Clinical trial NCT04436276: A Study of Ad26.COV2.S in Adults (COVID-19)
Official title: A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26COVS1 in Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Covid-19 Prevention
Keywords: COVID-19
Ad26COVS1
Ad26.COV2.S
SARS CoV 2
Vaccine
Lead sponsor: Janssen Vaccines & Prevention B.V.
Sponsor class: INDUSTRY
First posted: 2020-06-18
Enrollment: 1085
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study is to assess the safety, reactogenicity, and immunogenicity of Ad26.COV2.S at 2 dose levels, administered intramuscularly (IM) as a single-dose or 2-dose schedule, with a single booster vaccination administered in one cohort in healthy adults aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 years and in adults aged \>= 65 years in good health with or without stable underlying conditions. The purpose of the study is also to assess the safety and reactogenicity of Ad26.COV2.S administered as ad hoc booster vaccination in healthy adults aged \>= 18 to \<= 55 years and in adults \>= 65 years in good health with or without stable underlying conditions.


Eligibility criteria: 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
* All female participants of childbearing potential must have a negative highly sensitive urine pregnancy test at screening; and have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration
* Participant must have a body mass index (BMI) less than or equal to (\<=) 30.0 kilograms per square meter (kg/m\^2)
* Applicable to Cohorts 1 and 2 only: Participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, clinical laboratory assessments, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe coronavirus disease-2019 (COVID-19). Applicable to Cohort 3 only: In the investigator's clinical judgment, participant must be either in good or stable health Participants may have underlying illnesses such as hyperlipoproteinemia or hypothyroidism, as long as their symptoms and signs are medically controlled and not considered to be comorbidities related to an increased risk of severe COVID-19 (participants may have medical conditions of mild severity (according to the Toxicity Grading Scale), as long as it is stable and medically controlled as defined by no change in medication over the past 6 months (except for issues of tolerability or use of similar drug with same mechanism of action, for example, thiazides, Beta blockers, Alpha blockers at the same effective dose).

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 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 history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
* Participant has a history of any neurological disorders or seizures including Guillain-Barre syndrome, with the exception of febrile seizures during childhood
* Participant has a positive diagnostic test result for SARS-CoV-2 infection confirmed by polymerase chain reaction (PCR) at screening
* Participants with comorbidities that are or might be associated with an increased risk of progression to severe COVID-19, that is, participants with moderate-to-severe asthma; chronic lung diseases such as chronic obstructive pulmonary disease (COPD) (including emphysema and chronic bronchitis), idiopathic pulmonary fibrosis and cystic fibrosis; diabetes (including type 1 or type 2); serious heart conditions, including heart failure, coronary artery disease, congenital heart disease, cardiomyopathies, and (pulmonary) hypertension or high blood pressure; obesity (BMI \>= 30 kg/m\^2); chronic liver disease, including cirrhosis; sickle cell disease; thalassemia; cerebrovascular disease; neurologic conditions (dementia); smoking end stage renal disease; organ transplantation; cancer; HIV infection and other immunodeficiencies; hepatitis B infection; and sleep apnea. Applicable to Cohort 3 only: Participants may have hypertension of mild severity (according to the Toxicity Grading Scale), as long as it is stable and medically controlled as defined by no change in medication over the past 6 months (except for issues of tolerability or use of similar drug with same mechanism of action, for example, thiazides, Beta blockers, Alpha blockers at the same effective dose)
* Applicable to Cohorts 1 and 3 only: Participant currently working in an occupation with a high risk of exposure to SARS-CoV-2 (for example, health care worker or emergency response personnel) or considered at the investigator's discretion to be at increased risk to acquire COVID-19 for any other reason

Primary outcomes:
measure: Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen
timeFrame: 7 days post-vaccination 1 on Day 1 (Day 8)
measure: Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen
timeFrame: 7 days after vaccination 2 on Day 57 (Day 64)
measure: Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination
timeFrame: 7 days after ad hoc booster vaccination (Day 488 up to Day 604)
measure: Cohorts 2a and 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen
timeFrame: 7 days after Vaccination 1 on Day 1 (Day 8)
measure: Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 1
timeFrame: 7 days after booster vaccination 1 on Day 183 (Day 190)
measure: Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 2
timeFrame: 7 days after booster vaccination 2 on Day 366 (Day 373)
measure: Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination
timeFrame: 7 days after ad hoc booster vaccination (Day 384 up to Day 451)
measure: Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen
timeFrame: 7 days after Vaccination 2 on Day 57 (Day 64)
measure: Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 1
timeFrame: 7 days after booster vaccination 1 on Day 239 (Day 246)
measure: Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 2
timeFrame: 7 days after booster vaccination 2 on Day 422 (Day 429)
measure: Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination
timeFrame: 7 days after ad hoc booster vaccination (Day 369 up to Day 412)
measure: Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen
timeFrame: 7 days after vaccination 1 on Day 1 (Day 8)
measure: Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen
timeFrame: 7 days after Vaccination 2 on Day 57 (Day 64)
measure: Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination
timeFrame: 7 days after ad hoc booster vaccination (Day 488 up to Day 604)
measure: Cohorts 2a and 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen
timeFrame: 7 days after Vaccination 1 on Day 1 (Day 8)
measure: Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 1
timeFrame: 7 days after booster vaccination 1 on Day 183 (Day 190)
measure: Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 2
timeFrame: 7 days after booster vaccination 2 on Day 366 (Day 373)
measure: Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination
timeFrame: 7 days after ad hoc booster vaccination (Day 384 up to Day 451)
measure: Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen
timeFrame: 7 days after Vaccination 2 on Day 57 (Day 64)
measure: Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 1
timeFrame: 7 days after booster vaccination 1 on Day 239 (Day 246)
measure: Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 2
timeFrame: 7 days after booster vaccination 2 on Day 422 (Day 429)
measure: Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination
timeFrame: 7 days after ad hoc booster vaccination (Day 369 up to Day 412)
measure: Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen
timeFrame: 7 days after vaccination 1 on Day 1 (Day 8)
measure: Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen
timeFrame: 7 days post-vaccination 1 on Day 1 (Day 8)
measure: Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen
timeFrame: 7 days post-vaccination 2 on Day 57 (Day 64)
measure: Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen
timeFrame: 7 after post-vaccination 2 on Day 57 (Day 64)
measure: Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination
timeFrame: 7 days after ad hoc booster vaccination (Day 456 up to Day 711)
measure: Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination
timeFrame: 7 days after ad hoc booster vaccination (Day 456 up to Day 711)
measure: Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen
timeFrame: 28 days after vaccination 1 on Day 1 (Day 29)
measure: Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen
timeFrame: 28 days after vaccination 2 on Day 57 (Day 85)
measure: Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination
timeFrame: 28 days after ad hoc booster vaccination (Day 488 up to Day 625)
measure: Cohorts 2a and 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen
timeFrame: 28 days after Vaccination 1 on Day 1 (Day 29)
measure: Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 1
timeFrame: 28 days after booster vaccination 1 on Day 183 (Day 211)
measure: Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 2
timeFrame: 28 days after booster vaccination 2 on Day 366 (Day 394)
measure: Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination
timeFrame: 28 days after ad hoc booster vaccination (Day 384 up to Day 472)
measure: Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen
timeFrame: 28 days after Vaccination 2 on Day 57 (Day 85)
measure: Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 1
timeFrame: 28 days after booster vaccination 1 on Day 239 (Day 267)
measure: Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 2
timeFrame: 28 days after booster vaccination 2 on Day 422 (Day 450)
measure: Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination
timeFrame: 28 days after ad hoc booster vaccination (Day 369 up to Day 433)
measure: Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen
timeFrame: 28 days after vaccination 1 on Day 1 (Day 29)
measure: Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen
timeFrame: 28 days after vaccination 2 on Day 57 (Day 85)
measure: Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination
timeFrame: 28 days after ad hoc booster vaccination (Day 456 up to Day 732)
measure: Cohorts 1a and 1b and Cohort 3: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Day 1 up to 2 years after Vaccination 2 on Day 57 (Day 787)
measure: Cohorts 2a and 2b: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Day 1 up to 6 months post primary regimen (up to Day 183 for Cohort 2a; up to Day 239 for Cohort 2b)
measure: Cohorts 1a, 1b and 3: Number of Participants With Adverse Events of Special Interest (AESIs)
timeFrame: Day 1 up to 2 years after Vaccination 2 on Day 57 (Day 787)
measure: Cohorts 2a and 2b: Number of Participants With Adverse Events of Special Interest (AESIs)
timeFrame: Day 1 up to 6 months post primary regimen (up to Day 183 for Cohort 2a; up to Day 239 for Cohort 2b)
Secondary outcomes:
measure: Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)
timeFrame: Days 29, 57, 71, 85, 239, and 422
measure: Cohort 1b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)
timeFrame: Days 29 and 71
measure: Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)
timeFrame: Days 8, 29, 183, 190, 211, 366, 373, and 394,
measure: Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)
timeFrame: Days 8, 29, 57, 64, 85, 239, 246, 267 and 422
measure: Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)
timeFrame: Days 15, 29, 87, 100, 114 and 268
measure: Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA)
timeFrame: Days 29, 57, 71, 85, 239 and 422
measure: Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA)
timeFrame: Days 29, 183, 190, 211, 366, 373 and 394
measure: Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA)
timeFrame: Days 15, 29, 87, 100, 114 and 268
measure: Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2)
timeFrame: Baseline, Days 15, 29, 57, 71, 85, 239 and 422
measure: Cohorts 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2)
timeFrame: Baseline, Days 29 and 366
measure: Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2)
timeFrame: Baseline, Days 29, 57, 85 and 422
measure: Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2)
timeFrame: Baseline, Days 15, 29, 87, 100, 114 and 268
measure: Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+
timeFrame: Baseline, Day 15, 29, 57, 71, 85, 239 and 422
measure: Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+
timeFrame: Baseline, Days 29 and 366
measure: Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+
timeFrame: Baseline, Days 29, 57, 85 and 422
measure: Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+
timeFrame: Baseline, Days 15, 29, 87, 100, 114 and 268
measure: Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+
timeFrame: Baseline, Days 15, 29, 57, 71, 85, 239 and 422
measure: Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+
timeFrame: Baseline, Days 29 and 366
measure: Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+
timeFrame: Baseline, Days 29, 57, 85 and 422
measure: Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+
timeFrame: Baseline, Days 15, 29, 87, 100, 114 and 268
measure: Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1
timeFrame: Days 15, 29, 57, 71, 85, 239 and 422
measure: Cohort 2a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1
timeFrame: Days 29 and 366
measure: Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1
timeFrame: Days 29, 57, 85 and 422
measure: Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1
timeFrame: Days 15, 29, 87, 100, 114 and 268
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Optimal Research
state: California
city: Melbourne
country: United States
facility: Optimal Research
state: Florida
city: Peoria
country: United States
facility: Optimal Research
state: Illinois
city: Rockville
country: United States
facility: Optimal Research
state: Maryland
city: Boston
country: United States
facility: Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center
state: Massachusetts
city: Knoxville
country: United States
facility: AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
state: Tennessee
city: Austin
country: United States
facility: Optimal Research
state: Texas
city: Edegem
country: Belgium
facility: Universiteit Antwerpen - Centrum voor de Evaluatie van Vaccinaties (CEV)
city: Edegem
country: Belgium
facility: UZA-SGS
city: Gent
country: Belgium
facility: Center for Vaccinology (CEVAC)
city: Leuven
country: Belgium
facility: UZ Leuven
city: Merksem
country: Belgium
facility: Clinical Pharmacology Unit
Study officials:
affiliation: Janssen Vaccines & Prevention B.V.
name: Janssen Vaccines & Prevention B.V. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Sadoff J, Le Gars M, Brandenburg B, Cardenas V, Shukarev G, Vaissiere N, Heerwegh D, Truyers C, de Groot AM, Jongeneelen M, Kaszas K, Tolboom J, Scheper G, Hendriks J, Ruiz-Guinazu J, Struyf F, Van Hoof J, Douoguih M, Schuitemaker H. Durable antibody responses elicited by 1 dose of Ad26.COV2.S and substantial increase after boosting: 2 randomized clinical trials. Vaccine. 2022 Jul 30;40(32):4403-4411. doi: 10.1016/j.vaccine.2022.05.047. Epub 2022 Jun 3.
citation: Stephenson KE, Le Gars M, Sadoff J, de Groot AM, Heerwegh D, Truyers C, Atyeo C, Loos C, Chandrashekar A, McMahan K, Tostanoski LH, Yu J, Gebre MS, Jacob-Dolan C, Li Z, Patel S, Peter L, Liu J, Borducchi EN, Nkolola JP, Souza M, Tan CS, Zash R, Julg B, Nathavitharana RR, Shapiro RL, Azim AA, Alonso CD, Jaegle K, Ansel JL, Kanjilal DG, Guiney CJ, Bradshaw C, Tyler A, Makoni T, Yanosick KE, Seaman MS, Lauffenburger DA, Alter G, Struyf F, Douoguih M, Van Hoof J, Schuitemaker H, Barouch DH. Immunogenicity of the Ad26.COV2.S Vaccine for COVID-19. JAMA. 2021 Apr 20;325(15):1535-1544. doi: 10.1001/jama.2021.3645.
citation: Sadoff J, Le Gars M, Shukarev G, Heerwegh D, Truyers C, de Groot AM, Stoop J, Tete S, Van Damme W, Leroux-Roels I, Berghmans PJ, Kimmel M, Van Damme P, de Hoon J, Smith W, Stephenson KE, De Rosa SC, Cohen KW, McElrath MJ, Cormier E, Scheper G, Barouch DH, Hendriks J, Struyf F, Douoguih M, Van Hoof J, Schuitemaker H. Interim Results of a Phase 1-2a Trial of Ad26.COV2.S Covid-19 Vaccine. N Engl J Med. 2021 May 13;384(19):1824-1835. doi: 10.1056/NEJMoa2034201. Epub 2021 Jan 13.
citation: Bos R, Rutten L, van der Lubbe JEM, Bakkers MJG, Hardenberg G, Wegmann F, Zuijdgeest D, de Wilde AH, Koornneef A, Verwilligen A, van Manen D, Kwaks T, Vogels R, Dalebout TJ, Myeni SK, Kikkert M, Snijder EJ, Li Z, Barouch DH, Vellinga J, Langedijk JPM, Zahn RC, Custers J, Schuitemaker H. Ad26 vector-based COVID-19 vaccine encoding a prefusion-stabilized SARS-CoV-2 Spike immunogen induces potent humoral and cellular immune responses. NPJ Vaccines. 2020 Sep 28;5:91. doi: 10.1038/s41541-020-00243-x. eCollection 2020.