A Study of Ad26.COV2.S and Influenza Vaccines in Healthy Adults

NCT ID: NCT05091307

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 861 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-02
• Study Completion Date: 2022-11-15

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.

Conditions

COVID-19 Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-dose (SD) Influenza Vaccine and Placebo

Participants aged greater than or equal to (\>=) 18 years will receive a single intramuscular (IM) injection of Ad26.COV2.S and a seasonal Q SD influenza vaccine on Day 1 and placebo on Day 29.

Group Type: EXPERIMENTAL

Ad26.COV2.S

Intervention Type: BIOLOGICAL

Ad26.COV2.S will be administered as an IM injection.

Placebo

Intervention Type: OTHER

Placebo will be administered as an IM injection.

Influenza Vaccine

Intervention Type: BIOLOGICAL

Influenza vaccine high and standard dose will be administered as IM injection.

Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S

Participants aged \>=18 years will receive a single IM injection of placebo and a seasonal Q SD influenza vaccine on Day 1 followed by Ad26.COV2.S on Day 29.

Group Type: PLACEBO_COMPARATOR

Ad26.COV2.S

Intervention Type: BIOLOGICAL

Ad26.COV2.S will be administered as an IM injection.

Placebo

Intervention Type: OTHER

Placebo will be administered as an IM injection.

Influenza Vaccine

Intervention Type: BIOLOGICAL

Influenza vaccine high and standard dose will be administered as IM injection.

Group 3: Ad26.COV2.S + Q High-dose (HD) Influenza Vaccine and Placebo

Participants aged \>=65 years will receive a single IM injection of Ad26.COV2.S and a seasonal Q HD influenza vaccine on Day 1 followed by placebo on Day 29.

Group Type: EXPERIMENTAL

Ad26.COV2.S

Intervention Type: BIOLOGICAL

Ad26.COV2.S will be administered as an IM injection.

Placebo

Intervention Type: OTHER

Placebo will be administered as an IM injection.

Influenza Vaccine

Intervention Type: BIOLOGICAL

Influenza vaccine high and standard dose will be administered as IM injection.

Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S

Participants aged \>=65 years will receive a single IM injection of placebo and a seasonal Q HD influenza vaccine on Day 1 followed by Ad26.COV2.S on Day 29.

Group Type: PLACEBO_COMPARATOR

Ad26.COV2.S

Intervention Type: BIOLOGICAL

Ad26.COV2.S will be administered as an IM injection.

Placebo

Intervention Type: OTHER

Placebo will be administered as an IM injection.

Influenza Vaccine

Intervention Type: BIOLOGICAL

Influenza vaccine high and standard dose will be administered as IM injection.

Interventions

Ad26.COV2.S

Ad26.COV2.S will be administered as an IM injection.

Intervention Type: BIOLOGICAL

Placebo

Placebo will be administered as an IM injection.

Intervention Type: OTHER

Influenza Vaccine

Influenza vaccine high and standard dose will be administered as IM injection.

Intervention Type: BIOLOGICAL

Other Intervention Names

VAC31518; JNJ-78436735

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Vaccines & Prevention B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Vaccines & Prevention B.V. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Vaccines & Prevention B.V.

Locations

Fiel Family and Sports Medicine Clinical Research Advantage

Tempe, Arizona, United States

Wr McCr Llc

San Diego, California, United States

Clinical Research of South Florida, an AMR Company

Coral Gables, Florida, United States

AMR Fort Myers Clinical Physiology Associates, an AMR company

Fort Myers, Florida, United States

Office of Emilio Mantero-Atienza, MD

Miami, Florida, United States

University of Miami Health System

Miami, Florida, United States

Premier Research Associate, Inc

Miami, Florida, United States

Medisphere Medical Research Center, Llc

Evansville, Indiana, United States

Meridian Clinical Research, LLC

Norfolk, Nebraska, United States

Clinical Research Consortium, an AMR company

Las Vegas, Nevada, United States

I.D. Care, Inc.

Hillsborough, New Jersey, United States

Rochester Clinical Research, Inc

Rochester, New York, United States

Carolina Institute for Clinical Research

Fayetteville, North Carolina, United States

Coastal Carolina Research Center

North Charleston, South Carolina, United States

Ventavia Research Group, LLC

Keller, Texas, United States

Research Your Health

Plano, Texas, United States

Clinical Research Partners, LLC

Richmond, Virginia, United States

Anima

Alken, , Belgium

Institute of Tropical Medicine Antwerp

Antwerp, , Belgium

Clinical Pharmacology Unit

Merksem, , Belgium

Private Practice RESPISOM Namur

Namur, , Belgium

Synexus Polska Sp. z o.o. Oddzial w Czestochowie

Częstochowa, , Poland

Synexus Polska Sp. z o.o. Oddzial w Gdansku

Gdansk, , Poland

Gdanskie Centrum Zdrowia

Gdansk, , Poland

Synexus Polska Sp. z o.o. Oddzial w Gdynia

Gdynia, , Poland

Synexus Polska Sp z o o Oddzial w Katowicach

Katowice, , Poland

Synexus Polska Sp Z O O Oddzial W Lodzi

Lodz, , Poland

Synexus Polska Sp. z.o.o. Oddzial w Poznaniu

Poznan, , Poland

Centrum Medyczne Pratia Poznan

Skorzewo, , Poland

Synexus Polska Sp z o o Oddzial w Warszawie

Warsaw, , Poland

Synexus Polska Sp z o o Oddzial we Wroclawiu

Wroclaw, , Poland

Countries

United States; Belgium; Poland

References

Tapia-Calle G, Aguilar G, Vaissiere N, Truyers C, Ylisastigui P, Buntinx E, Le Gars M, Struyf F, Scheper G, Douoguih M, Ruiz-Guinazu J; COV3005 Study group. Safety, reactogenicity, and immunogenicity of Ad26.COV2.S co-administered with a quadrivalent standard-dose or high-dose seasonal influenza vaccine: a non-inferiority randomised controlled trial. EClinicalMedicine. 2025 Jan 7;79:103016. doi: 10.1016/j.eclinm.2024.103016. eCollection 2025 Jan.

Reference Type: DERIVED

PMID: 39866854 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2021-003953-43

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VAC31518COV3005

Identifier Type: OTHER

Identifier Source: secondary_id

CR109083

Identifier Type: -

Identifier Source: org_study_id