Clinical Trial to Evaluate the Safety and Immunogenicity of the Vivaxin Vaccine for Malaria Caused by Plasmodium Vivax."

NCT07172724 | Not Yet Recruiting Phase 1 DMC

• 4 other identifiers: Vivaxin-001U1111-1321-756089852825.0.0000.04447.783.109
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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 infection

Conditions

Malaria Vivax

Keywords

vaccine; malaria; Plasmodium vivax; prevention; malaria vivax

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  through study completion, an average of 18 months

• Dose selection

  Selection of a safe and immunogenic dose of Vivaxin to continue clinical development.

  Day 28 after the third dose of the vaccine of all participants

Secondary Outcomes (1)

• Levels of IgG antibodies

  Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 120, 180, 270 and 360 after immunization

Other Outcomes (4)

• Levels of IgM, IgG1, IgG2, IgG3, IgG4 and IgA against vaccine and parasitic antigens

  Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 120, 180, 270 and 360 after immunization

• Observe the multifunctional cellular immune response by evaluating the quality and frequency of CD4+ and CD8+ T lymphocytes in response to vaccine and parasite antigens

  Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 120, 180, 270 and 360 after immunization

• Levels of IFNγ and other cytokines

  Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 120, 180, 270 and 360 after immunization

Study Arms (4)

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.

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.

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.

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.

Other: Placebo

Interventions

Vivaxin vaccine manufactured by CT Vacinas/Cristália Laboratory BIOLOGICAL

lyophilized antigen for reconstitution with the adjuvant CTVad (a squalene-based nanoemulsion), at the time of use.

Arm 1 - 25 µg of Vivaxin; Arm 2 - 50 µg of Vivaxin; Arm 3 - 100 µg of Vivaxin

Placebo OTHER

adjuvant CTVad (a squalene-based nanoemulsion)

Placebo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• University of Sao Paulo: collaborator
• Financiadora de Estudos e Projetos: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• INCTV National Institute of Vaccine Science and Technology: collaborator
• The Ministry of Science, Technology and Innovation, Brazil: collaborator
• CT Vacinas - Centro de Tecnologia em Vacinas/Universidade Federal de Minas Gerais: collaborator

Study Sites (1)

Centro de Pesquisas Clínicas (CPC) do Hospital das Clínicas (HC) da UFMG/ Filial Ebserh

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

Related Links

• World Malaria Report 2024
• Malaria Day in the Americas - an overview of malaria in Brazil in 2022 and the first half of 2023

MeSH Terms

Conditions

Malaria, Vivax; Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Ricardo T Gazzinelli, DVM, PhD

  Vaccine Technology Center (CT Vacinas)

  STUDY CHAIR

Central Study Contacts

Helton C Santiago, MD, MSc, PhD

CONTACT

+55 31 98256-5656; heltonsantiago@icb.ufmg.br

Mariana A Faria Lima, MD, MSc

CONTACT

+55 31 99292-0207; mariana.antunes@ebserh.gov.br

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 15, 2025
• Study Start: September 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

BR (1)