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Candidate Plasmodium falciparum malaria vaccine
This vaccine stimulates the immune system to recognize and attack Plasmodium falciparum parasites, primarily targeting the parasite's pre-erythrocytic and blood-stage antigens to prevent malaria infection and disease.
This vaccine stimulates the immune system to recognize and attack Plasmodium falciparum parasites, primarily targeting the parasite's pre-erythrocytic and blood-stage antigens to prevent malaria infection and disease. Used for Plasmodium falciparum malaria prevention in endemic populations, Malaria prevention in children and infants in sub-Saharan Africa.
At a glance
| Generic name | Candidate Plasmodium falciparum malaria vaccine |
|---|---|
| Also known as | GSK Biologicals' candidate Plasmodium falciparum malaria vaccine adjuvanted with GSK Biologicals' proprietary Adjuvant System AS01E (RTS,S/AS01E) |
| Sponsor | GlaxoSmithKline |
| Drug class | Recombinant protein vaccine |
| Target | Plasmodium falciparum circumsporozoite protein (CSP) |
| Modality | Biologic |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains recombinant circumsporozoite protein (CSP) fused to hepatitis B surface antigen, combined with an AS01 adjuvant system that enhances immune response. It primes both cellular and humoral immunity against the malaria parasite, reducing parasitemia levels and clinical malaria episodes in vaccinated individuals.
Approved indications
- Plasmodium falciparum malaria prevention in endemic populations
- Malaria prevention in children and infants in sub-Saharan Africa
Common side effects
- Injection site pain or swelling
- Fever
- Fatigue
- Headache
- Myalgia
Key clinical trials
- First-in-Human PfSPZ-LARC2 Vaccination/CHMI (PHASE1)
- A Study to Assess the Experimental Malaria Vaccines RH5.2-VLP and R21 (PHASE1)
- A Challenge Study to Assess the Blood-stage Efficacy of Full-length SUM-101 Malaria Vaccine Candidate (PHASE1)
- A Study of the Plasmodium Falciparum Malaria Vaccine Candidate Pfs48/45 in Matrix-M Adjuvant in the UK (EARLY_PHASE1)
- A Study to Determine if New Types of Malaria Vaccines Are Safe, Effective and Lead to Immunity in Kenyan Adults (PHASE2)
- Study to Assess the Vaccine Efficacy Against Malaria Infection, in Children Immunized With the Primary and Yearly Booster of the RTS,S/AS01E Vaccine, as Part of Their Participation in the Malaria-094 (204889/NCT03276962) Study.
- Comparing Safety and Protective Efficacy of Vaccine Candidate PfSPZ-CVac and MVA ME-TRAP/ ChAd63 ME-TRAP in Adults (PHASE1, PHASE2)
- Safety and Immunogenicity of RH5.1/Matrix-M in Adults and Infants Living in Tanzania (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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