A Study to Evaluate Dose Levels of Ad26.COV2.S Administered as a Two-dose Schedule in Healthy Adults

COVID-19 Prevention Clinical Trial

Official title:

A Randomized, Double-blind, Phase 3 Study to Evaluate 6 Dose Levels of Ad26.COV2.S Administered As a Two-Dose Schedule in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04908722
• Other study ID #: CR108960
• Secondary ID: 2020-005801-14VA
• Status: Completed
• Phase: Phase 3
• Start date: June 18, 2021
• Est. completion date: July 10, 2023

Study information

• Verified date: April 2024
• Source: Janssen Vaccines & Prevention B.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate non-inferiority (NI) in terms of humoral immune responses after 6 dose levels of Ad26.COV2.S.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1609
• Est. completion date: July 10, 2023
• Est. primary completion date: July 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study

• Participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, and vital signs performed at screening. Participant may have underlying illnesses, as long as the symptoms and signs are medically controlled and not considered to be comorbidities related to an increased risk of severe Coronavirus disease 2019 (COVID-19), except for smoking, which is allowed. If on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participant will be included on the basis of physical examination, medical history, and vital signs

• All female participants of childbearing potential must: a) have a negative highly sensitive urine pregnancy test at screening; b) have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration

• Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine

• Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study

Exclusion Criteria:

• Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0 degree Celsius (C) (100.4 degree Fahrenheit [F]) within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor

• Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)

• Participant received or plans to receive: (a) licensed live attenuated vaccines - within 28 days before or after planned administration of the first or subsequent study vaccinations; and (b) other licensed (not live) vaccines - within 14 days before or after planned administration of the first or subsequent study vaccinations

• Participant received an investigational drug (including investigational drugs for prophylaxis of COVID-19) or used an invasive investigational medical device within 30 days or received investigational immunoglobulin (Ig) or monoclonal antibodies within 3 months, or received convalescent serum for COVID-19 treatment within 4 months or received an investigational vaccine within 6 months before the planned administration of the first dose of study vaccine or is currently enrolled or plans to participate in another investigational study during the course of this study

• Participant previously received a coronavirus vaccine

Related Conditions & MeSH terms

• COVID-19 Prevention

Intervention

Biological:
• Ad26.COV2.S
Participants will receive intramuscular (IM) injections of Ad26.COV2.S.

Locations

Country	Name	City	State
Brazil	Santa Casa de Misericordia de Belo Horizonte	Belo Horizonte
Brazil	Universidade Federal De Minas Gerais - Hospital das Clínicas	Belo Horizonte
Brazil	CECOR - Centro Oncológico de Roraima	Boa Vista
Brazil	Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro	Campinas
Brazil	Núcleo de Medicina Tropical - Universidade Federal do Ceará	Ceará
Brazil	Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose	Criciúma
Brazil	Centro de Estudos e Pesquisas em Moléstias Infecciosas - CEPCLIN	Natal
Brazil	Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP	Ribeirao Preto
Brazil	Municipio de Nova Iguacu - Hospital Geral de Nova Iguacu	Rio de Janeiro
Brazil	Centro de Referencia E Treinamento Dst/Aids	Sao Paulo
Brazil	CPQuali Pesquisa Clinica LTDA ME	São Paulo
Germany	Klinische Forschung Berlin-Mitte GmbH	Berlin
Germany	Clinical Research HamburggmbH	Hamburg
Germany	Klinische Forschung Hannover-Mitte GmbH	Hannover
Germany	Synexus Clinical Research GmbH	Leipzig
Germany	Universitaetsmedizin Rostock	Rostock
Poland	Gdanskie Centrum Zdrowia	Gdansk
Poland	Centrum Medyczne Medyk	Rzeszow
Poland	Centrum Medyczne Pratia Poznan	Skorzewo
South Africa	Synexus Helderberg Clinical Research Centre	Cape Town
South Africa	Ndlovu Elandsdoorn Site	Dennilton
South Africa	Stanza Clinical Research Centre : Mamelodi	Mamelodi East
South Africa	PHOENIX PHARMA (Pty) Ltd	Port Elizabeth
South Africa	Gct Sunnyside	Pretoria
South Africa	Setshaba Research Centre	Soshanguve
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	Velocity Clinical Research, Hallandale Beach	Hallandale Beach	Florida
United States	Ventavia Research Group, LLC	Keller	Texas
United States	Clinical Research Center of Nevada	Las Vegas	Nevada
United States	Baptist Health Center for Clinical Research	Little Rock	Arkansas
United States	Ark Clinical Research	Long Beach	California
United States	Medpharmics, LLC	Metairie	Louisiana
United States	Floridian Research Institute	Miami	Florida
United States	Coastal Carolina Research Center	North Charleston	South Carolina
United States	Research Your Health	Plano	Texas
United States	Wake Research Associates	Raleigh	North Carolina
United States	Paradigm Clinical Research Centers, Inc.	Redding	California
United States	Clinical Research Partners, LLC	Richmond	Virginia
United States	Rochester Clinical Research, Inc	Rochester	New York
United States	Wr-McCr, Llc	San Diego	California
United States	Ark Clinical Research	Tustin	California
United States	Trial Management Associates, LLC	Wilmington	North Carolina
United States	Tekton Research Inc.	Yukon	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Vaccines & Prevention B.V.

Countries where clinical trial is conducted

United States,  Brazil,  Germany,  Poland,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After First Vaccination	Geometric mean concentration of SARS-CoV-2 S protein binding antibodies measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.	28 days after first vaccination (at Day 29)
Primary	Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 14 Days After Second Vaccination	Geometric mean concentration of SARS-CoV-2 S protein binding antibodies measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.	14 days after second vaccination (at Day 71)
Secondary	Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA	Percentage of participants with serological response to vaccination to SARS-COV-2 S protein as measured by ELISA were reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) the baseline (pre-dose 1) sample value was less than or equal to (<=) lower limit of quantification (LLOQ) and the post-baseline sample was greater than (>) LLOQ; (2) the baseline sample (pre-dose 1) value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>=4-fold) increase from the baseline sample value. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.	Day 29, Day 57, Day 71, Week 32, and Week 60
Secondary	Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA	Geometric mean concentration of SARS-CoV-2 S protein binding antibody measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.	Day 29, Day 57, Day 71, Week 32, and Week 60
Secondary	Number of Subjects With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination	An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participant in their e-diary for 7 days after each vaccination. Solicited local AEs included injection site pain/tenderness, erythema and swelling at the study vaccine injection site. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.	7 days after each vaccination (first vaccination [at Day 8], second vaccination [at Day 64])
Secondary	Number of Subjects With Solicited Systemic AEs for 7 Days After Each Vaccination	An AE was any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic AEs (include body temperature, fatigue, headache, nausea, myalgia) were noted in the subject diary after 7 days of each vaccination. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.	7 days after each vaccination (first vaccination [at Day 8], second vaccination [at Day 64])
Secondary	Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination	Unsolicited AEs were all AEs for which the subject was not specifically questioned in the subject diary. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.	28 days after each vaccination (first vaccination [at Day 29], second vaccination [at Day 85])
Secondary	Number of Participants With Serious Adverse Events (SAEs)	SAE was any untoward medical occurrence that at any dose may results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.	From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Secondary	Number of Participants With Adverse Events of Special Interest (AESIs)	AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with thrombocytopenia syndrome were considered to be an AESI. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.	From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Secondary	Number of Participants With AEs Leading to Study Discontinuation	Number of participants with AEs leading to study discontinuation were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.	Up to 60 weeks
Secondary	Number of Participants With Medically-Attended Adverse Events (MAAEs)	MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.	6 months after second vaccination (up to 32 weeks)