A open label, active control, phase 2 clinical study to evaluate immunogenicity, safety and tolerability of single heterologous booster dose of Protein Subunit Vaccine against SARS-CoV-2 Virus.
- Conditions
- Healthy Volunteers
- Registration Number
- CTRI/2023/09/057398
- Lead Sponsor
- Reliance Life Sciences Pvt Ltd RLS
- Brief Summary
This is Prospective, multi-center, randomized, open label,active control, phase 2 clinical study to evaluate immunogenicity, safety andtolerability of single heterologous booster dose of RelCoVax® (Protein SubunitVaccine of Reliance Life Sciences against SARS-CoV-2 Virus) with Corbevax®(Protein Subunit Vaccine of Biological E Ltd. against SARS-CoV-2 Virus).
In this study we will only accept healthy Male and femalesubjects who have received their primary vaccination series with either twodoses of Covishield® or two doses of Covaxin® ≥ 6 months prior to enrolment, asconfirmed by COVID- 19 certificate issued by Cowin by before randomization.Subjects who have received COVID vaccine other than Covishield or Covaxin inpast would not be eligible for enrolment. Subjects will receive a singlebooster dose of RLS SARS CoV-2 vaccine (RelCoVax®) or Corbevax® on day 0 as perRandomization schedule. Subjects will be randomized in 1:1 ratio to receiveeither RLS SARS CoV-2 vaccine RelCoVax® Or Corbevax®. Enrollment will be suchthat 100 subjects will be those who have received primary vaccination withCovishield®. These subjects will berandomly assigned in equal proportion to either RelCoVax® group (50 subjects)or Corbevax® group (50 subjects) and 100 enrolled subjects will be those whohave received Covaxin® as primary vaccination. These subjects will also berandomly assigned in equal proportion to either RelCoVax® group (50 subjects)or Corbevax® group (50 subjects).
It is proposed to enroll 200 subjects. (100 subjects inRelCoVax® arm and 100 subjects in Corbevax® arm). 100 enrolled subjects will bethose who have received Covishield® as two doses of primary vaccination and 100enrolled subjects will be those who have received Covaxin® as two doses ofprimary vaccination.
Safety would be evaluated in all subjects till day 90 whileimmunogenicity will be evaluated in a subpopulation at baseline (i.e. beforereceipt of booster dose), at day 28 and day 56 as follows:
Anti RBD IgG, anti-NC IgG, neutralizing antibody (againstOmicron variant and additional variant) will be evaluated in at least 46subjects in each group (i.e. total 92 subjects) at baseline and at day 28.These evaluations will be conducted in 20 subjects in each group at day 56.
Interferon gamma, IL-4 and IL-17 will be evaluated in atleast 20 subjects in each group at baseline and at day 28 and at least 10subjects in each group at day 56
CD4 and CD8 assessment would be conducted in at least 10subjects in each group at baseline and day 28 and 56
For immunogenicity assessment following tests would beconducted:
• Anti RBD IgG,
• Anti-NC IgG,
• Neutralizing antibody assessment by PRNT/Microneutralization Tests / Pseudo Neutralization test.
• Assessment of T cell response as determined by –
o Levels of Interferon γ and / or count of antigen activatedT cells secreting interferon γ (indicative of Th1 response)
o IL 4 (indicative of Th2 response) and
o IL 17 (Indicative of Th17 response)
o CD4 and CD8 counts
Timepoints for immunogenicity assessment are day 0, day 28and day 56.
Safety of vaccine will be evaluated by reporting of adverseevents. Adverse events will be known by subject information, physicalexamination, laboratory investigations, telephonic follow up with subjects.Subjects would be provided with subject diary card to report the adverseevents. Total duration of follow up for safety is up to 90 days aftervaccination.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
- Male and female subjects who have received their primary vaccination series with either two doses of Covishield® or two doses of Covaxin® ≥ 6 months prior to enrolment, as confirmed by COVID- 19 certificate issued by CoWIN.
- Age is ≥18 years to ≤ 80 years.
- The subject voluntarily agreed to participate in the study, and signed an informed consent form and agrees to remain in study area for period of study and willing to comply with other protocol requirements.
- Subject of stable health as determined by investigator based on medical history, physical examination and laboratory examination at screening.
- Body temperature is between 95.6 to 99.0 ºF.
- Body mass index (BMI) at 18.0 to 35.0 kg/m2 (inclusive).
- Willing to allow storage and future use of biological samples for future research 7.
- Male and Female subjects of childbearing potential must be using adequate birth control measures, as discussed with the study doctor and should agree to continue such precautions for 6 months after receiving the last injection of study medication.
- Menopausal females must have experienced their last period more than 12 months prior to study entry to be classified as not of childbearing potential.
- Note-Female subjects of child bearing potential must agree to use adequate contraception during the study and continue at least six months after the vaccine dose of study.
- For this study, acceptable and effective methods of contraception for females include: • Intrauterine device placed at least 3 months prior to the start of the study and remaining in place during the study period, • Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide plus a male or female condom) or • Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner).
- For males, adequate birth control methods suggested and defined as double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel.
- History of any of the following: a.
- Any product (investigational or off-label or which is approved by regulatory authority) for prevention of COVID-19 disease within 6 months prior to enrolment.
- History of receipt of any COVID Vaccine as a booster dose c.
- Receipt of any licensed vaccine within 28 days before enrolment in study or planned administration of any vaccine for until 28 days after study vaccination.
- Individuals who report any medical condition as determined by investigator / clinician is not suitable to receive protein based subunit COVID -19 vaccines.
- Seropositive for HIV 1 and 2, HBsAg and HCV.
- Have a history of severe allergies such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis (Arthus reaction to any component of the research vaccine i.e. RLS Protein Subunit Vaccine against SARS-CoV-2 Virus (RelCoVax®) or Corbevax® or aluminium preparation.
- Subjects with any previous history of serious side effects of vaccines or drugs or history of allergic disease or reactions likely to be exacerbated by any component of the vaccines in study will also be excluded 5.
- Those with a history of confirmed SARS COVID-19 infection or current COVID-19 infection meeting any of the following: ➢ History of confirmed SARS-CoV 2 infection (Symptomatic or asymptomatic disease) in prior 6 months of enrollment as established by confirmed RTPCR test.
- ➢ RTPCR test which is positive within 72 hours prior to enrollment.
- Have taken antipyretics or analgesics within 24 hours before the study enrollment or planned use of any investigational or non-registered product other than study vaccine during study period including three months prior to enrollment.
- Current use or past history of alcohol abuse or consumption of drug of abuse.
- Long term use (> 2 weeks) of oral or parenteral steroids (glucocorticoids) or high dose inhaled steroids (> 800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months.
- (Inhaled and topical steroids are allowed).
- Any confirmed or suspected immunosuppressive or immunodeficient condition, due to underlying illness or treatment with immunosuppressive or cytotoxic or anticancer chemotherapy or radiation therapy within preceding 36 months.
- Any medical condition that in the judgment of the investigator would make study participation unsafe and / or can interfere with assessment or vaccine response.
- Acute or chronic, uncontrolled and / or clinically significant systemic disorders such as cardiovascular, gastrointestinal, respiratory, neurologic, hepatic, renal, endocrine, hematological, psychiatric or immunological disorders.
- Have received blood or blood-related products, including immunoglobulin within 3 months prior to enrollment; or plan to use it during the study.
- Lactating women or pregnant women (as determined by serum beta HCG).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate & compare the immunogenicity of single heterologous booster dose of RLS Protein Subunit Vaccine against SARS-CoV-2 Virus i.e. RelCoVax® & single heterologous booster dose of reference Protein Subunit Vaccine (Biological E Ltd.’s Corbevax®) after administration in subjects who have completed primary vaccination. From Day 0, Day 28, Day 56, Day 90
- Secondary Outcome Measures
Name Time Method To evaluate the safety & tolerability & additional immunogenicity of single heterologous booster dose of RLS Protein Subunit Vaccine against SARS-CoV-2 Virus i.e. RelCoVax® and single heterologous booster dose of reference Protein Subunit Vaccine (Biological E Ltd.’s Corbevax®) after administration in subjects who have completed primary vaccination From Day 0, Day 28, Day 56, Day 90
Trial Locations
- Locations (18)
D.Y.Patil Medical College
🇮🇳Thane, MAHARASHTRA, India
Grant Government Medical College and Sir J.J. Group of Hospitals
🇮🇳Mumbai, MAHARASHTRA, India
Ashirwad Hospital and research Centre
🇮🇳Thane, MAHARASHTRA, India
Bhrati Vidyapeeth (Deemed to be University) Medical College and Hospital
🇮🇳Pune, MAHARASHTRA, India
Chopda Medicare & Research Center Pvt. Ltd: Magnum Heart Institude,
🇮🇳Nashik, MAHARASHTRA, India
CIMETS Inamdar Multispeciality Hospital
🇮🇳Pune, MAHARASHTRA, India
Dr. D.y Patil Medical college and hospital and Research centre
🇮🇳Pune, MAHARASHTRA, India
HBT Trauma Care hospital
🇮🇳(Suburban), MAHARASHTRA, India
IPGME&R and SSKM Hospital
🇮🇳Kolkata, WEST BENGAL, India
KEM Hospital Research Center Vadhu Budruk
🇮🇳Pune, MAHARASHTRA, India
Scroll for more (8 remaining)D.Y.Patil Medical College🇮🇳Thane, MAHARASHTRA, IndiaDr Deepakkumar LangadePrincipal investigator9930550009deepak.langade@dypatil.edu