"First-in-human, Phase 1, Double-blind, Randomized, Placebo-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of the Vivaxin Vaccine for Malaria Caused by Plasmodium Vivax."
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Safety and reactogenicity of adverse events (AE) in the first 14 days
研究概览
简要总结
Phase 1 clinical trial to evaluate the safety, reactogenicity, and immunogenicity of a malaria vaccine named Vivaxin against the protozoan Plamodium vivax in participants with no prior malaria infection
详细描述
Vivaxin is being developed for use as a prophylactic vaccine against malaria caused by Plasmodium vivax, the dominant species in Brazil.
The study will consist of the assessment of the safety, reactogenicity, and immunogenicity of the vaccine following intramuscular administration of three doses of 0.3 mL/dose, with a 28-day interval between each dose, in healthy participants of both sexes, aged 18 to 59 years, with no prior exposure to malaria.
This will be a Phase 1, first-in-human, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety and immunogenicity of the investigational product, Vivaxin vaccine.
A total of 16 participants will be included in each of the 3 study arms, based on Vivaxin dose levels: 25 µg, 50 µg, and 100 µg. In each arm, 12 participants will receive the Vivaxin vaccine, and 4 participants will receive a placebo. Additionally, a sentinel cohort will be included within each arm:
Arm 1 - 25 µg of Vivaxin (N=12) or placebo (N=4):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-pregnant women and men aged between 18 and 59 years;
- •Willingness to participate in the study and undergo all study procedures, as demonstrated by signing the informed consent form (ICF);
- •In good general health, as determined by medical examination;
- •Women of childbearing potential must agree to use an acceptable* contraceptive method for at least 30 days prior to the first vaccination and for at least 6 months following administration of the first dose of the investigational product, ensuring at least 3 months after the final vaccine dose have elapsed;
- •Agreement not to donate blood during the course of study participation.
- •Acceptable contraceptive methods:
- •Barrier methods, including condom or cervical cap;
- •Surgically sterile partner/participant (including those who have undergone vasectomy, hysterectomy, bilateral oophorectomy, and/or tubal ligation) who is the sole sexual partner;
- •Intrauterine device (with or without hormones);
- •Hormonal birth control methods (oral, topical, injectable, or implantable);
- •True sexual abstinence that is consistent with the participant's preferred and usual lifestyle.
- •Note: Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) or withdrawal (coitus interruptus) will not be considered acceptable methods.
排除标准
- •Prior history of malaria infection confirmed by serological testing;
- •Prior history of malaria vaccination;
- •Intention to travel to a malaria-endemic area during the study period;
- •Pregnant or breastfeeding women, or those intending to become pregnant or breastfeed within the first 6 months of the study;
- •Evidence of clinically active disease, such as but not limited to: neurological, renal, cardiovascular, endocrine, pulmonary, hepatic, hematological, immunological, neoplastic, or infectious diseases;
- •Use of concomitant medication for control of an underlying medical condition;
- •Positive serological test for HBV, HCV, or HIV;
- •Any condition that, in the opinion of the study investigator, could pose a risk to the participant or confound the study results, including clinically stable chronic conditions such as diabetes, hypertension, or neuralgias, among others;
- •Psychiatric illness or cognitive impairment that, in the opinion of the investigator, may affect the participant's ability to comply with the clinical study schedule;
- •History of alcohol or substance abuse within 12 months prior to enrollment that resulted in family, medical, or occupational problems;
- •History of severe allergic reaction or anaphylaxis to any component of the vaccine;
- •History of asplenia;
- •Participation in any other investigational clinical trial within 12 months prior to inclusion in this study;
- •Plans to participate in other clinical trials concurrently with this study;
- •Use of any immunosuppressive therapy within 3 months prior to enrollment or plans to use such therapy within 3 months after vaccination, including corticosteroids or other immunosuppressive drugs. An immunosuppressive dose of corticosteroid is defined as the equivalent of 20 mg/day of prednisone for more than one week. Topical or nasal corticosteroids are not considered immunosuppressive;
- •Use of blood products (including blood or immunoglobulins) within 3 months prior to enrollment in this study, or plans to use them during the study period;
- •Suspected or confirmed fever (axillary temperature ≥ 37.8 °C) within 72 hours prior to study enrollment. Enrollment should be postponed until the participant has been afebrile for at least 72 hours;
- •Receipt of any live attenuated or inactivated vaccine within 28 or 14 days, respectively, prior to administration of the investigational product, or plans for immunization within 28 days after enrollment in the study.
研究组 & 干预措施
Arm 1 - 25 µg of Vivaxin
Twelve healthy participants of both sexes, aged 18 to 59 years, with no prior exposure to malaria will receive three doses of 25 µg of Vivaxin, with 28-day intervals between doses.
干预措施: Vivaxin vaccine manufactured by CT Vacinas/Cristália Laboratory (Biological)
Arm 2 - 50 µg of Vivaxin
Twelve healthy participants of both sexes, aged 18 to 59 years, with no prior exposure to malaria will receive three doses of 50 µg of Vivaxin, with 28-day intervals between doses.
干预措施: Vivaxin vaccine manufactured by CT Vacinas/Cristália Laboratory (Biological)
Arm 3 - 100 µg of Vivaxin
Twelve healthy participants of both sexes, aged 18 to 59 years, with no prior exposure to malaria will receive three doses of 100 µg of Vivaxin, with 28-day intervals between doses.
干预措施: Vivaxin vaccine manufactured by CT Vacinas/Cristália Laboratory (Biological)
Placebo
Four healthy participants of both sexes, aged 18 to 59 years, with no prior exposure to malaria will receive three doses of placebo, with 28-day intervals between doses.
干预措施: Placebo (Other)
结局指标
主要结局
Safety and reactogenicity of adverse events (AE) in the first 14 days
时间窗: Day 14 after each immunization
Frequency and intensity of solicited AEs with a possible causal relationship or higher up to 14 days after intramuscular administration of Vivaxin vaccine.
Safety and reactogenicity of EA in the first 28 days
时间窗: Day 28 after each immunization
Frequency and intensity of unsolicited AEs with a possible causal relationship or higher up to 28 days after intramuscular administration of Vivaxin vaccine.
Safety and reactogenicity of serious AEs (SAEs) and AEs of special interest (AESI) throughout the study duration
时间窗: through study completion, an average of 18 months
Frequency and intensity of SAEs and AESIs throughout the study duration after intramuscular administration of Vivaxin vaccine.
Dose selection
时间窗: Day 28 after the third dose of the vaccine of all participants
Selection of a safe and immunogenic dose of Vivaxin to continue clinical development.
次要结局
- Levels of IgG antibodies(Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 120, 180, 270 and 360 after immunization)
研究者
Helton da Costa Santiago
Study Director
Federal University of Minas Gerais