Malaria VivaxPhase 1Vivaxin-001NCT07172724
Clinical Trial to Evaluate the Safety and Immunogenicity of the Vivaxin Vaccine for Malaria Caused by Plasmodium Vivax."
A Phase 1 study testing Vivaxin vaccine manufactured by CT Vacinas/Cristália Laboratory in people with Malaria Vivax, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial 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 infection Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria Vivax
- What is being tested?
- Vivaxin vaccine manufactured by CT Vacinas/Cristália Laboratory
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2025to Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Centro de Pesquisas Clínicas (CPC) do Hospital das Clínicas (HC) da UFMG/ Filial Ebserh
Belo Horizonte, Minas Gerais, 30130-100
Mariana A Faria Lima, MD, MSc, +55 31 99292-0207, mariana.antunes@ebserh.gov.br
About this study
Official title: "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."
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
Read the 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, 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):
Twelve participants will receive three doses of 25 µg of Vivaxin, with 28-day intervals between doses, and four participants will receive three doses of placebo, also at 28-day intervals. The first four individuals enrolled will comprise the sentinel group. Three of these will receive Vivaxin and one will receive placebo, randomized in a blinded manner. They will be observed for at least 7 days prior to proceeding with vaccination of the remaining participants in this arm. Vaccination of the remaining participants will proceed only after confirming that no study-halting criteria have been met.
Arm 2 - 50 µg of Vivaxin (N=12) or placebo (N=4):
Twelve participants will receive three doses of 50 µg of Vivaxin, with 28-day intervals, and four participants will receive placebo under the same schedule. The first four individuals enrolled will comprise the sentinel group (three receiving Vivaxin, one receiving placebo). They will be observed for at least 7 days before vaccination continues in this arm. Continuation is contingent upon confirmation that no halting criteria have been met.
Arm 3 - 100 µg of Vivaxin (N=12) or placebo (N=4):
Twelve participants will receive three doses of 100 µg of Vivaxin, spaced 28 days apart, and four participants will receive placebo at the same intervals. As with the other arms, the first four individuals enrolled will form the sentinel group and will be observed for at least 7 days before vaccination of the remaining participants in the arm is permitted, conditional on the absence of any study-halting criteria.
All participants in the sentinel cohorts will be observed at the research center for 60 minutes post-vaccination (vaccine or placebo). All other participants will be observed for a minimum of 30 minutes. All participants will be followed for 360 days with regular clinical assessments, including:
Telephone follow-ups on Days 1 and 3 (post-first dose), Days 29 and 31 (1 and 3 days post-second dose), Days 57 and 59 (1 and 3 days post-third dose), and monthly thereafter until study completion;
In-person visits on Days 7 and 14 (1 and 2 weeks post-first dose), Day 28 (second dose), Days 35 and 42 (1 and 2 weeks post-second dose), Day 56 (third dose), Days 63 and 70 (1 and 2 weeks post-third dose), and Days 84, 120, 180, 270, and 360 post-vaccination (end of study).
Participants will be sequentially enrolled and allocated to Arms 1, 2, and 3 of the study, receiving 25 µg, 50 µg, and 100 µg of the investigational product, respectively. In each arm, 12 participants will receive the Vivaxin vaccine and 4 participants will receive placebo, totaling 16 participants per arm.
The first four randomized individuals in each arm will comprise the sentinel group and will be observed for at least 7 days prior to continuation of vaccination in that arm. Adverse events (AEs) from each sentinel cohort will be reviewed by the Protocol and Safety Review Team (PSRT) within 7 days following vaccination. If no halting criteria are met, vaccination of the remaining participants in the arm will proceed.
After the first 14 days of follow-up of all participants in Arm 1, a blinded safety review will be conducted by the PSRT to determine whether dose escalation may proceed. If no halting criteria are observed, the PSRT will recommend study continuation. Should any halting criteria be met or any PSRT member deem it necessary, a meeting with the Independent Data and Safety Monitoring Committee (DSMC) will be convened. The DSMC, upon review of the safety data, may recommend continuation as planned, propose protocol modifications, or advise study suspension. This procedure will be repeated at each dose escalation stage.
If the PSRT recommends proceeding, participants in Arm 2 (50 µg) will be vaccinated, beginning with the sentinel cohort of four individuals who will be observed for 7 days before continued randomization in the arm. Meanwhile, Arm 1 may continue with second and third immunizations, observing the sentinel group of each dose for 7 days prior to proceeding with full-arm administration.
Upon completion of the first 14 days of follow-up in Arm 2, a safety analysis will be conducted by the PSRT to determine whether escalation to Arm 3 may proceed. As with the previous arms, the first four individuals in Arm 3 will form the sentinel group and will be observed for 7 days prior to continued vaccination in that arm.
- Conditions
- Malaria Vivax
- Being tested
- Vivaxin vaccine manufactured by CT Vacinas/Cristália Laboratory, Placebo
- Keywords
- vaccine, malaria, Plasmodium vivax, prevention, malaria vivax
- Medical subject headings
- Malaria, Vivax, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivaxin vaccine manufactured by CT Vacinas/Cristália LaboratoryBiological
lyophilized antigen for reconstitution with the adjuvant CTVad (a squalene-based nanoemulsion), at the time of use.
PlaceboOther
adjuvant CTVad (a squalene-based nanoemulsion)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - 25 µg of Vivaxin | Experimental | 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. Receives: Biological: Vivaxin vaccine manufactured by CT Vacinas/Cristália Laboratory |
| Arm 2 - 50 µg of Vivaxin | Experimental | 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. Receives: Biological: Vivaxin vaccine manufactured by CT Vacinas/Cristália Laboratory |
| Arm 3 - 100 µg of Vivaxin | Experimental | 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. Receives: Biological: Vivaxin vaccine manufactured by CT Vacinas/Cristália Laboratory |
| Placebo | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and reactogenicity of adverse events (AE) in the first 14 days
Frequency and intensity of solicited AEs with a possible causal relationship or higher up to 14 days after intramuscular administration of Vivaxin vaccine.
Measured: Day 14 after each immunization
Safety and reactogenicity of EA in the first 28 days
Frequency and intensity of unsolicited AEs with a possible causal relationship or higher up to 28 days after intramuscular administration of Vivaxin vaccine.
Measured: Day 28 after each immunization
Safety and reactogenicity of serious AEs (SAEs) and AEs of special interest (AESI) throughout the study duration
Frequency and intensity of SAEs and AESIs throughout the study duration after intramuscular administration of Vivaxin vaccine.
Measured: through study completion, an average of 18 months
Dose selection
Selection of a safe and immunogenic dose of Vivaxin to continue clinical development.
Measured: Day 28 after the third dose of the vaccine of all participants
Secondary outcomes (1)
Levels of IgG antibodies
Mean levels of IgG antibodies, calculated by the geometric mean of the titers against vaccine and parasitic antigens on days 7, 14, 28, 35, 42, 56, 63, 70, 84, 120, 180, 270 and 360 in relation to time 0 and placebo, by ELISA.
Measured: Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 120, 180, 270 and 360 after immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria VivaxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo, Financiadora de Estudos e Projetos, Fundação de Amparo à Pesquisa do Estado de São Paulo, INCTV National Institute of Vaccine Science and Technology, The Ministry of Science, Technology and Innovation, Brazil, CT Vacinas - Centro de Tecnologia em Vacinas/Universidade Federal de Minas Gerais
- Responsible party
- Principal investigator, Helton da Costa Santiago, Federal University of Minas Gerais
- Investigators
- Ricardo T Gazzinelli, DVM, PhD, Study chair, Vaccine Technology Center (CT Vacinas)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172724
- Sponsor's protocol ID
- Vivaxin-001
- Other IDs
- U1111-1321-7560, 89852825.0.0000.0444, 7.783.109
- Acronym
- Vivaxin-001
- Status last verified
- Sep 2025
- First submitted
- 19 Aug 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are currently assessing the feasibility of sharing IPD, considering ethical, legal, and institutional requirements. A final decision has not yet been made.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "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."
- ClinicalTrials.gov ID
- NCT07172724
- Acronym / sponsor ID
- Vivaxin-001 / Vivaxin-001
- Conditions
- Malaria Vivax
- Keywords
- vaccine, malaria, Plasmodium vivax, prevention, malaria vivax
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- University of Sao Paulo, Financiadora de Estudos e Projetos, Fundação de Amparo à Pesquisa do Estado de São Paulo, INCTV National Institute of Vaccine Science and Technology, The Ministry of Science, Technology and Innovation, Brazil, CT Vacinas - Centro de Tecnologia em Vacinas/Universidade Federal de Minas Gerais
- Study start
- Sep 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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, 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):
Twelve participants will receive three doses of 25 µg of Vivaxin, with 28-day intervals between doses, and four participants will receive three doses of placebo, also at 28-day intervals. The first four individuals enrolled will comprise the sentinel group. Three of these will receive Vivaxin and one will receive placebo, randomized in a blinded manner. They will be observed for at least 7 days prior to proceeding with vaccination of the remaining participants in this arm. Vaccination of the remaining participants will proceed only after confirming that no study-halting criteria have been met.
Arm 2 - 50 µg of Vivaxin (N=12) or placebo (N=4):
Twelve participants will receive three doses of 50 µg of Vivaxin, with 28-day intervals, and four participants will receive placebo under the same schedule. The first four individuals enrolled will comprise the sentinel group (three receiving Vivaxin, one receiving placebo). They will be observed for at least 7 days before vaccination continues in this arm. Continuation is contingent upon confirmation that no halting criteria have been met.
Arm 3 - 100 µg of Vivaxin (N=12) or placebo (N=4):
Twelve participants will receive three doses of 100 µg of Vivaxin, spaced 28 days apart, and four participants will receive placebo at the same intervals. As with the other arms, the first four individuals enrolled will form the sentinel group and will be observed for at least 7 days before vaccination of the remaining participants in the arm is permitted, conditional on the absence of any study-halting criteria.
All participants in the sentinel cohorts will be observed at the research center for 60 minutes post-vaccination (vaccine or placebo). All other participants will be observed for a minimum of 30 minutes. All participants will be followed for 360 days with regular clinical assessments, including:
Telephone follow-ups on Days 1 and 3 (post-first dose), Days 29 and 31 (1 and 3 days post-second dose), Days 57 and 59 (1 and 3 days post-third dose), and monthly thereafter until study completion;
In-person visits on Days 7 and 14 (1 and 2 weeks post-first dose), Day 28 (second dose), Days 35 and 42 (1 and 2 weeks post-second dose), Day 56 (third dose), Days 63 and 70 (1 and 2 weeks post-third dose), and Days 84, 120, 180, 270, and 360 post-vaccination (end of study).
Participants will be sequentially enrolled and allocated to Arms 1, 2, and 3 of the study, receiving 25 µg, 50 µg, and 100 µg of the investigational product, respectively. In each arm, 12 participants will receive the Vivaxin vaccine and 4 participants will receive placebo, totaling 16 participants per arm.
The first four randomized individuals in each arm will comprise the sentinel group and will be observed for at least 7 days prior to continuation of vaccination in that arm. Adverse events (AEs) from each sentinel cohort will be reviewed by the Protocol and Safety Review Team (PSRT) within 7 days following vaccination. If no halting criteria are met, vaccination of the remaining participants in the arm will proceed.
After the first 14 days of follow-up of all participants in Arm 1, a blinded safety review will be conducted by the PSRT to determine whether dose escalation may proceed. If no halting criteria are observed, the PSRT will recommend study continuation. Should any halting criteria be met or any PSRT member deem it necessary, a meeting with the Independent Data and Safety Monitoring Committee (DSMC) will be convened. The DSMC, upon review of the safety data, may recommend continuation as planned, propose protocol modifications, or advise study suspension. This procedure will be repeated at each dose escalation stage.
If the PSRT recommends proceeding, participants in Arm 2 (50 µg) will be vaccinated, beginning with the sentinel cohort of four individuals who will be observed for 7 days before continued randomization in the arm. Meanwhile, Arm 1 may continue with second and third immunizations, observing the sentinel group of each dose for 7 days prior to proceeding with full-arm administration.
Upon completion of the first 14 days of follow-up in Arm 2, a safety analysis will be conducted by the PSRT to determine whether escalation to Arm 3 may proceed. As with the previous arms, the first four individuals in Arm 3 will form the sentinel group and will be observed for 7 days prior to continued vaccination in that arm.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - 25 µg of Vivaxin | Experimental | Biological: Vivaxin vaccine manufactured by CT Vacinas/Cristália LaboratoryTwelve 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. |
| Arm 2 - 50 µg of Vivaxin | Experimental | Biological: Vivaxin vaccine manufactured by CT Vacinas/Cristália LaboratoryTwelve 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. |
| Arm 3 - 100 µg of Vivaxin | Experimental | Biological: Vivaxin vaccine manufactured by CT Vacinas/Cristália LaboratoryTwelve 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. |
| Placebo | Placebo comparator | Other: PlaceboFour 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vivaxin vaccine manufactured by CT Vacinas/Cristália Laboratorylyophilized antigen for reconstitution with the adjuvant CTVad (a squalene-based nanoemulsion), at the time of use. | Biological | Arm 1 - 25 µg of Vivaxin, Arm 2 - 50 µg of Vivaxin, Arm 3 - 100 µg of Vivaxin |
| Placeboadjuvant CTVad (a squalene-based nanoemulsion) | Other | Placebo |
Primary outcome
Safety and reactogenicity of adverse events (AE) in the first 14 days
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Levels of IgG antibodies
Time frame: Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 120, 180, 270 and 360 after immunization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- World Malaria Report 2024Link provided by the sponsor.
- Malaria Day in the Americas - an overview of malaria in Brazil in 2022 and the first half of 2023Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. We are currently assessing the feasibility of sharing IPD, considering ethical, legal, and institutional requirements. A final decision has not yet been made.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ricardo T Gazzinelli, DVM, PhD study chair
Vaccine Technology Center (CT Vacinas)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vivaxin vaccine manufactured by CT Vacinas/Cristália Laboratory in people with Malaria Vivax, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helton C Santiago, MD, MSc, PhD (+55 31 98256-5656, heltonsantiago@icb.ufmg.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and reactogenicity of adverse events (AE) in the first 14 days (time frame: Day 14 after each immunization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.