The study to check the safety and immune response of (Covid-19 vaccine) COVOVAX in adults (more than 18 years of age) and pediatric population (more than 2 years and less than 17 years of age) in India.
A phase 2/3, observer-blind, randomized, controlled study to determine the safety and immunogenicity of COVOVAX [SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) with Matrix-M1™ adjuvant] in Indian adults aged ≥18 years and children aged 2 to 17 years
All India Institute of Medical Sciences (AIIMS), New Delhi
Department of Pulmonary Medicine and Sleep Disorders, All India Institute of Medical Sciences (AIIMS),Ansari Nagar, New Delhi – 110029 India New Delhi
01126588500
vijayhadda@yahoo.com
Dr Hira Lal Bhalla
All India Institute of Medical Sciences, Gorakhpur
Department of Pharmacology, All India Institute of Medical Sciences,
Department of Pharmacology,
Gorakhpur, Uttar Pradesh - 273008 Gorakhpur
05512205572
hirabhalla@gmail.com
Dr Dipu Thareparambil S
Amrita Institute of Medical Sciences, Kochi
Department of General Medicine and Division of Infectious diseases, T2F3, Amrita Institute of Medical Sciences, Department of General Medicine, Ponekkara, Kochi, Kerala-682041, India Kollam
04842852250
diputsmck@gmail.com
Dr Sanjay Lalwani
Bharati Vidyapeeth Deemed University Medical College and Hospital, Pune
Department of
Pediatrics Bharati
Vidyapeeth Deemed
University Medical
College and Hospital,
Dhankawadi, Pune-
Satara Road, Pune-
411043, Maharashtra,
India Pune
00912024364308
researchpedpune@gmail.com
Dr Clarence Samuel
Christian Medical College and Hospital, Ludhiana
Department of Community Medicine, Christian Medical College & Hospital, Brown Rd, Ludhiana, Punjab 141008, India Ludhiana
01612115389
clarencejs@yahoo.com
Dr Abhay Gaidhane
Datta Meghe Institute of Medical Sciences, Sawangi (M), Wardha
Acharya Vinoba Bhave Rural Hospital, First Floor, Room no 221 - School of Epidemiology and Public Health, Datta Meghe Institute of Medical Sciences, Sawangi (M), Wardha,
Maharashtra- 442004, India Wardha
07152287742
abhaygaidhane@gmail.com
Dr Varsha Bhatt
Dr. D. Y. Patil Medical college, Hospital And Research Centre, Pune
Department Of Medicine, Dr. D. Y. Patil Medical college, Hospital And Research Centre,
Sant Tukaram Nagar,
Pimpri, Pune, Maharashtra-411018, India Pune
02027805000
drvrbhatt@gmail.com
Dr Sushant Meshram
Government Medical College and Hospital, Nagpur
Department of Pulmonary Medicine, Super Specialty Hospital, GMC Nagpur, Government Medical College and Hospital, Tukdoji Square, Nagpur, Maharashtra – 440009 India Nagpur
07122743588
drsushant.in@gmail.com
Dr Sunil Kohli
Hamdard Institute of Medical Sciences and Research, New Delhi
Department of Medicine, Room No 110, Block B, Hamdard Institute of Medical Sciences and Research with Centre for health Research and Development (CHRD),Society for Apllied Studies (SAS),Guru Ravidas Marg,
Hamdard Nagar,
New Delhi-110062, India New Delhi
01126059688
drskohli.himsr@gmail.com
Dr Rakhi Ludam
Institute of Medical Sciences & SUM Hospital, Bhubaneshwar
Department of Pulmonary Medicine, Institute of Medical Sciences and SUM Hospital, Kalinga Nagar, Bhubaneswar, Khordha, Orissa 751003 Khordha
06742386281
rakhiludam@soa.ac.in
Dr Tamilarasu Kadhiravan
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry
Department of Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri Nagar, Puducherry- 605006, India Pondicherry
04132272380
kadhiravan@gmail.com
Dr Praveen Kulkarni
JSS Academy of Higher Education and Research, Mysore
Department of Community Medicine,
JSS Medical College, JSS Hospital,
Mahatma Gandhi Road, Mysuru – 570004
Karnataka, India Mysore
08212335555
prakulfi@gmail.com
Dr Sonali Kar
Kalinga Institute of Medical Sciences, Bhubaneswar
Department of Community Medicine, Kalinga Institute of Medical Sciences, Kushabhadra Campus , KIIT Campus, 5, KIIT Road, Patia, Bhubaneswar, Odisha 751024, India Bargarh
06742304400
sonsam72@yahoo.co.uk
Dr Ashish Bavdekar
KEM Hospital Research Centre Vadu
Clinical Research, KEM Hospital Research Centre
Vadu Rural Health Program,
Vadu Budruk, Taluka Shirur,
Pune, Maharashtra- 412216, India Pune
02066037342
a.bavdekar@kemhrcpune.org
Dr Ashwath Narayana
KIMS Hospital and Research centre, Bangalore
Preventive Medicine Unit, Department of Community Medicine, Room No-12, Ground Floor, B-Block, KIMS Hospital and Research centre, Krishna Rajendra Rd, Vishweshwarapura, Bengaluru, Karnataka 560004, India Bangalore
08026601162
dhashwathnarayana@gmail.com
Dr Madhav Prabhu
KLES Dr. Prabhakar Kore Hospital and Medical Research Center, Nehru Nagar, Belgavi
Department of Medicine, KLES Dr Prabhakar Kore Hospital and Medical Research Center, Nehru Nagar, Belgavi Karnataka 590010, India Belgaum
08312474414
maddy2380@gmail.com
Dr Abhishek Raut
Mahatma Gandhi Institute of Medical Sciences, Sewagram
Department of Community Medicine, Dr. Sushila Nayar School of Public Health,
Mahatma Gandhi Institute of Medical Sciences, Sewagram - 442102, Wardha, Maharashtra, India Wardha
07152284341
abhishekraut@mgims.ac.in
Dr Sidram Raut
Noble Hospital, Pune
Clinical Research Department, Noble Hospital,
153, Road, Magarpatta,
Hadapsar, Pune, Maharashtra-411013, India Pune
02066285568
skrcorporate@yahoo.co.uk
Dr Madhu Gupta
Post Graduate Institute of Medical Education & Research (PGIMER)
Department of
Community Medicine
and School of Public
Health, Post Graduate
Institute of Medical
Education & Research
(PGIMER), Sector -12,
Chandigarh- 160012
Punjab, India Chandigarh
0911722755223
madhugupta21@gmail.com
Dr Govind Kulkarni
Sahyadri Super speciality Hospital, Pune
Clinical Research - Department of Medicine, Sahyadri Super speciality Hospital, Survey no.185A, Shastri nagar, Yerwada, Nagar road, Pune, Maharashtra- 411004, India Pune
02067271111
drgdk2001@yahoo.co.uk
Dr Santanu Tripathi
School of Tropical Medicine, Kolkata
Department of Clinical and Experimental Pharmacology, School of Tropical Medicine
108, Chittaranjan Ave,
Kolkata, West Bengal 700073, India Kolkata
03322123695
tripathi.santanu@gmail.com
Dr Nithya Gogtay
Seth G S Medical College and KEM Hospital, Parel, Mumbai
Department of Clinical Pharmacology
1st Floor, M S Building,
Seth G S Medical College and KEM Hospital,
Parel, Mumbai 400012, India Mumbai
02224133767
njgogtay@hotmail.com
Dr Renuka Munshi
TN Medical College & BYL Nair Hospital, Mumbai
TN Medical College &
BYL Nair Hospital, 5th
floor, Department of
Clinical Pharmacology,
TN Medical College &
BYL Nair Hospital, Dr.
AL Nair Road, Mumbai
Central, Mumbai,
Maharashtra 400008 Mumbai
COVOVAX [SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) with Matrix-M1™ adjuvant]
Adult cohort:
Phase 2 part: COVOVAX [SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) with Matrix-M1™ adjuvant] Manufacturer: DS manufactured by Novavax and DP (fill finish) by SIIPL.
Phase 3 part:
COVOVAX; Manufacturer: Serum Institute of India Pvt. Ltd.
Pediatric cohort: Test vaccine: COVOVAX; DS and DP manufactured by SIIPL
Comparator Agent
Novavax-SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine
(SARS-CoV-2 rS) with Matrix-M1™ Adjuvant
Adult Cohort: Novavax-SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1™ Adjuvant. DS and DP manufactured by Novavax
Comparator Agent
Placebo
Adult Cohort (Phase 2 part) and Pediatric Cohort: Placebo: 0.9% Normal saline (Sodium chloride) for injection.
Adult Cohort:
1. Adults aged more than or equal to 18 years of either sex
2. Written informed consent by participants
3. The participant is resident of the study area and is willing to comply with study protocol requirements
4. Healthy, as determined by medical history and physical examination
5. Sexually active female participants of childbearing potential must have practiced adequate contraception for 28 days prior to study vaccine administration and agree to continue adequate contraception until completion of their Day 36 visit
6. Female participants of childbearing potential must have a negative
urine pregnancy test within 24 hours prior to study vaccine
Pediatric Cohort:
1. Children aged ≥ 2 to 17 years of either sex
2. The participant is a resident of the study area and is willing to comply with study protocol requirements, including availability for all scheduled visits of the study
3. Healthy or medically stable, as determined by medical history and physical examination as determined by the investigator.
4. Parent(s) willing and able to give written informed consent for 2- to 17 year old children
5. Participants assent (verbal assent for 7- to 11-year old children and written assent for 12- to 17-year old children), as required, prior to study enrolment and to comply with study procedures.
6. Female participants of 12 to 17 years of age who have attained menarche must have a negative urine pregnancy test within 24 hours prior to study vaccine administration
ExclusionCriteria
Details
Adult Cohort:
1. Acute illness including COVID-19 with or without fever at the time of study vaccine administration
2. History of laboratory confirmed (by PCR or serology to SARSCoV-2) COVID-19 disease.
3. History of severe allergic reactions after previous vaccinations or hypersensitivity to any component of study vaccines
4. Prior receipt of an investigational or licensed vaccine likely to
impact interpretation of the trial data
5. Current or planned participation in prophylactic drug trials for the
duration of the study
Pediatric Cohort
1. Acute illness including COVID-19 with or without fever at the time of study vaccine administration
2. History of laboratory confirmed (by PCR or serology to SARS-CoV-2) COVID-19 disease
3. History of severe allergic reactions after previous vaccinations or hypersensitivity to any component of study vaccines
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
At baseline and 35 days post first dose vaccination.
GMEUs of anti-S IgG antibodies
Baseline, Day 21, Day 35 and Day 179 post first dose vaccination
Occurrence of SAEs, related
MAAEs, and adverse events of
special interest (AESI) which encompasses potential immunemediated medical conditions (PIMMCs) and AESIs relevant to COVID-19
Throughout the study
duration following vaccination
Occurrence of solicited local and systemic adverse events (AEs)
7 days following each dose
Occurrence of unsolicited adverse
events including medically attended
adverse events (MAAEs) for
35 days post first dose vaccination
Pediatric cohort:
Immunogenicity Outcomes:
a. GMEUs of anti-S IgG antibodies and Seroconversion for anti-S IgG
At baseline, 21, 35- and 179-days post first dose vaccination.
Seroconversion for anti-S IgG
Day 21, Day 35 and Day 179 post first dose vaccination
This is a Phase 2/3,
observer-blinded, randomized, controlled study in adults ≥ 18 years and
children of ≥ 2 to 17 years of age in India.
Adult Cohort:
A total of 1600
eligible participants of ≥ 18 years of age will be enrolled in this study. Of
these, 460 participants will be part of reactogenicity and immunogenicity
cohort. The remaining 1140 participants will be part of safety cohort.
All eligible
participants (n=1600) will receive two doses of 0.5 mL each of either COVOVAX
or Control vaccine (Novavax- SARS-CoV-2 rS with Matrix-M1™ Adjuvant) or Placebo
on Day 1 and Day 22 as per randomization. Post vaccination site visits are
planned on Day 22, Day 36, Day 85 and Day 180.
The study will be
conducted in two parts as below:
Phase 2 part: Initial
200 participants have been enrolled in the Safety cohort with 3:1 allocation to
COVOVAX (n=150) or Placebo (n=50).
Phase 3 part:
Enrolment of remaining 1400 participants (940 from the Safety cohort and 460
from the reactogenicity and immunogenicity cohort) will be done.
Pediatric cohort:
The study objective in
this cohort is to evaluate the safety of COVOVAX in comparison with Placebo;
and immunogenicity of COVOVAX in children ≥ 12 to 17 years of age and ≥ 2 to 11
years of age in comparison with adult participants (adult participants in the
reactogenicity and immunogenicity cohort from COVOVAX group), separately.
A total of 920
eligible children of ≥ 2 years of age will be enrolled in this study. Of these,
460 participants will be of ≥ 12 to 17 years of age and 460 participants will
be of ≥ 2 to 11 years of age.
All eligible
participants (n=920) will be randomized in 3:1 ratio to receive two doses of
0.5 mL each of either COVOVAX or Placebo, respectively, on Day 1 and
Day 22.
