Pvs230D1-EPA/Matrix-M Vaccine for Malaria

Overseen By Joel A Goldberg, M.D.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Immunosuppressants, others

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 23

Duration: 2 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new malaria vaccine designed to prevent the spread of malaria, a mosquito-borne disease that causes symptoms like fever and weakness. Researchers will monitor healthy adults after they receive the vaccine injections to evaluate its performance. Participants will be divided into three groups to receive different doses of the vaccine. Healthy adults who have not traveled to malaria-risk areas and have not had malaria in the last 10 years are suitable candidates for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on chronic systemic immunosuppressive medications, you may need to stop them at least 6 months before starting the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Pvs230D1-EPA/Matrix-M vaccine for malaria has not raised any safety concerns in earlier studies. For instance, a study in rabbits found no safety issues with this vaccine. This suggests the vaccine is well-tolerated in animals, which is a positive sign for its use in humans.

Additionally, previous studies with human volunteers tested similar vaccines and reported generally positive safety results. Participants in these studies did not experience serious side effects, indicating the vaccine may be safe for humans. It's important to remember that this vaccine is still being tested, so researchers are closely monitoring its safety.

The trial under consideration is in an early stage, focusing primarily on assessing safety. This is a crucial part of any clinical trial. The fact that this trial is happening indicates there is enough evidence to suggest the treatment is safe enough to test in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Pvs230D1-EPA/Matrix-M vaccine for malaria because it targets a specific part of the malaria parasite's lifecycle, aiming to block the transmission of the disease. Unlike standard treatments, which typically involve antimalarial drugs to treat the infection or prevent it, this vaccine works by priming the immune system to stop the parasite from spreading through mosquitoes. This innovative approach could complement existing methods by potentially reducing malaria transmission rates more effectively. Additionally, the vaccine combines the Pvs230D1-EPA protein with the Matrix-M adjuvant, which boosts the body's immune response, potentially leading to more robust protection.

What evidence suggests that the Pvs230D1-EPA/Matrix-M vaccine might be an effective treatment for malaria?

Research shows that the Pvs230D1-EPA/Matrix-M vaccine, administered in varying dosages to trial participants, could effectively prevent malaria. It stops the malaria parasite from spreading in mosquitoes. Studies have found that similar vaccines, such as Pfs230D1M, are strong candidates for preventing malaria transmission. Currently, Pfs230D1-EPA is a leading option for blocking transmission. This vaccine type focuses on stopping the disease from spreading, rather than treating symptoms in those already infected. ^{4 5 6 7 8}

Who Is on the Research Team?

Joel A Goldberg, M.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

Are You a Good Fit for This Trial?

Healthy adults aged 18-50 who can consent to the study, understand it well, and have reliable access to NIHCC for visits. They must agree to use contraception and not donate blood during the trial. Excluded are pregnant or breastfeeding individuals, those with certain medical conditions or treatments that affect immune function, and anyone planning travel to malaria-endemic areas.

Inclusion Criteria

Individuals of childbearing potential must agree to use an acceptable method of contraception from 1 month prior to enrollment to 1 month after the final vaccination (i.e., from study day -28 until study day 84)

Willing to refrain from donating blood throughout the study until 1 month after the last study visit

Individuals capable of fathering children must agree to use an acceptable method of contraception from 1 month prior to enrollment to 1 month after the final vaccination (i.e., from study day -28 until study day 84)

Exclusion Criteria

Currently pregnant as determined by history or a positive human choriogonadotropin (Beta-hCG) test

I haven't taken strong immune system suppressing drugs for more than 2 weeks in the last 6 months.

Any other finding that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a subject s ability to give informed consent, or increase the risk of having an adverse outcome from participating in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive three doses of the vaccine at 1-month intervals

2 months

3 visits (in-person)

Monitoring

Participants have 12 additional clinic visits for monitoring, including physical exams and blood tests

8 months

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up phone calls

12 months

7 follow-up phone calls

What Are the Treatments Tested in This Trial?

Interventions

• Pvs230D1-EPA/Matrix-M

Trial Overview The trial is testing a new vaccine called Pvs230D1-EPA/Matrix-M designed to prevent the spread of malaria. Participants will receive three injections over several months and attend multiple clinic visits for health checks without being exposed to malaria.

How Is the Trial Designed?

Group I: Group 3 Experimental Treatment 1 Intervention

50 (micro)g Pvs230D1-EPA/50 (micro)g MM

Group II: Group 2 Experimental Treatment 1 Intervention

25 (micro)g Pvs230D1-EPA/50 (micro)g MM

Group III: Group 1 Experimental Treatment 1 Intervention

5 (micro)g Pvs230D1-EPA/50 (micro)g MM

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0264410X24013781

Distinct immunogenicity outcomes of DNA vaccines ... Our results demonstrate the potential of both Pfs230D1M and Pvs230D1 DNA vaccines as TBV candidates against P. falciparum and P. vivax.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05135273?tab=results

NCT05135273 | Study of the Transmission-Blocking ... Study of the Transmission-Blocking Vaccine Pfs230D1-EPA/​Matrix-M Against Malaria in Adults in Mali ... Efficacy of a low-dose candidate malaria vaccine, R21 in ...

3. withpower.com withpower.com/trial/phase-1-malaria-6-2023-5b468

Pvs230D1-EPA/Matrix-M Vaccine for Malaria The Pvs230D1-EPA/Matrix-M treatment is unique because it targets the sexual stage of the malaria parasite in mosquitoes, aiming to block transmission rather ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10615700/

A randomized controlled phase 1 trial of malaria ... Pfs230D1-EPA is now the leading malaria transmission-blocking vaccine candidate. Both Pfs230D1-EPA and Pfs25-EPA candidates are safe and can be ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/14760584.2025.2517720

Full article: Advances in transmission-blocking vaccines ... Safety and efficacy of malaria vaccine candidate R21/Matrix-M in African children: a multicentre, double-blind, randomised, phase 3 trial. Lancet. 2024;403 ...

6. reporter.nih.gov reporter.nih.gov/project-details/11189451

Malaria Vaccines: Pvs230D1-EPA and PvCSP A GLP rabbit toxicology study was completed in Q2 2021 with conjugated Pvs230D1M-EPA/Matrix-M; no safety concerns were observed. Pooled antiserum obtained from ...

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/results/NCT05135273

NCT05135273 | Study of the Transmission-Blocking ... Study of the Transmission-Blocking Vaccine Pfs230D1-EPA/​Matrix-M Against Malaria in Adults in Mali ... malaria transmission-blocking vaccine target antigens ...

8. mesamalaria.org mesamalaria.org/mesa-track/safety-immunogenicity-and-transmission-blocking-activity-of-p-vivax-vaccine-pvs230d1-epa-matrix-m-in-health-malaria-naive-adults/

Safety, immunogenicity, and transmission-blocking activity of ... vivax vaccine Pvs230D1-EPA/Matrix-M in health malaria-naïve adults. Objectives. The aim of this study is to test the effects of a new malaria vaccine.