THEMBA II T-CELL Vaccine: A Phase 1/2 Study of the Safety, Reactogenicity, and Immunogenicity of Vaccination With saRNA COVID-19 Vaccines
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Phase 1 Safety - Incidence of MAAEs Through 1 Week
研究概览
简要总结
This is a phase 1/2 open-label study assessing the safety, reactogenicity, and immunogenicity of saRNA COVID-19 boost vaccines in participants that have been previously vaccinated against or previously infected with COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults ≥ 18 years of age at time of enrollment.
- •Vaccinated with an EUA or approved vaccine against COVID-19 ≥ 3 months prior to enrollment on study or infection with COVID-19 ≥ 3 months prior to enrollment on study.
- •Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
- •Agrees to the collection of biospecimens (eg, nasopharyngeal [NP] swabs) and venous blood per protocol.
- •Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
- •Temperature < 38°C.
- •Agreement to practice effective contraception for female participants of childbearing potential and non-sterile males. Female participants of childbearing potential must agree to use effective contraception while on study until at least 1 month after the last dose of vaccine. Non-sterile male participants must agree to use a condom while on study until at least 1 month after the last dose of vaccine. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm), intrauterine devices (IUDs), oral contraceptives, injectable contraceptives, patches, implants and abstinence.
- •HIV-positive participants must have been on anti-retroviral therapy for ≥ 4 weeks and have HIV-1 viral load < 1,000 copies/mL at the time of enrollment.
排除标准
- •Serious adverse reaction to any vaccine, any unrelated medication or any component of the investigational vaccine, including a history of anaphylaxis and symptoms of a severe allergic reaction and history of allergies in the past.
- •Confirmed current COVID-19, previous SARS-CoV-2 infection in the last < 3 months, or PCR positive for SARS-CoV-2 at screening.
- •Vaccinated with an EAU-approved vaccine against COVID-19 in the last < 3 months.
- •Pregnant or breastfeeding women.
- •Chronic lung disease (included COPD) as evidenced by one or more exacerbations requiring a course of steroids in the last year, or the requiring chronic low dose oral steroids to prevent exacerbations. Uncontrolled asthma, defined as requiring reliever inhaler (short-acting beta agonist or ipratromium bromide) more than twice a week is also excluded.
- •Bone marrow or organ transplant recipient
- •Extreme obesity (defined as BMI of 40 kg/m2 or higher).
- •Chronic kidney disease requiring dialysis.
- •History of liver disease.
- •Any disease associated with acute fever, or any infection.
- •Participants with acquired or hereditary immunodeficiencies other than well-controlled HIV are excluded from enrollment.
- •Current diagnosis of active tuberculosis.
- •History of hereditary, idiopathic or acquired angioedema.
- •No spleen or functional asplenia.
- •Chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness including, but not limited to, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, or immunomodulators. The use of low dose topical, ophthalmic, inhaled and intranasal steroid preparations will be permitted.
- •According to the judgement of the investigator any medical, psychiatric, psychological, social, occupational or other conditions that could affect the participants ability to sign informed consent, provide safety assessment data or comply with the requirements of the study protocol.
- •Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
研究组 & 干预措施
Phase 1 Cohort 1A
AAHI-SC2 on Day 1 at dosage 25 μg IM
干预措施: AAHI-SC2 Vaccine (Biological)
Phase 1 Cohort 1B
AAHI-SC2 on Day 1 at dosage 50 μg IM
干预措施: AAHI-SC2 Vaccine (Biological)
Phase 1 Cohort 1C
AAHI-SC2 on Day 1 at dosage 70 μg IM
干预措施: AAHI-SC2 Vaccine (Biological)
Phase 1 Cohort 2A
AAHI-SC3 on Day 1 at dosage 25 μg IM
干预措施: AAHI-SC3 Vaccine (Biological)
Phase 1 Cohort 2B
AAHI-SC3 on Day 1 at dosage 50 μg IM
干预措施: AAHI-SC3 Vaccine (Biological)
Phase 1 Cohort 2C
AAHI-SC3 on Day 1 at dosage 85 μg IM
干预措施: AAHI-SC3 Vaccine (Biological)
Phase 2 Control arm
EUA or approved vaccine on Day 1
干预措施: EUA or approved vaccine (Biological)
Phase 2 Experimental arm 1
AAHI-SC2 on Day 1 Dose TBD as determined in phase 1 study
干预措施: AAHI-SC2 Vaccine (Biological)
Phase 2 Experimental arm 2
AAHI-SC3 on Day 1 Dose TBD as determined in phase 1 study
干预措施: AAHI-SC3 Vaccine (Biological)
Phase 2 Experimental arm 3
AAHI-SC3 on Day 1 and 29 Dose TBD as determined in phase 1 study
干预措施: AAHI-SC3 Vaccine (Biological)
结局指标
主要结局
Phase 1 Safety - Incidence of MAAEs Through 1 Week
时间窗: through 1 week post final vaccine administration
Incidence of medically-attended adverse events (MAAEs)
Phase 1 Safety - Incidence of Unsolicited AEs Through 30 Days
时间窗: through 30 days post final vaccine administration
Incidence and severity of unsolicited AEs
Phase 1 Safety - Incidence of SAEs Through 1 Week
时间窗: through 1 week post final vaccine administration
Incidence of serious adverse events (SAEs)
Phase 1 Safety - Incidence of SAEs Through 30 Days
时间窗: through 30 days post final vaccine administration
Incidence of SAEs
Phase 1 Safety - Incidence of Solicited Local Reactogenicity AEs
时间窗: through 1 week after each vaccine dose
Incidence and severity of solicited local reactogenicity AEs
Phase 1 Safety - Incidence of Solicited Systemic Reactogenicity AEs
时间窗: through 1 week after each vaccine dose
Incidence and severity of solicited systemic reactogenicity AEs
Phase 1 Safety - Incidence of Unsolicited AEs Through 1 Week
时间窗: through 1 week post final vaccine administration
Incidence and severity of unsolicited AEs
Phase 1 Safety - Incidence of SAEs Through 6 Months
时间窗: through 6 months post final vaccine administration
Incidence of SAEs
Phase 1 Safety - Incidence of MAAEs Through 30 Days
时间窗: through 30 days post final vaccine administration
Incidence of MAAEs
Phase 1 Safety - Incidence of MAAEs Through 6 Months
时间窗: through 6 months post final vaccine administration
Incidence of MAAEs
次要结局
未报告次要终点