CTRI/2023/09/057398已完成2 期
Prospective, multi-center, randomized, open label, active control, phase 2 clinical study to evaluate immunogenicity, safety and tolerability of single heterologous booster dose of RelCoVax® (Protein Subunit Vaccine of Reliance Life Sciences against SARS-CoV-2 Virus) with Corbevax® (Protein Subunit Vaccine of Biological E Ltd. against SARS-CoV-2 Virus) - NA
Reliance Life Sciences Pvt Ltd RLS0 个研究点目标入组 200 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. 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. 2. Age is =18 years to = 80 years. 3. 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. 4. Body temperature is between 95.6 to 99.0 ºF. 5. Body mass index (BMI) at 18.0 to 35.0 kg/m2 (inclusive). 6. 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
排除标准
- •1. 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. b. 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. 2. Individuals who report any medical condition as determined by investigator / clinician is not suitable to receive protein based subunit COVID -19 vaccines. 3. Seropositive for HIV 1 and 2, HBsAg and HCV. 4. 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. 6. 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. 7. Current use or past history of alcohol abuse or consumption of drug of abuse. 8. 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). 9. 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. 10. Acute or chronic, uncontrolled and / or clinically significant systemic disorders such as cardiovascular, gastrointestinal, respiratory, neurologic, hepatic, renal, endocrine, hematological, psychiatric or immunological disorders. 11. Have received blood or blood-related products, including immunoglobulin within 3 months prior to enrollment; or plan to use it during the study. 12. Lactating women or pregnant women (as determined by serum beta HCG).
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