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

NCT05091307 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: CR1090832021-003953-43VAC31518COV3005
• Study Type: interventional
• Target: 861
• Locations: 3 countries
• Sites: 31

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.

Conditions

COVID-19 Prevention

Outcome Measures

Primary Outcomes (2)

• 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

  GMTs of HI antibodies were measured using hemagglutination inhibition (HAI) assay against each of four influenza vaccine strains (A/Victoria \[H1N1\], A/Cambodia \[H3N2\], B/Victoria \[B/Victoria\] and B/Phuket \[B/Yamagata\]). This outcome measure was planned to be analyzed for specified arms only. PPII=Per-protocol influenza immunogenicity.

  28 days after vaccination with seasonal quadrivalent standard-dose influenza vaccine (Day 29)

• 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

  GMCs of antibody titers measured by S-ELISA at 28 days after administration of Ad26.COV2.S vaccine was reported. This outcome measure was planned to be analyzed for specified arms only. Seronegative participants (at Day 1) who became serology positive during the study, participants with positive molecular test for severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) and major protocol deviation were excluded from PPSI analysis.

  28 days after vaccination with Ad26.COV2.S vaccine (Group 1: Day 29, Group 2: Day 57)

Secondary Outcomes (12)

• Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Each Vaccination

  7 days after first vaccination on Day 1 (up to Day 8); 7 days after second vaccination on Day 29 (up to Day 36)

• Number of Participants With Solicited Systemic AEs up to 7 Days After Each Vaccination

  7 days after first vaccination on Day 1 (up to Day 8); 7 days after second vaccination on Day 29 (up to Day 36)

• Number of Participants With Unsolicited AEs up to 28 Days After Each Vaccination

  28 days after first vaccination on Day 1 (up to Day 29); 28 days after second vaccination on Day 29 (up to Day 57)

• Number of Participants With Serious Adverse Events (SAEs)

  From Day 1 (post-vaccination) to end of the study (up to 12.5 months)

• Number of Participants With Medically-attended Adverse Events (MAAEs)

  From Day 1 (post-vaccination) to end of the study (up to 12.5 months)

Study Arms (4)

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

EXPERIMENTAL

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.

Biological: Ad26.COV2.S; Other: Placebo; Biological: Influenza Vaccine

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

PLACEBO COMPARATOR

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.

Biological: Ad26.COV2.S; Other: Placebo; Biological: Influenza Vaccine

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

EXPERIMENTAL

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.

Biological: Ad26.COV2.S; Other: Placebo; Biological: Influenza Vaccine

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

PLACEBO COMPARATOR

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.

Biological: Ad26.COV2.S; Other: Placebo; Biological: Influenza Vaccine

Interventions

Ad26.COV2.S BIOLOGICAL

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

Also known as: VAC31518, JNJ-78436735

Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-dose (SD) Influenza Vaccine and Placebo; Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S; Group 3: Ad26.COV2.S + Q High-dose (HD) Influenza Vaccine and Placebo; Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S

Placebo OTHER

Placebo will be administered as an IM injection.

Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-dose (SD) Influenza Vaccine and Placebo; Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S; Group 3: Ad26.COV2.S + Q High-dose (HD) Influenza Vaccine and Placebo; Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S

Influenza Vaccine BIOLOGICAL

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

Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-dose (SD) Influenza Vaccine and Placebo; Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S; Group 3: Ad26.COV2.S + Q High-dose (HD) Influenza Vaccine and Placebo; Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Vaccines & Prevention B.V.: lead

Study Sites (31)

Fiel Family and Sports Medicine Clinical Research Advantage

Tempe, Arizona, 85283, United States

Location

Wr McCr Llc

San Diego, California, 92120, United States

Location

Clinical Research of South Florida, an AMR Company

Coral Gables, Florida, 33134, United States

Location

AMR Fort Myers Clinical Physiology Associates, an AMR company

Fort Myers, Florida, 33912, United States

Location

Office of Emilio Mantero-Atienza, MD

Miami, Florida, 33135, United States

Location

University of Miami Health System

Miami, Florida, 33136, United States

Location

Premier Research Associate, Inc

Miami, Florida, 33165, United States

Location

Medisphere Medical Research Center, Llc

Evansville, Indiana, 47714, United States

Location

Meridian Clinical Research, LLC

Norfolk, Nebraska, 68701, United States

Location

Clinical Research Consortium, an AMR company

Las Vegas, Nevada, 89119, United States

Location

I.D. Care, Inc.

Hillsborough, New Jersey, 08844, United States

Location

Rochester Clinical Research, Inc

Rochester, New York, 14609, United States

Location

Carolina Institute for Clinical Research

Fayetteville, North Carolina, 28303, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

Ventavia Research Group, LLC

Keller, Texas, 76248, United States

Location

Research Your Health

Plano, Texas, 75093, United States

Location

Clinical Research Partners, LLC

Richmond, Virginia, 23226, United States

Location

Anima

Alken, 3570, Belgium

Location

Institute of Tropical Medicine Antwerp

Antwerp, 2000, Belgium

Location

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Location

Private Practice RESPISOM Namur

Namur, 5101, Belgium

Location

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

Częstochowa, 42-202, Poland

Location

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

Gdansk, 80 382, Poland

Location

Gdanskie Centrum Zdrowia

Gdansk, 80-542, Poland

Location

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

Gdynia, 81 537, Poland

Location

Synexus Polska Sp z o o Oddzial w Katowicach

Katowice, 40 040, Poland

Location

Synexus Polska Sp Z O O Oddzial W Lodzi

Lodz, 90 127, Poland

Location

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

Poznan, 60-702, Poland

Location

Centrum Medyczne Pratia Poznan

Skorzewo, 60 185, Poland

Location

Synexus Polska Sp z o o Oddzial w Warszawie

Warsaw, 02 672, Poland

Location

Synexus Polska Sp z o o Oddzial we Wroclawiu

Wroclaw, 50 381, Poland

Location

Related Publications (1)

• 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.

  PMID: 39866854 DERIVED

MeSH Terms

Interventions

Ad26COVS1; Influenza Vaccines

Intervention Hierarchy (Ancestors)

COVID-19 Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Medical Leader
• Organization: Janssen Vaccines & Prevention B.V.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Vaccines & Prevention B.V. Clinical Trial

  Janssen Vaccines & Prevention B.V.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 25, 2021
• Study Start: November 2, 2021
• Primary Completion: June 17, 2022
• Study Completion: November 15, 2022
• Last Updated: May 25, 2025
• Results First Posted: August 8, 2023

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (17); PL (10); BE (4)