A Study to Evaluate Different Dose Levels of
Ad26.COV2.S vaccine in Healthy Adolescents from 12 to 17 Years Inclusive
Scientific Title of Study
A Randomized, Double-blind, Placebo-controlled, Phase
2/3 Adaptive Study to Evaluate the Safety,
Reactogenicity, and Immunogenicity of Different Dose Levels of Ad26.COV2.S Administered as a One- or Two dose Regimen in Healthy Adolescents From 12 to 17
Years Inclusive
Trial Acronym
Horizon 2
Secondary IDs if Any
Secondary ID
Identifier
2020-005720-11
EudraCT
VAC31518COV3006 Amendment 1 dated 13 Jul 2021
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Sanish Davis
Designation
R and D, Director, GCO India
Affiliation
Johnson and Johnson Pvt. Ltd.
Address
Arena Space, Behind Majas Bus Depot, Off. J. V. Link Road,
Jogeshwari (E).
Mumbai MAHARASHTRA 400060 India
Phone
Fax
Email
sdavis20@its.jnj.com
Details of Contact Person Scientific Query
Name
Dr Sanish Davis
Designation
R and D, Director, GCO India
Affiliation
Johnson and Johnson Pvt. Ltd.
Address
Arena Space, Behind Majas Bus Depot, Off. J. V. Link Road,
Jogeshwari (E).
Mumbai MAHARASHTRA 400060 India
Phone
Fax
Email
sdavis20@its.jnj.com
Details of Contact Person Public Query
Name
Dr Sanish Davis
Designation
R and D, Director, GCO India
Affiliation
Johnson and Johnson Pvt. Ltd.
Address
Arena Space, Behind Majas Bus Depot, Off. J. V. Link Road,
Jogeshwari (E).
Mumbai MAHARASHTRA 400060 India
Phone
Fax
Email
sdavis20@its.jnj.com
Source of Monetary or Material Support
Janssen Vaccines and Prevention BV-Archimedesweg
4, 2333 CN Leiden, The Netherlands
Primary Sponsor
Name
Janssen Vaccines and Prevention BV
Address
Johnson and Johnson Pvt. Ltd., 501 Arena space, Behind Majas Bus
Depot, off J.V. Link Road, Jogeshwari East, Mumbai400060
Maharashtra
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
Argentina Brazil Colombia India Mexico South Africa Turkey
Sites of Study
No of Sites = 11
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Sachin Damke
Acharya Vinoba Bhave Rural Hospital
Acharya Vinoba Bhave Rural
Hospital, Clinical Research Department room, Block A, 1st floor,Behind Endoscopy Department, Sawangi (Meghe),
Wardha, 442004 Wardha MAHARASHTRA
9323234457
buntydamke@gmail.com
Dr Parshottam Koradia
BAPS Pramukh Swami Hospital
BAPS Pramukh Swami Hospital, Clinical Research Department room, ground floor, Shri Pramukh Swami Maharaj
Marg, Adajan Char Rasta, Surat Surat GUJARAT
2612796344
purushottam_koradia@yahoo.co.in
Dr Pradeep Nanjappa Shetty
Cheluvamba Hospital
Mysore Medical college and Research Institute, Irwin Road, Department of Pediatrics, Mysore, Karnataka, 570001, India Mysore KARNATAKA
9611898080
drpradeepn80@yahoo.com
Dr Sharad Agarkhedkar
Dr. D.Y.Patil Medical College Hospital and Research Center
Dr. D.Y.Patil Medical College
Hospital and Research Center,OPD 12, First Floor,
Hightech Building,
Sant Tukaram Nagar, Pimpri,
Pune-411018 Pune MAHARASHTRA
9822030122
agarkhedkar@gmail.com
Dr Rupa Dalmia Singh
GSVM Medical College Swaroop Nagar
GSVM Medical College
Swaroop Nagar, Clinical
Research Department, Department of medicine,Kanpur,
UTTAR PRADESH , 208002, India Kanpur Nagar UTTAR PRADESH
7985290540
drrupa9@gmail.com
Dr Deepti Thandaveswar
JSS Hospital
JSS Hospital
CDSA-CCRE, Master Health
Check up room, 2nd Floor,
Mysore, Karnataka, 570004,
India Mysore KARNATAKA
9845023309
deeptiadarsh@gmail.com
Dr Anand Kawade
KEM Hospital Research Centre
Sardar Moodliar road, Rasta peth, Pune 411011 that owns KEM Hospital Research Centre,Vadu Rural Health Program, at post Vadu, Pune, Maharashtra, 412216, India Pune MAHARASHTRA
Sir Ganga Ram Hospital, Clinical research Room, Near ward No. 10( Male General Ward), First Floor, Sir
Ganga Ram Hospital Marg, Department of Pediatrics
Rajinder Nagar, New Delhi
110060 New Delhi DELHI
9811211205
docdineshkaul@gmail.com
Dr Padmasani Venkata Raman
Sri Ramchandra Medical College & Research Institute Sri Ramachandra Institute
Sri Ramchandra Medical College & Research Institute
Sri Ramachandra Institute of
Higher Education and Research (DU) Clinical Research facility, Dental College Basement, No.1, Ramachandra Nagar, Porur, Chennai- 600116, Tamil Nadu,
India Chennai TAMIL NADU
9445140200
padmasani2001@yahoo.com
Dr Pravin Dinkar Supe
Supe Heart & Diabetes Hospital & Research Center
Supe Heart & Diabetes Hospital
& Research Center, : Consulting Room & Research Room, First Floor, Gharpure Ghat,Near Rungtha
School, Opp.
Adharashram,Ashok Stambh,
Nashik, Maharashtra , 0422002,
India Nashik MAHARASHTRA
Institutional Ethics Committee JSS Medical College
Submittted/Under Review
Institutional Ethics Committee of DMIMS
Submittted/Under Review
Institutional Ethics Committee Sri Ramachandra University
Approved
Medanta Institutional Ethics Committee
Submittted/Under Review
Sir Ganga Ram Hospital Ethics Committee, Sir Ganga Ram Hospital
Submittted/Under Review
Supe Hospital Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Healthy adolescents for prevention of Covid-19
Intervention / Comparator Agent
Type
Name
Details
Intervention
Ad26.COV2.S
Biological/Vaccine, one dose of 2.5, 1.25, 0.625 and two dose of 1.25 and 0.625 57 days apart will be tested in the strength of 10 raised to the power 10 vp per ml.
Comparator Agent
Not applicable
Not applicable
Inclusion Criteria
Age From
12.00 Year(s)
Age To
17.00 Year(s)
Gender
Both
Details
Participant’s age is 12 to 17 years of age at the time of first vaccination
Participant must be healthy, in the investigator’s clinical judgement, as confirmed by medical history, physical
examination, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe coronavirus disease 2019 COVID19
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 and or parent or legal guardian are
available and willing to participate for the duration of the study visits and follow up
Each participant or participant’s parent or legal
guardian must have access to a consistent means of contact either by telephone contact or email or computer
ExclusionCriteria
Details
Participant has a history of malignancy, bone marrow transplant, or solid organ transplant within 5 years before screening
Participant has a known or suspected allergy, history of anaphylaxis, or other serious adverse reactions, related to vaccines or their excipients including specifically the
excipients of the study vaccine
Use of systemic corticosteroids at an
immunosuppressive dose treatment duration more than 14 days for one course or recurrent use within 6 months before administration of study vaccine and during the study
Participants with a history of illness or with an ongoing illness that, in the opinion of the investigator, may pose additional risk to the participant if he or she participates in
the study
Any serious, chronic, or progressive disease example, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, acquired immunodeficiency syndrome AIDS infection, blood dyscrasias, bleeding diathesis, signs of
cardiac or renal failure, or severe malnutrition
Method of Generating Random Sequence
Stratified randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Parts 1 and 2: Number of
Participants with Solicited
Local Adverse Events (AEs)
7 Days Post-dose 1 & 2,Parts 1 and 2:
7 days post-dose 1 (Day 8)
,7 days post-dose 2 (Day
64)
Secondary Outcome
Outcome
TimePoints
Parts 1 and 2: Severe Acute
Respiratory Syndrome
Coronavirus(-2) (SARS-CoV-2)
or Individual SARS-CoV-2
Protein Binding Antibody Titers
as Measured by S-ELISA (or
Equivalent Assay)
Days 1, 29, 57, 71, 184, 366
(Parts 1 and 2)
Parts 1 and 2: SARS-CoV-2
Neutralizing Antibody Titers as Measured by VNA Titers
Days 1, 29, 57, 71, 184, 366
(Parts 1 and 2)
Target Sample Size
Total Sample Size="4350" Sample Size from India="875" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
The primary purpose of this study is to assess the safety,
reactogenicity, and humoral immune response of
Ad26.COV2.S or placebo administered intramuscularly
(IM) as a 1-dose schedule or as a 2-dose schedule (56-
day interval) in adolescents (Part 1 and Part 2); and to
demonstrate non-inferiority (NI) of immune responses
induced by 1 dose or 2 doses or of a lower, to be
determined, dose level of Ad26.COV2.S in adolescents
versus 1 or 2 doses of Ad26.COV2.S in young adults
(Part 2).