A Phase III, Open Label, Single Arm, Multi-centre, Trial to Assess the Safety and Immunogenicity of a Booster Vaccination With a Recombinant Protein RBD Fusion Heterodimer Candidate (PHH-1V) Against SARS-CoV-2, in Adults Vaccinated Against COVID-19.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,646
- 试验地点
- 36
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)
研究概览
简要总结
This is a phase III clinical study to assess the safety, tolerability and immunogenicity of PHH-1V as a booster dose in healthy adult subjects vaccinated against COVID-19 with the Comirnaty, Spikevax, Vaxevria or Janssen vaccine.
详细描述
This is a phase III clinical study to assess the safety, tolerability and immunogenicity of PHH-1V as a booster dose in healthy adults vaccinated against COVID-19 with the Comirnaty, Spikevax, Vaxevria or Janssen vaccine at least 91 days before day 0. All the participants will receive a booster dose of the HIPRA's COVID-19 Vaccine and will be followed for 26 weeks or 52 weeks if they participate in the safety cohort, or the immunogenicity cohort, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, ≥ 16 years old at Day
- •Willing to provide consent indicating that she or he understands the purpose and potential risks and is willing and able to participate in the study and comply with all the study requirements and procedures.
- •Have a recognized primary vaccination scheme recognized by the authorities with Comirnaty, Spikevax, Vaxevria or Janssen at least 91 days and preferably a maximum of 240 days before Day
- •If having an underlying illnesses must be stable and well-controlled according to the investigator judgment.
- •Participant is willing to avoid receiving live attenuated vaccines (licensed) within 4 weeks before screening or after receiving any study vaccine, or other not live vaccines (licensed) within 14 days before and after receiving any study vaccine.
- •Participant agrees not to donate blood, blood products and bone marrow at least 3 months before and after vaccination.
- •Female participant of childbearing potential must have a negative pregnancy test on the on Day 0 prior to vaccination.
- •Female participant of childbearing potential must use any acceptable contraceptive method that should be started on day 0 and until 8 weeks after vaccination (hormonal contraception: oral, injectable or transdermal patch, intrauterine device, vasectomized partner, sexual abstinence or condom).
- •Male participants must use any acceptable contraceptive method that should be started on day 0 and until 8 weeks after vaccination (vasectomized participants, condom, sexual abstinence).
- •Male participants must refrain from donating sperm for at least 28 days after day 0.
排除标准
- •History of anaphylaxis to any prior vaccine.
- •Previous severe SARS-CoV-2 infections that required >24 hous of hospitalisation.
- •Participant received or plans to receive live attenuated vaccines within 4 weeks before and after day 0; or other not live vaccines within 14 days before and after day
- •Pregnancy or breast-feeding at screening or Day 0 or willingness/intention to become pregnant during the study.
- •Having a clinically significant acute illness or fever (temperature ≥38º C (100.4ºF)) at screening or within 48 hours prior to Day
- •Participant had a surgery requiring hospitalization before vaccination and he/she has not received the hospital discharge at day 0; or has a surgery requiring hospitalization planned within 12 weeks after study vaccine administration.
- •Having any active malignancy even if under treatment except for non-melanoma skin cancer, uterine cervical carcinoma, anal carcinoma, localized prostate cancer.
- •Having ongoing severe and non-stable psychiatric condition likely to affect participation in the study.
- •Having problematic or risk use of substances including alcohol that can compromise the study follow-up.
- •Having a bleeding disorder or has any condition that in the opinion of the investigator contraindicates intramuscular injections.
- •Having abnormal function of the immune system, except stable clinical conditions like controlled HIV.
- •Having clinically significant and unstable cardiovascular, respiratory, hepatic, neurological, gastrointestinal, renal, or any other medical disorder judged by the investigator within 3 months before screening.
- •Chronic or recurrent administration of systemic immunosuppressant medication.
- •Having received immunoglobulins and/or blood-derived products 12 weeks prior vaccination (Day 0) or expects to receive them during the study.
- •Having received any immunotherapy (monoclonal antibodies, plasma) aimed to prevent or treat COVID-19 within 90 days before day
- •Participation in any research involving an investigational product (drug, biologic, device) within 12 weeks prior to vaccination and during the study.
- •Participant has donated ≥ 450ml of blood products within 12 weeks before screening.
- •Participant has any medical condition and/or finding that in the investigator opinion might increase participant risks, interfere with the study or impair interpretation of study data.
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)
时间窗: Day 7
Number, percentage, and characteristics of solicited local and systemic reactions through Day 7 after vaccination.
Incidence of Serious Adverse Events (Safety and tolerability) (SAE)
时间窗: Day 365
Number and percentage of serious adverse events (SAEs) through the end of the study.
Incidence of Special Interest Adverse Events (Safety and tolerability) (AESI).
时间窗: Day 365
Number and percentage of adverse event of special interest (AESI) through the end of the study.
Incidence of Adverse Events in laboratory parameters (Safety and tolerability)
时间窗: Day 365
Grade 3 and 4 changes from baseline in safety laboratory parameters at Days 14, 91 and 182 after vaccination. through the end of the study.
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) (AEs)
时间窗: Day 28
Number, percentage, and characteristics of unsolicited local and systemic adverse events (AEs) through Day 28 after vaccination
Incidence of Medically Attended Adverse Events (Safety and tolerability) (MAAEs)
时间窗: Day 365
Number and percentage of medically attended adverse events (MAAE) related to study vaccine through the end of the study.
次要结局
- Changes in the immunogenicity measured by means of total antibody against RBD.(Day 14)
- Changes in the immunogenicity measured by pseudovirus neutralisation(Day 14)
- Changes in the immunogenicity measured by means of total antibody against RBD(Day 14)