Status:
NOT_YET_RECRUITING
Clinical Trial to Evaluate the Safety and Immunogenicity of the Vivaxin Vaccine for Malaria Caused by Plasmodium Vivax."
Lead Sponsor:
Federal University of Minas Gerais
Collaborating Sponsors:
University of Sao Paulo
Financiadora de Estudos e Projetos
Conditions:
Malaria Vivax
Eligibility:
All Genders
18-59 years
Phase:
PHASE1
Brief Summary
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 infecti...
Detailed Description
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, reacto...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT07172724
Start Date
September 1 2025
End Date
June 1 2027
Last Update
September 15 2025
Active Locations (1)
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1
Centro de Pesquisas Clínicas (CPC) do Hospital das Clínicas (HC) da UFMG/ Filial Ebserh
Belo Horizonte, Minas Gerais, Brazil, 30130-100