PfSPZ-LARC2 Vaccine for Malaria
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new malaria vaccine to determine its safety and effectiveness in preventing malaria infections. The vaccine uses a weakened version of the malaria parasite, aiming to trigger a strong immune response without causing the disease. Participants will be randomly assigned to receive either the PfSPZ-LARC2 Vaccine or a placebo (a shot with no active ingredients) for comparison. The trial seeks healthy adults between 18 and 45 years old who have never had malaria or participated in a malaria vaccine study. As a Phase 1 trial, the 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 that you must stop taking your current medications. However, you cannot use certain medications that have anti-malarial activity or those that interact with the trial drugs. It's best to discuss your specific medications with the trial team to ensure they don't pose any issues.
Is there any evidence suggesting that the PfSPZ-LARC2 Vaccine is likely to be safe for humans?
A previous study showed that the PfSPZ-LARC2 Vaccine is safe for adults. The vaccine was fully weakened, rendering it harmless, and did not cause any malaria infections. Some participants experienced moderate side effects after the second dose, possibly due to the vaccine. These findings suggest the vaccine is generally well-tolerated. However, as this is a Phase 1 trial, the primary goal is to assess safety, and further research will provide clearer information.12345
Why do researchers think this study treatment might be promising?
Unlike standard malaria treatments that typically involve antimalarial drugs like chloroquine or artemisinin-based therapies, the PfSPZ-LARC2 vaccine is unique because it targets the malaria-causing Plasmodium falciparum sporozoites directly. This vaccine uses a live, attenuated version of the parasite to stimulate a strong immune response, potentially offering long-lasting immunity after just a few doses. Researchers are excited because it could significantly reduce the risk of infection in malaria-naïve individuals, providing a proactive approach to malaria prevention rather than a reactive treatment after infection occurs.
What evidence suggests that the PfSPZ-LARC2 Vaccine might be an effective treatment for malaria?
Studies have shown that the PfSPZ-LARC2 Vaccine, which participants in this trial may receive, shows promise for protecting against malaria. Early findings suggest that the vaccine is safe and does not cause malaria. Research on a similar PfSPZ vaccine showed it could provide up to 90% protection against malaria in a controlled study. This vaccine uses genetically altered malaria parasites that stop growing before they can cause illness. These early results are encouraging and support further testing to evaluate the vaccine's effectiveness.13678
Are You a Good Fit for This Trial?
This trial is for malaria-naïve adults aged 18-45 with a BMI of 18.0-35.0 kg/m^2. Participants must consent to study procedures, be available for visits, and use effective contraception if of childbearing potential. Pregnant women or those not using contraception are excluded.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Vaccination
Participants receive the PfSPZ-LARC2 vaccine or placebo on Days 1, 29, and 57
Controlled Human Malaria Infection (CHMI)
Participants undergo CHMI to measure protective efficacy compared to placebo
Follow-up
Participants are monitored for adverse events and evidence of blood-stage infection
What Are the Treatments Tested in This Trial?
Interventions
- PfSPZ-LARC2 Vaccine
Trial Overview
The trial tests the PfSPZ-LARC2 Vaccine's safety and effectiveness against malaria in humans. It involves genetically modified Plasmodium falciparum sporozoites administered intravenously, aiming to provide better immunity than previous vaccines.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Healthy malaria-naïve participants aged between 18 and 45 years will receive 2x10\^5 PfSPZ of Plasmodium falciparum sporozoite vaccine (PfSPZ-LARC2) vaccine on Days 1, 29, and 57 followed by 3.2x10\^3 PfSPZ Challenge (7G8) Controlled Human Malaria Infection (CHMI) on Day 141 administered by direct venous inoculation (DVI). Placebo participants that drop out prior to CHMI will be replaced with infectivity controls. Infectivity controls will receive PfSPZ Challenge (7G8) CHMI N=12
Healthy malaria-naïve participants aged between 18 and 45 years will receive 2x10\^5 PfSPZ of Plasmodium falciparum sporozoite vaccine (PfSPZ-LARC2) vaccine on Days 1, 29, and 57 followed by 3.2x10\^3 PfSPZ Challenge (7G8) Controlled Human Malaria Infection (CHMI) on Day 169 administered by direct venous inoculation (DVI). Placebo participants that drop out prior to CHMI will be replaced with infectivity controls. Infectivity controls will receive PfSPZ Challenge (7G8) CHMI N=3
Healthy malaria-naïve participants aged between 18 and 45 years will receive saline placebo on Days 1, 29, and 57 followed by 3.2x10\^3 PfSPZ Challenge (7G8) Controlled Human Malaria Infection (CHMI) on Day 169 administered by direct venous inoculation (DVI). Placebo participants that drop out prior to CHMI will be replaced with infectivity controls. Infectivity controls will receive PfSPZ Challenge (7G8) CHMI N=1
Healthy malaria-naïve adult participants with no prior history of malaria vaccine study involvement and no exposure to Plasmodium parasites in the past two years, aged between 18 and 45 years will receive saline placebo on Days 1, 29, and 57 followed by 3.2x10\^3 PfSPZ Challenge (7G8) Controlled Human Malaria Infection (CHMI) on Day 141 administered by direct venous inoculation (DVI). Placebo participants that drop out prior to CHMI will be replaced with infectivity controls. Infectivity controls will receive PfSPZ Challenge (7G8) CHMI N=6
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
Citations
Sanaria Reports Positive Initial Safety Results for ...
Crucially, the initial data in adults confirmed the vaccine was safe, fully attenuated, and caused no malaria infections. Why PfSPZ-LARC2 ...
2.
clinicaltrials.gov
clinicaltrials.gov/study/NCT06862453?term=vaccine%20paracetamol%20ibuprofen&viewType=Table&rank=5Safety, Tolerability and Efficacy Against Controlled Human ...
Safety, Tolerability and Efficacy Against Controlled Human Malaria Infection of PfSPZ-LARC2 Vaccine in Malaria-naïve Adults (LARC-Tu) · Study Overview · Contacts ...
a randomised, double-blind, placebo-controlled, phase 2 trial
Data from malaria-endemic countries show that PfSPZ Vaccine is safe and well tolerated in infants, children, and adults (age range 5 months ...
Progressing PfSPZ vaccines for malaria to licensure and ...
The RTS,S/AS01 malaria vaccine, recommended in 2021 by WHO for use in young children, has limited efficacy in preventing malaria hospitalizations (21%) and ...
5.
pharmacytimes.com
pharmacytimes.com/view/single-dose-malaria-vaccine-demonstrates-90-efficacy-in-early-trialsSingle-Dose Malaria Vaccine Demonstrates 90% Efficacy ...
Data from a new study showed the vaccine provided 90% protection against controlled human malaria infection after a single injection.
Safety, tolerability and immunogenicity of a condensed ...
Green datapoints signify the four participants with possible vaccine-induced Grade 2 adverse reactions after the second dose of PfSPZ Vaccine.
Safety, tolerability, and protective efficacy of a radiation ...
Data from malaria-endemic countries show that PfSPZ Vaccine is safe and well tolerated in infants, children, and adults (age range 5 months ...
8.
malariaworld.org
malariaworld.org/news/sanaria-reports-positive-initial-safety-results-for-groundbreaking-pf-spz-larc-2-malaria-vaccineSanaria reports positive initial safety results for ...
Crucially, the initial data in adults confirmed the vaccine was safe, fully attenuated, and caused no malaria infections. Read more. Read more.
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