highly transmissible and pathogenic coronavirus that has spread rapidly and globally and Influenza is a worldwide public health problem, responsible for significant morbidity and mortality. Ad26.COV2.S (also known as VAC31518, JNJ-78436735) is a monovalent vaccine composed of a recombinant, replication-incompetent human adenovirus type 26 (Ad26) vector, constructed to encode SARS-CoV-2 spike (S) protein, stabilized in its prefusion conformation. The seasonal influenza vaccines to be used in this study are quadrivalent (standard dose) and quadrivalent (high-dose) or equivalent formulated. The aim is to demonstrate the concomitant administration of the Ad26.COV2.S vaccine and a seasonal quadrivalent influenza vaccine (standard-dose) is non-inferior than the administration of either seasonal quadrivalent influenza vaccine (standard-dose) alone as measured by HI titers against each of the 4 influenza vaccine strains at 28 days after the administration of a quadrivalent seasonal influenza vaccine or Ad26.COV2.S vaccine alone as measured by Spiked-Enzyme-linked Immunosorbent Assay (S-ELISA) antibody titers at 28 days after the administration of the Ad26.COV2.S vaccine. This study consists of 3 phases: screening phase (Day -28 to 1), treatment phase (vaccination visits on Days 1 and 29), and a follow-up phase (28 days after each vaccination). Some of safety assessments will include physical examination, vital signs, clinical safety laboratory assessments, pregnancy testing, monitoring of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESI). The total duration of the study is up to 7-8 months.

Note: The Informed Consent Form dated 25-Mar-2022 is final version of the study MASTER ICF, used by local countries to prepare the local language version of the ICF, which have been approved by the Ethics Committees. And the highlighted text in the ICF document are the guidance for country specific adaptation.

Eligibility criteria: Inclusion Criteria:

* Participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, and vital signs performed at screening. Participants may have underlying illnesses, as long as the symptoms and signs are medically controlled
* Participant either received complete primary vaccination with an authorized/licensed coronavirus disease-2019 (COVID-19) vaccine (completed greater than or equal to \[\>=\] 6 months prior to the last vaccination received against COVID-19) or is COVID-19 vaccine-naive
* All participants who were born female and are of childbearing potential must: a. Have a negative highly sensitive urine pregnancy test at screening, b. Have a negative highly sensitive urine pregnancy test on the day of vaccination prior to each study vaccine administration
* Participant agrees to not donate or receive bone marrow, blood, and blood products from the administration of the study vaccine until 3 months after receiving the study vaccines
* Participant must be willing to provide verifiable identification to be contacted and to contact the investigator during the study

Exclusion Criteria:

* Participant has a history of malignancy within 1 year before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancies considered cured with minimal risk of recurrence per investigator's clinical judgment)
* Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature \>= 38.0 degrees celsius (ºC) (100.4 degrees fahrenheit \[°F\]) within 24 hours prior to the planned dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator
* Participant has history of thrombosis with thrombocytopenia syndrome (TTS) or heparin-induced thrombocytopenia and thrombosis (HITT)
* Participant has history of capillary leak syndrome
* Participant received a licensed/registered severe acute respiratory syndrome coronavirus(-2) (SARS-CoV-2) vaccine less than 6 months prior to first study vaccination (other than study vaccination)
* Participant has a history of any neurological disorders or seizures including Guillain-Barre syndrome, with the exception of febrile seizures during childhood

Primary outcomes:
measure: Groups 1 and 2: Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Against Each of the Four Influenza Vaccine Strains 28 Days After the Administration of a Seasonal Quadrivalent Standard-dose Influenza Vaccine
timeFrame: 28 days after vaccination with seasonal quadrivalent standard-dose influenza vaccine (Day 29)
measure: Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Antibodies Measured by Spiked-Enzyme-linked Immunosorbent Assay (S-ELISA) 28 Days After Administration of Ad26.COV2.S Vaccine
timeFrame: 28 days after vaccination with Ad26.COV2.S vaccine (Group 1: Day 29, Group 2: Day 57)
Secondary outcomes:
measure: Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Each Vaccination
timeFrame: 7 days after first vaccination on Day 1 (up to Day 8); 7 days after second vaccination on Day 29 (up to Day 36)
measure: Number of Participants With Solicited Systemic AEs up to 7 Days After Each Vaccination
timeFrame: 7 days after first vaccination on Day 1 (up to Day 8); 7 days after second vaccination on Day 29 (up to Day 36)
measure: Number of Participants With Unsolicited AEs up to 28 Days After Each Vaccination
timeFrame: 28 days after first vaccination on Day 1 (up to Day 29); 28 days after second vaccination on Day 29 (up to Day 57)
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
measure: Number of Participants With Medically-attended Adverse Events (MAAEs)
timeFrame: From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
measure: Number of Participants With Adverse Events of Special Interest (AESIs)
timeFrame: From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
measure: Number of Participants With AEs Leading to Withdrawal From the Study
timeFrame: From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
measure: Groups 3 and 4: GMTs of HI Antibodies Against Each of the Four Influenza Vaccine Strains 28 Days After the Administration of a Seasonal Quadrivalent High-dose Influenza Vaccine
timeFrame: 28 days after vaccination with seasonal quadrivalent high-dose influenza vaccine (Day 29)
measure: Group 3 and 4: GMCs of Antibodies Measured by S-ELISA 28 Days After Administration of Ad26.COV2.S Vaccine
timeFrame: 28 days after vaccination with Ad26.COV2.S vaccine (Group 3: Day 29, Group 4: Day 57)
measure: GMCs of Antibodies Measured by S-ELISA 28 Days After Administration of Ad26.COV2.S Vaccine in COVID-19 Vaccine Naive Participants
timeFrame: 28 days after the administration of Ad26.COV2.S vaccine (that is, for Groups 1 and 3: Day 29; for Groups 2 and 4: Day 57)
measure: Percentage of Participants With Seroconversion for Each of the 4 Influenza Vaccine Strains at 28 Days After the Administration of a Seasonal Quadrivalent (High-dose and Standard-dose) Influenza Vaccine
timeFrame: 28 days after the administration of a seasonal quadrivalent influenza vaccine (Day 29)
measure: Percentage of Participants With Seroprotection for Each of the 4 Influenza Vaccine Strains as HI Titer >= 1:40 at 28 Days After the Administration of a Seasonal Quadrivalent (High-dose and Standard-dose) Influenza Vaccine
timeFrame: 28 days after the administration of a seasonal quadrivalent influenza vaccine (Day 29)
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Fiel Family and Sports Medicine Clinical Research Advantage
state: Arizona
city: San Diego
country: United States
facility: Wr McCr Llc
state: California
city: Coral Gables
country: United States
facility: Clinical Research of South Florida, an AMR Company
state: Florida
city: Fort Myers
country: United States
facility: AMR Fort Myers Clinical Physiology Associates, an AMR company
state: Florida
city: Miami
country: United States
facility: Office of Emilio Mantero-Atienza, MD
state: Florida
city: Miami
country: United States
facility: University of Miami Health System
state: Florida
city: Miami
country: United States
facility: Premier Research Associate, Inc
state: Florida
city: Evansville
country: United States
facility: Medisphere Medical Research Center, Llc
state: Indiana
city: Norfolk
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Research Consortium, an AMR company
state: Nevada
city: Hillsborough
country: United States
facility: I.D. Care, Inc.
state: New Jersey
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc
state: New York
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research
state: North Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Keller
country: United States
facility: Ventavia Research Group, LLC
state: Texas
city: Plano
country: United States
facility: Research Your Health
state: Texas
city: Richmond
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
city: Alken
country: Belgium
facility: Anima
city: Antwerpen
country: Belgium
facility: Institute of Tropical Medicine Antwerp
city: Merksem
country: Belgium
facility: Clinical Pharmacology Unit
city: Namur
country: Belgium
facility: Private Practice RESPISOM Namur
city: Czestochowa
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Czestochowie
city: Gdansk
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdansku
city: Gdansk
country: Poland
facility: Gdanskie Centrum Zdrowia
city: Gdynia
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdynia
city: Katowice
country: Poland
facility: Synexus Polska Sp z o o Oddzial w Katowicach
city: Lodz
country: Poland
facility: Synexus Polska Sp Z O O Oddzial W Lodzi
city: Poznan
country: Poland
facility: Synexus Polska Sp. z.o.o. Oddzial w Poznaniu
city: Skorzewo
country: Poland
facility: Centrum Medyczne Pratia Poznan
city: Warszawa
country: Poland
facility: Synexus Polska Sp z o o Oddzial w Warszawie
city: Wroclaw
country: Poland
facility: Synexus Polska Sp z o o Oddzial we Wroclawiu
Study officials:
affiliation: Janssen Vaccines & Prevention B.V.
name: Janssen Vaccines & Prevention B.V. Clinical Trial
role: STUDY_DIRECTOR
References: